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Study Objectives This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks. Conditions: Basal Cell Carcinoma Intervention / Treatment: DRUG: Vismodegib, DRUG: Placebo Location: Mexico, Germany, Canada, Italy, Netherlands, Spain, United States, Austria, Russian Federation, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Adult participants, >= 18 years of age * Participants with multiple basal cell carcinomas, including participants with Gorlin syndrome, with at least 6 clinically evident basal cell carcinomas at the time of randomization, of which 3 measure 5 mm or more in diameter and are considered target lesions. All other lesions are considered to be non-target lesions * Histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Adequate renal and hepatic function and hematopoietic capacity * Women of childbearing potential must agree to use contraception as defined by protocol during treatment and for at least 9 months after completion of study treatment * Male participants with female partners of childbearing potential must agree to use contraception as defined by protocol during treatment and for 2 months after completion of study treatment Exclusion Criteria: * Inability or unwillingness to swallow capsules * Pregnant or breastfeeding women * Any metastatic basal cell carcinoma * Locally advanced basal cell carcinoma lesion that is considered to be inoperable or to have medical contraindications to surgery * Recent (i.e., within the past 28 days prior to randomization) or current participation in another experimental drug study * Known or suspected alcohol abuse * One of the following known rare hereditary conditions: galactose intolerance, primary hypolactasia or glucose-galactose malabsorption

Study Objectives This phase I trial is studying the side effects and best dose of dasatinib in treating young patients with recurrent or refractory solid tumors or Philadelphia chromosome-positive acute lymphoblastic leukemia or chronic myelogenous leukemia that did not respond to imatinib mesylate. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Conditions: Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Childhood Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Meningeal Chronic Myelogenous Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Relapsing Chronic Myelogenous Leukemia, Unspecified Childhood Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: dasatinib, OTHER: pharmacological study, OTHER: laboratory biomarker analysis 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 diagnosis of 1 of the following: * Malignant extracranial solid tumor * Recurrent or refractory disease * Known bone marrow metastases* allowed * Imatinib mesylate-resistant Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), defined as M3 bone marrow in a patient who previously received imatinib mesylate-containing treatment regimen * Imatinib mesylate-resistant Ph+ chronic myelogenous leukemia (CML), as defined by any of the following: * Increasing WBC or platelet count while on imatinib mesylate therapy * Lack of any cytogenetic response after an adequate duration of imatinib mesylate therapy, as defined by 1 of the following: * Failed to achieve a complete hematologic response after completion of 3 months of imatinib mesylate treatment * Failed to achieve a partial or complete cytogenetic response (i.e., <= 35% Ph+ cells) after 6 months of imatinib mesylate treatment * Appearance of accelerated or blastic feature while on imatinib mesylate therapy * Reappearance of Ph+ clones after an initial complete cytogenetic response to imatinib mesylate * More than 30% increase in Ph+ cells in peripheral blood or bone marrow cytogenetics while on imatinib mesylate therapy * Imatinib mesylate intolerance, as defined by development of adverse effects requiring discontinuation of imatinib mesylate therapy * Measurable disease (for patients with CML or ALL) * Determined by hematologic, cytogenetic, and molecular studies for CML * Determined by bone marrow blast percentage for ALL * Measurable or evaluable disease (for patients with solid tumors) * No known curative therapy or survival-prolonging therapy with an acceptable quality of life * No CNS solid tumors * CNS-positive leukemia allowed * Karnofsky performance status (PS) >= 50% (for patients > 10 years of age) * Lansky PS >= 50% (for patients <= 10 years of age) * No evidence of graft-vs-host disease * Solid tumors: * Absolute neutrophil count >= 1,000/mm^3 (750/mm^3 if bone marrow infiltration) * Platelet count >= 100,000/mm^3 (transfusion independent) (50,000/mm^3 if bone marrow infiltration) * Hemoglobin >= 8.0 g/dL (red blood cell [RBC] transfusions allowed) * ALL/CML: * Platelet count >= 20,000/mm^3 (platelet transfusions allowed) * Hemoglobin >= 8.0 g/dL (RBC transfusions allowed) * Creatinine clearance or radioisotope glomerular filtration rate >= 70 mL/min OR creatinine based on age, as follows: * No greater than 0.6 mg/dL (1-23 months of age) * No greater than 0.8 mg/dL (2- 5 years of age) * No greater than 1.0 mg/dL (6-9 years of age) * No greater than 1.2 mg/dL (10-12 years of age) * No greater than 1.4 mg/dL (13 years of age and over [female]) * No greater than 1.5 mg/dL (13-15 years of age [male]) * No greater than 1.7 mg/dL (16 years of age and over [male]) * Bilirubin <= 1.5 times upper limit of normal (ULN) * ALT <= 110 U/L * Albumin >= 2 g/dL * Normal 12-lead EKG with corrected QTc < 450 msec AND meets 1 of the following criteria: * Shortening fraction normal * Ejection fraction normal * No evidence of dyspnea at rest * No exercise intolerance * Pulse oximetry > 94% if there is a clinical indication for determination * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection * No swallowing dysfunction that would prevent taking an oral or liquid medication * See Disease Characteristics * Recovered from prior chemotherapy, immunotherapy, or radiotherapy * No myelosuppressive chemotherapy within the past 3 weeks (6 weeks for nitrosoureas) * At least 7 days since prior growth factors * At least 14 days since prior pegfilgrastim * At least 7 days since prior biologic agents * At least 2 weeks since prior local small-port palliative radiotherapy * At least 3 months since prior total-body irradiation, craniospinal radiation, or radiation to >= 50% of the pelvis * At least 6 weeks since other prior substantial bone marrow radiation * At least 3 months since prior stem cell transplantation * Hydroxyurea cytoreduction for Ph+ leukemia allowed provided it is discontinued 24 hours before first dose of dasatinib * Prior intrathecal (IT) therapy allowed (for patients with CNS-positive leukemia) * Concurrent IT therapy comprising hydrocortisone, cytarabine, methotrexate, or cytarabine (liposomal) allowed (for patients with CNS-positive leukemia) * No other concurrent investigational drugs * No other concurrent anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy * No concurrent enzyme-inducing anticonvulsants, including any of the following: * Phenytoin * Phenobarbital * Carbamazepine * Felbamate * Primdone * Oxcarbazepine * No concurrent antithrombotic or antiplatelet agents, including any of the following: * Warfarin * Heparin * Low-molecular weight heparin * Aspirin * Ibuprofen * Other nonsteroidal anti-inflammatory drugs * No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, and voriconazole * No concurrent highly active antiretroviral treatment for HIV-positive patients

