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Study Objectives This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162. Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days. Conditions: Advanced Solid Tumors, Selected Solid Tumors Intervention / Treatment: DRUG: BKM120 + MEK162 Location: Germany, United States, Spain, Singapore, Netherlands, Canada, Switzerland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically/ cytologically confirmed, advanced non resectable solid tumors * Measurable or non-measurable, but evaluable disease as determined by RECIST Exclusion Criteria: * Patients with primary CNS tumor or CNS tumor involvement. * Diabetes mellitus * Unacceptable ocular/retinal conditions

NCT_ID NCT01363232

Study_NameSafety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients

Study Objectives RATIONALE: Pomalidomide and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pomalidomide and bortezomib together with dexamethasone may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with pomalidomide and dexamethasone and to see how well it works in treating patients with relapsed or refractory multiple myeloma. Conditions: Refractory Multiple Myeloma Intervention / Treatment: DRUG: pomalidomide, DRUG: bortezomib, DRUG: dexamethasone, OTHER: laboratory biomarker analysis, OTHER: gene expression analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Serum Creatinine =< 3 mg/dL * Absolute neutrophil count >= 1000/uL * Platelet count >= 75,000/uL * Measurable disease of multiple myeloma as defined by at least ONE of the following: * serum monoclonal protein >= 1.0 g/dL * > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis * serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio * monoclonal bone marrow plasmacytosis >= 30% (evaluable disease) * measurable plasmacytoma that has not been radiated * ECOG Performance status (PS) 0, 1, or 2 * Previously treated relapsed or refractory multiple myeloma * Patients must have received at least one prior therapy but no more than 4 therapies. * one or more of the prior regimens must have included lenalidomide and it has been determined the patient is refractory, resistant, or relapsed this therapy * prior bortezomib not required but if prior exposure, patients should not be refractory (Refractory means progression on therapy or within 60 days from the last dose of bortezomib.) * Provide informed written consent * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide; FCBP must also agree to ongoing pregnancy testing * Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy * All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure * Willing and able to take aspirin or alternate prophylactic anticoagulation * All previous cancer therapy, including chemotherapy, high dose corticosteroids, immune modulatory drugs or proteosome inhibitors must have been discontinued >= 2 weeks prior to study registration * Any prior treatment with investigational agents must be discontinued >= 28 days prior to study registration * Willing to abstain from donating blood during study participation and for 28 days after discontinuation of study drug * Men must agree to abstain from donating semen or sperm during study participation and for 28 days after discontinuation of study drug * Willingness to return to enrolling institution for follow-up Exclusion Criteria: * Concomitant high dose corticosteroids (concurrent use of corticosteroids); EXCEPTION: Patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than myeloma, i.e., adrenal insufficiency, rheumatoid arthritis, etc * Another malignancy undergoing active treatment with the exception of non melanoma skin cancer or in situ cervical or breast cancer * Pregnant women or women of reproductive ability who are unwilling to use effective contraception * Nursing women * Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment * Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease * Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational: NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment * Active DVT or PE that has not been therapeutically anticoagulated * Known positive for HIV or active hepatitis infection * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * Known hypersensitivity to thalidomide or lenalidomide including development of erythema nodosum if characterized by a desquamating rash * > grade 2 peripheral neuropathy * Any prior use of pomalidomide

NCT_ID NCT01212952

Study_NamePomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Study Objectives This is an open-label, Phase I, dose-escalation study using a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered QD. This study will include patients with locally advanced or metastatic solid tumors, NHL, or multiple myeloma (MM) (expansion stage only) for which standard therapy either does not exist or has proven ineffective or intolerable. Conditions: Non-Hodgkin's Lymphoma, Solid Cancers Intervention / Treatment: DRUG: GDC-0941 Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically documented, incurable, locally advanced or metastatic solid malignancy or NHL without leukemic phase that has progressed or has failed to respond to at least one prior regimen * Multiple myeloma (MM) patients (only in Stage 2): documented pathologic diagnosis of MM that has relapsed or that has failed to respond after treatment with at least one prior systemic therapy (other than corticosteroid monotherapy) * Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) or per International Working Group (IWG) response criteria for Non-Hodgkin's lymphoma (NHL) patients * Life expectancy of >= 12 weeks * Documented willingness to use an effective means of contraception for both men and women while participating in the study * For patients participating in Stage 1 after an adequate exposure has been predicted or observed on the basis of PK analysis and for approximately 12 patients participating in Stage 2 (excluding patients with MM): A biopsy-accessible lesion from which tissue can be obtained safely with CT guidance or direct visualization and agreement from the patient to undergo sequential (pre-treatment and post-treatment) biopsies. * For patients participating in Stage 2 DCE-MRI and MRS imaging: Patients will have at least one metastatic liver lesion measuring >= 5 cm in one dimension or one tumor lesion elsewhere measuring >= 2 cm in one dimension (lung and mediastinum lesions do not qualify) on the basis of CT scans Exclusion Criteria: * Leptomeningeal disease as the only manifestation of the current malignancy * History of Type 1 or 2 diabetes mellitus requiring regular medication * Any condition requiring anti-coagulants, such as warfarin, heparin, or thrombolytics * Inability or unwillingness to swallow pills * Malabsorption syndrome or other condition that would interfere with enteral absorption * Known untreated CNS malignancies or treated brain metastases that are not radiographically stable for >= 3 months * Congenital long QT syndrome or QTc > 500 msec, as determined by at least two of the three baseline ECG measurements * Active congestive heart failure or ventricular arrhythmia requiring medication * Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment * Active infection requiring intravenous (IV) antibiotics * Patients requiring any daily supplemental oxygen * DLco, 50% predicted value corrected for AV and Hgb prior to initiation of study treatment * Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal (LLN) or hypercalcemia above the ULN for the institution despite adequate electrolyte supplementation or management * Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis * Known human immunodeficiency virus (HIV) infection * Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications * Significant traumatic injury within 3 weeks before Day 1 * Major surgical procedure within 4 weeks prior to initiation of study treatment * Prior allogeneic hematopoietic stem cell transplantation (HSCT) at any time or autologous HSCT within 12 weeks of study entry * Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment (exceptions are kinase inhibitors that are approved by the local regulatory authorities, which may be used within 2 weeks prior to initiation of study treatment, provided that any drug-related toxicity has completely resolved and after approval by the Medical Monitor has been granted) * Palliative radiation to bony metastases within 2 weeks prior to initiation of study treatment * Need for chronic corticosteroid therapy * Treatment with an investigational agent within 4 weeks prior to initiation of study treatment * Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy * Pregnancy or lactation * Inability to comply with study and follow-up procedures * For patients eligible to participate in Stage 2 DCE-MRI and MRS assessments, any contraindication to MRI examination, including the following: Imbedded metallic material/devices (metal implants or large tattoos in the field of view) Severe claustrophobia Physical characteristics (weight or size) that exceed the capabilities of the MRI scanner Known allergy or hypersensitivity reactions to gadolinium, verse

NCT_ID NCT00876122

Study_NameA Study of GDC-0941 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable

Study Objectives In this pilot study, eligible patients will be treated with 5 days of low dose daunorubicin for one cycle only. Any patient who receives treatment on this protocol will be evaluable for toxicity. Each patient will be assessed for the development of toxicity at all scheduled visits (Days 1-5). Following participation on this brief pharmacodynamic trial, patients can then proceed to other conventional or investigational therapies, as clinically indicated. Conditions: Acute Lymphocytic Leukemia, Acute Myeloid Leukemia Intervention / Treatment: DRUG: Daunorubicin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent or have parental consent. * Age >= 18 years * Pathological confirmation by bone marrow documenting the following: 1. AML which has relapsed after Complete Remission 2. AML which has been refractory to two prior induction attempts 3. ALL which has relapsed after Complete Remission 4. ALL which has been refractory to two prior induction attempts * Disease status allows delay of additional anti-leukemia therapy for the duration of the study (hydroxyurea is allowed for control of WBC throughout study) * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 <= age <= 3 * Able to adhere to the study visit schedule and other protocol requirements * Cardiac ejection fraction >=45% by ECHO * Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN * Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Exclusion Criteria: * Concurrent use of conventional or investigational anticancer agents, except hydroxyurea (Standard prophylactic anti-infectives and medications to prevent/treat tumor lysis syndrome are allowed. Hydroxyurea may be used to keep the WBC<25,000. Additional anti-leukemia therapy is prohibited during the study.). * Patient has received chemotherapy or radiotherapy within 2 weeks prior to entering the study or has not recovered from adverse events due to agents administered more than 2 weeks earlier, with the exception of hydroxyurea. * Patients with known active uncontrolled central nervous system (CNS) leukemia * History of allergic reactions attributed to compounds of similar chemical or biologic composition to daunorubicin * Patients with a total lifetime anthracycline exposure exceeding the equivalent of 900 mg/m2 of daunorubicin * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Unwilling or unable to undergo serial bone marrow aspirate/biopsy * Pregnant or nursing

NCT_ID NCT02914977

Study_NameLow-Dose Daunorubicin in Relapsed/Refractory Acute Leukemia

Study Objectives Primary Objectives: To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in patients with solid tumors. To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors. Secondary Objectives: To characterize the pharmacokinetic profile of SAR405838 and pimasertib. To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib. To characterize genetic status in tumor tissue and circulating tumor DNA. Conditions: Neoplasm Malignant Intervention / Treatment: DRUG: SAR405838, DRUG: Pimasertib Location: France, Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Histologically or cytologically confirmed diagnosis of a solid tumor. * Presence of locally advanced or metastatic disease with at least one measurable lesion. * Ability to provide written informed consent. Evidence of a personally signed informed consent. Exclusion criteria: * Age <18 years. * Eastern Cooperative Oncology Group performance status of >1. * Inadequate functions of bone marrow, liver, and kidney. * Positive pregnancy test in women of child-bearing potential. * Pregnancy or breast-feeding. * Extensive prior radiotherapy. * The patient has retinal degenerative disease, history of uveitis, or history of retinal vein occlusion, or history of retinal detachment, or has medically relevant abnormalities identified on screening ophthalmologic examination. * Prior history of myositis or rhabdomyolysis. * Recent major surgery or trauma, unhealing/open wounds. * The patient has had congestive heart failure, unstable angina, a myocardial infarction, cardiac conduction abnormality or pacemaker or a stroke within 3 months of entering the study. * The patient has a baseline corrected QT interval (QTc) >480 ms or left ventricular ejection fraction (LVEF) <50% or less than the lower limit of normal. * The patient has a previously-identified allergy or hypersensitivity to components of the study treatment formulations. * Unwillingness or inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions. * Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods. * Recent history of acute pancreatitis. * Clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that could affect the safety of the patient; alter the absorption of the study drugs; or impair the assessment of study results. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

NCT_ID NCT01985191

Study_NameA Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients

Study Objectives This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. This study will also make a preliminary assessment of the anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI regimen plus bevacizumab. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: bevacizumab, DRUG: cetuximab, DRUG: FOLFIRI regimen, DRUG: irinotecan, DRUG: PRO95780 Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Signed informed consent * Age >= 18 years * Histologically confirmed CRC with evidence of metastases and measurable tumor lesions * Documented disease progression following, or intolerance to, treatment with 5-fluorouracil, oxaliplatin, and bevacizumab-based therapy * Life expectancy > 3 months * For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 6 months following their final exposure to study treatment * Willingness and capability to be accessible for study follow-up Exclusion Criteria: * Patients who have a Kras mutation will be excluded from receiving cetuximab-containing regimens * Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy * Recent radiotherapy to a peripheral lesion, thoracic, abdominal, or pelvic field * Recent chemotherapy, hormonal therapy, or immunotherapy * Evidence of clinically detectable ascites * Other invasive malignancies within 5 years * History or evidence of active central nervous system (CNS) disease * Current or recent participation in another experimental drug study * Clinically significant cardiovascular disease * Active infection requiring parenteral antibiotics * Recent major surgical procedure, open biopsy, significant traumatic injury, fine needle aspirations, or anticipation of need for major surgical procedure during the course of the study * Known or suspected to be positive for the human immunodeficiency virus (HIV) * Known to be positive for hepatitis C or hepatitis B surface antigen * History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or specified study treatment * Pregnancy (positive pregnancy test) or breast feeding * Serious, non-healing wound, ulcer, or bone fracture * Known sensitivity to any of the products administered during the study * Any disorder that compromises the ability of the patient to provide written informed consent and/or comply with study procedures

NCT_ID NCT00497497

Study_NameA Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)

Study Objectives This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea. Conditions: Genital Warts, Perianal Warts Intervention / Treatment: DRUG: Polyphenon E (Veregen) 15% ointment, OTHER: Green Tea Beverage with defined catechin content Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: For both subject groups (treatment arms 1 + 2): * Male and female subjects, 18 years or older at the time of enrollment. Subjects will be stratified by gender. * Written informed consent. * Ability to comply with the requirements of the study. For patients (treatment arm 1, additionally): * Clinical diagnosis of external genital and perianal warts which can be located: in men: over the glans penis, foreskin, penis shaft, and scrotum; in women: on the vulva; in both gender: in the inguinal, perineal, and perianal areas. * A total wart area of at least 100 mm² and a maximum of 2500 mm². * For women of child-bearing potential: negative pregnancy test and willingness to use two effective methods of contraception throughout their study participation is mandatory (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant, or sterilization (for contraception) plus condom (for prevention of reinfection). For male patients and partners of male patients who are of childbearing potential: use of two methods of effective contraception during the treatment period is mandatory (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant, or sterilization (for contraception) plus condom (for prevention of reinfection). Exclusion Criteria: For both subject groups (treatment arms 1 + 2): * Participation in an investigational trial within 30 days prior to enrollment and for the whole study duration. * Any current uncontrolled infection. * Current known acute or chronic infection with Hepatitis virus B or C. * Known Human immunodeficiency virus infection. * Subjects with known history of chronic (diabetes, hypertension, gastritis, etc.) or consuming diseases (cancer, multiple sclerosis, etc.), chronic inflammation, or liver or renal insufficiency. * Any chronic or acute condition including the skin, susceptible, in the opinion of the investigator, of interfering with the evaluation of the drug effect. * Laboratory data above the upper normal range. * Systemic intake of virostatics within 30 days prior to enrollment and for the whole study duration, with the exception of acyclovir and the related drugs famciclovir and valaciclovir. * Systemic intake of immunosuppressive or immuno-modulatory medication or vaccination within 30 days prior to enrollment and for the whole study duration. * Organ allograft recipient. * Medication intake, including over the counter products and dietary supplements such as iodine, fluoride, or vitamins, which would interfere with study results, except paracetamol and oral contraceptives, within one week before and during the study course. Subjects are not allowed to consume green, black or Oolong tea as well as red wine or any other beverages or foods containing green tea extract within three days before each blood sampling visit. * For female patients: pregnancy or lactation. * Blood transfusion within 30 days prior to enrollment. * Subjects who are placed in an institution due to a judicial or official directive. For patients (treatment arm 1, additionally): * Previous participation in a trial investigating sinecatechins in the treatment of external genital and perianal warts. * Treatment of external genital warts within 30 days prior to enrollment and for the whole study duration. * Current infection with Herpes genitalis or history of Herpes genitalis infection within the last 3 months prior to enrollment. * Any current and/or recurrent pathologically relevant genital infections other than genital warts. * Known allergies against any of the ingredients of the ointment.

NCT_ID NCT01082302

Study_NamePharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage

Study Objectives Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years, without vital organ dysfunction or ongoing graft-verus-host disease (GVHD). Number of subjects: 50, Single center, one group, prospective. Drug: pegylated interferon alpha-2b (Peg Intron®; Schering-Plough) 1\~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments. Conditions: Hematological Neoplasms, Recurrence Intervention / Treatment: DRUG: Peg interferon alfa-2b Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age 14 <= age <= 60 years, male or female * Allo-HSCT recipients with malignant hematological diseases * Disease relapse after allo-HSCT, including hematological relapse, molecular relapse * Able to provide written informed consent and to comply with all study procedures Exclusion Criteria: * Pregnant or nursing woman * Cardiac ejection factor < normal lower limit * Active acute or chronic GVHD with immunosuppressant treatment * Known hypersensitivity or allergy to interferon * Patient might develop serious complications according to investigator's experiences * Patient is undergoing other experimental medication

NCT_ID NCT02634294

Study_NamePeg Interferon α-2b for Relapsed Hematological Malignancies After Allo-HSCT

Study Objectives This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in combination with metronomic temozolomide in terms of progression-free survival. Conditions: Glioblastoma Multiforme Intervention / Treatment: DRUG: Bevacizumab, DRUG: Metronomic Temozolomide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically confirmed diagnosis of WHO grade IV primary malignant glioma * Karnofsy Performance Status (KPS) >= 60% * Evidence of measurable primary CNS neoplasm on contrast-enhanced MRI. * An interval of at least 4 weeks between prior surgical resection or 1 week from a biopsy and enrollment on this protocol * An interval of at least 4 weeks from the end of prior radiotherapy or one week from the end of a cycle of chemotherapy and enrollment on this protocol. * No evidence of CNS hemorrhage on the baseline MRI or CT scans Exclusion Criteria: * Life expectancy < 8 weeks * Pregnancy or breast feeding * Progression to metronomic temozolomide, defined as tumor progression while taking daily temozolomide or progression within 4 weeks of stopping metronomic temozolomide * Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)

NCT_ID NCT00501891

Study_NameBevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma

Study Objectives This study aimed to assess the efficacy and safety for biweekly TPF as induction chemotherapy for locally advanced head and neck cancer Conditions: Locally Advanced Head and Neck Carcinoma Intervention / Treatment: DRUG: docetaxel, cisplatin, fluorouracil Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The patient has histopathologically or cytologically confirmed diagnosis of stage 3 or 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx. * The patient has local advanced, and no distant metastatic, and unresectable disease. * The patient has measurable or valuable disease. 4 Age >= 20 years. * ECOG performance status 0, 1 or 2 at study entry. 6. Life expectancy >= 3 months. 7. The patient must have adequate organ function, defined as: 7a Absolute neutrophil count (ANC) >= 1.5 x 109/L; Platelets >= 100 x 109/L; Hemoglobin * 9.0 g/dL. 7b Total Bilirubin <= 1.5 times upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 x ULN. 7c Alkaline phosphatase <= 2.5 x ULN. 7d Serum creatinine <= 1 x ULN or creatinine clearance >= 60 mL/min/1.73 m2. 8. Signed informed consent. 9 Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment. Exclusion Criteria: * The patient had previous chemotherapy or radiotherapy for squamous cell carcinoma of head and neck. * The patient has uncontrolled disorder(s), serious illness or medical condition(s) is/are not be enrolled to study that be confirmed by investigator. * Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated and without evidence of recurrence for at least 3 years prior to the study. * Peripheral neuropathy > Grade 2. * The patient is pregnant or breastfeeding.

NCT_ID NCT04397341

Study_NameBiweekly TPF Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of Head and Neck

Study Objectives Dexmedetomidine is a selective α2 adrenergic agonist that can be considered analgesics, anxiolytic,and anti-stress effect . This randomized, double-blind placebo-controlled trial of intraoperative dexmedetomidine for improvement of quality of recovery and analgesia from surgery. Patients scheduled to undergo video-assisted thoracoscopic surgery (VATS) will be enrolled. Patients will be recruited before the date of their surgery and will complete the Quality of Recovery-40 (QoR-40) questionnaire before their surgery and at 24 and 48 hours post op. They will also complete clinically significant pains score and oxygenation from the postanesthetic recovery unit (PACU). Conditions: Lung Cancer, Video-assisted Thoracoscopic Surgery Intervention / Treatment: DRUG: Dexmedetomidine, DRUG: Normal saline Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * The inclusion criteria included patients scheduled video-assisted thoracoscopic surgery for lung cancer * Adults above 20 years and providing informed consent. * American Society of Anesthesiologists (ASA) Physical class II, & III patients Exclusion Criteria: * severe functional liver or kidney disease * history of chronic pain requiring opioid treatment * arrhythmia or received treatment with antiarrythmic drug . * severe bradycardia (HR < 45 bpm) and AV block * pathologic esophageal lesion (esophageal stricture or varix ) * pregnancy * psychiatric/central nervous system disturbance that would preclude completion of the QoR-40 questionnaire * History of alcohol or drug abuse

NCT_ID NCT02537249

Study_NameEffects of Dexmedetomidine on Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery

Study Objectives The goal of this phase I clinical study is to find the highest safe dose of gemcitabine and CT-2103 that can be given in combination for the treatment of metastatic breast cancer. The safety and effectiveness of this combination will also be studied. This clinical trial will be offered to patients who are being considered for treatment with gemcitabine. Research lab samples and research biopsies will not be requested as part of this study. Conditions: Metastatic Breast Cancer, Breast Cancer Intervention / Treatment: DRUG: CT-2103, DRUG: Gemcitabine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically confirmed breast cancer that is either metastatic or unresectable. * Patients must have received anthracyclines as treatment of either early stage or metastatic breast cancer. * Previous taxane therapy is allowed. * Age >= 18 years. There is limited data regarding the use of CT-2103 in children under 18 and they will be excluded from this combination dose finding study. * Eastern Cooperative Oncology Group (ECOG) performance status <= 2 (Karnofsky >= 60%). * Measurable disease is not required. * Previous endocrine therapies are allowed but should be discontinued prior to initiation of therapy. * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy. * The effects of CT-2103 on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Females of childbearing potential are defined as females who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 months. * Patients must have normal organ and marrow function as defined below: leukocytes >= 3,000/ul; absolute neutrophil count >= 1,500/ul; platelets >= 100,000/ul; total bilirubin within normal institutional limits; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) <= 2.5 * institutional upper limit of normal; creatinine within normal institutional limits or creatinine clearance >= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal; coagulation prothrombin time (PT) and Partial thromboplastin time (PTT) within normal limits unless patients are already anti-coagulated for other reasons (i.e., atrial fibrillation, etc.). * Patients with Her-2/neu positive tumors should have received prior trastuzumab if clinically appropriate. Exclusion Criteria: * Patients with preexisting neuropathy >= grade 2. * Patients may not be receiving any other investigational agents. * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to CT-2103, gemcitabine or other agents used in study. History of typical paclitaxel- or docetaxel-induced Grade 1 <= age <= 2 hypersensitivity reactions is permitted. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study. * Previous history of stem cell transplantation. * History of central nervous system metastases. * While there is no strict exclusion based upon previous number of therapies, patients who experienced grade 3 or 4 hematologic toxicity requiring the use of white blood count (WBC) growth factor support during their most recent chemotherapy prior to enrollment are excluded. Exceptions to this would include patients who received growth factor support as mandated by a clinical study, and/or patients who have been off all chemotherapy for at least 6 months.

NCT_ID NCT00270907

Study_NameCT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer

Study Objectives The objective of this research work is two-fold: (i) to conduct a systematic literature review to identify surrogate endpoints in this specific drug class (review registered in the PROSPERO database) and (ii) to assess the surrogate properties of candidate surrogate endpoints in the specific context of melanoma cancer. Conditions: Cancer Treated With Immune-checkpoint Inhibitors Intervention / Treatment: DRUG: Immune checkpoint inhibitor Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients included in phase III randomized clinical trials (RCT) * Metastatic melanoma Exclusion Criteria: * N/A

NCT_ID NCT03963518

Study_NameImmune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)

Study Objectives Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy. Conditions: Neoplasms Intervention / Treatment: DRUG: BI 2536 Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment * Evaluable tumour deposits * Age >= 18 years * Life expectancy of at least six months * Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation * Eastern Cooperative Oncology Group (ECOG) performance score <= 2 * Full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies Exclusion Criteria: * Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol * Pregnancy or breastfeeding * Active infectious disease * Known brain metastases * Second malignancy requiring therapy * Absolute neutrophil count less than 1500/mm3 * Platelet count less than 100 000/mm3 * Bilirubin greater than 1.5 mg/dl (> 26 μmol/L) * Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) * Serum creatinine greater than 1.5 mg/dl (> 132 μmol/L) * Women and men who are sexually active and unwilling to use a medically acceptable method of contraception * Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)

NCT_ID NCT02211859

Study_NameDose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

Study Objectives The purpose of this study is to determine in a randomized, placebo-controlled, phase II trial if the combination of sulindac and erlotinib causes a significant regression of duodenal and colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP (AFAP) patients. Conditions: Adenomatous Polyposis Coli Intervention / Treatment: DRUG: Erlotinib, DRUG: Sulindac, DRUG: Placebo A, DRUG: Placebo B Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Patients who are >= 18 years with a clinical or genetic diagnosis of FAP or attenuated FAP. * Presence of duodenal polyps with a sum of diameters >= 5mm. * Minimum of two weeks since any major surgery * WHO performance status <=1 * Adequate bone marrow function as show by: normal leukocyte count, platelet count >= 120 x 109/L, Hgb > 12 g/dL * Adequate liver function as shown by: normal serum bilirubin(<= 1.5 Upper Limit Normal {ULN}) and serum transaminases (<= 2.0 ULN) * Patient must discontinue taking any Nonsteroidal anti-inflammatory drugs (NSAIDS) within one month of treatment initiation. * Patients must be able to provide written informed consent. Exclusion Criteria: * Prior treatment with any investigational drug within the preceding 4 weeks. * Malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skins. * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study as determined by the Principal Investigator such as: 1. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction <= 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia 2. Severely impaired lung function 3. Any active (acute or chronic) or uncontrolled infection/ disorders. 4. Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy 5. Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis * Screening clinical laboratory values that indicate any of the following: 1. anemia 2. thrombocytopenia 3. leucopenia 4. elevations of transaminases greater than 2X ULN 5. elevation of bilirubin > 1.5 X ULN 6. alkaline phosphatase elevation > 1.5 X ULN 7. increased creatinine, urinary protein, or urinary casts outside the clinically normal range. * Gastrointestinal bleeding (symptoms including dyspnea, fatigue, angina, weakness, malaise, melena, hematochezia, hematemesis, anemia or abdominal pain will require clinical assessment to rule out gastrointestinal bleeding). * Patient who is currently taking any anti-coagulation medication. * Women who are pregnant or breast feeding. * Patients with a known hypersensitivity to sulindac or erlotinib or to their excipients

NCT_ID NCT01187901

Study_NameA Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients

Study Objectives The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with uterine fibroids. Conditions: Uterine Fibroids Intervention / Treatment: DRUG: Leuprorelin (GF), DRUG: Leuprorelin (GC) Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Female patients with measurable uterine fibroids confirmed by vaginal or abdominal ultrasound, deemed otherwise healthy. * A body mass index in the range 18 to 28. * Oestradiol, progesterone, luteinizing hormone and follicle stimulating hormone results within the range of normal ovarian function. * Regular menstruation (except for symptoms of fibroids). * Females of childbearing potential who are sexually active must agree to use barrier contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. Exclusion Criteria: * Acute pelvioperitonitis, ovarian cysts, persistent corpus luteum. * History of bilateral oophorectomy, hysterectomy, or hypophysectomy. * Clinically relevant abnormal history, physical findings, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the patient. * Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the patient participation in the study or make it unnecessarily hazardous. * Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness. * Presence or history of severe adverse reaction to any drug. * Participation in other clinical studies of a new chemical entity or a prescription medicine within the previous 3 months. * Presence or history of drug or alcohol abuse, or smoking of more than 10 cigarettes daily. * Evidence of drug abuse on urine testing. * Positive test for hepatitis B, hepatitis C, human immune deficiency virus 1 or human immune deficiency virus 2. * Severe bleedings from fibroids. * Anemia (hemoglobin less than 11 g/dL), loss of more than 400 mL blood during the 3 months before the study. * Use of oral contraceptives or other estrogen containing medication, progestins, danazol, progesterone antagonists, antiandrogens, steroids or gonadotropins which might affect sex steroid production or activity or assay (e.g. norethindrone) within 30 days prior to study enrolment.

NCT_ID NCT00776074

Study_NameA Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.