Study Objectives This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0919, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively. Conditions: Solid Tumor Intervention / Treatment: DRUG: GDC-0919 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 or cytologically confirmed solid tumor that is relapsed/refractory to standard therapies or for which no approved or curative therapy exists * Age > or = 18 * Eastern Cooperative Oncology Group (ECOG) performance status < 2 * Life expectancy > or = 12 weeks * Adequate hematologic and organ function before initiation of GDC-0919 * For some patients only: Accessible lesions amenable to paired fresh tumor biopsies Exclusion Criteria: * Some prior cancer immunotherapies * Untreated brain metastases * Active or history of autoimmune disease

Study Objectives Obesity among breast cancer survivors is known to be associated with recurrence and other co-morbidities. However, there have been no studies on weight reduction program combining diet and anti-obesity drug for obese breast cancer survivors. The purpose of this randomized clinical trial is to examine the effects of Mediterranean Diet and naltrexone/bupropion treatment on inflammation and metabolic risk factors in overweight or obese breast cancer patients after breast cancer treatment. Conditions: Breast Cancer, Obesity, Overweight Intervention / Treatment: DRUG: naltrexone/bupropion, BEHAVIORAL: Mediterranean Diet Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Female, 20 to 65 years of age * Diagnosed with breast cancer stage Ⅰ-Ⅲ, and have completed cancer treatment including breast surgery and/or adjuvant chemotherapy, radiotherapy, hormonal therapy * BMI >=25 kg/m2, or BMI >=23 kg/m2 with one or more of the metabolic risk factors (waist circumference >=80 cm, fasting glucose >=100 mg/dL, BP >=130/85 mmHg, HDL-cholesterol <50 mg/dL or controlled diabetes, hypertension, dyslipidemia with medications) * If woman of child bearing potential, agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug * Able to speak and read Korean * Able to comply with all required study procedures and schedule * Willing and able to give written informed consent Exclusion Criteria: * Participants with cancer recurrence or metastasis * Participants with uncontrolled hypertension (systolic blood pressure (SBP) >180 mmHg, or diastolic blood pressure (DBP) >120 mmHg) * Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >3 x institutional upper limit of normal) or renal disease (serum creatinine >2.0 mg/dL) * Participants with significant cardiovascular disease or stroke * Participants with history of seizures * Participants with serious psychiatric illness, including bipolar disorder, schizophrenia, or other psychosis, bulimia, anorexia nervosa, or suicidal ideation * Participants who are taking medications such as monoamine oxidase (MAO) inhibitors, opioid-containing medications, other naltrexone or bupropion containing medications, and Tamoxifen * Current smokers or use of nicotine replacement products in the previous 6 months * Pregnant or breast-feeding women * Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study

Study Objectives The purpose of this clinical study is to identify the maximum tolerated dose (MTD) of BMS-690514 once daily orally in Japanese subjects with advanced or metastatic solid tumors. Conditions: Cancer Intervention / Treatment: DRUG: BMS-690514 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate, with adequate kidney, liver and cardiac function.

Study Objectives The primary objective of this study is to evaluate the effects of aflibercept on the QTc interval in cancer patients. Secondary objectives are to evaluate the effects of aflibercept on other electrocardiogram (ECG) parameters, clinical safety and pharmakokinetic (PK) parameters. Conditions: Cancer Intervention / Treatment: DRUG: aflibercept (AVE0005), DRUG: placebo Location: Germany, Turkey, Italy, Romania, Denmark, United States, Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion criteria: * Solid malignancy, documented by pathologic report, for which treatment with single-agent docetaxel (administered every 3 weeks, at dose <75 mg/m2)is planned. * Written informed consent Exclusion criteria: * Patient has received more than 2 prior lines of cytotoxic-containing chemotherapy * Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter * QTcF >480 msec on screening ECG The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives The purpose of the study is to assess the safety, tolerability and the HPV-specific immune responses of different doses of ISA101 vaccine with or without pegylated IFNα as combination therapy with carboplatin and paclitaxel. To qualitatively assess the safety profile and the HPV-specific immune responses of ISA101b vaccine compared to ISA101 at the same dose levels. To assess the safety and the HPV-specific immune responses of ISA101b vaccine with carboplatin, paclitaxel with or without bevacizumab. Conditions: Cervical Cancer Intervention / Treatment: DRUG: ISA101/ISA101b Location: Belgium, Netherlands, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Women >= 18 years of age. * Cervical cancer confirmed by histology. * Advanced or metastatic or recurrent cervical cancer confirmed by clinical and/or radiological proof with no curative treatment options. * For cohort 10 (and 12), i.e. patients eligible to receive bevacizumab at each site per standard of care, patients may be primary stage IVB (including persistent) or first recurrent carcinoma of the uterine cervix (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma). Prior treatment with chemotherapy for recurrent disease is not permitted. However, one prior line of chemotherapy with platinum during primary radio-chemotherapy or platinum-base chemotherapy as neoadjuvant chemotherapy prior to surgery is permitted * Tumour must be HPV16 positive. * Patients should be eligible for chemotherapy with carboplatin and paclitaxel, and have consented with chemotherapy with carboplatin and paclitaxel, before the start of the informed consent procedure for the study. * Performance status (WHO scale/ECOG) 1. * Written informed consent according to local guidelines. * Written approval by the treating physician/investigator of his/her clinical judgment that the patient has a reasonable life expectancy and is sufficiently fit and motivated to complete the study treatment and comply to all study procedures conform the protocol. Exclusion Criteria: Treatment: * Prior treatment with anti-HPV agents. * Chronic systemic steroid use. Local application (i.e. stable doses of topical or inhaled corticosteroids) is allowed. * Less than 4 weeks since the last treatment with other cancer therapies, (i.e. endocrine therapy, immunotherapy, radiotherapy, chemotherapy, etc), less than 8 weeks for cranial radiotherapy, and less than 6 weeks for nitrosoureas and mitomycin C. * Toxicities resulting from previous anti-cancer therapy must be resolved to <= grade 2. * Recent treatment (within 30 days of first study treatment) with another investigational drug. * Patients with known hypersensitivity to any component of the Investigational Medicinal Product. * Any contraindication to the use of authorized applied products (i.e. paclitaxel, carboplatin or bevacizumab). Haematology and biochemistry: * Inadequate bone marrow function: Absolute Neutrophil Count (ANC) < 1.5 x 109/L, or platelet count < 100 x 109/L or hemoglobin < 6 mmol/L. * Inadequate liver function, defined as: * Serum (total) bilirubin > 2 x upper normal limit (ULN); * Aspartate Aminotransferase (ASAT) or Alanine Aminotransferase (ALAT) > 2.5 x ULN (> 5 x ULN in patients with liver metastases); * Alkaline phosphatase levels > 2.5 x ULN (> 5 x ULN in patients with liver metastases, or > 10 x ULN in patients with bone metastases). Other: * Clinical suspicion or radiological evidence of brain or leptomeningeal metastases. * Previous or current malignancies at other sites, with the exception of basal or squamous cell carcinoma of the skin and with the exception of other malignancies from which the patient may be considered cured as evidenced by complete regression of all lesions >10 years ago. * Active HIV, chronic hepatitis B or C infection. * Patients of childbearing potential not willing to consistently and correctly us a contraceptive method according to ICH (M3) resulting in low failure rate, i.e. less that 1% per year such as oral contraceptives or use of effective means of contraception. * Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to study treatment start in patients of childbearing potential. * Major surgical procedure within 28 days prior to the first study treatment. * Uncontrolled sustained hypertension (systolic > 180 mm Hg and/or diastolic > 110mm Hg). * Clinically significant (i.e. active) cardiovascular disease defined as: * Stroke within <= 6 months prior to day 1; * Transient Ischemic Attack (TIA) within <= 6 months prior to day 1; * Myocardial infarction within <= 6 months prior to day 1; * Unstable angina; * New York Heart Association (NYHA) Grade II or greater Congestive Heart Failure (CHF); * Serious cardiac arrhythmia requiring medication; * History of severe bronchial asthma and/or severe allergy. * Evidence of any other medical conditions that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.