Study Objectives This phase II trial studies the side effects and how well letrozole and imatinib mesylate work in treating postmenopausal participants with estrogen or progesterone positive breast cancer that has spread to other places in the body. Letrozole is an antihormonal drug used in the standard treatment of hormonal sensitive breast cancer. Imatinib mesylate is a drug that binds to certain proteins on the tumor cells and prevents them from further growth. Imatinib mesylate is thought to prevent the potential resistance to letrozole, which may make the letrozole more effective. Giving letrozole and imatinib mesylate may work better in treating participants with breast cancer. Conditions: Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, KIT Positive, PDGFR Positive, Postmenopausal, Progesterone Receptor Positive, Prognostic Stage IV Breast Cancer AJCC v8 Intervention / Treatment: DRUG: Imatinib Mesylate, DRUG: Letrozole Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Postmenopausal women able to comply with the protocol requirements with metastatic breast cancer, whose tumors are estrogen (ER) and/or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with greater than 10% positive malignant epithelial cells * Patients must have documented expression of either PDGFR or CD117 (c-kit) by immunohistochemistry * Patients may have received tamoxifen in the adjuvant/neoadjuvant or setting. Patients may have previously received chemotherapy in the adjuvant/ neoadjuvant setting, though this is not required. Prior chemotherapy for metastatic breast cancer is allowed. Concomitant bisphosphonates are allowed for patients with bone metastases and who have another site of measurable disease * Post menopausal status defined by one of the following: no spontaneous menses for at least 1 year, in women greater than or equal to 55 years spontaneous menses within the past 1 year in women greater than or equal to 55 years with postmenopausal gonadotrophin levels (luteinizing hormone [LH] and follicle stimulating hormone [FSH] levels greater than 40 IU/L ) or postmenopausal estradiol levels (less than 5 mg/dl) or according to the definition of "postmenopausal range" for the laboratory involved bilateral oophorectomy * Performance status, Eastern Cooperative Oncology Group (ECOG) greater than or equal to 2 * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 10 mm with conventional techniques. Bone disease only will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease * Absolute neutrophil count (ANC) = 1.5 x 10 to the 9th power/L * Platelets greater than or equal to 100.0 x 10 to the 9th power/L * Hemoglobin greater than 10.0 g/dL * Creatinine less than 1.5 mg/dl * Total (T.) bilirubin less than 1.5 x normal * Aspartate aminotransferase (AST) less than 2.5 x normal * A life expectancy of at least 6 months * Localized radiotherapy, which does not influence the signal of evaluable lesion, is allowed prior to the initiation of imatinib mesylate. Patients must have recovered from the myelosuppressive effects of previous radiotherapy (at least 2 <= age <= 4 weeks) * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Prior treatment with Femara or Gleevec * Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's syndrome, Addison's disease (treated or untreated) * Patients with unstable angina, or uncontrolled cardiac disease (e.g. class III or IV New York Heart Association's functional classification) * Other concurrent malignant disease with the exception of cone-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin's disease or non-Hodgkin lymphoma (NHL), provided 5 years have elapsed from completion of therapy, and there has been no recurrence * Concomitant treatment with steroids, e.g. glucocorticoids for indications other than cancer, except aerosol for obstructive airways diseases and steroid injection to the joints for treatment of inflammation * Other investigational drugs within the past 3 weeks and the concomitant use of investigational drugs * History of non-compliance to medical regimens and patients who are considered potentially unreliable * Patients with known brain metastasis * Patients with known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis) * Patients with known diagnosis of human immunodeficiency virus (HIV) infection * Patients who received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing * Patients who previously received radiotherapy to greater than or equal to 25% of the bone marrow * Patients who had a major surgery within 2 weeks prior to study entry

NCT_ID NCT00338728

Study_NameLetrozole and Imatinib Mesylate in Treating Postmenopausal Participants With Estrogen or Progesterone Positive Metastatic Breast Cancer

Study Objectives The goal of this clinical research study is to learn if the study drug ceftolozane-tazobactam is more effective in controlling febrile neutropenia (fever and low white blood cell counts) than using approved antibiotics in patients with cancer. The safety of ceftolozane-tazobactam will also be studied. This is an investigational study. Ceftolozane-tazobactam is FDA approved and commercially available to treat certain types of infections. It is not approved for the treatment of febrile neutropenia, either by itself or in combination with other antibiotics. Its use to treat febrile neutropenia is investigational. All other antibiotics given on this study are FDA approved and commercially available for the treatment of infections. However, only cefepime is specifically FDA approved to treat febrile neutropenia. The study doctor can explain how the study drugs are designed to work. Up to 100 participants will take part in this study. All will be enrolled at MD Anderson. Conditions: Other Infectious Diseases Intervention / Treatment: DRUG: Cefepime, DRUG: Ceftolozane, OTHER: Laboratory Biomarker Analysis, DRUG: Meropenem, DRUG: Piperacillin-Tazobactam, DRUG: Tazobactam Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Has provided written informed consent, and has the willingness and ability to comply with all study procedures * Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation; neutropenic fever is defined as the presence of neutropenia defined by: 1) absolute neutrophil count (ANC) < 500 cells/mm^3 or has an ANC that is expected to decrease to < 500 cells/mm^3 within 48 hours of trial entry and fever defined as: 2) single oral temperature measurement of > 101 degree Fahrenheit (F) (38.3 degree Celsius [C]) or a temperature of > 100.4 degree F (38.0 degree C) sustained over a 1-hour period * Requires hospitalization for IV empiric antibiotic therapy * If female: not breastfeeding; agrees to not attempt to become pregnant during the study; is surgically sterile or at least 2-years postmenopausal, or if of childbearing potential, has negative screening serum pregnancy test (if serum pregnancy test results are not available at the time of enrollment, a negative urine pregnancy test is required within 24 hours.); if of childbearing potential (including being < 2 years postmenopausal), is willing to practice sexual abstinence or use an effective dual form of contraception with her partner (eg, 2 barrier methods, barrier method plus hormonal method) during treatment and for >= 28 days after the last dose of any study therapy (IV or oral) Exclusion Criteria: * History of any hypersensitivity or allergic reaction to any cephalosporin antibiotic or tazobactam * Fever suspected to be caused by a noninfectious cause (eg, fever related to drug or blood product administration) * Confirmed fungal infection (eg, Pneumocystis jirovecii etiology in patients with pneumonia) that justifies adding additional empiric antimicrobial therapy (eg, antifungals) * Confirmed viral infection that justifies adding additional empiric antiviral therapy (eg, ganciclovir, foscarnet) * Known acute viral hepatitis * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 5 times the upper limit of normal (x ULN); patients with values > 3 x ULN and < 5 x ULN are eligible if the value is acute and directly related to the infectious process being treated * Total bilirubin > 3 x ULN unless isolated hyperbilirubinemia is directly related to the acute infection or due to known Gilbert disease; manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy * Known to be human immunodeficiency virus positive * Severely impaired renal function, defined as creatinine clearance (CrCl) =< 30 mL/min estimated by the Cockcroft-Gault formula * Expected requirement for hemodialysis while on study therapy * Received > 24 hours of IV antibacterial therapy (with study drugs) within 72 hours of the initiation of inpatient IV study drug for treatment of suspected infection; antibiotic prophylaxis and oral antibiotics is allowed; prophylactic use of antiviral or antifungal medication is permitted * Requirement for any non-study potentially effective concomitant systemic antibacterial therapy * Past or current history of epilepsy or seizure disorder; exception: well-documented febrile seizure of childhood * Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less (eg, moribund or with shock unresponsive to fluid replacement) * Unable or unwilling to adhere to the study-specified procedures and restrictions * Any condition that would make the patient, in the opinion of the investigator, unsuitable for the study (eg, would place a patient at risk or compromise the quality of the data * Participation in any other ongoing ceftolozane/tazobactam trial

NCT_ID NCT03485950

Study_NameComparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam

Study Objectives This phase I trial studies the side effects and best dose of c-Met inhibitor INCB028060 and erlotinib hydrochloride when given together in treating patients with previously treated non-small cell lung cancer. C-Met inhibitor INCB028060 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Recurrent Non-small Cell Lung Cancer Intervention / Treatment: DRUG: INC280, DRUG: erlotinib hydrochloride Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must provide written informed consent prior to any screening procedures * Willing and able to comply with scheduled visits, treatment plan and laboratory tests * Patient is able to swallow and retain oral medication * Histologically or cytologically documented diagnosis of NSCLC * Must have evidence of MET expression by fluorescence in situ hybridization (FISH), MET immunohistochemistry (IHC) score of 2 <= age <= 3+, reverse-transcriptase polymerase chain reaction (RT-PCR) or a mutation * Tumor tissue for correlative studies is mandatory * Patients in expansion cohort A will have a biopsy (which is standard of care) at the time of progression that shows evidence of MET positivity and meets the criteria for acquired resistance per the Jackman criteria * Previously received treatment with a single-agent erlotinib * A tumor that harbors an EGFR mutation known to be associated with drug sensitivity (i.e. G719X, exon 19 deletion, L858R, L861Q) * Systemic progression of disease (Response Evaluation Criteria in Solid Tumors [RECIST] or World Health Organization [WHO]) while on continuous treatment with gefitinib or erlotinib * Patients must have measurable disease; disease in previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy * Failed 1 <= age <= 2 prior chemotherapies for advanced disease; prior erlotinib is allowed in the dose finding phase and expansion cohort A (Patients in expansion cohort B must be erlotinib naïve and have v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog [KRAS] wild type tumor) * Patients must be willing to be off therapy for a minimum of two weeks (In expansion cohort A patients on erlotinib do not have to discontinue treatment) * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2 * Life expectancy greater than 3 months * Hemoglobin > 9 g/dL (International System [SI] units: 90 g/L) without transfusion support or growth factors within 10 days of starting INC280 * Platelet count >= 75 x 10^9/L * Absolute neutrophil count (ANC) >= 1.2 x 10^9/L without growth factor support * Total bilirubin =< 2 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 2.5 x upper limit of normal (ULN) * Serum creatinine =< 2 x ULN * Serum amylase =< ULN * Serum lipase =< ULN * Fasting serum triglyceride level =< 500 mg/dL Exclusion Criteria: * Patients who have had major surgery within 4 weeks of initiation of study medication, excluding the placement of vascular access * Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data * Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia * Severely impaired lung function * Active (acute or chronic) or uncontrolled infection * Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy * Liver disease (i.e. cirrhosis, chronic active hepatitis, chronic persistent hepatitis) * Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease * Note: Patients with controlled CNS metastases are allowed; radiotherapy or surgery for CNS metastases must have been completed > 2 weeks prior to study entry; patients must be neurologically stable, having no new neurologic deficits on clinical examination, and no new findings on CNS imaging; steroid use for management of CNS metastases must be at a stable dose for two weeks preceding study entry * Receiving drugs known to be strong inducers of cytochrome P450 3A4 (CYP3A4) or inhibiting drugs known to interact with erlotinib including, but not limited to: enzyme-inducing anticonvulsants, rifampicin, rifabutin, St John wort and ketoconazole * Treatment with proton pump inhibitors within 3 days prior to study entry * Currently receiving any prohibited medications including vitamins and herbal supplements * Any other condition that would, in the investigator's judgment, contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL) * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after stopping study drug; highly effective contraception methods include: * Total abstinence or * Male or female sterilization or * Combination of any two of the following (a+b or a+c or b+c): * (a) Use of oral, injected or implanted hormonal methods of contraception * (b) Placement of an intrauterine device (IUD) or intrauterine system (IUS) * (c) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository * Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential * Sexually active males must use a condom during intercourse while taking the drug and for 3 months after stopping study drug and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid * Patients unwilling or unable to comply with the protocol * Prior treatment with a MET inhibitor or hepatocyte growth factor (HGF) targeting agent * No history of another active cancer * Human immunodeficiency virus (HIV) seropositivity

NCT_ID NCT01911507

Study_NameINC280 and Erlotinib Hydrochloride in Treating Patients With Non-small Cell Lung Cancer

Study Objectives The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity. Conditions: Metastatic Renal Cell Carcinoma Intervention / Treatment: DRUG: placebo, DRUG: Sorafenib, DRUG: Sorafenib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: DOUBLE

Inclusion Criteria: * Histologically or cytologically confirmed metastatic clear cell renal cell cancer; * At least one lesion that can be accurately measured in at least one dimension; * Patients must not have been treated with prior anti-timor kinase inhibitors or VEGF pathway inhibitors; * Age 18 and older; * ECOG performance status 0 <= age <= 2; * Blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart; * Normal organ function: total bilirubin less than upper limit of normal, AST less than 2.5 X upper limit of normal, creatinine less than 2.8 mg/dl; * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation; * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Chemotherapy or radiotherapy within 4 weeks prior to entering the study; * Any other investigational agents; * Known brain metastases; * Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; * Pregnancy.

NCT_ID NCT00606866

Study_NameMRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma

Study Objectives The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®. Conditions: Lymphoblastic Leukemia, Lymphoma Intervention / Treatment: DRUG: Depocyte® Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with acute lymphoblastic leukemia or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse. CNS involvement must be demonstrated by: * A positive ventricular or lumbar CSF cytology defined as CSF cell counts > 5/µl (19/3 cells), obtained within 10 days prior to inclusion OR * Characteristic signs and symptoms of neoplastic meningitis PLUS an MRI or CT scan indicating the presence of meningeal involvement. Patients with combined relapse in CNS and other locations may be included in case that systemic therapy with CNS active drugs (HDMTX;HDAC, Thiotepa) can be postponed for at least 2 weeks. * Karnofsky >60% * Age >18 years * Recovery from grade III/IV toxicities attributable to prior treatment with the exception of hematotoxicity. * No severe heart, lung, liver or kidney dysfunction. * The patient or guardian must be competent to provide informed consent and must provide written informed consent prior to the initiation of study procedures Exclusion Criteria: * Failure (as defined by no clearance of the CSF) to > 1 dose of prior intrathecal MTX or cytarabine or triple (MTX, ARAC, dexamethasone) therapy * History of previous severe neurotoxicity (grade III-IV) attributed to intrathecal therapy or systemic high-dose therapy with methotrexate or cytarabine (vincristine induced peripheral neuropathy is accepted) * Prior CNS relapse < 1 month before * uncontrolled infection * The patient must not be pregnant or breast feeding. If the patient is a female of child-bearing potential she must have a negative (urine or serum) pregnancy test and be using effective methods to prevent pregnancy

NCT_ID NCT00388531

Study_NameDepocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma

Study Objectives The aim of the present Phase III study is to assess the positive predictive value of NPC-07 (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and pharmacokinetics following a single dose of NPC-07 orally, at a dose of 20mg/kg/body weight, 3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent malignant glioma (WHO grades III/IV). Positive predictive value will be confirmed by percentage of patients showing positive tumor cell identification in all biopsies taken from areas of strong and weak fluorescence. This study will be divided into two stages. After reviewing of the result of safety and pharmacokinetics of NPC-07 in small number of subjects by independent safety monitoring committee, more subjects will receive NPC-07 in Step II. Conditions: Malignant Glioma Intervention / Treatment: DRUG: NPC-07 for oral administration Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Aged between 18 and 70 years. * Radiological suspicion of newly- or recurrent malignant glioma (WHO grades III/IV). * Indication for surgical tumor resection. * Karnofsky Performance Score of 60 or higher. * Provides signed informed consent prior to any study procedures. * Comply with visit schedule and other rules for patients in study protocol. Exclusion Criteria: * Porphyria, hypersensitivity to porphyrins. * Renal insufficiency: Creatinine 2.0 mg/dL or higher * Hepatic insufficiency: ALT 100 IU/L or higher, AST 100 IU/L or higher, γ-GTP 100 IU/L or higher or total bilirubin 3 mg/dL or higher * Chemotherapy or other treatment for other malignant tumors * Females who are pregnant or potentially childbearing or are breastfeeding * Participation in other clinical trial in the previous 1 month * Ineligible patient based on the judgement of the investigator.

NCT_ID NCT01167322

Study_NameStudy of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas

Study Objectives The purpose of this study is to determine the safety and maximum tolerated dose, pharmacokinetics, and anti-neoplastic response of AVN-944 in patients with advanced hematologic malignancies. Conditions: Acute Leukemia, Chronic Leukemia, Multiple Myeloma, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Waldenstrom's Macroglobulinemia Intervention / Treatment: DRUG: AVN-944 capsules for oral administration Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed chronic myelogenous leukemia, acute myeloid leukemia, acute lymphocytic leukemia, multiple myeloma, Waldenstrom's macroglobulinemia, non-Hodgkin's lymphoma or Hodgkin's disease. * Patients must be refractory to, intolerant of, or decline to receive established therapy known to provide clinical benefit for their condition. * Age > 18 years * ECOG performance score of 0 or 1 * Adequate renal function as evidenced by serum creatinine < 2.0 mg/dL * Adequate hepatic function as evidenced by: * Serum total bilirubin < 2.0 mg/dL (Patients with known Gilbert's syndrome may have total bilirubin values of up to 3 mg/dL.) * Alkaline phosphatase < 3X the upper limit of normal (ULN) for the reference lab (< 5X the ULN if considered related to underlying disease) * SGOT/SGPT < 3X the ULN for the reference lab (< 5X the ULN if considered related to underlying disease * Patients must be recovered from the clinically significant effects of any prior surgery, radiotherapy or other antineoplastic therapy. * Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial. * Women of childbearing potential as well as fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method). Exclusion Criteria: * Patients with an uncontrolled active infection * Prior treatment with an inosine-5-monophosphate dehydrogenase (IMPDH)-inhibitor * History of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancers, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate specific antigen (PSA) of < 1.0 mg/dL Patients with other curatively treated malignancies who have no evidence of metastatic disease may be entered after discussion with the Medical Monitor. * Patients with known hypersensitivity to any of the components of AVN-944 * Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 14 days of the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication). Clinically significant toxicities from this therapy must have resolved to < Grade 2. * Grade 2 peripheral neuropathy * Patients who are pregnant or lactating * Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign the informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. * History of solid organ transplant * Known HIV or hepatitis B or C (active, previously treated or both)

NCT_ID NCT00273936

Study_NameTrial of AVN-944 in Patients With Advanced Hematologic Malignancies

Study Objectives The goal of this clinical research study is to find the best dosing schedule of a combined treatment of PEG Intron® (pegylated Interferon-alfa 2b) plus a peptide vaccine (gp100) that may help improve immune response in patients that had Stage II or Stage III melanoma and are free of the disease. The safety and tolerability of this drug combination will also be studied. Researchers also want to collect long-term follow-up information. Conditions: Melanoma Intervention / Treatment: DRUG: Pegylated Interferon-Alfa 2b (PEG Intron), DRUG: GP-100 Peptide Vaccine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must be free of disease after surgical resection for American Joint Committee on Cancer (AJCC) stage II or III (N1a) melanoma (T2b, T3a, T3b, T4a, T4b and N1a or N2a). Diagnosis must be confirmed by the Pathology Department of MD Anderson Cancer Center. * Patients must be HLA-A0201 positive. * Patients must be fully recovered from surgery, for at least one month, but not more than 90 days after surgery and before study entry. * Patients must have no other malignancies. Patients with prior history of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible. Patients with other malignancies are eligible, if they have been continuously disease-free for 5 years prior to the time of study entry. * Patients must be >= 18 years. * Patients must give signed written informed consent. * Women of childbearing potential (WOCBP) must not be pregnant (negative urine human chorionic gonadotropin (HCG) within 2 weeks of treatment) or lactating. A WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months). * Women of childbearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 3 months after completing or discontinuing treatment. Simultaneous use of two contraceptive methods such as, intrauterine device (IUD) or condom and contraceptive jelly is considered the accepted method of contraception. * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Patients must have white blood cell count (WBC) >= 3,000/mm3, platelet count >= 100,000/mm3, and hemoglobin >= 9 g/dL or 5.6 mmole/L obtained within 2 weeks of study entry. * Patients must have AST, ALT, LDH, alkaline phosphatase, and bilirubin within institutional upper limit (IUL) of normal and serum creatinine < 2.0 mg/dl or < 140 micromol/L all obtained within 2 weeks of study entry. Patients with Gilbert's Disease may have bilirubin <= to 2 x (ULN). * Patients must have a CT of chest, abdomen, pelvis, and a MRI or CT scan of the brain performed within 4 weeks of study entry. Exclusion Criteria: * Patients with clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or any distant metastatic disease. * Patients with autoimmune disorders or receiving immunosuppressive therapy including chemotherapy, steroids or methotrexate. * Patients requiring consistent use of antihistamines or non-steroidal anti-inflammatory drugs. * Patients with a history of active ischemic heart disease or cerebro-vascular disease, congestive heart failure (NYHA class >2) or anginal syndrome requiring ongoing medical treatment. * Patients have a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the protocol. Any questionable patients will be reviewed by the investigator or attending physician. * Patients having prior radiotherapy, chemotherapy or any immunotherapy including, tumor vaccines, interferon, interleukins, levamisole or other biologic response modifiers for any type of cancer. * Patients with a history of central nervous system (CNS) demyelinating, inflammatory disease or hereditary or acquired grade 2 or higher peripheral neuropathy. * Patients with any other significant medical or surgical condition or psychiatric disorder, which includes any serious psychiatric illness that has not been adequately controlled despite intervention (with our without medication) with known history of HIV or hepatitis infection may interfere with the completion of this trial or with the evaluation of safety and efficacy of the study compound. * Patients with thyroid dysfunction not responsive to therapy. * Patients with pre-existing psychiatric condition including, but not limited to: a. History of severe depression, including the following: 1) Hospitalization for depression 2) Electroconvulsive therapy for depression 3) Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions. b. Suicidal or homicidal ideation and/or suicidal or homicidal attempt. c. History of severe psychiatric disorders (eg. psychosis, post-traumatic stress disorder or mania). d. Past history or current use of lithium and/or antipsychotic drugs.

NCT_ID NCT00861406

Study_NameAdjuvant Therapy of Pegylated Interferon- 2b Plus Melanoma Peptide Vaccine

Study Objectives This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK) profile and preliminary efficacy of SBP-101. Conditions: Pancreatic Cancer, Ductal Adenocarcinoma of the Pancreas Intervention / Treatment: DRUG: SBP-101 Location: United States, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with acinar cell carcinoma may also be included. * Measurable disease on CT or MRI scan by RECIST criteria (required for Phase 1b only). * ECOG Performance Status 0 or 1. * Received and failed, or were intolerant to, at least 1 prior systemic therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma. * Adult, at least 18 years, male or female * Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception during the study. All sexually active males must also use an adequate method of contraception during the study. * Adequate bone marrow, hepatic, renal and coagulation function as defined by the following: Absolute neutrophil count >=1.5 x 10^9/L, Hemoglobin >=9.0 g/dL (90 g/L), Platelets >=100 x 10^9/L, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 x upper limit of normal (ULN) (if no hepatic metastases). If hepatic tumor involvement, AST and ALT <=5 x ULN, Bilirubin <=1.5 x ULN, Prothrombin time (PT) / international normalized ratio (INR) <=1.5 x ULN, Calculated creatinine clearance >50 mL/min using the Cockcroft and Gault equation * QTc interval <= 470 msec at Baseline * Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required, including possibility of onset of exocrine pancreatic insufficiency with subsequent requirement for life-long pancreatic enzyme replacement Exclusion Criteria: * Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded. * Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance * Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma * Have symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required. * Serum albumin <30 g/L (3.0 g/dL) * Glycosylated hemoglobin (Hgb A1C) > 8.0% * Life expectancy <16 weeks * Presence of known active bacterial, fungal, or viral infection requiring systemic therapy * Known infection with human immunodeficiency virus (HIV), hepatitis B or C * Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction * Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure, New York Heart Association (NYHA) class III or IV * Maldigestion/malabsorption syndrome pre-dating the diagnosis of pancreatic cancer. * Known, existing coagulopathy or receiving anticoagulants * Pregnant or lactating * Major surgery within 4 weeks of the start of study treatment, without complete recovery * Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug

NCT_ID NCT02657330

Study_NameStudy of SBP-101 in Pancreatic Cancer

Study Objectives The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast reconstruction. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast. Conditions: Breast Cancer Intervention / Treatment: DRUG: Chlorhexidine irrigation, DRUG: triple antibiotic irrigation Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: DOUBLE

Inclusion Criteria: * females between 18 - 81 years * and are undergoing bilateral mastectomy * and are candidates for immediate breast reconstruction with tissue expanders. Exclusion Criteria: * females younger than 18 and older than 81 years; * undergoing unilateral mastectomy and reconstruction; * bilateral reconstruction using other techniques, * patients allergic to one or more components of the antibiotic solution; * allergy to CHG

NCT_ID NCT02395614

Study_NameSurgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation

Study Objectives This phase Ib combination study is being conducted to assess the safety and tolerability of radium Ra 223 dichloride in combination with paclitaxel in cancer subjects with bone lesions with special focus on Grade 3/4 incidence of neutro- and/or thrombocytopenia and exploration of the mode of interaction (i.e. additive or synergistic interaction) between the selected chemotherapy and radium Ra 223 dichloride with regard to myelosuppression. Conditions: Neoplasms, Bone Diseases Intervention / Treatment: DRUG: Radium Ra 223 dichloride (Xofigo, BAY88-8223), DRUG: paclitaxel Location: Israel, Finland, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female patients >= 18 years * Subjects diagnosed with histologically or cytologically confirmed malignant solid tumors and at least two according bone lesions. A standard of practice bone scan for the documentation of at least 2 bone lesions can be used as long as it is within 3 months of planned start of treatment. If no bone scan within a 3 month window is available, then technetium 99m or NaF PET bone scan will be obtained at screening (within 28 days of planned start of study drug) * Eligible to treatment with paclitaxel as single agent, following the assessment of the investigator. If treatment with paclitaxel has already been initiated before signing the informed consent, patients will not be eligible. * For women: documentation of menopausal status: pre menopausal or post menopausal subjects. Post menopausal status is defined either by: one year or more of amenorrhea in the absence of other biological or physiological causes, or surgical menopause with bilateral oophorectomy. * Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and for 6 months after the last radium Ra 223 dichloride administration. These procedures should be documented in source documents, the investigator or a designated associate is requested to advise the subject on how to achieve birth control. * Women of childbearing potential must have a serum pregnancy test performed within 7 days before start of study treatment, and a negative result must be documented before start of study treatment * Life expectancy of at least 16 weeks * Adequate bone marrow function assessed within 7 days of starting the study treatment, judged by the following laboratory values: * Platelet count >= 100.000/cubic millimeters (mm3), within 7 days of starting the study treatment AND * Hemoglobin (HB) >= 9.0g/dl, within 7 days of starting the study treatment AND * Absolute neutrophil count (ANC) >= 1500/mm3 within 7 days of starting the study treatment * Adequate liver function assessed within 7 days of starting the study treatment, judged by the following laboratory values: * Total bilirubin <= 1.5 x the upper limit of normal range (ULN) (except for subjects with documented Gilbert's disease) AND * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x ULN (<=5 x ULN for subjects whose cancer involves their liver including liver metastasis) within 7 days of starting the study treatment AND * Albumin > 30 g/L within 7 days of starting the study treatment * International normalized ratio (INR) <= 1.5 and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) <= 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant, e.g. heparin, will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists and INR of the patient is < 3. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care If patients are on newer generation therapeutic blood thinning agents without the requirement of monitoring (e.g. Xarelto, Dabigatran), patients are eligible and management (e.g. discontinuation of the anticoagulant) will be handled by good medical practice standards under direction of the investigator * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Estimated creatinine clearance (CLCr) >= 30 mL/min as calculated using the Cockcroft-Gault equation Exclusion Criteria: * History of other malignancy which could affect compliance with the protocol or interpretation of results. * Received systemic therapy with radionuclides (e.g., strontium 89, samarium 153, rhenium 186, rhenium 188 or radium 223), including radium Ra 223 dichloride, for the treatment of bone metastases * Previous (within 4 weeks prior to first treatment within this study) or concomitant participation in another clinical study with investigational medicinal product(s) * Imminent or established spinal cord compression based on clinical findings and/or MRI. * Active brain metastases or meningeal tumors if the subject is < 2 months from definitive therapy, has evidence of tumor growth on an imaging study within 4 weeks prior to study entry and is on dexamethasone and not clinically stable with respect to the tumor at the time of study entry. * Prior hemibody external radiotherapy * Bone fracture in weight bearing bones without acceptable orthopedic stabilization within 4 weeks prior to start of treatment * Confirmed Paget's disease of the bone * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) or pulmonary embolism within 6 months before the start of study medication or deep vein thrombosis within 3 months before the start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication) * Subjects with evidence or history of bleeding diathesis; any hemorrhage or bleeding event CTCAE Grade >= 3 or higher within 4 weeks of start of investigational treatment * History of Bone marrow dysplasia * Pregnancy and lactation (breast feeding) * Evidence of peripheral neuropathy > grade 1 * Blood transfusion or use of erythropoietin within 6 weeks prior to start of study treatment (chemotherapy). Platelet transfusions are not allowed within 3 weeks prior to start of study treatment (chemotherapy). Use of biologic response modifies, such as granulocyte macrophage-colony-stimulating factor (GM-CSF or granulocyte-colony-stimulating factor (G-CSF), within 6 weeks prior to start of study treatment (chemotherapy). * Intake of clozapine within 4 weeks before start of study treatment.

NCT_ID NCT02442063

Study_NamePhase Ib Study of Radium Ra 223 Dichloride in Combination With Paclitaxel in Cancer Subjects With Bone Lesions

Study Objectives Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer. Primary endpoints * to assess Response Rate Secondary endpoints * to assess Overall response duration, Time to progression, Overall survival Conditions: Carcinoma, Small Cell Intervention / Treatment: DRUG: Belotecan, DRUG: Etoposide, DRUG: Cisplatin Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * ECOG Performance status 0~2(those with performance status 2 must have been stable with no deterioration over the previous 2 weeks) * Histologically or cytologically confirmed small cell lung cancer Patient without chemotherapy and radiotherapy * Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site * Life expectancy of at least 3 months * Provision of written informed consent Exclusion Criteria: * As judged by the investigator, any evidence of severe or uncontrolled systemic disease * Serum bilirubin greater than 3 times the upper limit of reference range(ULRR) * Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)greater than 2.5 times ULN if no demonstrable liver metastases (or > 5 times in presence of liver metastases) * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study * Pregnancy or breast-feeding women(women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy * Evidence of brain metastasis

NCT_ID NCT00826644

Study_NameTrial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient

Study Objectives This is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. Patients with initially unresectable NSCLC underwent immunochemotherapy and response to treatment was assessed after every two treatment cycles. Clinicopathologic features of patients including epidemiological data, clinical manifestations, operation strategies, pathological findings, and prognostic information were recorded and evaluated. Conditions: Non Small Cell Lung Cancer, Immunotherapy, Chemotherapy, Tumour, Residual Intervention / Treatment: DRUG: Timing of drug administration Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients with stage III NSCLC who received neoadjuvant immunochemotherapy. * early-stage NSCLC patients who were initially unresectable. * 18 years or older. * Karnofsky performance status (KPS) score of 100 or 90. Exclusion Criteria: * Patients with stage IV NSCLC * Patients with known ALK translocations or EGFR mutations. * Karnofsky performance status (KPS) score <90.

NCT_ID NCT05637580

Study_NamePathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable NSCLC

Study Objectives The purpose of this study is to determine whether S-1 in combination with Cisplatin is effective as 1st line therapy in slowing tumor activity in patients with advanced non-small cell lung cancer. The study is also looking at the safety of S-1. Conditions: Advanced Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: S-1 Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 1. Has given written informed consent. 2. Patients with histologically and/or cytologically proven unresectable NSCLC stage IIIB with pleural effusion or pericardial effusion, or stage IV (mixed forms with small cell lung cancer are excluded). 3. Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, ie, has at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter >= 20 mm using conventional techniques or >= 10 mm using spiral Computed Tomography (CT) scan. 4. Is able to take medications orally. 5. Is >= 18 years. 6. Has an ECOG performance status 0 or 1. 7. Has adequate organ function as defined by the following criteria: 1. AST (SGOT) and ALT (SGPT) <= 2.5 x ULN; if liver function abnormalities are due to underlying liver metastasis AST (SGOT) and ALT (SGPT) <= 5 x ULN. 2. Total serum bilirubin of <= 1.5 x ULN. 3. Absolute granulocyte count of >= 1,500/mm3. 4. Platelet count >= 100,000/mm3. 5. Hemoglobin of >= 9.0 g/dL. 6. Calculated creatinine clearance (CrCl) >= 60 mL/minute (Cockcroft-Gault formula). 8. Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: * 1. Has had treatment with any of the following within the specified time frame prior to study drug administration: 1. Any prior cytotoxic chemotherapy except for adjuvant or neo-adjuvant therapy for NSCLC beyond 12 months. 2. Any radiation therapy to a target lesion unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease). 3. Radiotherapy within the prior 2 weeks. 4. Adjuvant or neo-adjuvant therapy within the past 12 months. 5. Prior cisplatin as neo-adjuvant and/or adjuvant chemotherapy with cumulative dose > 300 mg/m2. 6. Any investigational agent, either concurrently or within the past 30 days. 7. Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study. 2. Has a serious illness or medical condition(s) including, but not limited to, the following: <!-- --> 1. Other active malignancies. 2. Symptomatic brain metastasis not controlled by corticosteroids. 3. Leptomeningeal metastasis. 4. Known neuropathy Grade 2 or higher. 5. Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV. 6. Chronic nausea, vomiting, and/or diarrhea. 7. Psychiatric disorder that may interfere with consent and/or protocol compliance. 8. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 9. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study. 3. Is receiving concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: <!-- --> 1. Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1 activity). 2. Allopurinol (may diminish S-1 activity). 3. Phenytoin (S-1 may enhance phenytoin activity). 4. Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity).4. Is receiving concomitant treatment with drugs interacting with cisplatin. The following drugs are prohibited because there may be an interaction with cisplatin: <!-- --> 1. Phenytoin (cisplatin may diminish phenytoin activity). 2. Aminoglycosides (should be avoided within 8 days after cisplatin administration). 5. Is a pregnant or lactating female. 6. Has known hypersensitivity to cisplatin. 7. With reproductive potential and refuses to use an adequate means of contraception (including male patients).

NCT_ID NCT00651833

Study_NamePhase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy in Advanced Non-Small Cell Lung Cancer

Study Objectives Primary Objective: * To demonstrate progression free survival (PFS) improvement for ombrabulin compared to placebo, in combination with taxane and platinum, as first line treatment for patients with metastatic non-small cell lung cancer (NSCLC). Secondary Objective: * To determine overall survival (OS), overall response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite, RPR258063, using a population approach. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DRUG: ombrabulin (AVE8062), DRUG: placebo Location: Poland, Germany, Ukraine, United States, Australia, Italy, Serbia, Croatia, Russian Federation, Romania, France, Korea, Republic of, Chile Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion criteria: * Histologically proven squamous metastatic non-small cell lung cancer (stage IV, according to Tumor Nodes Metastasis (TNM) classification seventh edition) * Patients with measurable disease, Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion criteria: * Prior chemotherapy, immunotherapy or targeted therapy for lung cancer disease (including adjuvant/neoadjuvant therapy) * History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis * History of another neoplasm. Adequately treated basal cell or squamous skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for >5 years are allowed * Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization * Acquired immunodeficiency syndrome (AIDS-related illness) or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment * Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results * Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization * Patient with reproductive potential (Male/Female) who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. The definition of "effective method of contraception" will be based on the investigator's judgment * Inadequate organ function * Pre-existing peripheral neuropathy > grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V.4.03 * Pre-existing hearing impairment > grade 2 * Known hypersensitivity due to taxanes and /or polysorbate 80 or any other compound of the study drug combination * Other serious illness or medical conditions such as (but not restricted): Active infection, Superior vena cava syndrome, Pericardial effusion requiring intervention (drainage) * Documented medical history of myocardial infarction, documented angina pectoris, arrhythmia especially severe conduction disorder such as second or third-degree atrioventricular block, stroke, or history of arterial or venous thromboembolism within the past 6 months still requiring anticoagulants. * Uncontrolled hypertension within 3 months prior to study treatment or patient with organ damage related to hypertension. * Patient with Left Ventricular Ejection Fraction (LVEF) value lower than institution inferior normal limit, evaluated by echocardiography or angiocardiography * 12-lead Electrocardiogram (ECG): Infarction Q-wave, ST segment depression or elevation >=1 mm in at least 2 contiguous leads * History of gross hemoptysis (i.e. 1/2 teaspoon of red blood or more per episode) within the past 1 month. * Has non-squamous NSCLC(adenocarcinoma/large cell or other) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

NCT_ID NCT01263886

Study_NameTrial of Ombrabulin (AVE8062) in Combination With Taxane and Platinum in Patients With Non-small Cell Lung Cancer

Study Objectives It is the aim of this clinical study to evaluate the skeletal-related event rate under therapy with zoledronic acid in patients with renal cell cancer having at least one cancer-related bone lesion. Conditions: Renal Cell Cancer, Neoplasm Metastasis Intervention / Treatment: DRUG: Zoledronic acid Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * A histologically confirmed diagnosis of renal cell carcinoma with none, one or, at maximum, 2 of the following risk factors: 1. Karnofsky performance status less than 80% 2. Lactate dehydrogenase greater than 1.5 times upper limit of normal 3. Hemoglobin less than lower limit of normal 4. Absence of nephrectomy * Patients must have evidence of at least one cancer-related bone lesion. If diagnosis of bone metastases in bone scan or magnetic resonance imaging (MRI)-QuickScan is unclear radiographic (X-ray, computed tomography [CT] or MRI) confirmation of at least one focus is required. * ECOG performance status of 0, 1 or 2. * Life expectancy of >= 6 months * Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value * Patient has given written informed consent prior to any study-specific procedures Exclusion Criteria: * Only patients who received 3 or less applications of an i.v. Bisphosphonate in the past are eligible * Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) is allowed. However, other loci of bone metastasis must be present, which were not treated with radiation therapy and thus can be assessed for primary and secondary endpoints. * Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula: CrCl = [140-age (years)] x weight (kg) {x 0.85 for female patients} [72 x serum creatinine (mg/dL)] * Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or >= 12.0 mg/dl (3.00 mmol/L) * Patients with clinically symptomatic brain metastases * History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism * Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG. * Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates * Pregnancy and lactation * Women of childbearing potential not on a medically recognized form of contraception (i.e., oral contraceptives or implants, intrauterine device [IUD], vaginal diaphragm or sponge, or condom with spermicide) * Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion * Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion * Participation in another trial * Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient) * Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study * Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. * Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) Other protocol-defined inclusion and exclusion criteria may apply.

NCT_ID NCT00172003

Study_NameEffect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis

Study Objectives This study evaluates taste function and eating habits in patients with PCOS compared to healthy women and before and after oral contraceptive use. Conditions: Polycystic Ovary Syndrome Intervention / Treatment: DRUG: Contraceptive Location: Turkey Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Women diagnosed with PCOS (Rotterdam criteria) who will receive oral contraceptive pill for long-term management Exclusion Criteria: * Any systemic illness * Any other medication use * Age<18 or >35 years * Pregnant or nursing * Untreated hypothyroidism or hyperthyroidism * Known rhinoplasty or nasal surgery * Known defect in smell or taste function * Being active smoker.

NCT_ID NCT04238078

Study_NameTaste Function and Eating Habits in Polycystic Ovary Syndrome

Study Objectives This phase II open label study will evaluate adolescents (≥ 16 years of age) and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with the MEK inhibitor PD-0325901. The primary aim of the study will be to assess quantitative radiographic response in a target lesion. Subjects will receive PD-0325901 by mouth on a bid dosing schedule of 2 mg/m2/dose with a maximum dose of 4 mg bid. Each course is 4 weeks duration, and subjects will receive drug on a 3 week on/1 week off schedule. Subjects may receive additional courses beyond course 8 only if there is at least 15% reduction in volume of the target tumor. Subjects who have a 20% or greater reduction in target tumor volume at the end of 12 courses can continue on therapy for up to an additional year (maximum of 24 total courses). However, subjects who do not achieve at least 15% reduction in volume of the target tumor after 8 courses (\~8 months) will be considered treatment failures and taken off study. The Primary purpose of this protocol is to determine whether PD-0325901 results in objective radiographic responses based on volumetric MRI measurements in adolescents and adults with NF1 and growing or symptomatic inoperable PN. There are several secondary aims of this protocol: To evaluate the feasibility and toxicity of chronic PD-0325901 administration in this patient population To estimate the objective response rate of up to 2 non-target plexiform neurofibromas to PD-0325901 by MRI To characterize the pharmacokinetic profile of PD-0325901 when administered to this patient population To evaluate quality of life and pain during treatment with PD-0325901 Conditions: Neurofibromatosis Type 1 and Growing or Symptomatic, Inoperable PN Intervention / Treatment: DRUG: PD-0325901 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * All studies to determine eligibility must be performed within 2 weeks prior to enrollment unless otherwise indicated below. All clinical and laboratory data required for eligibility of a subject must be available in the subject's medical or research record. * All subjects must have EITHER the clinical diagnosis of NF1 using the NIH Consensus Conference criteria OR have a constitutional NF1 mutation documented in a CLIA/CAP certified lab. * Subjects must have plexiform neurofibroma(s) that are progressive OR are causing significant morbidity, such as (but not limited to) head and neck lesions that are compromising the airway or great vessels, brachial or lumbar plexus lesions that are causing nerve compression and loss of function, lesions causing major deformity (e.g., orbital lesions) or are significantly disfiguring lesions of the extremity that cause limb hypertrophy or loss of function, and painful lesions. Subjects with paraspinal plexiform neurofibromas will be eligible for this trial. Histologic confirmation of tumor is not necessary in the presence of consistent clinical and radiographic findings * For subjects enrolled for tumor progression, progression is defined as: * Presence of new plexiform neurofibroma on MRI or CT (documented by comparison with prior MRI or CT), OR * A measurable increase in plexiform neurofibroma size (>= 20% increase in the volume, or a >= 13% increase in the product of the two longest perpendicular diameters, or a >= 6% increase in the longest diameter) documented by comparison of two scans (MRI or CT) approximately one year or less prior to evaluation for this study. * For subjects enrolled for a "major deformity" or "significantly disfiguring" tumor, eligible tumors will be limited to tumors of the head & neck or those on other areas of the body that are unable to be concealed by standard garments. In order to enroll a plexiform neurofibroma for these indications, the Study Chair or Co-Chair must be contacted to review subject eligibility prior to enrollment. * Measurable disease: Subjects must have measurable plexiform neurofibroma(s) amenable to volumetric MRI analysis. The target lesion must be seen on at least 3 consecutive MRI slices and the field of view must contain the entire tumor of interest. Tumors must be at least 3 mL in volume (most PNs 3 cm in longest diameter will meet this criteria). If the tumor is <3 cm in longest diameter, the subject may still be eligible. Central review of the MRI of the target plexiform is required prior to enrollment to ensure that the tumor is measurable and amenable to volumetric analysis. After consenting, images will be sent for Central review * Age: Subjects must be >= 16 years at the time of study entry. * Durable Power of Attorney: Adults who are unable to provide informed consent will NOT be enrolled on this study. * Performance Level: Karnofsky greater than or equal to 50% Note: Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. * Prior Therapy: Subjects are only eligible if complete resection of a plexiform neurofibroma with acceptable morbidity is not feasible, or if a subject with surgical option refuses surgery. * Subjects who underwent surgery for a progressive plexiform neurofibroma will be eligible to enter the study after the surgery, provided the plexiform neurofibroma was incompletely resected and is evaluable by volumetric analysis. * Subjects may have been previously treated for a plexiform neurofibroma or other tumor/malignancy, but must have fully recovered from the acute toxic effects of all prior chemotherapy or radiotherapy prior to entering this study. * Myelosuppressive chemotherapy: Must not have received within 4 weeks of entry onto this study. * Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor that supports platelet, red or white cell number or function. * Biologic (anti-neoplastic agent): At least 14 days since the completion of therapy with a biologic agent. These subjects must be discussed with the Study Chair on a case-by-case basis. * Investigational Drugs: Subjects must not have received an investigational drug within 4 weeks. * Steroids: Subjects with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. * 6 months from involved field radiation to index plexiform neurofibroma(s); 6 weeks must have elapsed if subject has received radiation to areas outside index plexiform neurofibroma(s). Subjects who have received radiation to the orbit at any time are excluded. * Surgery: At least 2 weeks since undergoing any major surgery and must be recovered from effects of surgery. * Organ Function Requirements * Adequate Bone Marrow Function * Adequate Renal Function * Adequate Liver Function Exclusion Criteria: * Chronic treatment with systemic steroids or another immunosuppressive agent. Subjects with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. * Evidence of an active optic glioma or other low-grade glioma, requiring treatment with chemotherapy or radiation therapy. Subjects not requiring treatment are eligible for this protocol. * Patients with malignant glioma, malignant peripheral nerve sheath tumor, or other malignancy requiring treatment in the last 12 months. * Subjects who have received radiation to the orbit at any time previously * Subjects with glaucoma, intraocular pressure >21 mmHg, or any other significant abnormality on ophthalmic examination (performed by an ophthalmologist). * Ophthalmological findings secondary to long-standing Optic Pathway Glioma such as optic nerve pallor or strabismus will NOT be considered significant for the purposes of the study. * Tumor not able to be reliably evaluated by volumetric analysis. * Other concurrent severe and/or uncontrolled medical disease, which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration, congestive heart failure, etc.) * Subjects who have an uncontrolled infection. * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of PD-0325901 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection). A nasogastric tube (NG tube) or gastric tube (G tube) is allowed. * Women who are pregnant or breast feeding. * Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during the period they are receiving the study drug and for 3 months thereafter. Abstinence is an acceptable method of birth control. Women of childbearing potential will be given a pregnancy test within 7 days prior to administration of PD-0325901 and must have a negative urine or serum pregnancy test. * History of noncompliance to medical regimens. * Subjects unwilling to or unable to comply with the protocol, or who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study. * Prior treatment with a MEK inhibitor of any kind

NCT_ID NCT02096471

Study_NameMEK Inhibitor PD-0325901 Trial in Adolescents and Adults With NF1

Study Objectives Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992 administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade III and IV). Phase II Part: To estimate the efficacy and safety of BIBW 2992 monotherapy and BIBW 2992 / TMZ combination therapy compared to TMZ monotherapy (three treatment arms) in patients with recurrent GBM. To evaluate molecular determinants of response to BIBW 2992. Conditions: Glioma Intervention / Treatment: DRUG: BIBW 2992, DRUG: TMZ, DRUG: BIBW 2992 plus TMZ Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria: Phase I Part: * Histologically-confirmed WHO Grade III or IV malignant glioma that is recurrent after prior chemoradiotherapy. Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO Grade III or IV malignant glioma. * Age at least 18 years at entry * KPS at least 60% * Patients must have recovered from previous surgery and chemotherapy. * Written informed consent that is consistent with local law and ICH-GCP guidelines. Phase II Part: * Histologically-confirmed WHO Grade IV malignant glioma at first episode of recurrence after prior combined chemoradiotherapy. Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO Grade IV malignant glioma and if prior treatment included temozolomide chemotherapy and radiotherapy. * Bi-dimensionally measurable disease with a minimum measurement of 1 cm (10 mm) in one diameter on Gd MRI performed within 14 days prior to first treatment (Day 1). * Age at least 18 years at entry * KPS at least 70% * Patients must have recovered from previous surgery and chemotherapy. * Written informed consent that is consistent with local law and ICH-GCP guidelines. * Patients receiving corticosteroids have to receive a stable or decreasing dose for at least 14 days before start of study treatment. Exclusion criteria: Phase I and Phase II Parts: * Less than 12 weeks between radiotherapy and start of study treatment, unless new enhancing lesion outside of radiation field or radiologically progressive on two consecutive MRI scans at least four weeks apart or biopsy-proven recurrence. * Less than two weeks from surgical resection (one week from prior stereotactic biopsy) or major surgical procedure. * Less than two weeks after previous chemotherapy (6 weeks from nitrosureas). * Treatment with other investigational drugs; participation in another clinical study within the past 2 weeks before start of therapy or concomitantly with this study. * Progressive disease or toxicity =CTCAEv3 Grade 3 to protracted temozolomide dosing (defined as temozolomide administered more than 5 days/28 day cycle). * Active infectious disease requiring intravenous therapy. * Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C. * Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea. * Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol. * Patient is <3 years free of another primary malignancy except: if the other primary malignancy is either not currently clinically significant or does not require active intervention (such as a basal cell skin cancer or a cervical carcinoma in situ). Existence of any other malignant disease is not allowed. * Cardiac left ventricular function with resting ejection fraction <50%. * Absolute neutrophil count (ANC) less than 1500/mm3. * Platelet count less than 100,000/mm3. * Bilirubin greater than 1.5 x upper limit of institutional norm. * Aspartate amino transferase (AST) greater than 3 x upper limit of institutional norm. * Serum creatinine greater than 1.5 x upper limit of institutional norm. * Patients who are sexually active and unwilling to use a medically acceptable method of contraception. * Pregnancy or breast-feeding. * Patients unable to comply with the protocol. * Known pre-existing interstitial lung disease (ILD). Phase I part only: * Less than four weeks from prior treatment with bevacizumab. Phase II Part only: * Prior EGFR-directed therapy. * Prior bevacizumab therapy. * Patients presenting with second or higher number of episodes of recurrence. * Requirement of treatment with any of the prohibited concomitant medications listed in Section 4.2.2 (Restrictions regarding concomitant treatment).

NCT_ID NCT00727506

Study_NameBIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma

Study Objectives The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice. Conditions: Relapsed/Refractory Multiple Myeloma Intervention / Treatment: DRUG: Ixazomib Location: Japan Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * All patients who have been confirmed as administration of the drug. Exclusion Criteria: * None

NCT_ID NCT03169361

Study_NameNINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"

Study Objectives The study is an open-label, single arm multicenter Phase II study to evaluate the safety and efficacy of the combination of Abraxane and Avastin as first-line therapy for patients with unresectable metastatic malignant melanoma. The patient sample will be approximately 50 individuals, males and females 18 years of age or older with measurable metastatic melanoma. Patients will be treated with Abraxane administered weekly for 3 weeks via a 30-minute IV infusion at150 mg/m2 followed by 1 week rest (28-day cycle). Avastin will be administered in a dose of 10 mg/kg every 2 weeks (without rest period). Patients will be evaluated for disease progression every 2 months and those who do not have disease progression or unacceptable toxicity will be offered ongoing therapy until they have progressive disease or unacceptable toxicity. Conditions: Metastatic Malignant Melanoma Intervention / Treatment: DRUG: Avastin, DRUG: Abraxane Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed, (surgically incurable or unresectable) stage III or IV metastatic malignant melanoma.. * Must be chemo naïve. Surgical adjuvant therapy with interferon, vaccines, or cytokines is permitted. Prior adjuvant therapy with chemotherapeutic agents is not allowed. Prior therapy for metastatic disease that is not chemotherapy is allowed. Must have discontinued prior allowable therapy at least 4 weeks prior to initiation of dosing. * A minimum of 1 measurable lesion according to RECIST criteria. * ECOG performance status of 0 <= age <= 1. * Age >= 18 years. * Adequate hematologic, renal and liver function as defined by laboratory values performed within 14 days prior to initiation of dosing. * Patients must have recovered from effects of major surgery. * Women of childbearing potential should be using an effective method of contraception. Women of childbearing potential must have a negative urine or serum pregnancy test up to 28 days prior to commencement of dosing and be practicing medically approved contraceptive precautions for at least 6 months after completion of treatment as directed by their physician. * Men should use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. * Must have recovered from all prior treatment-related toxicities to NCI CTCAE (v 3.0) Grade of 0 or 1, except for toxicities not considered a safety risk such as alopecia. * Before study entry, written informed consent must be obtained. Written informed consent must be obtained from the patient prior to performing any study-related procedures. Exclusion Criteria: * Prior systemic therapy for metastatic disease with chemotherapy. * Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before trial entry. * Major surgery or radiation therapy within 4 weeks of starting the study treatment. * Known CNS disease. * Previous Grade 2 or higher sensory neuropathy * NCI CTCAE (V 3.0) grade 3 hemorrhage within 4 weeks of starting the study treatment. * History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. * Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. * Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >= 2. * Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications) * Any prior history of hypertensive crisis or hypertensive encephalopathy * Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study. * Previous cancer (unless a DRS interval of at least 5 years) or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin. * Known clinically uncontrolled infectious disease including HIV positivity or AIDS-related illness. * Pregnant or nursing. Use of effective means of contraception (men and women) in subjects of child-bearing potential. * New York Heart Association (NYHA) Grade II or greater congestive heart failure. * Symptomatic peripheral vascular disease. * Significant vascular disease (e.g. aortic aneurysm, aortic dissection). * Evidence of bleeding diathesis or coagulopathy. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study * Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0 * Proteinuria at screening as demonstrated by urine dipstick for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate <= 1g of protein in 24 hours to be eligible). * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0 * Serious, non-healing wound, ulcer, or bone fracture * Inability to comply with study and/or follow-up procedures

NCT_ID NCT00462423

Study_NameAbraxane and Avastin as Therapy for Patients With Malignant Melanoma, a Phase II Study

Study Objectives The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: Vandetanib, DRUG: FOLFIRI Location: Spain, United States, United Kingdom, Norway, Korea, Republic of, Argentina Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Histologically confirmed colorectal cancer * Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as: * Progression on or following treatment for metastatic colorectal cancer * Progression within 12 months of adjuvant chemotherapy for colorectal cancer Exclusion Criteria: * Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab. * Previous adjuvant therapy with irinotecan within 12 months of randomization * More than one prior course of chemotherapy for treatment of metastatic colorectal cancer.

NCT_ID NCT00454116

Study_NameA Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients

Study Objectives The purpose of this study is to determine whether the Litx™ treatment is safe and effective in treating inoperable hepatocellular carcinoma (HCC). Litx™ is an integrated treatment system comprising an intravenously administered photosensitizing agent, Talaporfin Sodium (LS11), that is activated by non-coherent light generated inside the tumor by an implanted light emitting diode (LED) array light source. Conditions: Carcinoma, Hepatocellular, Liver Neoplasms Intervention / Treatment: PROCEDURE: Photodynamic therapy, DRUG: Talaporfin Sodium Location: Singapore, Taiwan, Hong Kong Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the following criteria in a clinical setting suggestive of HCC: (i) Two different imaging techniques that suggests HCC; (ii) Combination of one imaging technique that suggests HCC and serum alpha-fetoprotein (AFP) level >400 ng/mL; (iii) Histological evidence of HCC; * Subjects with at least 1 but no more than 3 lesions in the liver may be considered for enrollment in the study; * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2; * Life expectancy of at least 16 weeks; * Prior treatment failure with locally ablative techniques is allowed. Subjects who were not candidates for surgery, systemic chemotherapy, chemoembolization (TACE), intratumoral ethanol injection (PEI), radiofrequency ablation (RFA), cryoablation or other locally ablative technology may be eligible, but at least 4 weeks must have elapsed since the completion of any prior therapy and the subject must have recovered from acute side effects; * Understanding and ability to sign written informed consent; * 18 years or more; * Adequate hematologic, liver and renal functions as evidenced by the following: *WBC > 2,400/mm; *Platelet Count > 75,000/µl; *Hemoglobin > 9.4 gm/dL; *PT and PTT < 1.5 Control; *AST, ALT < 5 x ULN; *Bilirubin < 1.5 X ULN; *Alk Phos < 3X ULN; *Creatinine < 2.5 mg/dL (SI: 221 mmol/L) Exclusion Criteria: * Subjects who are candidates for surgery with curative intent; * Subjects with lesions larger than 8 cm in diameter and more than 40% of parenchymal disease involvement; * Known sensitivity to porphyrin type drugs; * Known history of porphyria; * Known presence of extrahepatic metastases; * Anticipated need for systemic chemotherapy during the first 8 weeks of the study; * Child-Pugh C cirrhosis; * Diffuse HCC; * Concurrent participation in another clinical trial involving experimental treatment; * Any concurrent disease or condition that in the opinion of the investigator impairs the subject's ability to complete the trial. Psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data.

NCT_ID NCT00122876

Study_NameTumor Ablation With Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)

Study Objectives This study proposes a single-arm, phase II study of irinotecan with panitumumab as second-line therapy for patients with advanced esophageal adenocarcinoma. Efficacy will be assessed by response rate, with an exploratory outcome endpoint of time to progression (as panitumumab may result in prolonged stable disease). In addition to the usual safety assessments, molecular correlates will be carried out in order to search for pharmacodynamic and pharmacogenomic features that may correlate with response. Measures of host/patient immune function will be assessed by evaluating the relationship between Fc receptor polymorphisms and response in patients treated with panitumumab. Measures of EGFR protein and phosphoprotein expression by immunohistochemical- (IHC-) staining, K-ras mutation status1 and reverse-phase protein arrays (RPPA) and EGFR gene amplification by fluorescence in situ hybridization (FISH) will be assessed as exploratory correlates. Conditions: Esophageal Cancer Intervention / Treatment: DRUG: Panitumumab, DRUG: Irinotecan Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically or cytologically confirmed diagnosis of locally recurrent or metastatic adenocarcinoma of the esophagus which is incurable with standard therapy. * Patients must have measurable disease outside a previous radiation port, or which has developed in the port since the conclusion of radiation and is biopsy-proven to be recurrent cancer. * One prior chemotherapy regimen for metastatic disease, with the exception of prior irinotecan or panitumumab. * Prior radiation therapy to no more than 20% of the bone marrow is allowed. No treatment with wide field radiation within 4 weeks of entry onto this study. * Full recovery from the effects of any prior surgery. * Man or woman >18 years. * ECOG performance status <2 (Karnofsky >60%) * Life expectancy of >3 months * Absolute neutrophil count (ANC) >= 1.5 x 109/L * Platelet count >= 100 x 109/L * Hemoglobin >= 9.0 g/dL * Creatinine < or = to 1.5 mg/dL * Creatinine clearance > or = to 50 mL/min calculated by the Cockcroft-Gault method as follows: * Male creatinine clearance = (140 - age) x (weight in Kg) / (serum Cr x 72) * Female creatinine clearance = (140 - age) x (weight in Kg) x 0.85 / (serum Cr x 72) * Aspartate aminotransferase (AST) < or = to 3 x ULN (if liver metastases less than or equal to 5 x ULN) * Alanine aminotransferase (ALT) < or = to 3 x ULN (if liver metastases less than or equal to 5 x ULN) * Total bilirubin < or = to 1.5 x ULN * Magnesium >= lower limit of normal * Potassium > or = to lower limit of normal * Because the effects of irinotecan and panitumumab on the developing human fetus are unknown, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Exclusion Criteria: * History or known presence of central nervous system (CNS) metastases unless CNS metastases have been irradiated and are stable. * History of another primary cancer, except: * Curatively treated in situ cervical cancer * Curatively resected non-melanoma skin cancer * Other primary solid tumor curatively treated with no known active disease present and no treatment administered for greater than or equal to 5 years prior to enrollment * Pre-existing peripheral neuropathy > grade 1. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to panitumumab or irinotecan. * Patients receiving any medications or substances that are established or probable inhibitors or inducers of P450 3A4 are ineligible. * Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) * Radiotherapy < or = to 14 days prior to enrollment. * Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (or small molecules for Phase I studies) (eg, bevacizumab)< or = to 30 days before enrollment * Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine) * Any investigational agent or therapy < or = to 30 days before enrollment * Prior therapy with Irinotecan or panitumumab. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or any evidence of interstitial lung disease on baseline chest CT scan * History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results. * Women who test positive for serum or urine pregnancy test < 72 hours before randomization or is breast feeding * Known positive test(s) for acute or chronic active hepatitis B infection * Major surgery within 28 days or minor surgery within 14 days of study enrollment * Men or women of child-bearing potential (women who are post-menopausal < 52 weeks, not surgically sterilized, or not abstinent) not consenting to use adequate contraception (per institutional standard of care) during treatment and for six months after the last investigational product(s) administration * Any underlying condition which in the opinion of the principal investigator will interfere with safety or with compliance with the study.