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

Study Objectives This randomized phase III trial studies the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in treating patients with stage IVB, cervical cancer that has come back or is persistent. Drugs used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether paclitaxel is more effective when given together with cisplatin or topotecan with or without bevacizumab in treating patients with cervical cancer. Conditions: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma, Stage IVB Cervical Cancer Intervention / Treatment: BIOLOGICAL: Bevacizumab, DRUG: Cisplatin, OTHER: Laboratory Biomarker Analysis, DRUG: Paclitaxel, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, DRUG: Topotecan Hydrochloride Location: United States, Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must have primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy * All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT; biopsy confirmation is required if the lesion(s) measures < 30 mm or if the treating physician determines it is clinically indicated; patients must have at least one "target lesion" to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST); this lesion should be the one that was biopsied if one was performed; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy * Absolute neutrophil count (ANC) >= 1500/mcl * Platelets >= 100,000/mcl * Serum creatinine =< upper limit of normal (ULN) (Common Toxicity Criteria [CTC] grade 0) or calculated creatinine clearance (Jeliffe formula) >= 60 ml/min * Bilirubin =< 1.5 x institutional normal * Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x institutional normal * Alkaline phosphatase =< 2.5 x institutional normal * Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus) * Partial thromboplastin time (PTT) < 1.2 times the upper limit of normal * Urine protein-creatinine ratio (UPC ratio) < 1.0 * Patients must have a GOG performance status of 0 or 1 * Patients must have recovered from the effects of surgery, radiation therapy, or chemoradiotherapy; at least six weeks must have elapsed from the last administration of chemoradiotherapy, and at least three weeks must have elapsed from the last administration of radiation therapy alone; at least six weeks must have elapsed from the time of any major surgical procedure prior to randomization * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients must meet all of the pre-entry requirements, including baseline QOL questionnaire * Patients must be free of active infection requiring antibiotics Exclusion Criteria: * Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage * Patients previously treated with chemotherapy except when used concurrently with radiation therapy * Patients who have received concurrent paclitaxel and/or concurrent topotecan with radiation therapy are ineligible * Patients with craniospinal metastases * Patients with a concomitant malignancy other than non-melanoma skin cancer * Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy * Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess for which an interval of 3 to 6 months must pass before study entry; in addition, the patient must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations * Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels * Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study * Patients with clinically significant cardiovascular disease; this includes: * Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg * Myocardial infarction or unstable angina < 6 months prior to registration * New York Heart Association (NYHA) grade II or greater congestive heart failure * Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate * CTCAE grade 2 or greater peripheral vascular disease (at least brief [< 24 hours (hrs)]) episodes of ischemia managed non-surgically and without permanent deficit) * History of CVA within six months * Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * Patients with or with anticipation of invasive procedures as defined below: * Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy * Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression, such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures * Core biopsy, within 7 days prior to randomization * Patients who are pregnant or nursing; bevacizumab should not be administered to pregnant women; bevacizumab should not be administered to nursing women; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy * Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab * Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition * Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regard * Patients with significant peripheral vascular disease * Patients with pre-existing grade 2 or greater peripheral neuropathy