NCT_ID NCT00836277

Study_NamePhase II Study of Irinotecan and Panitumumab

Study Objectives The aim of this study is to evaluate if the multi modality treatment pemetrexed combined with cisplatin and radiotherapy can lead to a better tumor control and/or a better side-effect profile in patients with locally advanced NSCLC. Patients will be randomized between 3 cycles of induction chemotherapy followed by concurrent chemoradiotherapy or concurrent chemoradiotherapy followed by 3 cycles of adjuvant combination chemotherapy. Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: combination chemotherapy (pemetrexed + cisplatin), RADIATION: thoracic irradiation + pemetrexed Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * cytological or histological proven NSCLC * unresectable stage III NSCLC * presence of at least one measurable lesion (RECIST criteria) * adequate haematological, renal and hepatic function * adequate lung function reserve * good condition, weight loss <10 % over previous 6 months, life expectancy > 3 months Exclusion Criteria: * previous chemo- or radiotherapy for NSCLC * distant metastasis or a malignant pleural or pericardial effusion * second active primary malignancy or serious concomitant medical disease * interstitial lung disease * auto-immune systemic disease with potential involvement of the lungs * inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period * concomitant use of amiodarone

NCT_ID NCT00497315

Study_NameEvaluation of Pemetrexed Combined With Cisplatin and Radiotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Objectives This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of tizanidine in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single oral dose of tizanidine on Day 1, vemurafenib orally twice daily on Days 2 to 21, and tizanidine and vemurafenib on Day 22. Eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764). Conditions: Malignant Melanoma, Neoplasms Intervention / Treatment: DRUG: Tizanidine, DRUG: Vemurafenib Location: Cyprus, United States, Brazil, Canada, Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Adults 18 <= age <= 70 of age, inclusive * Unresectable Stage IIIc or IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type which harbors a V600 activating mutation of BRAF, as determined by Cobas 4800 BRAFV600 Mutation Test or a DNA sequencing method * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Life expectancy greater than or equal to (>=) 12 weeks * Participant has not consumed tobacco or nicotine-containing products for 42 days prior to first dose of study drug, and must agree to refrain from such products while on study * Adequate hematologic, renal and liver function Exclusion Criteria: * Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Day 1 * History of or current clinically significant cardiac or pulmonary dysfunction, including current uncontrolled Grade >= 2 hypertension or unstable angina * Current dyspnea at rest due to complications of advanced malignancy or any requirement for supplemental oxygen * Active central nervous system lesions (participants with radiographically unstable, symptomatic lesions) * Participants with CYP1A2 gene mutation (-3113G->A), either in one or two alleles * Allergy or hypersensitivity to vemurafenib or tizanidine formulations * Current severe uncontrolled systemic disease * Inability or unwillingness to swallow pills * History of malabsorption or other condition that would interfere with enteral absorption of study treatment * History of clinically significant liver disease (including cirrhosis), current alcohol abuse, or human immunodeficiency (HIV) infection requiring antiretroviral treatment, acquired immune deficiency syndrome (AIDS)-related illness, or active hepatitis B or C * Pregnant or breastfeeding women

NCT_ID NCT01844674

Study_NameA Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies

Study Objectives Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with advanced epithelial cancer, malignant lymphoma, or sarcoma Conditions: AIDS-related Peripheral/Systemic Lymphoma, AIDS-related Primary CNS Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Chondrosarcoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Intraocular Lymphoma, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Metastatic Osteosarcoma, Nodal Marginal Zone B-cell Lymphoma, Ovarian Sarcoma, Primary Central Nervous System Non-Hodgkin Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Osteosarcoma, Recurrent Small Lymphocytic Lymphoma, Recurrent Uterine Sarcoma, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Hodgkin Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Adult Soft Tissue Sarcoma, Stage IV Adult T-cell Leukemia/Lymphoma, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Mycosis Fungoides/Sezary Syndrome, Stage IV Small Lymphocytic Lymphoma, Stage IV Uterine Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: tanespimycin, OTHER: pharmacological study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed advanced epithelial cancer, malignant lymphoma, or sarcoma for which no standard curative therapy exists * Brain metastases allowed after definitive radiotherapy * Performance status - ECOG 0 <= age <= 2 * Absolute neutrophil count at least 1,500/mm^3 * Platelet count at least 100,000/mm^3 * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 2 times normal * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for at least 1 week before, during, and for at least 2 weeks after study completion * No active infection * No other serious concurrent condition * No prior allergic reaction to egg products * At least 4 weeks since prior biologic therapy (regional or systemic) * At least 4 weeks since prior chemotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy

NCT_ID NCT00004241

Study_Name17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma

Study Objectives The treatment of cancer often involves the use of more than one drug at the same time. In this study, patients are treated with the already marketed drug paclitaxel (administered every 3 weeks by infusion)and with the investigational drug CHR-2797 (given orally, once daily). The purpose of this study is to evaluate if it is safe to administer these two drugs together, and how well the combination is tolerated by patients. The first patients will receive a 90mg dose of CHR-2797; doses will be increased in subsequent patients, as long as they are adequately tolerated. Conditions: Solid Tumor Intervention / Treatment: DRUG: CHR-2797 Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed, informed consent. * Age > 18 years * Histologically or cytologically documented locally advanced or metastatic solid tumour refractory to standard therapy or for which no standard therapy exists. * Patients should have recovered from the acute adverse effects of prior therapies (excluding alopecia). * Adequate bone marrow, hepatic and renal function including the following: * Hb > 9g/dl (transfusion independent) or >10g/dl (transfusion permitted), absolute neutrophil count > 1.5 x 109/L, platelets >= 100 x 109/L; * Total bilirubin <= 1.5 x upper normal limit; * AST (SGOT), ALT (SGPT) <= 2.5 x upper normal limit * Creatinine <=1.5 x upper normal limit. * Performance status (PS) <= 2 (ECOG scale). * Estimated life-expectancy greater than 3 months. * Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Exclusion Criteria: * Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to first dose of medication in this trial or within a longer period, depending on the defined characteristics of the agent e.g. 6 weeks for nitrosurea or mitomycin. Bisphosphonates for bone disease are permitted provided the doses are stable before and during the trial. * Co-existing active infection or serious concurrent illness. * Significant cardiovascular disease as defined by: * history of congestive heart failure requiring therapy; * history of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry; * presence of severe valvular heart disease; * presence of a ventricular arrhythmia requiring treatment. * Any co-existing medical condition that in the investigator's judgement will * substantially increase the risk associated with the patient's participation in the study. * Psychiatric disorders or altered mental status precluding understanding of the * informed consent process and/or completion of the necessary studies. * Gastrointestinal disorders that may interfere with absorption of the study drug. * Persistent grade II or greater toxicity from any cause. * Patients with known brain tumours or metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events. * More than 4 prior chemotherapy regimens.

NCT_ID NCT00737555

Study_NameA Study of the Safety and Tolerability of the Addition of CHR-2797 to Paclitaxel in Patients With Advanced or Refractory Tumours

Study Objectives This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer. The study is an open-label design, consisting of 3 parts: dose-finding portion including food effect (Part 1), G1T48 monotherapy expansion portion (Part 2), and G1T48 in combination with palbociclib expansion portion (Part 3). All parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 184 patients may be enrolled in the study. Conditions: Carcinoma, Ductal, Breast, Breast Cancer Female, Breast Neoplasm, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Stage IV Breast Cancer Intervention / Treatment: DRUG: G1T48, DRUG: Palbociclib Location: Georgia, Ukraine, United States, Netherlands, Bulgaria, Belgium, Moldova, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * For Part 1, postmenopausal women only * For Parts 2 and 3, any menopausal status * Confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable to curative therapy * For Part 1, prior treatment with less than 4 prior lines of chemotherapy * For Part 2, prior treatment with less than 2 prior line of chemotherapy * For Part 3, prior treatment with no more than 1 prior line of chemotherapy * For Parts 1 and 2, prior treatment with less than 4 prior endocrine therapies for metastatic breast cancer * For Part 3, prior treatment with no more than 1 prior line of endocrine therapies for metastatic breast cancer * For Parts 1 and 2, patients must satisfy 1 of the following criteria for prior therapy: * Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor * Progressed after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer * For Part 3, patients must satisfy 1 of the following criteria for prior therapy: * Received >= 24 months of endocrine therapy in the adjuvant setting prior to recurrence or progression * Received >= 6 months of endocrine therapy in the advanced/metastatic setting prior to progression * For Part 1, evaluable or measurable disease * For Parts 2 and 3, evaluable (approximately 25%) or measurable disease (approximately 75%) as defined by RECIST, Version 1.1 including bone-only disease * ECOG performance status 0 to 1 * Adequate organ function Exclusion Criteria: * For Part 3, prior treatment with CDK4/6 inhibitor, investigational oral SERDs or SERCAs in any setting * Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease * Anticancer therapy within 14 days of first G1T48 dose or within 28 days for antibody-based therapy * Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow * Prior hematopoietic stem cell or bone marrow transplantation

NCT_ID NCT03455270

Study_NameG1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer

Study Objectives Activated T cell were manufactured through in vitro T cell expansion of autologous T cell. We designed this study to determine the feasibility and safety of Activated T-lymphocyte cell therapy for refractory/relapsed neuroblastoma patients. Conditions: Neuroblastoma Intervention / Treatment: BIOLOGICAL: Activated T lymphocyte Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Informed consent * Age 21 years or younger * Histologically confirmed neuroblastoma * Progressive disease after standard treatment or relapsed patient * ECOG scale (ECOG-PS) <=2 * Expected survival at least 3 months Exclusion Criteria: * Patients with autoimmune disease * Patients with immunodeficiency * Other malignancy 5 year prior to this study * Severe organ dysfunction * Severe allergic disease * Severe psychiatric disorder * Pregnancy or lactating woman

NCT_ID NCT01802138

Study_NameA Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma

Study Objectives The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TAK-659 and venetoclax when administered in combination in participants with non-Hodgkin lymphoma (NHL) relapsed and/or refractory after at least 1 prior line of therapy and to evaluate safety and tolerability of TAK-659 and venetoclax when administered in combination. Conditions: Lymphoma, Non-Hodgkin, Lymphoma, Large B-cell, Diffuse, Lymphoma, Follicular Intervention / Treatment: DRUG: TAK-659, DRUG: Venetoclax Location: Canada, Germany, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * For the Dose Escalation phase, participants must have histologically confirmed diagnosis of advanced NHL of any histology (with the exception of participants with mantle cell lymphoma [MCL] or chronic lymphoma leukemia [CLL]). * For the Safety Expansion phase, participants must have histologically confirmed diagnosis of advanced DLBCL or FL. * Radiographically or clinically measurable disease with greater than or equal to (>=) 1 target lesion per IWG criteria for malignant lymphoma. * Refractory or relapsed after at least 1 prior line of therapy for whom no effective standard therapy is available per investigator's assessment. o Participants who are either treatment-naive to, relapsed after, or refractory to ibrutinib, idelalisib, or any other investigational B cell receptor (BCR) pathway inhibitors not directly targeting spleen tyrosine kinase (SYK) are allowed. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Life expectancy of greater than 3 months. * Suitable venous access for the study-required blood sampling that is, including PK and pharmacodynamic sampling. * Recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the reversible effects of prior anticancer therapy. Exclusion Criteria: * Central nervous system (CNS) lymphoma; active brain or leptomeningeal metastases, as indicated by positive cytology from lumbar puncture or computed tomography (CT) scan/magnetic resonance imaging (MRI). * History of drug-induced pneumonitis requiring treatment with steroids; history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted. * Participants requires the use of warfarin (use in prophylactic doses [example, deep vein thrombosis prophylaxis]) is allowed. * Prior exposure to targeted SYK inhibitors. * History of a prior intolerable toxicity, in the opinion of the investigator from another B-cell lymphoma (BCL)-2 family protein inhibitor study. * Participants who are relapsed after or refractory to regimens containing venetoclax or other BCL2 inhibitors. * Systemic anticancer treatment (including investigational agents) or radiotherapy less than 2 weeks before the first dose of study treatment (<=4 weeks for large molecule agents; <=8 weeks for cell-based therapy or anti-tumor vaccine), or not recovered from the reversible effects of prior anticancer therapy. * Prior autologous stem cell transplant (ASCT) within 6 months preceding Cycle 1 Day 1. * Prior allogeneic stem cell transplant and/or chimeric antigen receptor T-cell therapy at any time. * Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery. * Known human immunodeficiency virus (HIV) positive or HIV-related malignancy. * Received a live viral vaccine within 6 months prior to the first dose of study drug. * Use or consumption of: * Medications or supplements that are known to be strong or moderate Cytochrome P4503A (CYP3A) inhibitors or strong or moderate CYP3A inducers and/or P-glycoprotein (P-gp) inhibitors or inducers within 7 days or within 5 times the inhibitor or inducer half-life (whichever is longer) before the first dose of study drugs. In general, the use of these agents is not permitted during the study except in cases in which an adverse event (AE) must be managed during interruption of study drug dosing. * Food or beverages containing grapefruit, Seville oranges, or Star fruit within 5 days before the first dose of study drugs. Note that food and beverages containing grapefruit, Seville orange, or Star fruit are not permitted during the study. * Preparations containing St. John's wort within 7 days before the first dose of study drugs. Note that preparations containing St. John's wort are not permitted during the study.

NCT_ID NCT03357627

Study_NameA Study of TAK-659 in Combination With Venetoclax for Adult Participants With Previously Treated Non-Hodgkin Lymphoma

Study Objectives The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size. Conditions: Non Small Cell Lung Cancer Intervention / Treatment: DRUG: Pemetrexed, DRUG: Cisplatin, DRUG: Folic Acid, DRUG: Vitamin B12, DRUG: Dexamethasone Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy * Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2) * Tumor considered potentially resectable * Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG) * No prior therapy for lung cancer * Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (RECIST) Criteria * Life expectancy of at least 6 months * Organs are functioning well (bone marrow reserve, liver, kidney, lung) * Signed Informed Consent * Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding. * Men must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after last dose of study drug. * Be fit for surgery at the time of enrollment Exclusion Criteria: * Receiving or have received an investigational drug or device within the last 30 days * Have previously completed or withdrawn from this study or any other study investigating pemetrexed * Serious concomitant systemic disorder * Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease * Receiving concurrent administration of any other anticancer therapy * Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination * Inability or unwillingness to take Pemetrexed supplementation/premedication (folic acid, vitamin B12, or corticosteroids) * Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day

NCT_ID NCT01165021

Study_NameA Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

Study Objectives Assessment of safety and efficacy of with fludarabine and cyclophosphamide (FC) combined with ofatumumab (FCO2) in previously untreated "young" patients with Chronic Lymphocytic Leukemia (CLL). Conditions: B-cell Lymphoid Leukemia, Young Patients Intervention / Treatment: DRUG: Cyclophosphamide, DRUG: Fludarabine, DRUG: Ofatumumab Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * B-cell CLL diagnosis by 2008 revised IWCLL criteria. * Treatment requirement according to the 2008 revised IWCLL criteria. * No previous treatment. * Age > 18 year and . 65 years. * ECOG performance status of 0 <= age <= 1 at study entry and CIRS score .6. * Adequate renal function (creatinine clearance.60 ml/min estimated using the Cockcroft-Gaultequation) . * For male and female subjects of childbearing potential, agreement to use effective contraception. * Signed written informed const according to ICH/EU/GCP and national local laws. Exclusion Criteria: * Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease and/or laboratory abnormality which in the opinion of the investigator may represent a risk for the patient and/or that would prevent the subject from signing the informed consent form. * Pregnant or lactating females. * Known positive serology for HIV. * Positive serology for Hepatitis B (HBV) defined as a positive test for HBsAg and HBV-DNA. * HCV-RNA positive. * Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection, tuberculosis and active hepatitis. * History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months. * Known presence of alcohol and/or drug abuse. * Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to the inclusion in the study, congestive heart failure (NYHA III-IV), arrhythmia unless controlled by therapy.. grade 2 neuropathy; history of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae. * Uncontrolled autoimmune hemolytic anemia or thrombocytopenia. * One or more laboratory abnormalities: 1. Calculated creatinine clearance (Cockroft-Gault)<60mL/min. 2. Absolute granulocyte count <1500/ƒÊL not disease related. 3. Platelet count < 75000/ƒÊL not disease related. 4. GOT, GPT, GT, alkaline phosphatase > 1,5 x upper limit of normal value unless due to disease involvement); serum bilirubin >1.5mg/dL, subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones) * Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study * Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.

NCT_ID NCT01762202

Study_NameAssessment of Efficacy and Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab Chemoimmunotherapy in Young Patients With Chronic Lymphocytic Leukemia.

Study Objectives RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma. Conditions: Melanoma (Skin) Intervention / Treatment: BIOLOGICAL: PEG-interferon alfa-2b Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Histologically confirmed stage IV melanoma * Stage M1a, M1b, or M1c * Mucosal, ocular, or unknown primary melanoma * Previously untreated OR received up to 3 prior systemic therapy regimens (excluding vaccine therapy) for metastatic disease * Plasma basic fibroblast growth factor level at least 15 pg/mL * Measurable or evaluable disease * Central nervous system (CNS) involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for >= 3 months * Brain computed tomography (CT) scan or Magnetic resonance imaging (MRI) to confirm stable disease required <= 4 weeks prior to study entry * Age: 18 and over * ECOG Performance status of 0 <= age <= 2 * Life expectancy at least 6 months * Absolute neutrophil count at least 1,500/mm^3 * Platelet count at least 100,000/mm^3 * Hemoglobin at least 8 g/dL (transfusions allowed) * Bilirubin no greater than 2 times upper limit of normal (ULN) * Alanine Aminotransferase (ALT) no greater than 2 times ULN * Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min * At least 4 weeks since prior interferon in the adjuvant or metastatic setting * At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting * At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting * At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting * At least 4 weeks since prior surgery in the adjuvant or metastatic setting * At least 4 weeks since other prior therapy in the adjuvant or metastatic setting * Negative pregnancy test * Fertile patients must use effective contraception Exclusion criteria: * Myocardial infarction within the past 6 months * Other active malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Other concurrent illness that would preclude study participation * History of severe depression * Pregnant or nursing

NCT_ID NCT00049530

Study_NamePEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma

Study Objectives Patients with locally advanced rectal or rectosigmoid cancer staged cT3 CRM-negative with MRI will receive 6 cycles of neoadjuvant treatment with mFOLFOX6 (Arm A) vs. mFOLFOX6 + aflibercept (Arm B) followed by surgery. Conditions: Rectal Cancer, Rectosigmoid Cancer Intervention / Treatment: DRUG: Oxaliplatin, DRUG: 5-FU, DRUG: Leucovorin, BIOLOGICAL: Aflibercept Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age >= 18 years on day of signing informed consent * Signed and dated informed consent, and willing and able to comply with protocol requirements * WHO/ECOG Performance Status (PS) 0 <= age <= 1 * Diagnosis of rectal adenocarcinoma * Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon, i.e. no patient will be included for whom surgeon indicates need for abdomino-perineal resection (APR) at baseline. * Clinical staging is based on the combination of the following assessments: * Physical examination by the primary surgeon * CT scan of the chest/abdomen * Pelvic MRI * Rigid rectoscopy / endoscopic ultrasound (ERUS). * Both examinations (i.e. MRI and ERUS) are mandatory. * The tumor has to fulfill the following criteria: * No symptomatic bowel obstruction * Locally advanced rectal and rectosigmoid cancer, i.e. lower border of tumor > 5 cm and < 16 cm from anal verge as determined by rigid rectoscopy * MRI criteria: 1. Lower border of tumor below a line defined by promontorium and symphysis, regardless of the criterion "< 16 cm from anal verge as determined by rigid rectoscopy". 2. No evidence that tumor is adjacent to (defined as within 2 mm of) the mesorectal fascia on MRI (i.e. CRM > 2 mm) 3. Only T3-tumors are included, i.e infiltration into perirectal fat < 10 mm provided CRM > 2 mm 4. Note: MRI criteria are used for the definition of T3 tumor (i.e. exclusion of T2 and T4 situation). * Hematological status: * Neutrophils (ANC) >= 2 x 10^9/L * Platelets >= 100 x 10^9/L * Hemoglobin >= 9 g/dL (previous transfusion of packed blood cells allowed) * Adequate renal function: * Serum creatinine level <= 1.5 x upper limit normal (ULN) or <= 1.5 mg/dl * Creatinine clearance >= 30 ml/min * Adequate liver function: * Serum bilirubin <= 1.5 x upper limit normal (ULN) * Alkaline phosphatase < 3 x ULN * AST and ALT < 3 x ULN * Proteinuria < 2+ (dipstick urinalysis) or <= 1 g/24hour or <= 500mg/dl * Regular follow-up feasible * For female patients of childbearing potential, negative pregnancy test within 1 week (7 Days) prior of starting study treatment * Female patients of childbearing potential (i.e. did not undergo surgical sterilization - hysterectomy, bilateral tubal ligation, or bilateral oophorectomy - and is not post-menopausal for at least 24 consecutive months) must commit to using high effective and appropriate methods of contraception until at least 6 months after the end of study treatment such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence. If an oral contraception is used, a barrier method of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge) has to be applied additionally * Fertile male patients with a partner of childbearing potential must commit to using high effective and appropriate methods of contraception (details see above) until at least 9 months after the end of study treatment. Exclusion Criteria: * Distant metastases (CT scans of thorax and abdomen are mandatory) * cT2 and cT4 tumors (defined by MRI criteria) * Exclusion of potentially compromised CRM as defined by MRI criteria (i.e. > 2 mm distance from CRM) * Prior antineoplastic therapy for rectal cancer * History or evidence upon physical examination of CNS metastasis * Uncontrolled hypercalcemia * Pre-existing permanent neuropathy (NCI-CTCAE grade >= 2) * Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy * Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy, radiotherapy) * Treatment with any other investigational medicinal product within 28 days prior to study entry * Known dihydropyrimidine dehydrogenase (DPD) deficiency * Treatment with CYP3A4 inducers unless discontinued > 7 Days prior to randomization * Any of the following in 3 months prior to inclusion: * Grade 3 <= age <= 4 gastrointestinal bleeding * Treatment resistant peptic ulcer disease * Erosive esophagitis or gastritis * Infectious or inflammatory bowel disease * Diverticulitis * Any active infection within 2 weeks prior to study inclusion * Vaccination with a live, attenuated vaccine within 4 weeks prior to the first administration of the study medication * Other concomitant or previous malignancy, except: * Adequately treated in-situ carcinoma of the uterine cervix * Basal or squamous cell carcinoma of the skin * Cancer in complete remission for > 5 years * Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days prior to study entry * Pregnant or breastfeeding women * Patients with known allergy to any constituent to study drugs * History of myocardial infarction and/or stroke within 6 months prior to randomization, NYHA class III and IV congestive heart failure * Severe renal insufficiency (creatinin clearance < 30 ml/min) * Bowel obstruction * Contra-indication to the assessment by MRI * Involvement in the planning and/or conduct of the study (applies to both Sanofi staff and/or staff of Sponsor and study site) * Patient who might be dependent on the sponsor, site or the investigator * Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG * Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].

NCT_ID NCT03043729

Study_NamemFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer

Study Objectives The purpose of this study is to find a safe and tolerable dose of Lipotecan® when administered to patients with advanced solid tumors. Conditions: Advanced Solid Tumors Intervention / Treatment: DRUG: Lipotecan Location: Taiwan, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Adult patients defined by age >=18 years. * Pathologically confirmed advanced solid tumors for which standard therapy proven to provide clinical benefit does not exist or is no longer effective * Evaluable disease, either measurable on imaging or with informative tumor marker(s), by RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Exclusion Criteria: * Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment. Male and female patients of childbearing potential must agree to use appropriate birth control (barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records). * Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry. * Receipt of more than 3 prior regimens of chemotherapy. * Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to baseline. Receipt of radiotherapy to >25 % of bone marrow. Major surgery within 4 weeks prior to baseline. * Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents which are potent inhibitors or inducers of cytochrome P450 enzymes unless approved by the Sponsor. * Uncontrolled intercurrent illness that would jeopardize patient safety, interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator.

NCT_ID NCT00747474

Study_NamePhase I Study of Intravenous Lipotecan® (TLC388 HCl for Injection) in Patients With Advanced Solid Tumors

Study Objectives The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow. Conditions: Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer Intervention / Treatment: DRUG: AMG 386, DRUG: AMG 386 Placebo, DRUG: Paclitaxel, DRUG: Paclitaxel Location: Peru, Poland, United Kingdom, South Africa, Australia, Croatia, France, Korea, Republic of, Chile, India, Slovenia, Greece, Canada, Estonia, Portugal, Sweden, Spain, Czech Republic, Italy, Romania, Switzerland, Hong Kong, Malaysia, Israel, United States, Brazil, Japan, Bulgaria, Latvia, Belgium, Russian Federation, Mexico Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Female 18 years or older at the time the written informed consent is obtained * Gynecologic Oncology Group (GOG) Performance Status of 0 or 1 * Life expectancy >= 3 months (per investigator opinion) * Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with clear cell or mucinous histology are excluded) * Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy * Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications * Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment. * Adequate organ and hematological function * Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and diastolic blood pressure <= 90 mmHg prior to randomization. The use of anti-hypertensive medications to control hypertension is permitted * Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer Exclusion Criteria: * Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers * Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded * Subjects with primary platinum-refractory disease * Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy * Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities * Previous abdominal or pelvic radiotherapy * History of arterial or venous thromboembolism within 12 months prior to randomization * History of clinically significant bleeding within 6 months prior to randomization * History of central nervous system metastasis * Has not yet completed a 21 day washout period prior to randomization for any previous anti cancer systemic therapies (30 days for prior bevacizumab) * Enrolled in or has not yet completed at least 30 days (prior to randomization) since ending other investigational device or drug, or currently receiving other investigational treatments * Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except alopecia * Known active or ongoing infection (except uncomplicated urinary tract infection [UTI]) within 14 days prior to randomization * Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor * Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide * Clinically significant cardiovascular disease within 12 months prior to randomization * Major surgery within 28 days prior to randomization or still recovering from prior surgery * Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure.

NCT_ID NCT01204749

Study_NameTRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

Study Objectives Open-label, phase I, non-randomized, multicentric study of single-agent birabresib (MK-8628) (formerly known as OTX015) administered according to two distinct regimens to participants with selected advanced tumors. The study will be performed in two parts. Dose Escalation Part: This step is designed to determine the maximum tolerated dose (MTD) in each of the two regimens, which will be evaluated in parallel. Participants will receive oral birabresib according to: Continuous Dosing Regimen: continuous, once daily for 21 consecutive days (21-day cycles). OR Days 1-7 Dosing Regimen: once daily on Days 1 to 7, repeated every 3 weeks (21-day cycles; 1 week ON/2 weeks OFF). Participants will be sequentially assigned to Continuous Dosing Regimen or Days 1-7 Dosing Regimen according to the next available place and receive birabresib at escalating doses levels (DL). Cohorts of 3 participants will be treated, and an additional 3 participants will be treated at the first indication of dose-limiting toxicity (DLT). MTD assessment will be based on the tolerability observed during the first 21 days of treatment. Expansion Part: The efficacy of birabresib in each of the five indications (i.e., Bromodomain-Nuclear Protein in Testis \[BRD-NUT\] midline carcinoma, triple negative breast cancer \[TNBC\], non-small cell lung cancer \[NSCLC\] harboring a rearrangement Anaplastic Lymphoma Kinase \[ALK\] gene/fusion protein or Kirsten Ras \[KRAS\] mutation, castrate-resistant prostate cancer, and pancreatic ductal carcinoma) will be assessed in terms of response (Response Evaluation Criteria in Solid Tumors v1.1 \[RECIST v1.1\] or Prostate Cancer Clinical Trials Working Group 2 \[PCWG2\]) using a selected regimen. Conditions: NUT Midline Carcinoma, Triple Negative Breast Cancer, Non-small Cell Lung Cancer With Rearranged ALK Gene/Fusion Protein or KRAS Mutation, Castrate-resistant Prostate Cancer, CRPC, Pancreatic Ductal Adenocarcinoma Intervention / Treatment: DRUG: Birabresib Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed informed consent obtained prior to initiation of any study-specific procedures and treatment; * Histologically or cytologically confirmed diagnosis of one of the following advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective, intolerable or inacceptable for the patient: * NUT midline carcinoma (ectopic expression of NUT protein as determined by immunohistochemistry (IHC) and/or detection of BRD-NUT gene translocation as determined by fluorescence In situ hybridization [FISH]); * Triple negative breast cancer defined according to American Society of Clinical Oncology (ASCO) recommendations (Hammond et al., 2010; Wolff et al., 2007); * Non-small cell lung cancer harboring a rearranged ALK gene/fusion protein (FISH or IHC) or KRAS mutation (as defined by any molecular analysis); * Castrate-resistant prostate cancer (CRPC); * Pancreatic ductal adenocarcinoma; * At least one measurable lesion as per RECIST version 1.1., except for CRPC participants who may be enrolled with objective evidence of disease as per PCWG2 criteria; * Age >=18 years at the time of informed consent; * Life expectancy >=3 months; * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) <=1; * Adequate bone marrow reserve, renal and liver function: * Absolute neutrophil count >=1.5 x10^9/L, * Platelet count >=150 x10^9/L, * Hemoglobin >=9 g/dL, * Creatinine clearance >=30 mL/min calculated according to the Cockroft and Gault formula or Modification of Diet in Renal Disease (MDRD) formula for participants aged >65 years, * Alanine aminotransferase (ALT), aspartate aminotransferase (AST) <=3 x upper limit of normal (ULN) and total bilirubin <=1.25 x ULN (in case of liver involvement, ALT/AST <=5 x ULN and total bilirubin <=2 x ULN will be allowed), * Serum albumin >=2.8 g/dL, * International Normalized Ratio (INR) <=1.5 x ULN or INR <3 for participants treated with antivitamin K; * An interval of >=3 weeks since chemotherapy (>=6 weeks for nitrosoureas or mitomycin C), immunotherapy, hormone therapy or any other anticancer therapy or surgical intervention resection, or >=3 half-lives for monoclonal antibodies, or >=5 half-lives for other non-cytotoxic agents (whichever is longer); * CRPC participants must maintain ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue, antagonist or orchiectomy providing serum testosterone is <50 ng/dL (<1.7 nmol/L); * Participants receiving bisphosphonate or denosumab therapy must be on stable doses for at least 4 weeks before initiating study treatment. Exclusion Criteria: * Inability to swallow oral medications or presence of a gastrointestinal disorder (e.g. malabsorption) deemed to jeopardize intestinal absorption of birabresib; * Persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy <= grade 2 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.4.0 is accepted. * Known primary central nervous system (CNS) malignancy or CNS involvement; * History of prior or concomitant malignancies (other than excised non-melanoma skin cancer or cured in situ cervical carcinoma) within 3 years of study entry; * Other serious illness or medical conditions, such as active infection, unresolved bowel obstruction, or psychiatric disorders; * Known human immunodeficiency virus (HIV) positivity; * Participation in another clinical trial or treatment with any investigational drug within 30 days prior to study entry; * Other concomitant anticancer treatment; * Concomitant therapy with strong CYP3A4 interfering drugs; * Current use of anticoagulants (e.g. warfarin, heparin) at therapeutic levels within 7 days prior to the first dose of birabresib. Low-dose (prophylactic) low molecular weight heparin (LMWH) is permitted; * Pregnant or breast-feeding participants, and men and women with childbearing potential not using effective contraception while on study drug.