Study Objectives This phase I trial is studying the side effects and best dose of belinostat when given together with azacitidine in treating patients with advanced hematologic cancers or other diseases. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving belinostat together with azacitidine may kill more cancer cells. Conditions: Accelerated Phase of Disease, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL, Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blastic Phase, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia, Previously Treated Myelodysplastic Syndrome, Primary Myelofibrosis, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Disease, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome Intervention / Treatment: DRUG: Belinostat, DRUG: Azacitidine, OTHER: Laboratory Biomarker Analysis Location: United States, New Zealand, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed diagnosis of 1 of the following: * Relapsed or refractory acute myeloid leukemia (AML) * Relapsed or refractory acute promyelocytic leukemia (must have failed both tretinoin and arsenic trioxide) * Relapsed or refractory acute lymphoblastic leukemia * Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes (MDS) or myeloproliferative disorders, OR therapy-related AML * Chronic myelogenous leukemia in accelerated or blast phase * Advanced phases of Philadelphia chromosome-negative (Ph-) chronic myeloproliferative disorders, as defined by >= 1 of the following: * Presence of anemia (hemoglobin < 10 g/dL and/or red blood cell transfusion dependent) * Presence of palpable splenomegaly * MDS, including chronic myelomonocytic leukemia * Must have intermediate or high-risk International Prognostic Scoring System (IPSS) scores (>= 0.5) * Low-risk IPSS scores allowed provided >= 1 of the following criteria are met: * Hemoglobin < 10 g/dL and/or red blood cell transfusion dependent * Platelet count < 50,000/mm³ * Absolute neutrophil count < 1,000/mm³ * Refractory disease OR no standard therapy exists * Evidence of AML associated with dysplasia on bone marrow histology for elderly patients (i.e., > 60 years old) who are previously untreated and not candidates for or unwilling to undergoing induction therapy * No known active CNS involvement with disease * CALGB performance status (PS) 0-2 OR Karnofsky PS 60-100% * Bilirubin <= 2.0 mg/dL (unless due to Gilbert's syndrome) * ALT <= 3 times upper limit of normal (unless due to disease) * Creatinine <= 2 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101 or Azacitidine * No history of allergic reactions to mannitol * No history of dose-limiting toxicity during prior treatment with Azacitidine * No concurrent uncontrolled illness including, but not limited to, the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would preclude compliance with study requirements * No marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 500 msec) * No long QT syndrome * No uncontrolled cardiovascular disease, including the following: * Severe uncontrolled hypertension * Uncontrolled congestive heart failure related to primary cardiac disease * Uncontrolled cardiac arrhythmia * Uncontrolled ischemic or severe valvular heart disease * Myocardial infarction within the past 6 months * See Disease Characteristics * Recovered from prior therapy * At least 2 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) * At least 2 weeks since prior radiotherapy * At least 4 weeks since prior investigational agents * At least 24 hours since prior hydroxyurea * At least 2 weeks since prior valproic acid * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * No concurrent medication that may cause torsade de pointes * No other concurrent anticancer therapy, including chemotherapy, radiotherapy, or biological agents

Study Objectives The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Lenalidomide and low-dose dexamethasone, DRUG: Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles, DRUG: Melphalan, Prednisone and Thalidomide Location: Canada, Portugal, United States, Greece, Taiwan, Austria, France, Italy, United Kingdom, Ireland, Spain, Belgium, China, Sweden, Germany, Korea, Republic of, New Zealand, Switzerland, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Must understand and voluntarily sign informed consent form * Age >= 18 years at the time of signing consent * Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: * MM diagnostic criteria (all 3 required): * Monoclonal plasma cells in the bone marrow >=10% and/or presence of a biopsy-proven plasmacytoma * Monoclonal protein present in the serum and/or urine * Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis AND have measurable disease by protein electrophoresis analyses as defined by the following: * IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level >= 1.0 g/dl or urine M-protein level >= 200 mg/24 hours * IgA multiple myeloma: Serum M-protein level >= 0.5 g/dl or urine M-protein level >= 200 mg/24 hours * IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level >= 1.0 g/dl or urine M-protein level >= 200mg/24hours * IgD multiple myeloma: Serum M-protein level >= 0.05 g/dl or urine M-protein level >= 200 mg/24 hours * Light chain multiple myeloma: Serum M-protein level >= 1.0 g/dl or urine M-protein level >= 200 mg/24 hours AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because: * The patient declines to undergo stem cell transplantation or * Stem cell transplantation is not available to the patient due to cost or other reasons * ECOG performance status of 0, 1, or 2 * Able to adhere to the study visit schedule and other protocol requirements * Females of child-bearing potential (FCBP)^2: 1. Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence. 2. Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy. * Male Patients: 1. Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy. 2. Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy. 3. Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy. * All patients must: 1. Have an understanding that the study drug could have a potential teratogenic risk. 2. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. 3. Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure. Exclusion Criteria: * Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]). * Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment. * Pregnant or lactating females. * Any of the following laboratory abnormalities: * Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L) * Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L) * Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) * Renal failure requiring hemodialysis or peritoneal dialysis. * Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for >= 3 years. Exceptions include the following: * Basal cell carcinoma of the skin * Squamous cell carcinoma of the skin * Carcinoma in situ of the cervix * Carcinoma in situ of the breast * Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) * Patients who are unable or unwilling to undergo antithrombotic therapy. * Peripheral neuropathy of > grade 2 severity. * Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis. * 1 A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related. * 2 A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Study Objectives After the KFDA (Korea Food and Drug Administration) approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the Health Authority in 6 years. In this Observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (Velcade). Conditions: Multiple Myeloma Intervention / Treatment: DRUG: bortezomib Location: Korea, Republic of Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma Exclusion Criteria: * Patients who are hypersensitive to the bortezomib or any component of the bortezomib or with a history of the hypersensitivity * Patients with severe hepatic impairment * Pregnant women

Study Objectives A prospective, randomized study was performed. The patients were randomized into 2 groups: those patients undergoing subcutaneous vitamin E ointment application (Group 1) and those patients who not (Group 2). Incisional surgical site infection (SSI), microbiological cultures from the infected surgical wounds, postoperative pain and acute phase reactants were investigated. Conditions: Surgical Site Infection Intervention / Treatment: DRUG: Vitamin E ointment application Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Diagnosis of colorectal neoplasms and plans to undergo an elective laparoscopic surgery with curative aims Exclusion Criteria: * Open surgical approach or conversion to laparotomy * Performance of a stoma * Immunodepression status * Anastomotic leak

Study Objectives The main objectives of the BI 754091 monotherapy dose-finding part (Part I) of the trial are to investigate the following items in advanced solid tumours: * Safety, tolerability, and pharmacokinetics (PK) of BI 754091 as monotherapy. * Maximum tolerated dose (MTD) and/or recommended dose (RD) of BI 754091 monotherapy. The main objectives of the Combination dose-finding part (Part II) of the trial are to investigate the following items in advanced solid tumours: * Safety, tolerability, and PK of the combination treatment of BI 754091 and BI 754111. * MTD and/or RD of the combination treatment of BI 754091 and BI 754111. The main objectives of the expansion part (Part III) of the trial are: * To further investigate the safety, tolerability, and PK of the RD of BI 754091 and BI 754111 combination in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or non-small cell lung cancer (NSCLC) * To explore the efficacy of the RD of the combination of BI 754091 and BI 754111 in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or NSCLC Conditions: Neoplasms Intervention / Treatment: DRUG: BI 754091, DRUG: BI 754111 Location: Japan, Korea, Republic of, Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Of full age (according to local legislation) at the time of signing of the informed consent form (ICF) * Women of childbearing potential (WOCBP)1 with negative serum pregnancy test at screening and men able to father a child, who agree to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. The requirement of contraception does not apply to women of no childbearing potential but they must have an evidence of such at screening * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial * Patients with measurable lesions according to RECIST v1.1 * Conditions specific to respective part of the trial: * Part I (BI 754091 dose-finding part): * Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type) * For whom no therapy of proven efficacy exists, or who are not amenable to standard therapies. * Previous treatment with an anti-PD-1 mAb is allowed as long as the last administration of the anti PD-1 mAb on the previous treatment is a minimum of 28 days prior to the first BI 754091 treatment. * Part II (Combination dose-finding part): * Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type) * For whom no therapy of proven efficacy exists, or who are not amenable to standard therapies. * Previous treatment with an anti-PD-1 mAb is allowed as long as the last administration of the anti PD-1 mAb on the previous treatment is a minimum of 28 days prior to the first BI 754091 treatment. * Part III (Expansion part): * Cohort A: Patients with gastric/esophagogastric junction cancer, with no prior treatment with anti-PD-1/PD-L1 antibody, and who received at least one line of systemic medical treatment excluding adjuvant therapy * Cohort B: Patients with esophageal cancer with no prior treatment with anti-PD-1/PD-L1 antibody, and who received at least one line of systemic medical treatment excluding adjuvant therapy * Cohort C: Patients with hepatocellular cancer with no prior treatment with anti-PD-1/PD-L1 antibody, who received at least one line of systemic medical treatment excluding adjuvant therapy, and whose Child-Pugh score is 7 or less * Cohort D: Patients with gastric/esophagogastric junction cancer, esophageal cancer, or hepatocellular cancer with a prior treatment with anti-PD-1/PD-L1 antibody * Cohort E: First line squamous or non-squamous NSCLC patients: * Without EGFR mutations or ALK rearrangements * PD-L1 expression level <50% * All cohorts: Patients with advanced and/or metastatic disease, with at least 1 tumour lesion amenable to biopsy, and must be medically fit for biopsy at screening as determined by investigator and willing to undergo a biopsy before first treatment (if adequate archival tissue is not available) and, unless clinically contraindicated, after 6 weeks on therapy. * Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 to 1 at screening Exclusion Criteria: * Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to study entry or planned within 12 months after screening, e.g. hip replacement * Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial * Previous treatment with study medications in this trial * Any investigational or anti-tumour treatment within 4 weeks or 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment * Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 neuropathy due to prior platinum-based therapy * (Part II and III only) Prior treatment with anti-LAG-3 agents * Patients with lung cancer that have epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, unless disease has progressed following available EGFR or ALK targeted therapy * Presence of other active invasive cancers other than the one treated in this Trial within 5 years Prior to screening, with the exception of appropriately treated basal or squamous-cell carcinoma of the skin or in situ carcinoma of the uterine cervix, or other local tumours considered cured by local treatment * Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of PD by imaging for at least 4 weeks prior to the first dose of trial treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases * Inadequate organ function or bone marrow reserve as demonstrated by the following laboratory values: * Absolute neutrophil count <1.5 x 10^9/L (<1500/mm^3) * Platelet count <100 x 10^9/L (<100,000/mm^3) * Haemoglobin <9.0 g/dL * Alanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN) if no demonstrable liver lesion(s) (primary or metastases) or >5 times ULN in the presence of liver lesion(s) * Aspartate aminotransferase (AST) >2.5 times ULN if no demonstrable liver lesion(s) or >5 times ULN in the presence of liver lesion(s) * Total bilirubin >1.5 times ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 times ULN or direct bilirubin >1.5 times ULN * Serum creatinine (measured by enzymatic assay, Isotope dilution mass spectroscopy [IDMS] standardized Jaffe assay, or non-IDMS Jaffe assay) >1.5 times ULN or estimated glomerular filtration rate (eGFR) <30mL/min/1.73m^2 (Chronic Kidney Disease Epidemiology [CKD-EPI] Collaboration equation); confirmation of eGFR is only required when creatinine is >1.5 X ULN * International normalized ratio (INR) (only tested if clinically indicated) >1.5 times ULN (if treated with anticoagulants, prolonged INR is acceptable) * Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) >470 msec * Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle branch block, third degree heart block * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval * Patients with an ejection fraction <55% or the lower limit of normal of the institutional standard will be excluded. Only in cases where the Investigator (or the treating physician or both) suspects cardiac disease with negative effect on the EF, will the EF be measured during screening using an appropriate method according to local standards to confirm eligibility (e.g., echocardiogram [ECHO], multi-gated acquisition scan [MUGA]). A historic measurement of EF no older than 6 months prior to first administration of study drug can be accepted provided that there is clinical evidence that the EF value has not worsened since this measurement in the opinion of the Investigator or of the treating physician or both. * History of pneumonitis within the last 5 years * History of severe hypersensitivity reactions to other mAbs * History of severe hypersensitivity reactions to the ingredients of study drug * Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study treatment * Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy, or asthma well controlled with steroids * Active infection requiring systemic treatment (antibacterial, antiviral, or antifungal therapy) at start of treatment in this trial * Known history of human immunodeficiency virus (HIV) infection or laboratory evidence of hepatitis virus infection with positive results of hepatitis B surface (HBs) antigen and/or presence of HBc antibody together with HBV-DNA and/or hepatitis C RNA (HIV and hepatitis test results obtained in routine diagnostics are acceptable if done within 14 days before the informed consent date). However, for patients with hepatocellular cancer in Part III Cohorts C and D, patients with HBV and/or HCV infection are allowed. Hepatocellular cancer patients in Part III Cohorts C and D with HBV infection must be receiving effective antiviral therapy (viral load <100 IU/mL) * Current or history of interstitial lung disease * Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes him/her an unreliable trial patient, unlikely to complete the trial, or unable to comply with the protocol procedures. However, for patients with hepatocellular cancer in Part III Cohorts C and D, past chronic alcohol abuse are allowed * Women who are pregnant, nursing, or who plan to become pregnant during the trial