NCT_ID NCT02259114

Study_NameA Dose-Finding Study of Birabresib (MK-8628), a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors (MK-8628-003)

Study Objectives The purpose of this research study is to develop a geriatric oncology collaborative care intervention to enhance the quality of life, symptom burden, and functional outcomes of older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancers. Conditions: Other Cancer Intervention / Treatment: OTHER: Usual Care, OTHER: Geriatric Oncology Collaborative Care Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age >= 65 years * Diagnosed with advanced (defined as metastatic or receiving therapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, renal, bladder, or prostate cancer within the past 8 weeks (includes patients with a new diagnosis, progression or recurrence). * ECOG performance status of 0 <= age <= 2 * Ability to read and respond to questions in English * Planning to receive care at MGH Exclusion Criteria: * Uncontrolled psychiatric illness or impaired cognition

NCT_ID NCT03721926

Study_NameA Geriatric Oncology Collaborative Care Intervention for Older Adults With Advanced Cancer

Study Objectives Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose (RD) of PM01183. Conditions: Major Advanced Solid Tumors Other Than Colorectal Intervention / Treatment: DRUG: PM01183 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Voluntarily signed and dated written informed consent * Age >= 18 years. * Non or minimally daily activities-interfering disease related symptoms. * Life expectancy >= 3 months. * Patients with solid tumor other than CRC. * Adequate bone marrow, renal, hepatic, and metabolic function (tests within normal limits or only minimally altered as assessed <= 7 days before inclusion in the study)Recovery to asymptomatic or minimally altered or to baseline from any adverse event (AE) derived from previous treatment (mild alteration for alopecia, skin toxicity or fatigue are allowed). * Normal cardiac function cardiac function by appropriate image testing. * Women of childbearing potential must have a negative serum pregnancy test before study entry. Exclusion Criteria: * Primary colorectal cancer diagnosis * Prior treatment with PM01183. * Concomitant diseases/conditions: a) History of a clinically relevant cardiac condition c) Known chronic liver disease. d) Active uncontrolled infection. e) Known human immunodeficiency virus (HIV) infection. f) Limitation of the patient's ability to comply with the treatment or follow-up protocol. * Symptomatic and progressive or corticosteroid-requiring documented brain metastases * Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding. * History of extensive prior pelvic irradiation. * History of previous bone marrow and/or stem cell transplantation.

NCT_ID NCT01405391

Study_NameStudy of PM01183 in Non-Colorectal Cancer Patients as a Days 1 and 8 Intravenous Short Infusion Every 3 Weeks

Study Objectives The purpose of this study is to evaluate: 1. whether an imaging test called a PET (Positron emission tomography) scan performed after two cycles of standard chemotherapy is able to identify patients who have a high cure rate after completing standard chemotherapy alone; and 2. whether high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) when used in combination with an antibody called Rituximab results in high cure rates for those patients predicted to do poorly with standard chemotherapy by the PET scan. Conditions: Diffuse Large B Cell Lymphoma Intervention / Treatment: PROCEDURE: Autologous Blood Stem Transplantation, DRUG: R-CHOP Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age 18 <= age <= 65 years * Diagnosis of Diffuse Large B-Cell Lymphoma * Adverse Prognosis = Stage 3 or 4 and elevated LDH * No more than one prior cycle of R-CHOP chemotherapy * Adequate cardiac function * No central nervous system involvement by lymphoma Exclusion Criteria: * Histological diagnosis other than Diffuse Large B-cell Lymphoma * Pregnant or lactating females * Use of other anti-cancer therapies * Other serious illness that would compromise study participation * Prior malignancy * Prior stem cell transplant or radiotherapy

NCT_ID NCT00530179

Study_NameFDG-PET-Stratified R-DICEP and R-Beam/ASCT For Diffuse Large B-Cell Lymphoma

Study Objectives The purpose of the study was to understand if there was benefit in continued treatment with a medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a standard chemotherapy for prostate cancer), after the prostate cancer had gotten worse when treated with enzalutamide alone. Conditions: Metastatic Castration Resistant Prostate Cancer Intervention / Treatment: DRUG: Enzalutamide, DRUG: Docetaxel, DRUG: Prednisolone, DRUG: Placebo Location: Poland, Germany, Sweden, Spain, Czechia, United Kingdom, Italy, Netherlands, Austria, Belgium, Greece, Norway, Russian Federation, Turkey, France, Switzerland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features; * Ongoing androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of initiation of investigational medicinal product (IMP), or bilateral orchiectomy (i.e., surgical or medical castration); * Metastatic disease documented by at least 2 bone lesions on bone scan, or soft tissue disease documented by computed tomography (CT)/magnetic resonance imaging (MRI); * Progressive disease at study entry defined as the following occurring in the setting of castrate levels of testosterone: Prostate specific antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of >= 1 week between each determination. * Asymptomatic or minimally symptomatic prostate cancer (Brief Pain Inventory - Short Form (BPI-SF) question 3 score of < 4); * Eastern Cooperative Oncology Group (ECOG) performance score of 0 <= age <= 1; * Estimated life expectancy of >= 12 months; * Be suitable and willing to receive chemotherapy as part of the trial; * Able to swallow the IMP and comply with study requirements; * Subject agreed not to participate in another interventional study while on treatment. Exclusion Criteria: * Prior treatment with the following agents for the treatment of prostate cancer: Aminoglutethimide; Ketoconazole; Abiraterone; Enzalutamide or participation in a clinical trial of enzalutamide; 223Ra, 89Sr, 153Sm, 186Re/188Re; Immunomodulatory therapies; Cytotoxic chemotherapy; Participation in a clinical trial of an investigational agent that inhibits the AR or androgen synthesis unless the treatment was placebo; * Current or prior treatment within 4 weeks prior to initiation of investigational medicinal product (IMP) with the following agents for the treatment of prostate cancer: Antiandrogens; 5-α reductase inhibitors; Estrogens; Anabolic steroids; Drugs with antiandrogenic properties; Progestational agents; * Subject had received investigational therapy within 28 days or 5 half-lives whichever was longer, prior to initiation of IMP; * Use of opiate analgesia for pain from prostate cancer within 4 weeks prior to initiation of IMP; * Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to initiation of IMP; * Major surgery within 4 weeks prior to initiation of IMP; * History of seizure or any condition that may predispose to seizures at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months prior to Screening; * Known or suspected brain metastasis or active leptomeningeal disease; * History of another malignancy within the previous 5 years other than non-melanoma skin cancer; * Clinically significant cardiovascular disease; * Gastrointestinal disorders affecting absorption; * Medical contraindications to the use of prednisolone or docetaxel; * Allergies to any of the active ingredients or excipients in the study drugs

NCT_ID NCT02288247

Study_NameA Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone

Study Objectives The purpose of the study is to determine whether amrubicin is safe and effective in the treatment of patients with advanced solid tumors. The study will assess the pharmacokinetics of the amrubicin and if it has an effect on the heart. Conditions: Advanced Solid Tumors Intervention / Treatment: DRUG: Amrubicin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients meeting all of the following criteria will be considered for enrollment into the study: 1. Males or females, aged 18 <= age <= 65 years; 2. Histological or cytological diagnosis of solid malignancy for which no acceptable standard therapy exists or for which approved standard therapy has failed; 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 4. Life expectancy greater than 3 months; 5. Nonsmoker or not smoked or used tobacco products for at least 3 months before the screening visit and agree to abstain from smoking/using tobacco products throughout the formal study and until the End of Study visit; 6. Capable of giving informed consent, has signed the informed consent form, and is willing to comply with scheduled visits, dose administration, and other study procedures; 7. Women of childbearing potential may participate, providing they have a negative serum pregnancy test (β-HCG) at screening, and a negative urine pregnancy test prior to dosing on Day 1 of each cycle; 8. Males and females of childbearing potential must agree to the use of at least 2 effective contraceptive methods until at least 28 days following the last dose of study drug; 9. Serum potassium, magnesium and corrected calcium that is within institutional normal range at screening; 10. Adequate organ function including the following: * Adequate bone marrow reserve: absolute neutrophil count (segmented and bands) (ANC) >=1.5 x 109/L, platelet count >=100 x 109/L, and hemoglobin >=90 g/L, * Hepatic: bilirubin <=1.5 x the upper limit of normal (ULN), ALT and AST <=2.0 x ULN, * Renal: serum creatinine <=1.5 x ULN or calculated creatinine clearance >80 mL/min. Exclusion Criteria: * Patients meeting any of the following criteria will be excluded from the study: 1. Hypersensitivity to amrubicin or related compounds; 2. Radiotherapy with curative intent to a primary disease complex <= 28 days before first dose; cranial radiotherapy <= 21 days before first dose; radiotherapy to all other areas <= 7 days before first dose of amrubicin; 3. History or presence of clinically significant abnormal 12-lead ECG or triplicate ECGs with a mean QT interval corrected for heart rate (HR) using Fridericia's method (QTcF) of >450 msec (males) or >470 msec (females), a PR interval >240 msec or a QRS interval >110 msec (within 3 months of screening visit); 4. Left ventricular ejection fraction (LVEF) <50%; 5. Recent history (within 3 months of screening visit) of pericarditis and pericardial effusion; 6. History within 6 months of the screening visit of one of the following: * cardiac disease including congenital long-QT syndrome, * angina, congestive heart failure, * myocardial ischemia or infarction, * myocarditis, chest pain or dyspnea on exertion of cardiac origin,, * idiopathic or hypertrophic cardiomyopathy, * sarcoidosis, * syncope, * epilepsy, * or other clinically significant cardiac disease; 7. Family history of long QT syndrome; 8. Use of implantable pacemaker or implantable cardioverter defibrillator; 9. Clinically significant bradycardia (<50 beats per minute); 10. Systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg; 11. Previous treatment with an investigational agent or any anticancer therapy within 4 weeks prior to the 'off-drug' visit; 12. Previous treatment with anticancer therapy and has not fully recovered (Common Terminology Criteria Adverse Event [CTCAE] Grade 1, except alopecia) from the toxic effects of that treatment; 13. Treatment with any medication known to produce QT prolongation enzyme-inducing anticonvulsants, non-prescription medications including topical medications, all vitamins, minerals, herbs or dietary supplements/remedies (e.g., Saint John's Wort or Milk Thistle) for at least 7 days before the start of the off-drug visit; 14. Previous treatment with any anthracycline; 15. Any condition that would put the patient at undue risk or discomfort as a result of adherence to study procedures; 16. Women who are pregnant or nursing; 17. Uncontrolled intercurrent illness such as myelosuppression, renal impairment, hepatic impairment, infection and uncontrolled diabetes; 18. Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable for >= 2 weeks after radiotherapy, if the patient is on corticosteroids, the dose of corticosteroids must have been stable for >= 2 weeks prior to the first dose of study treatment, or be in the process of being tapered; 19. Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis not related to prior treatment; 20. History of seropositive HIV or patients who are receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications; 21. Positive urine drug screen for undeclared concomitant medications and/or illegal drug use at screening.

NCT_ID NCT00915083

Study_NameA Phase I Study to Assess the Safety, Pharmacokinetics, and Potential Effects of Amrubicin on the QT/QTc Interval in Cancer Patients With Advanced Solid Tumors.

Study Objectives This study is a phase 1, dose finding, open-label study in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This is a dose escalating study to define the maximum tolerated dose (MTD) of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) in DLBCL patients who are not eligible for autologous stem cell transplant. The study will also assess safety and tolerability, pharmacokinetics, biodistribution and efficacy. Conditions: Relapsed, Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma Intervention / Treatment: DRUG: Betalutin Location: Germany, United Kingdom, United States, Spain, Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Male or female aged >=18 years. * Histologically confirmed DLBCL (WHO classification). * Received at least one prior line of therapy including immuno-chemotherapy. * In first or subsequent relapse, or refractory to the last treatment (defined as less than a complete metabolic response to the last treatment, or disease progression within 6 months from the last treatment). * Not suitable for, or declined/unwilling to undergo intensive therapy, including high dose chemotherapy and autologous stem cell transplantation (ASCT). * Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (at least one objectively bi-dimensionally measurable (nodal) lesion (>1.5 cm in its largest dimension by CT scan). * Negative human anti-mouse antibody (HAMA) test. * Life expectancy of at least 3 months. * Bone marrow tumour infiltration <25% tumour cells. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. * Normal organ and bone marrow function defined as: 1. Absolute neutrophil count >=1.5 x 109/L 2. Platelet count >=150 x 109/L; 3. Haemoglobin >=9 g/dL 4. Total bilirubin <=1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome) 5. Liver enzymes: Aspartate transaminase (AST); Alanine transaminase (ALT) or Alkaline phosphatase (ALP) <=2.5 x ULN (or <=5.0 x ULN if liver involvement by primary disease) 6. Adequate renal function as demonstrated by a serum creatinine <=1.5 mg/dL or a creatinine clearance >60 mL/min 7. Normal coagulation parameters (elevated international normalized ratio (INR), prothrombin time or activated partial thromboplastin time (APTT) <=1.3 ULN range acceptable) * Women of childbearing potential must: 1. Understand that the study medication may have teratogenic risk 2. Have a negative serum pregnancy test at screening and before Betalutin injection 3. Commit to continued abstinence from heterosexual intercourse (excluding periodic abstinence or the withdrawal method) or begin two acceptable methods of birth control with a Pearl-Index <= 1%. without interruption from 4 weeks before starting study drug, throughout study drug therapy and for 12 months after end of study drug therapy, even if she has amenorrhoea. Apart from abstinence, acceptable methods of birth control are: * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomised partner * Male patients must agree to use condoms during intercourse throughout study drug therapy and the following 12 months. * Ability to give written, informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice. * Capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document. * A negative Hepatitis B test (HBsAg and anti-HBc) and negative HIV test during screening Exclusion Criteria: * Prior hematopoietic allogenic stem cell transplantation. * Prior autologous stem cell transplantation. * Previous total body irradiation. * Prior anti-lymphoma therapy (chemotherapy, immunotherapy or other investigational agent), excluding corticosteroids within 4 weeks prior to start of study treatment (i.e. rituximab) (G-CSF or GM-CSF are permitted up to 2 weeks prior to start of study treatment.) * Patients who are receiving any other investigational agents. * Patients with known or suspected central nervous system involvement of lymphoma. * History of a previous treated cancer except for the following: 1. Adequately treated local basal cell or squamous cell carcinoma of the skin 2. Cervical carcinoma in situ 3. Superficial bladder cancer 4. Localized prostate cancer undergoing surveillance or surgery 5. Localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy 6. Other adequately treated Stage 1 or 2 cancer currently in complete remission * Pregnant or breastfeeding women. * Exposure to another CD37 targeting drug. * Allergy to X ray contrast agents. * A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, lilotomab or Betalutin. * Has received a live attenuated vaccine within 30 days prior to enrolling in the study. * Evidence of severe or uncontrolled systemic diseases: 1. Uncontrolled infection including evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment 2. Pulmonary conditions e.g. unstable or uncompensated respiratory disease 3. Hepatic, renal neurological or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives 4. Psychiatric conditions e.g. patients unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the study 5. History of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome 6. Cardiac conditions, including: * history of acute coronary syndromes (including unstable angina) * class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; * known uncontrolled arrhythmias (except sinus arrhythmia) in the past 24 weeks.

NCT_ID NCT02658968

Study_NameStudy of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)

Study Objectives This study is being conducted to demonstrate the superiority in progression-free survival (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants with del 17p or in the overall population who are refractory to either fludarabine treatment or chemoimmunotherapy. Conditions: Chronic Lymphocytic Leukemia (CLL) Intervention / Treatment: DRUG: Dinaciclib, DRUG: Ofatumumab Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Aged >= 18 years * Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) * Fludarabine or chemoimmunotherapy refractory disease defined as: failing to respond to or relapsed within 6 months of completing fludarabine or another purine analog alone or in combination regimens, or failing to respond to chemoimmunotherapy or relapsed within 24 months of completing therapy with a combination of chemotherapy plus an anti-CD20 monoclonal antibody * Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2 * Adequate organ function and laboratory parameters * Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study Exclusion Criteria: * Symptomatic brain metastases or primary central nervous system malignancy * Treatment with a CYP3A4 inhibitor or inducer within 1 week prior to randomization, or any chemotherapy or biologic therapy within 4 weeks prior to randomization * Known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy * Participants with with clinically active hepatitis B or C defined as disease that requires therapy * Positive test for glucose-6 phosphate dehydrogenase (G6PD) deficiency * Prior allogeneic bone marrow transplant * Presence of Richter's transformation * Indeterminate deletion 17p status * Previous treatment with ofatumumab, dinaciclib, or other CDK inhibitors * Active autoimmune anemia or thrombocytopenia unless stable, which is defined as being responsive to corticosteroids or other standard therapy

NCT_ID NCT01580228

Study_NameA Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714)

Study Objectives Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec® remains unknown. The objective of this study is to determine the feasibility of Glivec® treatment interruption with reintroduction at progression in GIST patients. Conditions: Sarcoma, Gastro-intestinal Stromal Tumors (GIST) Intervention / Treatment: DRUG: interruption of Glivec® Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients 18 years or over. * Histologically documented diagnosis of malignant GIST. * Immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases using the DAKO assay. * Performance status 0,1, 2, 3 (ECOG) * Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.0 x 109/L, platelets > 100 x 109/L. * Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 2 weeks (according to updated Invest. Brochure) following discontinuation of study drug. * Written, voluntary, informed consent. Exclusion Criteria: * Patient has another malignant tumor in CR<3 years (except if the other primary malignancy is inactive and not requiring active intervention). Previous basal cell skin cancer or a cervical carcinoma in situ are allowed. * Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) * Female patients who are pregnant or breast-feeding. * Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. * Patients received chemotherapy within 2 weeks prior to study entry, unless the disease is rapidly progressing * Patients had a major surgery within 2 weeks prior to entry study * Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent. * Previous treatment with Glivec®

NCT_ID NCT00367861

Study_NameProspective Multicentric Randomized Study of Glivec® in Advanced GIST Expressing C-kit: Interruption After 5 Years vs Maintenance

Study Objectives The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent cancer pain. Conditions: Cancer, Pain Intervention / Treatment: DRUG: Fentanyl sublingual spray Location: Canada, United States, India Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: SUPPORTIVE_CARE Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: All subjects who have completed the Double-blind Period and Final Visit of protocol INS-05 <= age <= 001(NCT00538850), Multicenter Randomized Double-blind Trial of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain are eligible for participation in this open-label extension study. All de novo subjects must meet all of the following criteria to be eligible for participation in the study: * Male or female, > 18 years. * Diagnosis of cancer. * Opioid treatment. Patients who are treated with opioids are defined as those patients who are taking at least 60 mg of oral morphine/day, at least 25 µg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of oral hydromorphone/day or an equianalgesic dose of another opioid for > 7 days for cancer-related pain. * Experience persistent pain related to the cancer or its treatment of moderate or lesser intensity in the 24 hours prior to assessment by a verbal rating scale at the Screening Visit. * Experience on average 1 to 4 breakthrough cancer pain episodes per day usually at least partially controlled by supplemental medication of at least 5 mg immediate-release morphine or an equivalent short-acting opioid (eg, oxycodone, hydrocodone, or codeine with acetaminophen). * Able to evaluate pain relief, assess medication performance, report adverse events (AEs), report use of the study drug or supplemental medication (a caregiver may provide the subject the medication). * Able and willing to give informed consent. * Women of childbearing potential must have a) a negative urine pregnancy test, b) not be breast feeding and c) agree to practice a reliable form of contraception. Exclusion Criteria: * Intolerable side effects to opioids or fentanyl. * Rapidly increasing/uncontrolled pain. * A history of major organ system impairment or disease, that in the Investigator's or his/her designee's opinion could increase the risk associated with the use of opioids. * Uncontrolled hypertension (systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 90 mm Hg on 2 occasions at least 6 hours apart) despite antihypertensive therapy, or has a history of hypertensive crisis within the past 2 years. * A recent history (within the past 2 years) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms. * Serum creatinine, ALT or AST that is greater than 3 times the upper limit of normal. * Diagnosis of sleep apnea. * Brain metastases with signs or symptoms of increased intracranial pressure. * Inability to assess pain or response to pain medications for any reason, including psychiatric disorder, concurrent medical disorder, or concomitant therapy. * Has used methadone within 14 days of the Screening Visit. * Received an investigational study product(s) within 30 days of the Screening Visit. * Use of monoamine oxidase (MAO) inhibitors within 14 days of the Screening Visit.

NCT_ID NCT00538863

Study_NameLong-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain

Study Objectives Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The trial is to explore ALTN for the effectiveness of advanced medullary thyroid carcinoma and security. Conditions: Tumor Intervention / Treatment: DRUG: Anlotinib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 1.late medullary thyroid carcinoma; 2.18 <= age <= 70years, ECOG:0 <= age <= 2,Expected survival period >3 months; 3.Calcitonic>=500pg/ml, thyroid function normal; 4.HB>=100g/L,ANC(Absolute Neutrophil Count) >=1.5×109/L；PLT * 80×109/L ,BIL/Cr in normal range,ALT/AST(aspartate aminotransferase )<=1.5*ULN(for hepatic metastases,ALT/AST(aspartate aminotransferase )<=5*ULN) ;TG<= 3.0mmol/L，cholesterol<=7.75mmol/L; LVEF * LLN. 5.Username contraceptive during the study and after 6 months; 6.Volunteer. Exclusion Criteria: * 1.Received vascular endothelial growth inhibitor type of targeted therapy; 2.Subject was diagnosed with The second cancer; 3.Participated in other clinical trials in four weeks; 4.Received in other radiotherapy or chemotherapy treatment in four weeks; 5.With AE> 1; 6.Has influence of oral drugs; 7.Brain metastases, spinal cord compression, cancerous meningitis, or the brain/soft meningeal disease patient; 8.Any serious or failed to control the disease 9.Artery/venous thrombotic; 10.Coagulant function abnormality; 11.Arteriovenous thrombosis event; 12.History of psychiatric drugs abuse or a mental disorder; 13.Immunodeficiency history; 14.Concomitant diseases.

NCT_ID NCT01874873

Study_NameA Phase II Study of Anlotinib in MTC Patients

Study Objectives The different alternatives used since 1996 to treat metastatic colorectal cancer (MCRC) have increased the mean survival of these patients. This outstanding advance is due to the extended indications for resection of hepatic metastases and to the use of new chemotherapeutic drugs (fluoropyrimidine, irinotecan and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab and panitumumab). However, none of these treatments is curative and the majority of patients are overwhelmed by the illness. The first line of treatment for MCRC is FOLFOX and the second, irinotecan plus cetuximab for patients with wild type KRAS gene (60%) with a 30% responses, and bevacizumab plus irinotecan with a 5-10% of responses, in patients with mutated KRAS (40%). A treatment with autologous dendritic cells (DCs) pulsed with autologous tumour antigens is proposed as a third line of therapy. A randomized phase II trial would be performed, by selecting two groups of patients, one of them would be treated with the best supportive treatment and the other with DCs plus the best supportive treatment. The aim of the study would be to analyze the outcome after 4 months of treatment. In patients treated with DCs, IFN-γ spot forming cells and proliferative responses would be determined pre and post treatment in lymphocytes stimulated with autologous DCs pulsed with autologous tumour antigens. Pre and post treatment serum levels of IFN-γ, TNF-α, TGF-β e IL-12, would also be measured. Conditions: Colorectal Neoplasms Intervention / Treatment: DRUG: Dendritic Cell Vaccine, OTHER: Supportive treatment Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age > 18 years. * Capacity of understanding and signing the informed consent and to undergo the study procedures. * Previously treated with 2 lines of chemotherapy. * ECOG <= 2. * Adequate renal, hepatic and bone marrow function * Confirmed diagnosis of colorectal cancer with hepatic metastasis, suitable for biopsy. * Availability of tumor tissue, for maturing dendritic cells * RECIST.1 criteria Exclusion Criteria: * Clinically relevant diseases or infections (HBV, HCV, HIV). * Pregnant or breast feeding women. * Immunosuppressant treatment. * Concurrent cancer, with the exceptions allowed by the principal investigator (PI).

NCT_ID NCT01413295

Study_NameRandomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer

Study Objectives The purpose of this study is to find out how safe and effective treatment with a new combination of drugs, vorinostat and etoposide, is in treating cancer. The medication etoposide is a standard medication used in the treatment of cancer in children. Vorinostat is an experimental drug which targets a protein(s) that control the way cancer cells grow and divide. Vorinostat is approved by the FDA in adults with certain cancers but not approved yet in children. There are two parts to this study. In the first part of this study, the phase I portion, a safe dose of the combination, vorinostat and etoposide. The goal of second part of this study, the phase II portion, is to see how effective the combination of vorinostat and etoposide is in treating cancer. Conditions: Solid Tumors, Relapsed/Refractory Sarcomas Intervention / Treatment: DRUG: Vorinostat and Etoposide Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Phase I Component: Histologic confirmation of relapsed/refractory solid tumors, including tumors of the central nervous system that have failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. Patients with diffuse pontine glioma are not required to have histologic confirmation of disease, and are eligible with radiologic confirmation. Phase II Component: the population will be restricted to relapsed/refractory sarcomas * Patient must be between 4 <= age <= 21 years at the time of study enrollment. Efforts will be made to enroll patients <13 years so that adequate information about the biologic effects of this agent in younger patients can be obtained. * Patient must have Karnofsky > or = to 60% for patients >10 years; Lansky Play Scale > or = to to 60 for children < or = to 10 years * Patient must have a life expectancy of > 8 weeks. * There is no limit to the number of prior treatment regimens provided that performance status and life expectancy meet the criteria above. * Absolute neutrophil count (ANC) >= 1000 / mcL * Platelets >=100,000 / mcL (transfusion not permitted) * Hemoglobin >= 9 g/dL qualifications (transfusion permitted) * Coagulation Prothrombin Time or INR <= 1.5x upper limit of normal (ULN) * Serum creatinine <= 1.5x upper limit of normal (ULN) OR calculated creatinine clearance >= 60 mL/min for patients with creatinine levels > 1.5x institutional ULN. or calculated creatinine clearance Creatinine clearance should be calculated per institutional standard. * Serum total bilirubin <= 1.5 x ULN Patient's who don't meet this criteria must have a Direct bilirubin <= 1.5 x ULN * AST (SGOT) and ALT (SGPT) Alkaline Phosphatase (liver fraction) <= 2.5 x ULN. If AST or ALT is > 2.5 x ULN, then the liver fraction of Alkaline Phosphatase should be <= 2.5 x ULN * Phase I component: Patients may have measurable or non-measurable disease. Phase II component: Patients may only have measurable disease. * Patient must have no persistent toxicities from prior therapy > or = to Grade 2 with the exception of hematologic indices (i.e. hemoglobin, WBC, ANC, ALC). * For females of childbearing potential, a negative serum pregnancy test must be documented within 72 hours of receiving the first dose of vorinostat. * Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent. * Female patients of childbearing potential must be willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study, starting with visit 1. * Male patients must agree to use an adequate method of contraception for the duration of the study. * Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. * Myelosuppressive chemotherapy: At least 2 weeks must have elapsed since the administration of previous therapy. Six weeks must have elapsed since administration of nitrosoureas or mitomycin C. Seven days must have elapsed since the administration of G-CSF and/or GM-CSF. * Biologic agents: At least 14 days must have elapsed since the completion of therapy with a biologic agent such as a monoclonal antibody. Seven days must have elapsed since the last dose of retinoids. * Radiation therapy (XRT): > or = to 2 weeks must have elapsed for local XRT (small port); > or = to 6 months must have elapsed if prior radiation to > or = to 50% of the pelvis or if other substantial bone marrow irradiation, including total body irradiation. * Patient must be able to swallow capsules. * Patient must have an available archival/pre-treatment block or fresh tumor biopsy for molecular profiling to be performed. Exclusion Criteria: * A patient meeting any of the following criteria is not eligible to participate in this study: * Patients currently participating or has participated in a study with an investigational compound or device within 4 weeks of initial dosing with study drugs. * Patients with a prior history of treatment with HDAC inhibitors ( e.g. SNDX-275/entinostat, LAQ-824, LBH589, PXD-101/belinostat, etc). Patients who have received Valproic acid will be excluded from this study. * Patients with non CNS primary tumors who have known brain metastases or symptomatic CNS disease (e.g. cranial nerve abnormalities) without cytologic abnormality in the CSF should be excluded from this clinical trial because of their poor prognosis and known propensity for the development of progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with metastatic CNS tumors will not be excluded from enrollment on this study in the phase I component only. * Patients who have undergone prior autologous stem cell transplantation or allogeneic transplantation. * Uncontrolled intercurrent illness or circumstances that could limit compliance with the study requirements including, but not limited to: ongoing or active bacterial or fungal infection, acute or chronic graft versus host disease, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations. * Patients who are pregnant or breastfeeding, or expecting to conceive within the projected duration of the study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with vorinostat, lactating patients will be excluded from this study. * Patients known to be Human Immunodeficiency Virus (HIV)-positive. * Patients with known hypersensitivity to the components of the study drugs or their analogs. * Patients with symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible. * Patients who are at the time of signing informed consent, a regular user of any illicit drugs, substance abuser or who have a recent history of drug or alcohol abuse. * Patients with a known history of Hepatitis B or C. * Patients who have a history of gastrointestinal surgery or other procedures that might in the opinion of the investigator, interfere with the absorption or swallowing of the study drug. * Patients who are unable to take or tolerate oral medications on a continuous basis. * Patients with a history of a prior malignancy who have undergone potentially curative therapy with no evidence of that disease for five years or patients, who are deemed low risk for recurrence by his/her treating physician are permitted to enroll.