Study Objectives This is an open-label, non-randomised, multi-centre phase I-II study of CHR-2797 administered orally once a day. The study involves two distinct phases: * Phase I: an open-label, dose-escalating phase of the study to explore the safety, tolerability, and pharmacokinetics (PK) of CHR-2797. * Phase II: the recommended dose level of CHR-2797, as determined in phase I, will be administered to a further cohort of approximately 40 patients to determine whether CHR-2797 has sufficient biological activity against the disease(s) under study. Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Multiple Myeloma Intervention / Treatment: DRUG: CHR-2797 (tosedostat): Aminopeptidase inhibitor Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed, informed consent. * Patients with AML, MDS (subtype RAEB-1 or RAEB-2), or MM whose disease has relapsed or is refractory to front line and/ or salvage therapy; elderly patients (>= 60 years) with AML, MDS, MM who are not candidates for chemotherapy and for whom other therapy is inappropriate. * Patients should have recovered from the acute adverse effects of prior therapies (excluding alopecia and grade II neuropathy). * AML, MDS and MM are diseases of the haematopoietic system and can cause myelosuppression. Consequently supportive therapy should be given to ensure adequate values, according to local guidelines. * A bone marrow aspirate/ biopsy performed within four weeks prior to study entry. * Adequate bone marrow, hepatic and renal function including the following: 1. Patients with high blast counts can be included in the trial, if they can be controlled by the use of hydroxyurea (500-3000 mg daily). 2. Total bilirubin <= 1.5 x upper normal limit. 3. AST (SGOT), ALT (SGPT) <= 2.5 x upper normal limit. 4. Creatinine <=1.5 x upper normal limit. * Age >= 18 years * 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 the start of the trial. A woman with reproductive potential is defined as one who is biologically capable of becoming pregnant. Patients who are not surgically sterile or postmenopausal must agree to use a medically acceptable and highly effective method of birth control for the duration of the study and to continue after the end of CHR-2797 treatment for a further 3 months (female patients) or for a further 6 months (for male patients and their partners). A highly effective method of birth control is defined as any method that results in a low failure rate, including implants, injectables, some intra-uterine devices (IUD's), sexual abstinence, and vasectomy/ sterilization. Sexually active males and females using oral contraceptive pills should also use barrier contraception. Although there is no reason to believe that the use of CHR-2797 has an effect on the pharmacokinetics of hormonal contraceptives, this has not yet been proven. Exclusion Criteria: * Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry- except for hydroxyurea (maximum daily dose is 3 g). * Indolent, smouldering myeloma, monoclonal gammopathy with unknown significance. * Patients who need a daily dose of hydroxyurea greater than 3 g to control leukocytosis. * Co-existing active infection or serious concurrent illness. * 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. * Patients with platelet count(s) < 20,000. * Patients who have had a blood transfusion (platelet support or packed cells) within 7 days prior to study entry. * Persistent grade II or greater toxicity from any cause (except haematological toxicities and peripheral neuropathy). * Patients with grade III-IV peripheral neuropathy. * Pregnant or breast-feeding women.

Study Objectives Phase I clinical trial of hypofractionated radiotherapy to an isolated index lesion in combination with the PD-1 inhibitor, Pembrolizumab in patients with metastatic cancers who have failed anti-PD-1 therapy (melanoma and NSCLC) and patients with metastatic cancers who have have progressed after at least one regimen of systemic therapy (breast, pancreas, and other). Conditions: Metastatic Cancers Intervention / Treatment: DRUG: Pembrolizumab, RADIATION: Radiotherapy 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: * Be willing and able to provide written informed consent/assent for the trial. * Be 18 years of age on day of signing informed consent. * Histologically confirmed diagnosis of cancer as per the cohort specifications * Stage IV cancer by AJCC staging criteria (except for pancreatic cancer cohort) * Locally advanced or metastatic pancreatic cancer for the pancreatic cancer cohort * Progression of disease while on anti-PD-1 or anti-PD-L1 therapy for melanoma and NSCLC patients. For this group, patients must met the following criteria: 1. Received at least 2 doses of an anti-PD1 or anti-PD-L1 therapy 2. Had progressive disease documented radiologically by RECIST v1.1 criteria. * Progression or refractory disease to at least one regimen of therapy for metastatic disease in the breast and pancreatic cancer cohorts * Presence of an index lesion > 1 cm amenable to hypofractionated radiotherapy * Patients who have metastatic cancer must have at least one lesion that is outside the radiation field that measures greater than one cm that can be followed by RECIST 1.1. This lesion, if it is close to the radiated lesion, must receive no more than 10% of the dose prescribed to the target lesion. * Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion. * Have a performance status of 0 or 1 on the ECOG Performance Scale. * Ability to tolerate hypofractionated radiation therapy (e.g. lie flat and hold position) * Demonstrate adequate organ function , all screening labs should be performed within 14 days of treatment initiation. * Adequate Organ Function Laboratory Values System Laboratory Value Hematological Absolute neutrophil count (ANC) >=1,500 /mcL Platelets >=100,000 / mcL Hemoglobin >=9 g/dL or >=5.6 mmol/L Renal Serum creatinine OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl) * 1.5 X upper limit of normal (ULN) OR >=60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Hepatic Serum total bilirubin * 1.5 X ULN OR Direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) * 2.5 X ULN OR * 5 X ULN for subjects with liver metastases Creatinine clearance should be calculated per institutional standard * Female subject of childbearing potential should 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 should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. * Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria * The subject must be excluded from participating in the trial if the subject: * Is currently participating in or has participated in a study of an investigational agent or using 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. Systemic steroids administered specifically as a premedication for chemotherapy infusion or radiotherapy are allowed. * Has had a prior monoclonal antibody 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. * A history of prior radiotherapy that precludes delivery of hypofractionated radiotherapy * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. * 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. * Has an active automimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study. * Has evidence of interstitial lung disease or active, non-infectious 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 trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). * Has received a live vaccine within 30 days prior to the first dose of trial treatment.

Study Objectives The purpose of this study is to learn how myeloma cells grow and become a cancer, how to distinguish them from normal cells and how to eliminate these cells selectively. Conditions: Multiple Myeloma Intervention / Treatment: OTHER: No drugs are involved Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Any subject evaluated for a MIRT protocol Exclusion Criteria: * Subjects who have not been evaluated for a MIRT protocol

Study Objectives Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment. Conditions: Small Cell Lung Cancer Intervention / Treatment: DRUG: Chiauranib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female, age >= 18 years and <=75 years; * Cytologically or histologically confirmed small cell lung cancer; * Patients have received at least 2 different systemic chemotherapy regimens (contained platinum based regimen) , and progressed or relapsed * At least one measurable lesion that can be accurately assessed ( RECIST1.1 criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Laboratory criteria are as follows: Complete blood count: hemoglobin (Hb) >=80g/L ; absolute neutrophil count (ANC) >=1.5×109/L ; platelets >=75×109/L Biochemistry test: total bilirubin≦1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≦2.5×ULN(ALT,AST≦5×ULN if liver involved); serum creatinine(cr)≦1.5×ULN; Coagulation test: International Normalized Ratio (INR) < 1.5. * Life expectancy of at least 12 weeks. * All patients must have given signed, informed consent prior to registration on study. Exclusion Criteria: * Patients receiving any anti-cancer therapy (including chemotherapy, target therapy, immunotherapy, radiotherapy, and anti-cancer Chinese traditional medicine, et al) within 4 weeks from the last dose prior to study entry; Subjects receiving any supportive treatment for haematology (including transfusion, blood products, or drugs that stimulate blood cells growth like G-CSF, et al) within 2 weeks from the last dose prior to study entry; * Patients with second primary cancer, except: adequately treated basal cell or squamous cell skin cancer, curatively treated in-situ cancer of the cervix, unless received curative treatment and with documented evidence of no recurrence during the past five years; * Patients with uncontrolled or significant cardiovascular disease, including: A) Grade II or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (NYHA Classification) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) < 50% during screening stage. B) Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al). C) History of significant QT interval prolongation, or Corrected QT Interval QTc>=450ms(male),QTc>=470ms（female）at screening. D) Symptomatic coronary heart disease requiring treatment. E) Uncontrolled hypertension (> 140/90 mmHg) with single medication. * History of active bleeding within 6 months prior to screening; or patients receiving anticoagulation therapy; or patients with upper GI bleeding potential; or patients with active hemoptysis. * Patients with uncontrolled pleural effusion, pericardial effusion or ascites. * Patients with untreated central nervous system (CNS) metastasis; or requiring corticosteroids, anticonvulsants for CNS diseases treatment; or with evidence of progression or haemorrhage within 1 month prior to study entry; or clinical evidence of brain stem or leptomeninx involvement. * History of deep vein thrombosis or pulmonary embolism. * History of interstitial lung disease(ILD). * With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy. * Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy. . * 6 weeks or less from the last major surgery that involved general anaesthesia, or 2 weeks or less from the last minor surgery prior to screening (excluding placement of vascular access ) . * Proteinuria positive(>=1g/24h). * Patients with active or unable to control infections including human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, or other serious infectious diseases. * Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study; * Any previous treatment with aurora kinase inhibitors, or VEGF/VEGFR inhibitors. * Candidates with drug and alcohol abuse. * Women of childbearing potential not willing to use and utilize an adequate method of contraception (such as intrauterine device, contraceptive and condom) throughout treatment and for at least 12 weeks after the last dose; pregnant or breastfeeding women; the result of urine pregnancy test was positive at screening; Man participants not willing to use and utilize an adequate method of contraception throughout treatment. * Any other condition which is inappropriate for the study according to investigators' judgment.

Study Objectives The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from the original protocol as of an amendment. The original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. An amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). Therefore, the study was completed as per this amendment. No secondary objectives were included for this trial from the amendment; this was a change from the original protocol. Conditions: Hodgkin's Lymphoma Intervention / Treatment: DRUG: Panobinostat, DRUG: Placebo Location: Israel, Canada, Germany, Italy, Brazil, Netherlands, New Zealand, United States, Belgium, Australia, Singapore, Russian Federation, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Patient age is greater than or equal to 18 years * Patient has a history of histologically confirmed classical HL (i.e. Nodular sclerosing (NSHL), Mixed-cellularity (MCHL), Lymphocyte-rich (LRHL), Lymphocyte depleted (LDHL)) * Patient has achieved a complete response by CT/MRI scan within 9 weeks (± 1 week) from the day of their first autologous peripheral blood/ bone marrow stem cell transfusion (AHSCT) following HDT. Complete response is defined as: Normalization of all nodes and lesions compared to pre-transplant scan performed prior to salvage therapy for relapse. Any residual abnormal masses on the post transplant CT/MRI must be metabolically inactive on a PET scan. * Patient has at least one of the following factors that places them at risk for relapse: * Primary refractory disease (including relapse in <= 3 months of completion of 1st line treatment) * First relapse >3 but <12 months from last dose of 1st line treatment * Multiple relapses (prior to transplant) * Stage III/IV disease (at relapse, prior to transplant) * Hemoglobin <10.5 gm/dL (at relapse, prior to transplant) Exclusion Criteria: Patient has been treated with allogeneic transplant 2. Patient has received any anti-lymphoma therapy after AHSCT including but not limited to: * chemotherapy prior to start of study * biologic immunotherapy including monoclonal antibodies or experimental therapy prior to start of study * radiation therapy 3. Patient has not recovered from reversible toxicity due to any prior therapies (e.g. returned to baseline or Grade <=1) except for hematological laboratory parameters Note: Patient does not meet this criteria if the toxicity is stable and irreversible, and there is no evidence that panobinostat causes a similar toxicity 4. Patient has received prior treatment with DAC inhibitors including panobinostat

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.