NCT_ID NCT01294670

Study_NameClinical Study of Vorinostat in Combination With Etoposide in Pediatric Patients < 21 Years at Diagnosis With Refractory Solid Tumors

Study Objectives Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy. Conditions: Breast Cancer Intervention / Treatment: DRUG: FEC3-D3 Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Performance status 0 or 1 * Clinically stage 2 or 3 with histologically proven lymph node involvement * Tumor or lymph node greater than 1.5 cm Exclusion Criteria: * Pregnancy or lactation * Prior chemotherapy or radiotherapy for any malignancy * Documented history of cardiac disease contraindicating anthracyclines * Currently active infection

NCT_ID NCT02001506

Study_NameNeoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer

Study Objectives The goal of this clinical research study is to learn if the combination of bevacizumab and carboplatin can help to control recurrent ependymoma. The safety of this drug combination will also be studied. Conditions: Ependymoma, Anaplastic Ependymoma Intervention / Treatment: DRUG: Carboplatin, DRUG: Bevacizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

INCLUSION CRITERIA: * Histologically proven intra-cranial or spinal ependymoma or anaplastic ependymoma. There must be pathologic or imaging confirmation of tumor progression or regrowth. * The patient must have at least 1 block of tissue or 15 unstained slides at a minimum available for central pathology review and molecular profiling of the tissue sample. * All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information. * Patients must be greater than or equal to 18 years. * Patients must have a Karnofsky performance status of > 60. * Patients must have adequate bone marrow function (white blood cell (WBC) greater than or equal to 3,000/microliter, absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, platelet count of greater than to equal to 100,000/mm^3, and hemoglobin greater than or equal to 10 gm/dl), adequate liver function (Serum glutamic oxaloacetic transaminase (SGOT) [aspartate aminotransferase (AST) <92.5 Units/L] and bilirubin less than or equal to 1.5 mg/dL), and adequate renal function (creatinine < 1.5 mg/dL and calculated creatinine clearance greater than or equal to 60 cc/min) before starting therapy. Eligibility level for hemoglobin may be reached by transfusion. * Patients must have shown unequivocal radiographic evidence for tumor progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan. * At the time of registration: Patients must have recovered from the toxic effects of prior therapy: greater than or equal to 28 days from any investigational agent, greater than or equal to 28 days from prior cytotoxic therapy, greater than or equal to 14 days from vincristine, greater than or equal to 42 days from nitrosoureas, greater than or equal to 21 days from procarbazine administration, and greater than or equal to 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the Principal Investigator. * Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: * They have recovered from the effects of surgery. * A minimum of 28 days have elapsed from the day of surgery to the day of registration Step 2. * For core or needle biopsy, a minimum of 7 days must have elapsed prior to registration Step 2. * Residual disease following resection of recurrent ependymoma is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to consent. If the within 96-hour after surgery scan is more than 14 days before consent the scan needs to be repeated. If the steroid dose is increased between the date of imaging and consent, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days. * Patients must have failed prior radiation therapy* and must have an interval of greater than or equal to 42 days from the completion of radiation therapy to study entry. Note: Patients with an indication for craniospinal radiotherapy (i.e., extensive leptomeningeal disease) but have refused palliative craniospinal radiotherapy are eligible. * Patients with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon either positron emission tomography (PET) or Thallium scanning, MR spectroscopy, or surgical/pathological documentation of disease. * Women of childbearing potential must have a negative B (Beta)-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration. * Women of childbearing potential and male participants agree to practice adequate contraception. EXCLUSION CRITERIA: * Patients with any significant medical illnesses that in the investigators opinion cannot be adequately controlled with appropriate therapy or would compromise the patients ability to tolerate this therapy. * Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma insitu of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible. * Patients with an active infection or serious intercurrent medical illness. * Patients found to be pregnant/breast feeding. Patients must not be pregnant because animal studies show that carboplatin and bevacizumab are teratogenic * Patients with any disease that will obscure toxicity or dangerously alter drug metabolism. * Patients who have received prior therapy with bevacizumab, or related drugs (previous therapy with carboplatin is allowed). * Inadequately controlled hypertension (defined as systolic blood pressure >150 millimeters of mercury (mmHg) and/or diastolic blood pressure > 100 mmHg) despite antihypertensive medication. * New York Heart Association (NYHA) Grade II or greater congestive heart failure. * History of myocardial infarction or unstable angina within 12 months prior to Day 1. * History of stroke or transient ischemic attack. * Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1. * History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1. * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation). (To be eligible, Prothrombin time/international normalized ratio (prothrombin time (PT) international normalized ratio (INR)) should be < 1.4 for patients not on warfarin.) * Patients receiving full-dose anticoagulants therapy (e.g., warfarin or Low-molecular-weigh (LMW) heparin) and does not meet both of the following criteria: * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices). * In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of treatment or anticipation of need for major surgical procedure during the course of the study. * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1. * History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1. * Serious, non-healing wound, active ulcer, or untreated bone fracture. * Proteinuria as demonstrated by a urine protein:creatinine (UPC) ratio greater than or equal to 1.0 at screening, or Urine dipstick for proteinuria greater than or equal to 2+ (patients discovered to have greater than or equal to 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate less than or equal to 1g of protein in 24 hours to be eligible). * Known hypersensitivity to any component of bevacizumab. * Patients has current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment).

NCT_ID NCT01295944

Study_NameCarboplatin and Bevacizumab for Recurrent Ependymoma

Study Objectives This phase II, single-center study will assess the efficacy of pembrolizumab + nab-paclitaxel in patients who have metastatic urothelial tumor and do not respond to chemotherapy. The time between drug administration and progression of the disease will be assessed to determine if the drug will work. Conditions: Metastatic Urothelial Carcinoma Intervention / Treatment: DRUG: Pembrolizumab and Nanoparticle Albumin-bound Paclitaxel Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Be willing and able to provide written informed consent/assent for the trial, and be willing and able to follow trial procedures. * Be 18 years-old on day of signing informed consent. * Have an histologically-confirmed diagnosis of UC of the bladder or the urothelium, originating from either the bladder or the urinary tract (including upper tract), with predominant (>50%) UC component if other divergent histologies (e.g. squamous cell carcinoma, adenocarcinoma, small cell carcinoma) are found. * Have a life expectancy of at least 12 weeks. * Have experienced failure of 1 or 2 platinum-based conventional chemotherapy regimens for metastatic disease (2nd-to-3rd line only); a relapse should be occurred within 6 months from the last cycle of chemotherapy. * Have measurable disease based on RECIST 1.1. * Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may provide an archived specimen. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Demonstrate adequate organ function. * (Female subject of childbearing potential) Have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * (Female subjects of childbearing potential ) Be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. * (Male subjects of childbearing potential) Agree to use an adequate method of contraception, starting from the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria: * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment * Has a known history of active Bacillus Tuberculosis * Had prior administration of taxane-based chemotherapy * Is taking regular oral steroids, above the allowed limit of 10mg/day methylprednisolone or analogues, for any reason. Patients must not have had steroids for 28 days prior to study entry * Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., Grade <=1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent * Note: Subjects with Grade <=2 neuropathy are an exception to this criterion and may qualify for the study * Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Has an active infection requiring systemic therapy. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) * Has known active Hepatitis B or Hepatitis C * Has received a live vaccine within 30 days of planned start of study therapy

NCT_ID NCT03464734

Study_NamePembrolizumab and Nab Paclitaxel in Patients With Metastatic Urothelial Carcinoma

Study Objectives To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim. Conditions: Neutropenia Intervention / Treatment: DRUG: pegfilgrastim Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * patients diagnosed as malignant lymphoma * patients who were refractory to anthracycline or anthraquinone containing chemotherapy * patients who are going to receive ESHAP or CHASE treatment regimen * ECOG performance status =< 2 * patients who have appropriate bone marrow, hepatic and renal functions * written informed consent Exclusion Criteria: * double cancer * history of bone marrow transplantation or PBSCT * more than 2 prior chemotherapy regimens * primary hematologic disease such as myelodysplastic syndrome * previous radiotherapy within 4 weeks of enrollment * woman of childbearing potential who were either pregnant, breast feeding * patients who participated in other clinical trials within the last 4 weeks of enrollment

NCT_ID NCT00364468

Study_NameDose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients

Study Objectives Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Participants, who were not treated previously for DLBCL, will receive MabThera in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy according to registered indication. Patients will be followed up for safety and efficacy evaluation in accordance with routine practice. The study will be non-interventional and by its design purely observational. All treatments prescribed during the observation period will be at the treating physician's discretion and will be prescribed according to package labeling, within approved indication and local approval status of respective drugs. Conditions: Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma Intervention / Treatment: DRUG: Cyclophosphamide, DRUG: Hydroxydaunorubicin, DRUG: Oncovin, DRUG: Prednisone, DRUG: Rituximab Location: Serbia Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Histologically confirmed cluster of differentiation antigen 20 (CD20) positive Diffuse Large B-Cell Lymphoma according to the World Health Organization/Revised European-American Classification of Lymphoid Neoplasms (WHO/REAL) classification * Age > or =18 years * Performance status < or = 2 on the Eastern Cooperative Oncology Group (ECOG) scale * Women of child-bearing potential must agree to use effective contraception for the entire treatment period and during the 12 months thereafter Exclusion Criteria: * Transformed lymphoma (secondary to "low-grade" follicular lymphoma) * Grade 1, 2 or 3a follicular lymphoma * Primary or secondary central nervous system (CNS) involvement * Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer * Major surgery (excluding lymph node biopsy) within 28 days prior to registration. * Poor renal function: Serum creatinine > 2.0 mg/dl (177 micromol/L) * Pregnancy * Poor hepatic function: total bilirubin > 2.0 mg/dl (34 micromol/L), aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]) or alkaline phosphatase (AP) > 3 x the upper limit of normal unless these abnormalities are related to lymphoma. * Known human immunodeficiency virus (HIV) infection or active viral hepatitis, specifically hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. * Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial * Life expectancy < 6 months * Known sensitivity or allergy to murine products * Treatment within a clinical trial within 30 days prior to trial entry

NCT_ID NCT02486952

Study_NameMabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma

Study Objectives PURPOSE: A primary aim of phase II FOCULM study is to explore whether cetuximab in combination with FOLFOXIRI as first treatment could improve surgical conversion in patients with KRAS/NRAS wild-type, unresectable liver - only metastases of colorectal cancer. The first secondary aim is to evaluate the safety and tolerability of the chemotherapy of FOLFOXIRI plus Cetuximab targeted therapy regimen in this patient population. Secondary aims include determination of objective response rate, progression free survival, quality of life and time to recurrence for patients undergoing complete resection and/or ablation of liver. Conditions: Metastatic Colorectal Cancer Intervention / Treatment: DRUG: FOLFOXIRI + Cetuximab, DRUG: FOLFOXIRI Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Signed informed consent obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent. * Male or female subjects > 18 years < 65 of age * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and must be considered a potential candidate for a major hepatic surgical procedure. * Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded. * There must be documentation by PET/CT scan, CT scan, MRI, or intraoperative palpation (at the time of resection of the primary colorectal tumor, if applicable) that the patient has evidence of metastases confined to the Liver (Histologic confirmation of hepatic metastasis is not required.). The liver metastases must have been determined by a hepatic surgeon approved to participate in the study to be unresectable based on at least one of the following criteria: All of the liver metastases can not be resected (and/or ablated) with negative margins, i.e., lesion(s) located in an area that would result in the resection of all of the hepatic veins or the main portal vein or the right and left hepatic arteries or the common bile duct; Complete resection and/or ablation would require greater than 60% of the liver parenchyma to be removed. * Patients are eligible with any of the following: primary tumor and regional nodes resected with clear surgical margins and no evidence of extra-hepatic disease or; unresected primary tumor with plans to resect the primary tumor prior to study entry or; unresected primary tumor with plans to resect the primary tumor and the liver metastases in a single surgical procedure performed within 8 weeks after the last preoperative dose of chemotherapy/cetuximab or; unresected primary with plans to resect the primary tumor and the liver metastases in staged procedures performed within 8 weeks after the last preoperative dose of chemotherapy/cetuximab. * The colorectal primary tumor or metastatic tumor must be determined to be KRAS and NRAS wild-type. * At least one measurable lesion in liver metastases according to according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria measured within 4 weeks prior to registration. * No previous any systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy and hormonal therapy for metastatic disease for metastatic disease (adjuvant chemotherapy for non-metastatic disease is allowed if terminated more than 6 months ago). * Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: * Leukocytes >= 3.0 x109/ L, absolute neutrophil count (ANC) >= 1.5 x109/ L, platelet count >= 100 x109/ L, hemoglobin (Hb) >= 9g/ dL. * Total bilirubin <=1.5 x the upper limit of normal (ULN). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 5 x ULN. * Alkaline phosphatase limit <= 5x ULN. * Amylase and lipase <= 1.5 x the ULN. * Serum creatinine <= 1.5 x the ULN. * Calculated creatinine clearance or 24 hour creatinine clearance >= 50 mL/ min. Exclusion Criteria: * Any evidence of extra-hepatic metastases, lymph node (including portal lymph nodes) metastases and primary tumor recurrence. * Previous hepatic resection and/or ablation, hepatic arterial infusion therapy, radiation therapy to the liver (Patients who have only had an excisional biopsy are eligible). * Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization. * Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization. Subjects must have recovered from all therapy-related toxicities. * Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks before start of study medication. * Uncontrolled hypertension. (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management). * Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication. * Any evidence of active infection. * Known history of human immunodeficiency virus (HIV) infection. * Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy. * History of bleeding diathesis or coagulopathy. * Uncontrolled hypertension. (systolic blood pressure ﹥150 mmHg or diastolic pressure ﹥ 90 mmHg despite optimal medical management). * History of interstitial pneumonitis or pulmonary fibrosis * Pregnancy or lactation at the time of study entry. * Any history of or currently known brain metastases. * Known dihydropyrimidine dehydrogenase (DPD) deficiency * Any illness or medical conditions that are unstable or could jeopardize the safety of the subjects and his/her compliance in the study. * Unresolved toxicity higher than CTCAE v. 4.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity ﹥ Grade 2. * Active inflammatory bowel disease or other bowel disease causing chronic diarrhea * Subjects with known allergy to the study drugs or to any of its excipients. * Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.

NCT_ID NCT02063529

Study_NameFOLFOXIRI With or Without Cetuximab as First-line Treatment of Patients With Non-resectable Liver - Only Metastatic Colorectal Cancer

Study Objectives The purpose of this study is to determine whether MBP-426 (liposomal oxaliplatin suspension for injection) is safe and effective in the treatment of advanced or metastatic solid tumors. Conditions: Cancer Intervention / Treatment: DRUG: MBP-426 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pathologically-confirmed malignancy that is locally advanced or metastatic solid tumor and is refractory to standard therapy or for which conventional therapy is not reliably effective or no effective therapy is available * 18 years or older * ECOG Performance Status of 0, 1, or 2 * Adequate clinical laboratory values: * absolute neutrophil count greater than or equal to 1500 cells/microliter * platelets greater than or equal to 100,000 cells/microliter * serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) for the institution * creatinine clearance (calculated) > 60 mL/min (using the Cockcroft-Gault equation) * bilirubin less than or equal to 1.5 x ULN * alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 x ULN (patients with known liver metastases may have up to 5 times ULN AST and ALT levels). * Ability to cooperate with treatment and follow-up schedules * Negative pregnancy test and using at least one form of contraception as approved by the Investigator prior to study entry if a female patient of childbearing potential or a male patient with a female partner of childbearing potential * Measurable disease as defined by RECIST criteria or non-measurable disease * Patients with known brain metastases may be included as long as they have been clinically stable for one month or more, and are not receiving dexamethasone * Ability to maintain a central intravenous access (e.g. PICC, Groshong, or Hickman line) * Signed informed consent prior to the start of any study specific procedures Exclusion Criteria: * Received previous anticancer chemotherapy, immunotherapy, radiotherapy or any other investigational therapy in the 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry * Received extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation * Any concomitant condition that could compromise the objectives of this study and the patient's compliance * Pregnant or lactating women * Current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer or have demonstrated no evidence of disease for 5 years or more * Clinically evident HIV, HBV, or HCV infection * Hematologic malignancy * Documented or known bleeding disorder * Requirements for therapeutic anticoagulation that increases INR or aPTT above the normal range (low dose deep vein thrombosis [DVT] or line prophylaxis is allowed) * Congestive heart failure * Greater than Grade 1 peripheral neuropathy according to the National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (CTCAE version 3.0) * History of allergic reactions to platinum-based or liposomal agents * Creatinine clearance (calculated) less than or equal to 60 mL/min (using the Cockcroft-Gault equation) * Receiving or initiating treatment with any other investigational agents

NCT_ID NCT00355888

Study_NameSafety Study of MBP-426 (Liposomal Oxaliplatin Suspension for Injection) to Treat Advanced or Metastatic Solid Tumors

Study Objectives RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving lenalidomide together with rituximab and bendamustine hydrochloride may kill more cancer cells. PURPOSE: This phase I trial studies the side effects and the best dose of giving lenalidomide together with rituximab and bendamustine hydrochloride in treating patients with refractory or relapsed indolent non-Hodgkin lymphoma. Conditions: Refractory/Relapsed Indolent Non-Hodgkin Lymphoma Intervention / Treatment: BIOLOGICAL: rituximab, DRUG: bendamustine, DRUG: lenalidomide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age >= 18 years * Histologically confirmed relapsed (recurrent after previous therapy (-ies)) or refractory (no response to previous therapy (-ies)), CD20 + indolent/low-grade B-cell non-Hodgkin lymphoma (NHL) expressing CD20 antigen. Criteria for diagnosis can be found in reference J Clin Oncol 17(4): 1244 <= age <= 53, 1999. The biopsy confirming relapse can be up to 12 weeks prior to registration as long as there is no intervening therapy. If patients have been on active treatment within the the last 12 weeks, the tumor biopsy must be repeated before study enrollment to evaluate for transformation. * Small lymphocytic lymphoma (SLL) excluding chronic lymphocytic leukemia (CLL) (patients with peripheral blood lymphocyte count > 5,000) * Follicular lymphoma, grades 1, 2 (grade 3 excluded) * Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphatic tissue (MALT) type * Lymphoplasmacytic lymphoma including Waldenstrom macroglobulinemia * Measurable disease (at least 1 lesion of >= 1.5 cm in diameter) as detected by computed tomography (CT) or the CT images of the positron emission tomography (PET)/CT. Patients with Waldenstrom macroglobulinemia are not required to have measurable disease by CT or PET/CT if monoclonal protein is detectable by serum protein electrophoresis and/or IgM level is at least 2 times upper limit of normal * ECOG Performance Status (PS) 0, 1 or 2 * Required laboratory values obtained <= 21 days prior to registration: * ANC >= 1,500/mL * Platelet count >= 100,000/mL * Total bilirubin <= 1.5 x institutional upper limit of normal (ULN) OR, if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal * SGOT (AST) <= 5 x ULN * Creatinine clearance >= 50 mL/min by Cockcroft-Gault formula as outlined in the protocol * All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. The Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods are provided in the protocol for more information. * Females of childbearing potential (FCBP) as defined per the protocol must have: 1. A negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL <=10 - 14 days prior to registration and again <= 24 hours prior to starting cycle 1 of lenalidomide 2. >=28 days prior to registration, throughout the duration of the study, and for up to 28 days from the last dose of lenalidomide, FCBP must agree to either continued abstinence from heterosexual intercourse or must begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME 3. Must agree to ongoing pregnancy testing throughout the duration of the study and for up to 28 days from the last dose of lenalidomide. * Men must agree to abstinence or to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. * Willing to provide informed written consent. * Willing to return to enrolling institution for follow-up. * If currently not on anticoagulation medication, willing and able to take low-dose aspirin (81 mg) daily. NOTE: The dose of aspirin should be a minimum of 81 mg and can be higher if the patient is on the agent for other reasons. If aspirin is contraindicated, the patient may be considered for the study after consultation with the study chair regarding other alternatives including the possible use of warfarin or low molecular weight heparin. Patients unable to take any prophylaxis are not eligible. * Life expectancy >=6 months * Ability to swallow oral medications Exclusion Criteria: * This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown: * Pregnant women * Nursing women (lactating females are eligible provided that they agree not to breast feed while taking lenalidomide) * Men or women of childbearing potential who are unwilling to employ adequate contraception * Active CNS lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells that requires therapy * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. * Prior AIDS-defining conditions. Note: HIV positive patients without history of AIDS- defining conditions are eligible * If HIV positive, CD4 cells < 400/mm^3 * Current treatment with zidovudine (AZT) (which may cause overlapping adverse events, primarily myelosuppression). Patients receiving anti-retroviral therapy other than AZT are eligible * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * Receiving any other agent which would be considered as a treatment for the lymphoma. Note: Prior use of rituximab is allowed. * Another active malignancy requiring concomitant active therapy such as radiation, chemotherapy, or immunotherapy. Exceptions to this are as follows: * Localized non-melanotic skin cancer * Cancers that are inactive that are being treated with hormonal therapy * Any cancer that in the judgment of the investigator will not interfere with the study treatment plan and response assessment and require concomitant anticancer therapy for the duration of this study Contact the study chair regarding any questions related to eligibility of patients with concomitant active malignancy * History of myocardial infarction <= 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * History of life threatening (i.e. pulmonary embolism), DVT or recurrent thrombosis/embolism and are not on or unwilling to receive anticoagulation * Patients with history of DVT or life threatening or recurrent thrombosis/embolism (PE) may enter the study but must receive anticoagulation with low molecular weight (LMW) heparin or therapeutic warfarin during the protocol treatment and for >=6 months afterwards. Patients with strong family history of thrombosis should be considered for thrombophilia work up and/or anticoagulated at the discretion of treating MD. * Patients with a prior history (>6 months prior to study entry) of a non-life threatening, provoked thrombosis (e.g. history of catheter related thrombus or similar) and without known thrombophilia can participate in the study and receive standard prophylaxis with ASA (aspirin) or LMW heparin/warfarin at the discretion of treating MD. Active smokers should be advised on thrombosis risk and smoking cessation and may participate in the study if prophylaxis with ASA (aspirin) or LMW heparin/warfarin (at the discretion of treating MD) is given. Patients on estrogen birth control pills should be advised of the risks. * Known myelodysplastic syndrome * Receiving erythroid stimulating agents (EPO: Procrit, Aranesp). Note: Use of erythroid stimulating agents is not allowed during the study treatment. * Prior treatment with bendamustine.

NCT_ID NCT01429025

Study_NameRituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Refractory or Relapsed Indolent Non-Hodgkin Lymphoma

Study Objectives This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone. Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Sorafenib, DRUG: Erlotinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed stage IIIB/IV or relapsed non-small cell lung carcinoma (squamous carcinoma, adenocarcinoma, or large cell carcinoma). Patients with mixed tumors with small-cell elements are ineligible. * Patients with no more than 2 prior lines of therapy, with the latest of those therapies being single-agent erlotinib. * Evidence of progressive disease on erlotinib as assessed by the treating physician. Erlotinib must be the last treatment for NSCLC prior to enrollment into this study. Patients may be on erlotinib until enrollment. If erlotinib has already been stopped, the period of time off Erlotinib cannot exceed 14 days prior to study enrollment. * Patients must have experienced a clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) from prior therapy with erlotinib for a period of 8 weeks. * Patient must have one measurable lesion measuring at least 10 mm in the longest diameter (LD) by spiral computed tomography (CT), or 20 mm with conventional techniques according to the Response Evaluation Criteria in Solid Tumors (RECIST). * Recovery from any toxic effects of erlotinib to <= grade 1 per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). * Completion of palliative radiation therapy prior to the start of study treatment. Previously irradiated lesions in the advanced setting cannot be included as target lesions unless clear tumor progression has been observed following the completion of radiation therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Absolute neutrophil count (ANC) >=1,500 and platelets >=75,000 (within 7 days prior to initial study treatment). * Hemoglobin >=9 g/dL (within 7 days prior to initial treatment). * International normalized ratio (INR) <=1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution if not on anticoagulation therapy. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate with the therapeutic range established prior to study treatment initiation. * Serum creatinine <=1.5 x institutional upper limit of normal (ULN) within 7 days prior to initial study treatment. If the absolute value is greater than 2mg/dL, the creatinine clearance, calculated according to the Cockroft-Gault formula, must be >=45 mL/min to be eligible. * Bilirubin <=1.5 x the ULN; transaminases <=3 x institutional ULN, except in known hepatic metastasis, wherein these may be >=5 x institutional ULN. * Patients must be able to understand the nature of this study, give written informed consent, and comply with study requirements. * Agreement of male patients (with partners of childbearing potential) and female patients of childbearing potential to use effective contraception to prevent pregnancy during treatment and for a minimum of 90 days thereafter. Additionally, women should not breastfeed during this time. Exclusion Criteria: * Past or current history of neoplasm other than the entry diagnosis, with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone, and a disease-free survival (DFS) >=3 years. * Pregnancy or lactation. All females of child-bearing potential must have negative serum or urine pregnancy tests within 7 days prior to study treatment. * Prior epithelial growth factor receptor (EGFR) inhibitors, with the exception of erlotinib, are not allowed. This includes both tyrosine kinase inhibitors (TKIs) and monoclonal antibodies. Prior vascular endothelial growth factor (VEGF) inhibitors, with the exception of bevacizumab, are not allowed. * Significant cardiac disease within 90 days of starting study treatment including: * superior vena cava syndrome * new onset angina * congestive heart failure (CHF) > Class 2 per New York Heart Association (NYHA) classification * arrhythmia * valvular heart disease. * Myocardial infarction within 6 months prior to initiation of study treatment * Cardiomegaly on chest imaging or ventricular hypertrophy on electrocardiogram (ECG) unless the left ventricular ejection fraction (LVEF) is within normal range for the institution. * Poorly controlled hypertension (defined as systolic blood pressure [BP] >150 mm Hg and/or diastolic BP >100 mm Hg on antihypertensive medications). * Unstable angina (anginal symptoms at rest). * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. * Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia. * A serious active infection (> grade 2) at the time of treatment * A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment. * Untreated brain metastases. Patients who have treated metastases >=4 weeks out (with surgery and/or radiation therapy) and no evidence of central nervous system (CNS) progression are eligible. * Treatment with a non-approved or investigational drug within 28 days of initial study treatment. * A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment or anticipation of need for major surgery during the course of the study. * Thrombolic or embolic events such as a stroke and transient ischemic attack (TIA) within the past 6 months. * Any prior history of hypertensive crisis or hypertensive encephalopathy. * Pulmonary hemorrhage/bleeding event >= grade 2 within 28 days of initial study treatment. * Any other non-pulmonary hemorrhage/bleeding event >= grade 3 within 28 days of initial study treatment. * Evidence or history of bleeding diathesis or coagulopathy. * Serious non-healing wound, ulcer, or bone fracture. * Use of St. John's Wort or rifampin (rifampicin). * Known or suspected allergy/hypersensitivity to any agent given in the course of this trial. * Any malabsorption problem. * Any condition that impairs the patient's ability to swallow whole pills.

NCT_ID NCT00609804

Study_NameSorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

Study Objectives This phase II trial studies how well dasatinib works in treating patients with glioblastoma multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Neoplasm Intervention / Treatment: DRUG: Dasatinib, OTHER: Pharmacological Study Location: Canada, United States, Saudi Arabia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically proven diagnosis of GBM; gliosarcoma is also an eligible diagnosis * The patient must consent to submission of tissue for central pathology review * Patients who have already undergone central pathology review through their enrollment on another Radiation Therapy Oncology Group (RTOG) GBM trial do not need to consent to having their material re-reviewed by the central pathologist for this study * All patients must consent to molecular analysis of pre-dasatinib tumor tissue * Patients accrued to stage I (closed to accrual) or stage IB (opened to accrual May 5, 2009) must have tumors overexpressing at least 2 known dasatinib targets (i.e., SRC proto-oncogene, non-receptor tyrosine kinase [SRC], v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog [KIT], platelet-derived growth factor receptor [PDGFR], or ephrin type-A receptor 2 [EPHA2]) * Patients accrued to stage II (cohort closed; not currently applicable) do not require overexpression of SRC, KIT, PDGFR, or EPHA2 * History and physical examination, including height and weight, within 10 days prior to registration on study * Brain magnetic resonance imaging (MRI) with and without gadolinium within 10 days prior to registration on study * Contrast-enhanced computed tomography (CT) scans are allowed for patients who cannot undergo MRI scanning * Karnofsky performance status >= 60 * Absolute neutrophil count (ANC) >= 1,000 cells/mm^3 * Platelets >= 75,000 cells/mm^3 * Hemoglobin (Hgb) >= 8.0 g/dl; (note: the use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable) * Leukocytes >= 3,000 cells/mm^3 * Absolute lymphocyte count (ALC) >= 500 cells/mm^3 * Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 institutional upper limit of normal * Creatinine =< 3 X institutional upper limit of normal or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal * All patients must have undergone prior treatment with radiotherapy and temozolomide; no other prior treatments are allowed * There must be unequivocal radiographic evidence for tumor progression by MRI or CT scan, and the same type of scan (i.e., MRI or CT) must be used throughout the period of protocol treatment for tumor measurement; patients must be on a stable or decreasing dose of corticosteroids for at least 5 days before the baseline MRI/CT is performed * Patients having undergone recent surgery for recurrent/progressive disease are eligible as long as they have recovered from the effects of surgery; patients who recently underwent resection without measurable disease post-operatively are also eligible * Measurable disease is not required for eligibility in patients who recently underwent resection as long as the following conditions are met as applicable: * Progression of disease led to the surgery * Gliadel wafers were not placed during the most recent surgery * Neither convection enhanced delivery nor catheters for infusion of chemotherapy were used during the most recent surgery * Radioactive seeds were not placed during the most recent surgery * The histology of the most recent surgery documented recurrent/persistent/progressive malignant glioma * Women of childbearing potential must have a negative beta human chorionic gonadotropin (B HCG) pregnancy test =< 3 days prior to registration * Patient must sign study-specific informed consent prior to study entry Exclusion Criteria: * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) * Radiotherapy within 4 weeks or temozolomide within 14 days prior to registration or failure to recover from adverse events of either radiotherapy or temozolomide * Patients may not be receiving any other investigational agents * Severe, active comorbidity, defined as follows: * Any clinically significant cardiovascular disease including the following: * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * Transmural myocardial infarction or ventricular tachyarrhythmia within the past 6 months * Prolonged corrected QT interval (QTc) > 480 msec (Fridericia correction) * Ejection fraction less than institutional normal * Major conduction abnormality (unless a cardiac pacemaker is present) * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; breastfeeding should be discontinued if the mother is treated with dasatinib * History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib * Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible * Patients must not be taking hepatic enzyme inducing antiepileptic drugs (EIAEDs); if patients were previously on EIAEDs that have been discontinued, patients must have been off EIAEDs for >= 2 weeks prior to initiation of dasatinib * Patients who require antacids should use short-acting, locally active agents (e.g., Maalox, Mylanta etc.); however, these agents should not be taken within either 2 hours before or 2 hours after the dasatinib dose * Use of antithrombotic and/or antiplatelet agents (e.g., warfarin, heparin, low molecular weight heparin, aspirin, clopidogrel, ticlopidine, Aggrenox) * Use of ibuprofen or non-steroidal anti-inflammatory drugs (NSAIDs) * Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain dasatinib tablets are excluded * Prior treatment with stereotactic radiosurgery (including Gamma-Knife, Cyberknife, or other variants) or brachytherapy

NCT_ID NCT00423735

Study_NameDasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

Study Objectives The purpose of this study is to evaluate the tolerability and safety of JNJ-54767414 (daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: JNJ-54767414 (Daratumumab), DRUG: Bortezomib, DRUG: Dexamethasone Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Participants proven to have symptomatic (having symptoms) multiple myeloma (MM) according the International Myeloma Working Group (IMWG) diagnostic criteria * Participant must have documented MM as defined by following criteria: Monoclonal plasma cells in the bone marrow 10 percent (%), or presence of a biopsy-proven plasmacytoma at some point in their disease history, disease measurements: a) Serum M-protein greater than or equal to (>=) 1 gram per deciliter (g/dL) (>=10 gram per liter [g/L]) b) Serum immunoglobulin A [IgA] M-protein >= 0.5 g/dL); c) Urine M-protein >=200 milligram per 24 hour (mg/24 h); d) Serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio * Participant must have received at least 1 prior line of therapy for MM * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Participant must have achieved a response (partial response [PR] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen Exclusion Criteria: * Participant has received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies previously * Is refractory to bortezomib or another PI, like ixazomib and carfilzomib (had progression of disease while receiving bortezomib therapy or within 60 days of ending bortezomib therapy or another PI therapy, like ixazomib and carfilzomib * Is intolerant to bortezomib (ie, discontinued due to any adverse event while on bortezomib treatment) * Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of daratumumab first administration. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day [mg/day] for a maximum of 4 days) before treatment. A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the Site Investigational Product Procedures Manual (IPPM) * Has a history of malignancy (other than multiple myeloma) within 3 years before the date of daratumumab first administration * Has any concurrent medical condition or disease (eg, active systemic infection, pulmonary impairment) that is likely to interfere with study procedures

NCT_ID NCT02497378

Study_NameA Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Study Objectives Aim/Introduction: The treatment of differentiated thyroid cancer includes generally a total thyroidectomy, followed by a radioiodine (131I)-therapy. Due to their ability to concentrate iodine, the salivary glands may present inflammation after administration of 131I, which may be symptomatic, may lead to longer-term chronic abnormalities, resulting in alterations in patients' nutrition and quality of life. The incidence of salivary dysfunctions after 131I-therapy varies considerably between studies due to methodological limitations. Also, the occurrence of these dysfunctions may be linked to increased uptake and/or retention of 131I in the salivary glands and/or individual radiosensitivity. However, no clinical or genetic factors have been identified to date to define patients at risk, allowing the delivered activity to be adapted to the expected risk of salivary dysfunctions. The aims of this study are to estimate the incidence of salivary dysfunctions after 131I-therapy, to characterize patients at risk of developing post-treatment dysfunctions using clinical, biomolecular and biochemical factors, and to validate a dosimetric method to calculate the dose received at the salivary gland level in order to analyse the dose response relationship between exposure of salivary glands to 131I and salivary dysfunctions. Materials and Methods: This prospective cohort aims to include 120 patients, candidates for a 131I-therapy in the context of their differentiated thyroid cancer, treated in the Nuclear Medicine department of the Pitié-Salpêtrière hospital (40 and 80 patients in a 1.1GBq and a 3.7GBq dose groups respectively). The follow-up is based on 3 scheduled visits: at inclusion (immediately before 131I therapy), 6months and 18months after treatment. For each visit, questionnaires on salivary disorders (validated French tool), quality of life (HAD-scale, MOS-SF-36), and nutritional status are administered. At inclusion and at T6, saliva samples and individual measurement of the salivary flow, without and with salivary glands stimulation, are performed. External thermoluminescent dosimeters are placed opposite the salivary glands and at the sternal fork on the treatment's day before radioiodine administration and removed 5days after treatment. From dosimeters, a reconstitution of the dose received at the salivary glands will be established using physical and computational phantoms. Genetic and epigenetic analyses will be performed to find biomarkers of predisposition to develop salivary disorders after 131I-therapy. Expected results Inclusion of patients started in September 2020 and are still ongoing. Statistical analyses will study the links between salivary dysfunctions and the 131I dose received by the salivary glands, taking into account associated factors. In addition, impacts on the patients' quality of life will be analysed. Conditions: Thyroid Cancer Intervention / Treatment: DRUG: Radioiodine Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * treated for differencied thyroid cancer * aged of 18 and more Exclusion Criteria: * having been treated by chemiotherapy or radiotherapy * no French language * can't be follow at 6 months after treatment

NCT_ID NCT04876287

Study_NameSalivary dysfuncTion After Radioiodine Treatment

Study Objectives The purpose of this study is to determine the ability of G-CSF to disrupt the bone marrow microenvironment as a means to increase the efficacy of chemotherapy in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma Intervention / Treatment: DRUG: G-CSF, DRUG: Ifosfamide, DRUG: Etoposide, DRUG: Dexamethasone, DRUG: Mesna Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Acute lymphoblastic leukemia diagnosed according to WHO criteria (>25% lymphoblasts in BM) which is relapsed or refractory to therapy. Patients with t(9;22) must be refractory to BCR-ABL tyrosine kinase inhibitors. * Age >= 18 years * ECOG performance status <= 3. * Adequate organ function defined as: * Calculated creatinine clearance >= 50 ml/min * AST, ALT, total bilirubin <= 2 x institutional ULN except when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia) * Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study. * Able to provide signed informed consent prior to registration on study. Exclusion Criteria: * Previous salvage chemotherapy with ifosfamide and etoposide * Pregnant or nursing * Received any other investigational agent or cytotoxic chemotherapy within the preceding 2 weeks * Received colony stimulating factors filgrastim or sargramostim within 1 week or pegfilgrastim within 2 weeks of study * Severe concurrent illness that would limit compliance with study requirements

NCT_ID NCT01331590

Study_NameDisrupting the Bone Marrow Microenvironment With G-CSF in Acute Lymphoblastic Leukemia

Study Objectives This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) together with pegaspargase may kill more cancer cells. Conditions: Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia Intervention / Treatment: DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Dexamethasone, DRUG: Doxorubicin Hydrochloride, OTHER: Laboratory Biomarker Analysis, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Pegaspargase, DRUG: Prednisone, RADIATION: Prophylactic Cranial Irradiation, DRUG: Thioguanine, DRUG: Vincristine Sulfate Location: Canada, United States, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must be eligible for and enrolled on AALL03B1 or the successor classification study * Patients must have newly diagnosed high-risk B-precursor acute lymphoblastic leukemia (ALL) * WBC criteria * Age 1.00 <= age <= 9.99 years: WBC >= 50,000/uL * Age 10.00 - 30.99 years: Any WBC * Prior steroid therapy: Any WBC * Patients with testicular leukemia: Any WBC * Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine * Intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment; systemic chemotherapy must begin within 72 hours of this intrathecal therapy * Patients receiving prior steroid therapy are eligible for study; the dose and duration of previous steroid therapy should be carefully documented * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: * Pregnant female patients are ineligible; pregnancy tests with a negative result must be obtained in all post-menarchal females; males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; lactating females must agree that they will not breastfeed a child while on this study * Patients with Down syndrome (DS) are ineligible since excessive toxicities and death have been noted for those enrolled on AALL0232 receiving the prednisone/Capizzi methotrexate (PC) arm of treatment, which is the backbone regimen for the current study

NCT_ID NCT00866307

Study_NamePegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)

Study Objectives This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients. The main objective is to detect an increase in progression-free survival rate at 6 months (according to RECIST version 1.1) from 60% in patients with BTC treated with standard chemotherapy (CT) approach to 75% when treated with CT combined with pembrolizumab. Conditions: Biliary Tract Cancer, Metastatic Cancer, Advanced Cancer, Gallbladder Cancer Intervention / Treatment: DRUG: Pembrolizumab, DRUG: Cisplatin, DRUG: Gemcitabine Location: United Kingdom, Germany, Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * A histopathological / cytological diagnosis of non-resectable or recurrent / metastatic biliary tract carcinoma (intra- or extra-hepatic) or gallbladder * Availability of archival FFPE tumor tissue for biobanking * Measurable disease by CT/MRI (RECIST 1.1) within 28 days of enrollment * ECOG performance status 0, 1 * Age >= 18 with estimated life expectancy >3 months * Adequate hematological function: screening labs should be performed within 14 days (± 3 days) prior to enrollment: * Hemoglobin >= 10 g/dl* (prior transfusions for patients with low hemoglobin are allowed) * White blood cell (WBC) >= 3.0 x 109/L * Absolute neutrophil count (ANC) >= 1.5 x 109/L * Platelet count >= 100 x 109/L * Adequate liver function: screening labs should be performed within 14 days (± 3 days) prior to enrollment: * Total bilirubin <= 1.5 x upper limit of normal (ULN) * ALT and/or AST & alkaline phosphatase <= 5 x ULN * Adequate renal function: screening labs should be performed within 14 days (± 3 days) prior to enrollment: * Serum creatinine < 1.5 x ULN * and a calculated GFR >= 45 mL/min (using Cockcroft-Gault formula). If the calculated GFR is below 45 mL/min, isotope EDTA confirmation of adequate renal function is required (see Appendix F). If isotope EDTA methods are not available, then a 24-hour urine creatinine clearance can be used. * Adequate coagulation: screening labs should be performed within 14 days (± 3 days) prior to enrollment: * International Normalized Ratio (INR) or Prothrombin Time (PT): <= 1.5xULN unless patient is receiving anticoagulant therapy as long as PT or Partial Thromboplastin Time (PTT) is within therapeutic range of intended use of anticoagulants * Adequate biliary drainage with C-reactive protein (CRP) levels in normal ranges (based on institution's standard): screening labs should be performed within 14 days (± 3 days) prior to enrollment * Patient is not currently participating and receiving study therapy or has not participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks prior to enrollment * Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. * Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include: * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomised partner * Sexual abstinence. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard. * Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 120 days after the last study treatment. * Before patient enrollment, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Patients with ascites grade 2 or higher * Child Pugh B or C hepatic impairment * Incomplete recovery from previous surgery or unresolved biliary tract obstruction * Active infection requiring therapy. Antibiotic treatment should have been completed 5 days before enrollment * Patients who are candidates for curative surgery * History of (non-infectious) pneumonitis that required steroids or current pneumonitis. No history of or current interstitial lung disease * Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment * Diagnosis of immunodeficiency, systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment * Known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C * Patients with hyperthyroidism or hypothyroidism unless stable on hormone replacement * History of another malignancy or a concurrent malignancy. Exceptions include patients who have been disease-free for 5 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ. * Patients who received treatment with live vaccines within 30 days prior to the first dose of study medication. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, seasonal flu, H1N1 flu, rabies, BCG and typhoid vaccine. * Prior treatment with any anti-CTLA4 monoclonal antibody or anti-PD-1, or PD-L1 or PD-L2 agent. Examples of PD-1 inhibitors (include, but are not limited to): pembrolizumab (Merck); Nivolumab (also known as BMS-936558, MDX-1106, ONO-4538) (Bristol-Myers Squibb); Pidilizumab (CT-11) (Cure-Tech/Teva); and AMP-224 (Amplimmune). Examples of PD-L1 inhibitors (include, but are not limited to): BMS-936559 (also known as MDX-1105) (Bristol-Myers Squibb); MPDL3280A (also known as RG7446) (Roche Genentech); and MEDI4736 (MedImmune). * Prior systemic chemotherapy for locally advanced or metastatic disease. * Prior adjuvant chemotherapy is allowed if the last treatment was completed at least 6 months before trial entry and neither gemcitabine nor cisplatin were given. Also the following treatment modalities are allowed within the rules described (provided there has been a full recovery): * Surgery - patients may have undergone a non-curative operation (i.e. R2 resection [with macroscopic residual disease] or palliative bypass surgery only). Patients who have previously undergone curative surgery, must have evidence of non-resectable disease relapse requiring systemic chemotherapy prior to study entry. * Radiotherapy - patients may have received prior radiotherapy (with or without radiosensitising low-dose chemotherapy) for localised disease. However, there must be clear evidence of disease progression prior to inclusion in this study. * Photodynamic therapy (PDT) for localized disease only with no evidence of metastatic disease - patients may have received prior PDT, provided the patient has fully recovered and at least 28 days have elapsed since the PDT and there is clear evidence of disease progression at the local site or disease or at a new metastatic site. * PDT for localised disease to relieve biliary obstruction in the presence of metastatic disease - patients may have received prior PDT provided the patient has fully recovered and at least 28 days have elapsed since the PDT. Patients may enter trial provided the non-PDT treated lesion(s) only are followed for response assessment. * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before enrollment in the trial.

NCT_ID NCT03260712

Study_NamePembrolizumab in Biliary Tract Cancer

Study Objectives This research study is studying a combination of targeted therapies as a possible treatment for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation The interventions involved in this study are: * LY3022855 * Vemurafenib * Cobimetinib Conditions: Melanoma Intervention / Treatment: DRUG: LY3022855, DRUG: Vemurafenib, DRUG: Cobimetinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * For enrollment to the phase I portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. * For enrollment to the phase II portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) and cannot have received prior BRAF or MEK inhibitor therapy. * Participants enrolling to the phase I portion of the trial must have evaluable or measurable disease (see Section 11 for definitions). * Participants enrolling to the phase II portion of the trial must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease. * Age >= 18 years. As no dosing or adverse event data are currently available in participants < 18 years, children are excluded from this study but will be eligible for future pediatric trials. * ECOG performance status 0 - 1 (see APPENDIX A). * Participants must have normal organ and marrow function as defined below: * Absolute neutrophil count >= 1.5 K/uL * Platelets >= 100 K/uL * Hemoglobin >= 9 g/dL * Total bilirubin <= 1.5 × institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) <= 2.5 × institutional ULN * Serum creatinine <= 1.5 × institutional ULN * PT-INR <= 1.5 × institutional ULN (for participants on anticoagulation therapy, <= 1.5 × their baseline value) * aPTT <= 1.5 × institutional ULN (for participants on anticoagulation therapy, <= 1.5 × their baseline value) * Participants must have a left ventricular ejection fraction (LVEF) >= 50%. * Participants must have a QTc of <= 470 msec on the screening EKG. * The effects of LY3022855 on the developing human fetus are unknown. For this reason and because anti-cancer agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of LY3022855 administration. * Ability to understand and the willingness to sign a written informed consent document. * Participants must have archival tumor tissue available. Participants without archival tissue may be enrolled at the discretion of the principal investigator. Exclusion Criteria: * Participants who have had chemotherapy, radiotherapy, biologic therapy, major surgery, or another investigational agent within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. * Participants who have not recovered to <= CTCAE grade 1 or baseline from toxicity as a result of previous cancer treatment prior to entering the study (with the exception of alopecia and peripheral neuropathy which can be <= grade 2). * For enrollment to the phase II portion: participants who have received prior BRAF or MEK inhibitor therapy. * Participants with known untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with a history of brain metastases that have been treated, are no longer taking corticosteroids, and have been stable on imaging for >= 4 weeks following the last date of treatment are permitted. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to LY3022855, vemurafenib, or cobimetinib. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because LY3022855 is an anti-cancer agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LY3022855, breastfeeding should be discontinued if the mother is treated with LY3022855. These potential risks may also apply to the other agents used in this study. * Participants with a known history of HIV are ineligible because of the potential for pharmacokinetic interactions with LY3022855, vemurafenib, and cobimetinib with antiretroviral agents. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated. * Participants with a personal or family history of long QT syndrome. * Participants with a history of a second primary malignancy. Exceptions include: patients with a history of malignancies that were treated curatively and have not recurred within 3 years prior to study entry; resected basal and squamous cell carcinomas of the skin, and completely resected carcinoma in situ of any type. * Participants with impairment of GI function or GI disease that may significantly alter the absorption of vemurafenib and cobimetinib in the opinion of the treating investigator (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection). * Participants who are unable to swallow or retain oral medication. * Participants that require co-administration of strong or moderate CYP3A inhibitors, as these medications may alter vemurafenib and cobimetinib concentrations. * Participants who require treatment with medications that are strong or moderate CYP3A inducers, as these medications may alter the concentration of cobimetinib. * Participants with evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration.

NCT_ID NCT03101254

Study_NameLY3022855 With BRAF/MEK Inhibition in Patients With Melanoma

Study Objectives In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with standard doxorubicin formulation was used. The study aimed to determine whether the combination of PLD-docetaxel would increase tumour response in patients with breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: Pegylated Liposomal Doxorubicin and docetaxel Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with newly diagnosed breast cancer; * Age >18 years; * Eastern Cooperative Group (ECOG) performance status 0 <= age <= 2; * measurable disease (as per radiological imaging); life * expectancy >12 months; * adequate haematologic blood profile; * normal liver and kidney function; * adequate cardiac function; * no metastatic disease; * negative pregnancy test (premenopausal women); * signed informed consent. Exclusion Criteria: * Level 2 cardiac toxic effects were defined as asymptomatic systolic dysfunction (NYHA class I) or mildly symptomatic heart failure (NYHA class II) ; * Previous treatment for breast cancer, including surgery, radiation, cytotoxic and endocrine treatments (except surgical diagnostic procedures); * Active infection or other serious underlying medical or psychiatric condition which would impair the ability of the patient to receive protocol treatment;

NCT_ID NCT03221881

Study_NameNeoadjuvant Chemotherapy With a Combination of Pegylated Liposomal Doxorubicin (Caelyx®) and Paclitaxel in Breast Cancer

Study Objectives A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: ABI-007 Location: Ukraine, Germany, United States, Spain, Australia, Italy, Austria, Canada, France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Must have been enrolled in the CA046 study Must have been living at the time of the last survival follow-up (approximate timeframe - end of March, 2013) Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (ie, next of kin, legal representative) will be obtained prior to collection of data) Exclusion Criteria: * Consent refused for any reason

NCT_ID NCT02021500

Study_NameA Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.

Study Objectives This is a Phase 2 open-label study to evaluate the efficacy and safety of ibrutinib in combination with bortezomib and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Ibrutinib, DRUG: Bortezomib, DRUG: Dexamethasone Location: Germany, Spain, Czechia, Italy, Greece, Turkey Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects with multiple myeloma (MM) who have received 1 <= age <= 3 prior lines of therapy and have demonstrated disease progression since the completion of the most recent treatment regimen. (Subjects may have received prior bortezomib exposure if it does not meet the exclusion criteria for prior proteasome inhibitor use) * Measurable disease defined by at least one of the following: * Serum monoclonal protein (SPEP) >=1 g/dL (for subjects with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE) or immunoglobulin M (IgM) multiple myeloma SPEP >=0.5 g/dL) * Urine monoclonal protein (UPEP) >=200 mg by 24 hour urine electrophoresis * Adequate hematologic, hepatic and renal function * Eastern Cooperative Oncology Group (ECOG) performance status of <=2 Exclusion Criteria: * Subject must not have primary refractory disease * Refractory or non-responsive to prior proteasome inhibitor (PI) therapy (bortezomib or carfilzomib) * Peripheral neuropathy Grade >=2 or Grade 1 with pain at Screening * Plasma cell leukemia, primary amyloidosis, or POEMS syndrome * Unable to swallow capsules or disease significantly affecting gastrointestinal function * Requires treatment with strong CYP3A inhibitors * Women who are pregnant or breast feeding

NCT_ID NCT02902965

Study_NameStudy of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma

Study Objectives This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the previous study. Conditions: Macular Edema, Retinal Vein Occlusion Intervention / Treatment: DRUG: Ranibizumab 0.5 mg Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed informed consent form * The 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g) * Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment Exclusion Criteria: * History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 1 month prior to Day 0 of this extension study * Concurrent use of systemic anti-VEGF agents * Use of RVO treatments not approved by the Food and Drug Administration (FDA) in the study eye * Use of intravitreal bevacizumab in the study eye and/or fellow eye * Macular edema in the study eye due to other causes than RVO such as diabetes * History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye * History of idiopathic or autoimmune-associated uveitis in either eye * Uncontrolled glaucoma in the study eye (defined as intraocular pressure >= 30 mmHg despite treatment with antiglaucoma medication) * Pregnancy or lactation * Premenopausal women not using adequate contraception * History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications * Current treatment for active systemic infection * Inability to comply with study or follow-up procedures

NCT_ID NCT01442064

Study_NameAn Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)

Study Objectives The treatment of the patients with recurrent and metastatic breast cancer remains a major problem. There is still a lack of effective targeted therapy for Her-2 negative breast cancer.Based on the present researches on the anti-angiogenesis drugs in advanced breast cancer, the investigators believe that it is necessary to further explore the efficacy and safety of apatinib in advanced breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: Apatinib Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * HER-2 negative advanced breast cancer with chest wall metastasis confirmed by histology or cytological examination (patients who have received anthracyclines and/or paclitaxel in adjuvant chemotherapy). * Patients with recurrence or metastasis who have received no more than two lines of chemotherapy. * If hormone receptor is positive, endocrine therapy must have been performed for the patients with recurrence or metastasis, or the recurrence or metastasis occurred in less than two years of endocrine therapy. * >= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 1. * A life expectancy of more than 3 months. * At least one measurable site of disease confirmed by CT or MRI according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was required. * If the target lesions are lymph nodes, the short diameter is required to be less than 1.5cm and the target lesions are not suitable for surgical treatment; target lesions have not been in radiotherapy or recurred in the radiation field. * Baseline blood routine examination in accordance with the following criteria: neutrophil counts more than 1.5*109/L; platelet counts greater than 100*109/L; hemoglobin greater than 9 g/dL (blood transfusion is allowed to achieve or maintain the index) * Liver function in accordance with the following criteria: total bilirubin less than 1.5 times the upper limit of normal value; aspartate aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal value, less than 5 times the upper limit of normal value in patients with liver metastases. * Renal function in accordance with the following criteria: serum creatinine less than 1.25 times the upper limit of normal value, or the creatinine clearance rate calculated greater than 50 mL/min; * Women with fertility are willing to take contraceptive measures in the trial: when seven days before the drug delivery of serum or urine pregnancy test negative. Exclusion Criteria: * receiving radiation therapy 28 days before enrolled. Radiotherapy before enrollment to relieve the metastatic bone pain is allowed, but medullary bone radiated should not exceed 30% of the total amount; * symptomatic central nervous system metastases; * current or recent (30 days before enrollment) use of another study drug or being involved in another clinical study; * Other malignant tumors that have occurred within 5 years (except for the cured or well-controlled cervical carcinoma in situ, skin squamous cell carcinoma, or skin basal cell carcinoma); * With hypertension and the blood pressure cannot be reduced to the normal range through antihypertensive drug treatment (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg). * With grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval more than or equal to 450 ms for men, more than or equal to 470 ms for female); * according to the criteria of NYHA, cardiac insufficiency of grade III and IV or left ventricular ejection fraction (LVEF) less than 50% revealed by echocardiography; * abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 times the ULN), with bleeding tendency or under thrombolysis or anticoagulation therapy; * within 3 months before enrollment, clinically significant bleeding symptoms occur, or having obvious bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, occult blood + + and above in baseline period, or suffering from vasculitis, et al; * within 4 months before enrollment receiving major surgery or getting severe traumatic injury, fracture or ulcer; * having factors that affect the absorption of the oral drugs obviously, such as the inability to swallow, chronic diarrhea and intestinal obstruction, et al; * urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g; * with symptomatic serous cavity effusion, which needs to be surgically managed (including pleural effusion, ascites, pericardial effusion); * with other possible conditions that can affect the clinical research or evaluation of the results judged by the researchers.

NCT_ID NCT02878057

Study_NameMulticenter Phase II Study of Apatinib in Patients With Advanced Breast Cancer(CABC006)

Study Objectives This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to 24) for those responding to the induction. Conditions: Mantle Cell Lymphoma Intervention / Treatment: DRUG: Bendamustine, Lenalidomide, Rituximab Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient has a diagnosis of MCL according to the WHO classification; * Patient age is >= 18 years; * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of <= 2; * Understands and voluntarily signs an informed consent form; * Able to adhere to the study visit schedule and other protocol requirements; * Patients treated with one prior regimen and relapsed, or refractory to front line therapy; front line consolidation with autologous stem cell transplantation is considered to be part of first line therapy; * Patient has at least one site of measurable nodal disease at baseline >= 2.0 cm in the longest transverse diameter as determined by CT scan (MRI is allowed only if CT scan can not be performed). Note: Patients with bone marrow involvement are eligible; * Adequate haematological counts: ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement by MCL; * Conjugated bilirubin up to 2 x ULN unless due to liver involvement by MCL; * Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MCL; * Creatinine clearance >= 30 ml/min; a dose reduction of Lenalidomide for patients with creatinine clearance >= 30 mL/min but < 50 mL/min is planned; * Written informed consent was obtained from the patient prior to any study-specific screening procedures; * Patient has the ability to swallow capsules or tablets; * Life expectancy >= 6 months; * Disease free of prior malignancies (a part MCL) with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast; Exclusion Criteria: * Patients who have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study; * Patient has a history of CNS involvement with lymphoma; * Patients with previous history of malignancies (a part MCL) <= 3 years before study accrual with the exception of currently treated basal cell and squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix; * History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances; * Patient has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol; * Creatinine clearance < 30 ml/min; * Patient has a known history of HIV seropositivity; * Patient has active HBV hepatitis. The following categories of HBV positive patients but with non evidence of active hepatitis may be considered for the study and treated with R2-B (see also Section 8.1.8): * patient is HBsAg + with HBV DNA < 2000 UI/ml (inactive carriers); HBV DNA > 2000 UI/ml is criteria of exclusion; * patient is HBsAg - HBsAb +; * patient is HBsAg - but HBcAb + * Patients with HCV active hepatitis are excluded from the study. Patient with no evidence of active hepatitis and/or advanced chronic liver disease according to liver biopsy or fibro-scan evaluation may be included into the study * Patients have received previous treatment with either Bendamustine and/or Lenalidomide.

NCT_ID NCT01737177

Study_NameBendamustine/Lenalidomide/Rituximab: Combination as a Second-Line Therapy for 1st Relapsed-Refractory MCL

Study Objectives This pilot research trial studies the antibody response to high-dose seasonal influenza vaccination in patients with myeloid malignancy receiving chemotherapy and healthy volunteers. Evaluating antibody response to high-dose seasonal influenza vaccine may serve as a basis for vaccine recommendations in patients with myeloid malignancies and provide insights into the status of the immune system in these patients. Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome Intervention / Treatment: BIOLOGICAL: Trivalent Influenza Vaccine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to undergoing any investigational biospecimen (blood) collection procedure * Willing to undergo seasonal influenza vaccination with Fluzone high dose at Roswell Park Cancer Institute within 2 weeks of enrollment of this study * Estimated survival of 8 weeks or more following enrollment on the study Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active influenza infection or influenza-like-illness * Women who are attempting pregnancy or known to be pregnant by clinical history or nursing female subjects * Unwilling or unable to follow protocol requirements * Use of prednisone > 10 mg/day (or its equivalent for other steroids) for > 2 weeks immediately prior to receiving seasonal influenza vaccination * Received dose of seasonal influenza vaccination prior to enrollment * Participation at the time of study enrollment in another clinical trial investigating immunotherapeutic agents (like anti-PD1 or anti-PDL1 or anti-CTLA4 antibodies or vaccines); concurrent participation in an observational/non-interventional study or an interventional study investigating tyrosine kinase inhibitor or other targeted agents use is acceptable * Inability to receive seasonal influenza vaccine due to prior hypersensitivity to eggs, chicken proteins, or any of the vaccine components * History of a life-threatening reaction to influenza vaccination or to a vaccine containing similar substances * Personal history of Guillain-Barre syndrome * Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive annual influenza vaccination or may potentially affect the response to influenza vaccination * Adults unable to consent, individuals who are not yet adults (infants, children, and teenagers), women who are known to be pregnant, attempting pregnancy, or nursing women, and prisoners will be excluded from the study

NCT_ID NCT04484532

Study_NameEvaluation of Antibody Response to High-Dose Seasonal Influenza Vaccination in Patients With Myeloid Malignancy Receiving Chemotherapy and Healthy Volunteers

Study Objectives Cancer cachexia syndrome (CCS) is frequent, causing high morbidity and mortality in affected ones. The mechanism is catabolism caused by the tumour. CRP is a surrogate marker for catabolism. There are no effective treatment options against CCS. Lenalidomide, a derivate of thalidomide, is an immunomodulatory drug (IMiD®). One of its' main effect is a decrease in inflammatory cytokines. As CCS treatment, thalidomide has shown in a randomized controlled trial to stabilize lean body mass. The effect of lenalidomide in solid tumour patients was negligible although, there might be a decrease in tumour progression. However, even if lenalidomide may be uninteresting as an anticancer treatment it might affect CCS dynamics. Respective data are currently lacking. Therefore, a dose level where an anticancer effect could be expected was chosen (group A). Relevant anti-inflammatory effect may occur below the commonly used doses to achieve tumour control, which is expected to be the main anti-cachexia effect. Therefore, a second CRP-response guided treatment arm (group B) was chosen. Hypothesis: To test whether the response rate under new standard basic cachexia management will be at the estimated 5% and with lenalidomide (either fixed dose or CRP-guided dose) in addition to basic cachexia management at least 25%. The primary objective of this study is to assess the efficacy of lenalidomide on lean body mass and handgrip strength in advanced solid tumour patients with inflammatory CCS. Conditions: Cancer Cachexia Syndrome Intervention / Treatment: DRUG: Lenalidomide, DRUG: Lenalidomide, OTHER: basic cachexia management (prokinetics, physical activity counselling, nutritional counselling) Location: Switzerland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Age: Patients must be older than 18 years. * Tumour situation: Patients with any type of advanced (defined as locally recurrent or metastatic), incurable solid tumour. * Cachexia: Presence of CCS, defined as involuntary loss of weight of >=2% in 2 months or >=5% in 6 months, which is ongoing in the last 4 weeks, and lack of fluid retention. * Inflammation: CRP must be >= 30mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder. * No simple starvation: Patients must be able to eat, defined as no severe structural barriers in the upper gastrointestinal tract and no bowel obstruction. * Life expectancy, physical performance: Patient must have an expected life expectancy > 3 months according to palliative performance (Pap) score and a WHO performance status (PS) <= 2. * No anti-cachexia or appetite-stimulating medications: Patients are not allowed to have corticosteroids unless for maximum 2 days per week for chemotherapy, progestin therapy, Cyclooxigenase-2 inhibitor (COX-2 inhibitor), and anabolic drugs 28 days before start of trial medication until study conclusion. Prokinetic medication, NSAR, paracetamol and novamin sulphate are allowed, if given in a fixed dose for two weeks before visit 1, and expected to be given during the whole trial period. * Laboratory test results: Granulocyte count >= 1.5 x 109/L, platelet count >= 100 x 109/L, serum creatinine <= 2.0 mg/dL (177 μmol/L), creatinine clearance ClCr >= 50ml/min, total bilirubin <=1.5 mg/dL (25μmol/L), and AST (SGOT)/ ALT (SGPT) <=2 x ULN or if hepatic metastases are present <= 5 x ULN. * No other trial: Patient is not participating any other clinical intervention 28 days before start of trial medication until study conclusion. * Women of childbearing potential (see Annex 1): A negative pregnancy test & effective contraception are mandatory in child-bearing age. * A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). * A FCBP potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mU/mL within 10 to 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. * FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See (Annex 2): Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. * Cognition: Presence of a normal level of consciousness (mandatory is a normal abbreviated screening mini-mental test or a common mini-mental >= 27/30; in elderly patients age >= 65 years or patients with low education a mini mental status of >=25/30 points will be considered adequate). * Logistics: The patient is able to comply with the study schedule and procedures (including fasting for blood draws on certain visits) * Consent: The patient has voluntarily signed and dated the informed consent (IC), approved by the Ethics Committee (EC), prior to any study-specific procedures. * Will consent to the use of asprin (100mg) or low molecular weight heparin (if intolerant to aspirin) in prophylactic dose (e.g. Fragmin 2500U sc od). * Study participant agrees to be registered in the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.(Appendix 18) Exclusion Criteria: * Untreated secondary causes of cachexia (oral thrush, nausea, vomiting, constipation, diarrhoea, pain VAS>3, depression, dyspnoea) * CTCAEv3.0 >= grade 2 due to anticancer treatment (chemotherapy, radiotherapy or surgery) * Any psychiatric disorder, alcohol and illicit drug abuse or language problem that would prevent the patient from filling in the questionnaires adequately or attend study visits according to protocol. * Parenteral nutrition * Presence of dysthyreosis, defined as TSH beyond normal ranges * Presence of long QT syndrome or QTc > 450ms or under treatment with a QT prolonging drug * Presence of lactose intolerance * Diabetes mellitus with secondary organ dysfunction (coronary heart disease, previous stroke, renal insufficiency) * Patients with cerebral metastases or prophylactic whole brain irradiation for possible cerebral metastases. * Known hypersensitivity to thalidomide or a history of development of erythema nodosum due to thalidomide or similar drugs. * Any prior use of lenalidomide * Known infection with HIV, hepatitis B or C * Patients with known myeloid malignancy or tumours having bone marrow involvement. * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent (IC) form. * Pregnant or breastfeeding females.

NCT_ID NCT01127386

Study_NameLenalidomide for Lean Body Mass and Muscle Strength in Inflammatory Cancer Cachexia Syndrome

Study Objectives The AML-12 study investigates the efficacy and toxicity of standard induction chemotherapy with idarubicin and cytarabine (IC) with G-CSF priming followed by a risk-adapted post remission therapy for patients up to the age of 70 diagnosed with de novo acute myeloid leukemia (AML). Modifications from the previous protocol AML-03 (NCT01723657) include removal of etoposide in induction, limitation of the GCSF priming to the induction phase and categorization of post remission therapy (stem cell transplant or 2 high dose cytarabine consolidations) according to diagnostic genetics as well as post-remission clearance of measurable residual disease. The aims of these modifications are to improve the overall survival and leukemia free survival of acute myeloid leukemia patients with a risk-adapted approach. Conditions: Leukemia, Myeloid, Acute Intervention / Treatment: DRUG: Idarubicin, DRUG: Ara-C, DRUG: G-CSF, PROCEDURE: Allogeneic matched or unrelated donor transplant., PROCEDURE: Autologous peripheral blood stem cell transplant, PROCEDURE: Measurable residual disease Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with newly diagnosed AML, classified using the World Health Organization (WHO) 2017 criteria. * Patients with 70 years or younger. Exclusion Criteria: * Patients previously treated for the AML with chemotherapy different from hydroxyurea. * Acute promyelocytic leukemia with t(15;17). * Chronic myeloid leukemia in blastic phase. * Secondary AML or therapy related AML. * Presence of concomitant active neoplastic disease. * Abnormal renal and hepatic functions with creatinin and/or bilirubin 2 times higher than the normal threshold, except when the alteration should be attributed to the leukemia. * Patients with a cardiac ejection fraction below 45%, symptomatic cardiac deficiency or both. * Patients with neurological or concomitant psychiatric disease. * HIV infection.

NCT_ID NCT04687098

Study_NameRisk-adapted Therapy for Primary Acute Myeloid Leukemia

Study Objectives Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis. Conditions: Prostate Cancer With Bone Metastasis Intervention / Treatment: DRUG: zoledronic acid Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Aged >=18 years. * Written informed consent. * With histologically-proven prostate carcinoma. * ECOG performance status <= 2 * Life expectancy > 12 months * Current or previously documented diagnosis of at least 1 bone metastasis due to prostate cancer (patient could be hormono naif, Hormono sensible or hormono refractory) * Patients with partners of childbearing potential should use a barrier method of contraception throughout the study. Exclusion Criteria: * ECOG performans status >3 * Prior treatment with bisphosphonates IV within the last 3 month to the study * Renal insufficiency (serum creatinine > 265 micromol/L or > 3.0 mg/dL) * Liver function tests > 2.5 ULN * Patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol. * History of concomitant disease with influence on bone metabolism such as Paget's disease or primary hyperparathyroidism * Disabling or non controlled concomitant disease likely to alter the quality of life * Patient unable to fill in a questionnaire: senile dementia, psychiatric or neurological disease, illiterate or partially sighted patient * Known hypersensitivity to zoledronic acid or other bisphosphonates Other protocol-defined inclusion / exclusion criteria may apply.

NCT_ID NCT00241111

Study_NameAssessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis

Study Objectives This randomized phase II trial studies how well irinotecan and cetuximab with or without bevacizumab work in treating patients with RAS wild-type colorectal cancer that has spread to other places in the body (locally advanced/metastatic) and cannot be removed by surgery. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as cetuximab and bevacizumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving irinotecan and cetuximab with or without bevacizumab may work betting in treating patients with colorectal cancer. Conditions: Colorectal Adenocarcinoma, RAS Wild Type, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7 Intervention / Treatment: BIOLOGICAL: Bevacizumab, BIOLOGICAL: Cetuximab, DRUG: Irinotecan, OTHER: Laboratory Biomarker Analysis, OTHER: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Metastatic or locally advanced (unresectable) colorectal cancer with histological confirmation of adenocarcinoma * Measurable disease * RAS wild-type tumor; Note: evidence of EGFR expression in the tumor is not required * Previous failure of at least one fluoropyrimidine- and irinotecan-containing chemotherapy regimen for metastatic disease; Note: previous failure is defined as disease progression while receiving treatment or within 6 weeks after the last dose of irinotecan; failure for this assessment is defined as any enlargement of measurable or assessable lesion(s) or the development of any new lesion; a rising tumor marker alone is not sufficient to define failure; patients can have received irinotecan in any previous line of therapy * Treatment with bevacizumab in at least one prior line of therapy for metastatic disease * Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only * Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 or 1 * Total serum bilirubin =< institutional upper limit of normal (ULN) obtained =<14 days prior to randomization * Absolute neutrophil count (ANC) >= 1500/mm^3 obtained =<14 days prior to randomization * Platelet count >= 100,000/mm^3 obtained =<14 days prior to randomization * Hemoglobin >= 9.0 g/dL (hemoglobin may be supported by transfusion) obtained =<14 days prior to randomization * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) obtained =<14 days prior to randomization * Creatinine within institutional limits of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal obtained =<14 days prior to randomization * Urinary protein =< 1+ obtained =<14 days prior to randomization * Patients discovered to have >= 2+ proteinuria must have a spot urine protein:creatinine ratio (UPCR) < 1.0 * Partial thromboplastin time (PTT) =< 1 x institutional ULN and international normalized ratio (INR) =< 1.5 , unless participant is on full dose anticoagulation therapy obtained =<14 days prior to randomization; patients on full-dose anticoagulation are eligible if the following criteria are met: * Patient has an in-range INR (usually 2 <= age <= 3) on a stable dose of warfarin or other anticoagulant =< 14 days or is on a stable dose of low molecular weight heparin * Patient has no active bleeding or pathological condition that carries a high risk of bleeding (i.e., tumor involving major vessels or known varices) * Patients receiving anti-platelet agents are eligible; in addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible * Life expectancy > 3 months * Provide informed written consent * Willing to provide blood samples for mandatory correlative and research purposes * Willing to provide tissue and blood samples for mandatory banking purposes * Any major surgery or open biopsy completed >= 4 weeks prior to randomization * Any minor surgery or core biopsy completed >= 1 week prior to randomization and patient must have fully recovered from the procedure; Note: insertion of a vascular access device is not considered major or minor surgery Exclusion Criteria: * Presence of a RAS mutation in exons 2, 3, or 4 of KRAS or NRAS (patients with mutations in exons 2, 3, or 4 of KRAS and/or NRAS are excluded) * Prior treatment with cetuximab or panitumumab * Prior intolerance to irinotecan and/or bevacizumab despite dose reduction * Known or suspected brain or central nervous system (CNS) metastases, or carcinomatous meningitis * Active, uncontrolled infection, including hepatitis B, hepatitis C * Concurrent anti-cancer therapy, including chemotherapy agents, targeted agents, or biological agents not otherwise specified in this protocol * Anti-cancer therapy =< 14 days prior to randomization * Prior radiotherapy to > 25% of bone marrow; Note: standard rectal cancer chemoradiation will not exclude subject from study protocol * Radiation therapy =< 2 weeks prior to randomization * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Co-morbid systemic illnesses or other severe concurrent disease, history of any psychiatric or addictive disorder, or laboratory abnormality, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Patients known to be human immunodeficiency virus (HIV) positive * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, symptomatic pulmonary fibrosis or interstitial pneumonitis, or psychiatric illness/social situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, or may interfere with the conduct of the study or the interpretation of the study results * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Other active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanoma skin cancer, prostatic intraepithelial neoplasia without evidence of prostate cancer, lobular carcinoma in situ in one breast, or carcinoma-in-situ of the cervix that has been treated * History of prior malignancy for which patient is receiving other specific treatment for their cancer * History of allergic reactions attributed to compounds of similar chemical or biologic composition to irinotecan, cetuximab, and/or bevacizumab that led to discontinuation of those agents * Significant history of bleeding events or pre-existing bleeding diathesis =< 6 months of randomization (unless the source of bleeding has been resected) * History of gastrointestinal perforation =< 12 months prior to randomization * Predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline pattern of > 3 loose stools daily in subjects without a colostomy or ileostomy; subjects with a colostomy or ileostomy may be entered at investigator discretion * Arterial thrombotic events =< 6 months prior to randomization; Note: this includes transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI) * Clinically significant peripheral artery disease (e.g., claudication with < 1 block) or any other arterial thrombotic event * Serious or non-healing wound, ulcer, or bone fracture * History of hypertension not well-controlled (>= 160/90) even though on a regimen of anti-hypertensive therapy * Evidence of Gilbert?s syndrome or known homozygosity for the UGT1A1*28 allele (special screening not required)

NCT_ID NCT02292758

Study_NameIrinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

Study Objectives PHEOCHROMOCYTOMA (PCC)/ PARAGANGLIOMA are catecholamine secreting tumors with varied manifestations. Besides hypertension, PCC patients may have subclinical to overt cardiac and vascular dysfunction, which are important to recognize to minimize perioperative morbidity and mortality. Cardiovascular (CV) dysfunction can be in the form of hypertension, left ventricular (LV) hypertrophy, heart failure, cardiomyopathy, dysrhythmias, angina and Myocardial infarction. Literature search revealed a few retrospective and a few prospective studies, including one prospective follow up study conducted at SGPGIMS to document CV changes in PCC. Our institutional study was the first to document the nature and extent of CV dysfunction and cardiomyopathy and their reversal after surgical cure. The studies revealed that PCC patients had significantly higher LV mass index, higher LV diastolic dysfunction, subclinical impaired LV systolic function. Earlier studies postulated apparent improvement in various cardiac indices even with selective α-blockade and continued after surgical cure, with near normalization at 3 -6 months postoperatively. Detailed cardiac and vascular evaluation in PCC patients can be of help in preoperative optimization of cardiac risk and may provide prognostic information The literature on PCC-mediated CV dysfunction and catecholamine cardiomyopathy is largely limited to case reports and retrospective studies, with few reports of their reversal after curative PCC operations. Whether the duration of disease influence the function of heart was not apparently addressed in earlier trials. Trials that established the differences in the degree of cardiac dysfunction between normotensive and hypertensive PCC patients involved smaller proportion of study subjects. Sub clinical changes in endomyocardium was presumed but not objectively assessed and hence its reversal after surgical cure is uncertain. The aim of this research is to study the cardiac and vascular changes in Pheochromocytoma/ Paraganglioma patients and their reversal following curative surgery Conditions: Pheochromocytoma, Paraganglioma, Cardiovascular Morbidity Intervention / Treatment: OTHER: Observational study Location: India Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients diagnosed of Pheochromocytoma (PCC) / Paraganglioma (secretory, extra adrenal PCC) Patients willing to consent for the study Patients not on α-blockade at the time of recruitment into study, can be on any other anti hypertensives Exclusion Criteria: * Non-secretory Paraganglioma Patients who refuse consent, not compliant in follow up Patients who are on α- blockade already Essential Hypertensives with compounding comorbidities that could interfere with cardio vascular evaluation

NCT_ID NCT05082311

Study_NameCardiac and Vascular Changes in Pheochromocytoma and Paraganglioma

Study Objectives Multicenter, open-label study of NPI-0052 in patients with advanced solid tumor malignancies or refractory lymphoma whose disease had progressed after treatment with standard, approved therapies that included 2 stages. The initial stage involved dose escalation to an MTD and determination of a recommended Phase 2 dose. The second stage comprised an expansion cohort at the recommended Phase 2 dose. Conditions: Cancer, Lymphomas Intervention / Treatment: DRUG: NPI-0052 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically-confirmed solid tumor malignancy (patients must be refractory to or demonstrate unacceptable toxicity towards effective therapy known to provide clinical benefit for their condition) OR refractory lymphoma (patients whose disease has progressed despite standard therapy including at least one-doxorubicin-containing regimen and one anti-CD20 monoclonal antibody-containing regimen. * KPS >=70%. * All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade <= 1 (except for hemoglobin). * Adequate bone marrow, renal, adrenal, pancreatic and liver function. * Signed informed consent. Exclusion Criteria: * Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin C; 12 weeks for radioimmunotherapy). Major surgery, other than diagnostic surgery, within 4 weeks before first study drug administration. Radiotherapy within 4 weeks. * Patients that require G-CSF and/or platelet support. * Patients with ongoing coagulopathies. * Patients with prior bone marrow transplant therapy (autologous or allogeneic). * Patients receiving intrathecal therapy. * Known brain metastases. * Significant cardiac disease. * Patients with a prior hypersensitivity reaction of CTCAE Grade >= 3 to therapy containing propylene glycol or ethanol. * Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. Female patients with childbearing potential must have a negative serum pregnancy test. Male patients must be surgically sterile or agree to use an acceptable method of contraception. * Concurrent, active secondary malignancy for which the patient is receiving therapy. * Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics. * Known to be positive for HIV; active hepatitis A, B, or C infection.

NCT_ID NCT00396864

Study_NamePhase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma

Study Objectives Phase 1: To determine the maximally tolerated dose (MTD) or recommended dose (RD) and any potential efficacy of PX-866 in combination with docetaxel in patients with solid tumors. Phase 2: To determine the antitumor activity and safety of PX-866 in combination with docetaxel versus docetaxel alone in patients with NSCLC or SCCHN. Conditions: Non Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of the Head and Neck (SCCHN) Intervention / Treatment: DRUG: Docetaxel, DRUG: PX-866 Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * At least 18 years at time of consent * Agrees to use a medically accepted form of contraception from the time of consent to completion of all follow up study visits * If female of child bearing potential, negative pregnancy test (not required for post menopausal females) * Signed an informed consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC) * Has either locally advanced, recurrent, or metastatic NSCLC for which they have received at least 1 and no more than 2 prior systemic treatment regimens that may include up to 1 platinum based chemotherapy regimen and/or an epidermal growth factor receptor (EGFR) inhibitor OR locally advanced, recurrent or metastatic SCCHN for which they have received at least one and no more than two prior systemic treatment regimens. * Measurable disease per Response Evaluation Criteria In Solid Tumors * Eastern Cooperative Oncology Group (ECOG) 0 or 1 * In the opinion of the clinical investigator, life expectancy >3 months * Adequate hematologic function as defined by: * Hemoglobin >= 9 g/dL * Absolute neutrophil count (ANC) >=1500 cells/µL * Platelets >=100,000/µL * Adequate hepatic function as defined by the following: * Bilirubin <= ULN * Aspartate aminotransaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) <=1.5 x upper limit of normal (ULN) * Creatinine level <=1.5 x ULN Exclusion Criteria: * Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures * Is breastfeeding * Treatment with any systemic chemotherapy, epidermal growth factor receptor (EGFR) inhibitor, radiation or experimental agent within 4 weeks of study drug dosing. Washout period following palliative radiation should be discussed with the study medical monitor * Previous treatment with docetaxel except for patients in Phase 2 who received a docetaxel containing regimen as part of adjuvant or neoadjuvant therapy which was completed at least 6 months prior to study drug dosing * Previous treatment with a phosphatidylinositol 3 kinase (PI 3K) inhibitor * Known human immunodeficiency virus (HIV) * Known or suspected clinically active brain metastases. Previously treated and stable brain metastases are allowable. Stable brain metastases are defined as no change on CT scan or MRI for minimum of two months AND no change in steroid dose for a minimum of four weeks, unless change due to intercurrent infection or other acute event * Grade >2 peripheral neuropathy, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.02 * Any other significant medical or psychiatric condition that in the opinion of the investigator renders the patient inadequate for participation * History of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate

NCT_ID NCT01204099

Study_NameStudy of PX-866 and Docetaxel in Solid Tumors

Study Objectives This pilot clinical trial studies sirolimus, idarubicin, and cytarabine in treating patients with newly diagnosed acute myeloid leukemia. Sirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sirolimus together with idarubicin and cytarabine may kill more cancer cells. Conditions: Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Untreated Adult Acute Myeloid Leukemia Intervention / Treatment: DRUG: Sirolimus, DRUG: Idarubicin, DRUG: Cytarabine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologic evidence of newly diagnosed acute myeloid leukemia (non-M3 AML) as documented by the presence of >20% myeloid blasts in the bone marrow * Subjects must be 18 years and <= 60 * Subjects must have an ECOG performance status of 2 or less. (see attachment 1). * Subjects must have a life expectancy of at least 4 weeks. * Subjects must be able to consume oral medication. * Required initial laboratory values: Creatinine 2.0mg/dL; total or direct bilirubin 1.5mg/dL; SGPT(ALT) 3xULN (if not due to the leukemia itself); negative pregnancy test for women with child-bearing potential. * Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing. * Subjects must have a left ventricular ejection fraction (LVEF) of >= 45%. Exclusion Criteria: * Subjects with APL - FAB M3 (t(15;17)(q22;q21)[PML-RAR] are not eligible * Subjects must not have received any chemotherapeutic agents for the AML (except Hydroxyurea). Intrathecal ARA-C and intrathecal methotrexate are permissible (as they are not systemic and only isolated to the central nervous system). * Subjects must not be receiving growth factors, except for erythropoietin. * Subjects with a "currently active" second malignancy, other than non-melanoma skin cancers are not eligible. * Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, myocardial infarction within the past 6 months or serious uncontrolled cardiac arrhythmia are not eligible. * Subjects taking the following are not eligible: 1. Carbamazepine (e.g., Tegretol) 2. Rifabutin (e.g., Mycobutin) 3. Rifampin (e.g., Rifadin) 4. Rifapentine (e.g., Priftin) 5. St. John's wort 6. Clarithromycin (e.g., Biaxin) 7. Cyclosporine (e.g. Neoral or Sandimmune) 8. Diltiazem (e.g., Cardizem) 9. Erythromycin (e.g., Akne-Mycin, Ery-Tab) 10. Itraconazole (e.g., Sporanox) 11. Ketoconazole (e.g., Nizoral) 12. Telithromycin (e.g., Ketek) 13. Verapamil (e.g., Calan SR, Isoptin, Verelan) 14. Voriconazole (e.g., VFEND) 15. Tacrolimus (e.g. Prograf) * Subjects taking fluconazole, voriconazole, itraconazole, posaconazole, and ketoconazole within 72 hours of study entry are not eligible. Reinstitution of fluconazole, voriconazole, itraconazole, posaconazole, ketoconazole and diltiazem is permissible 72 hours after the last dose of sirolimus. * Subjects who require HIV protease inhibitors or those with AIDS-related illness * Subjects with other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study are ineligible. * Subjects must not be pregnant or breastfeeding. Pregnancy tests must be obtained for all females of child-bearing potential. Pregnant or lactating patients are ineligible for this study due to the unknown human fetal or teratogenic toxicities of sirolimus. Males or females of reproductive age may not participate unless they have agreed to use an effective contraceptive method. * Subjects who have uncontrolled infection are not eligible. Patients must have any active infections under control. Fungal disease must be stable for at least 2 weeks before study entry. * Subjects with bacteremia must have documented negative blood cultures prior to study entry.

NCT_ID NCT01822015

Study_NameSirolimus, Idarubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Study Objectives This study is a Phase I study using vinblastine and sirolimus in patients with relapsed solid tumors including selected brain tumors and lymphoma. The investigators hypothesis is that the combination administration of weekly vinblastine and sirolimus is safe. Conditions: Solid Tumors, Central Nervous System Tumors Intervention / Treatment: DRUG: Vinblastine and Sirolimus Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age: 0 <= age <= 21 years at the time of diagnosis * Diagnosis: Histologic verification at either the time of original diagnosis or relapse of solid tumor including CNS tumors or lymphomas * Disease Status: All refractory/recurrent solid tumors including CNS tumors (all Diffuse Intrinsic Brain Stem Gliomas excluded) and lymphomas that have relapsed after, or are refractory to, a chemotherapy-containing treatment regimen * Measurable disease: * Measurable tumor by CT or MRI defined as >10 mm by spiral CT in at least one dimension * Current disease state must be one for which there is currently no known curative therapy * A negative urine pregnancy test is required for female participants of child bearing potential * Organ Function Requirements: * adequate liver function as defined by AST or ALT < 5 x upper limit of normal, bilirubin <=1.5 X upper limit of normal * adequate renal function: Serum creatinine < 1.5 X upper limit of normal for age * Adequate Bone Marrow Function Defined as: * ANC >= 1000/mm3, platelets >= 75,000/mm3 and hemoglobin >= 90 g/L * Transfusions are permitted to meet these platelet and Hgb criteria, if the patient is known to have a history of bone marrow involvement with tumor * Patients with platelet counts < 75,000/ mm3 who are refractory to platelet transfusions are not eligible for this study * Patients requiring transfusions of platelets or RBC to meet eligibility criteria will not be evaluable for platelet or hgb/hct hematological toxicity * Lansky Play Score (for patients < 16 years) must be more than 50 and/or ECOG performance status (for patients >= 16 years) must be 0 to 2 * Specific requirements for Neuroblastoma patients Stratum: * MIBG scan with positive uptake at minimum of one site (MIBG not required if subject's neuroblastoma is previously determined to not uptake MIBG and no measurable disease) * Bone marrow with tumor cells seen on routine morphology (not by NSE staining only) of bilateral aspirate and /or biopsy on one bone marrow sample * Written informed consent Exclusion Criteria: * Lansky score <50% * Investigational Drugs: Patients who are currently receiving another investigational drug(s) * Previous treatment with Vinblastine and/or mTor inhibitors * Anti-cancer Agents: Patients who are currently receiving other anticancer agents. Patients must have fully recovered from the effects of prior chemotherapy, generally at least 3 weeks from the most recent administration (6 weeks for nitrosoureas) * Infection: Patients who have an uncontrolled infection are not eligible until the infection is judged to be well controlled * Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal * One week from usage of hematopoietic Growth Factor * Patients who are refractory to platelet transfusions * Brain Stem Glioma patients

NCT_ID NCT01135563

Study_NameStudy of Vinblastine and Sirolimus in Children With Recurrent/Refractory Solid Tumours Including CNS Tumours

Study Objectives The study aim is to investigate the differences between sex and gender in the immune-related adverse events (irAEs) development associated with immune checkpoint inhibitors (ICI) treatment. The study will be a multicenter prospective observational study focusing on biological differences between females and males, possibly affecting discrepant irAEs incidence. Conditions: Melanoma, Lung Cancer, Head and Neck Cancer, Urogenital Neoplasms, Breast Cancer Intervention / Treatment: DRUG: Immunotherapy Location: Italy Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Signed informed consent. * Histologically confirmed diagnosis of one of the following cancers: melanoma, lung, head and neck, urogenital, breast cancer. In addition, other solid tumors characterized by the presence of microsatellite instability (MSI-high), treated with immunocheckpoint inhibitors (ICI) irrespective of treatment schedule. It is possible to include patients treated with Immunotherapy in a compassionate use setting. * Any disease stage. * Patients eligible for immune checkpoint inhibitors (ICI)-containing regimens: ICI single agent; Combination of ICIs; ICI-chemotherapy combination; ICI-radiotherapy combination. * Any treatment setting (neoadjuvant, adjuvant, advanced disease, maintenance). * Patient age >=18 years * ECOG Performance Status of 0 <= age <= 2. * Adequate bone marrow, liver and renal function. * Life expectancy of at least 12 weeks. Exclusion Criteria: * Patients not eligible for ICI-containing regimens.

NCT_ID NCT04435964

Study_NameGender Difference in sidE eFfects of ImmuNotherapy: a Possible Clue to Optimize cancEr tReatment

Study Objectives To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation. Conditions: Leiomyoma, Uterine, Intraoperative Blood Loss Intervention / Treatment: DRUG: Tranexamic acid, DRUG: Saline Location: Turkey Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Healthy volunteer female patients over the age of 18 who will undergo laparoscopic myomectomy in our clinic will be included in our study. Exclusion Criteria: * Patients who are planned to undergo different surgery along with myomectomy * Those with a diagnosis and suspicion of malignancy * Those with a history of thromboembolic disease * Those with cardiac, hepatic or renal disease * Those with a body mass index of 30 and above * Patients with abnormal coagulation test results * Patients using anticoagulants * Those who use drugs or diseases that may affect coagulation (serum creatinine > 1.5 mg/dL) * Those allergic to tranexamic acid

NCT_ID NCT05517590

Study_NameIntravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.