Study Objectives This Phase 1 study is being conducted to support the clinical development of acalabrutinib in hospitalized patients who are unable to swallow acalabrutinib tablet or capsule due to respiratory failure, eg, they may require endotracheal intubation for ventilator support and nasogastric (NG) tube placement, and it is important to have a clinically acceptable method to administer acalabrutinib via NG tube. Part 1 of the study is designed to evaluate relative bioavailability by comparing the pharmacokinetic (PK) of AT suspension in water administered via NG tube with the PK of acalabrutinib capsule suspension in flat COCA-COLA administered via NG tube. Additionally, the PPI effect will be evaluated by comparing the PK of AT suspension in water administered via NG tube plus rabeprazole with the PK of AT suspension in water administered via NG tube. Part 2 of the study is designed to evaluate the effect of NG administration on AT by comparing the PK of AT suspension in water administered via NG tube with the PK of AT orally administered with water. Conditions: Mantle Cell Lymphoma, COVID-19 Intervention / Treatment: DRUG: Acalabrutinib Treatment A, DRUG: Acalabrutinib Treatment B, DRUG: Acalabrutinib Treatment C, DRUG: Acalabrutinib Treatment D Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Provision of signed and dated, written informed consent form (ICF) prior to any study-specific procedures. * Healthy adult male and female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. * Male subjects and their female partners/spouses must adhere to the contraception methods. * Female subjects must have a negative pregnancy test at screening and on admission, must not be lactating, and must be of non childbearing potential, confirmed at screening. * Have a body mass index between 18.5 and 30 kg/m^2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive, at screening. * Understands the study procedures in the ICF and willing and able to comply with the protocol. Exclusion Criteria: * History or presence of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. * History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs, as judged by the Investigator. * Any clinically significant illness, medical/surgical procedure, or trauma within 30 days of the first administration of study medication. * Any clinically significant abnormalities in hematology, coagulation, clinical chemistry, or urinalysis results, at screening and on first admission to the Clinical Unit, as judged by the Investigator and defined as: (i) Hemoglobin less than lower limit of normal. (ii) Platelet count less than lower limit of normal. (iii) Absolute neutrophil count less than the lower limit of normal. (iv) Prothrombin time, Activated partial thromboplastin time or International normalized ratio above upper limit of normal (ULN). (v) Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) or serum bilirubin (total and direct) > 1.5 ULN. * Any clinically significant abnormal findings in vital signs at screening and on first admission to the Clinical Unit, as judged by the Investigator, eg: (i) Systolic blood pressure (BP) < 90 mmHg or >= 140 mmHg and diastolic blood pressure (DBP) < 50 mmHg or >= 90 mmHg sustained for at least 10 minutes while resting in a supine position. (ii) Pulse < 50 beats per minute (bpm) or > 90 bpm. * Any clinically significant abnormalities on standard 12-lead electrocardiogram (ECG) at screening and on first admission to the Clinical Unit, including but not limited to any of the following: (i) QTcF > 450 millisecond (ms) or < 340 ms or family history of long QT syndrome, (ii) Any significant arrhythmia, (iii) Conduction abnormalities: Clinically significant PR (PQ) interval prolongation (> 240 ms); intermittent second or third degree atrioventricular (AV) block, or AV dissociation, Complete bundle branch block and/or QRS duration > 120 ms. * Any positive result on screening for serum hepatitis B virus antigen or hepatitis B core antibody, hepatitis C antibody, and human immunodeficiency virus antibody. * Has received a new chemical or biological entity within 90 days or at least 5 half-lives, whichever is the longest, of the first administration of study medication in this study. * Plasma donation within 30 days of screening or any blood donation/loss more than 500 mL during the 90 days prior to screening. * History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to acalabrutinib or rabeprazole. * Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the 90 days prior to screening. * Positive screen for drugs of abuse or cotinine at screening and on each admission to the Clinical Unit; positive screen for alcohol on each admission to the Clinical Unit. * Treatment with a strong CYP3A inhibitor (within 14 days before first administration of study medication) or strong CYP3A inducer (within 28 days before first administration of study medication). * Use of any prescribed or non prescribed medication. * Known or suspected history of alcohol or drug abuse, or excessive intake of alcohol as judged by the Investigator. * Excessive intake of caffeine-containing drinks or food as judged by the Investigator. * Involvement of any AstraZeneca, Acerta Pharma, Parexel or study site employee or their close relatives. * Judgment by the Investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements. * Subjects who cannot communicate reliably with the Investigator. * Vulnerable subjects, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order. * Inability to swallow ATs or have a NG tube placed on separate occasions. * History of a disorder which would make NG tube placement contraindicated, eg, esophageal strictures, esophageal varices, or bleeding diathesis. * Evidence of ongoing systemic bacterial, fungal, or viral infection. * Subject has a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcriptase polymerase chain reaction before randomization. * Subject has clinical signs and symptoms consistent with corona virus disease 2019 (COVID-19), eg, fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission. * History of severe COVID-19 (hospitalization, extracorporeal membrane oxygenation, mechanically ventilated). * Subjects who are regularly exposed to COVID-19 as part of their daily life.

Study Objectives The goal of this clinical research study is to learn if methylphenidate (Ritalin) can help to control fatigue caused by cancer. Its effect on other symptoms such as drowsiness, depression, sleeplessness, physical activity, and anxiety will also be studied. Another goal of this study is to learn if receiving a phone call by a nurse improves fatigue in patients. Conditions: Advanced Cancer, Fatigue Intervention / Treatment: DRUG: Methylphenidate, BEHAVIORAL: Nursing Telephone Intervention, DRUG: Placebo, BEHAVIORAL: Non NTI Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Patients will be eligible to participate in this study if they have advanced cancer. * Patients will be eligible to participate in this study if they rate fatigue on the Edmonton Symptom Assessment System (ESAS) during the last 24 hours as greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue * Describe fatigue as being present every day for most of day for a minimum of 2 weeks * Lack clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered normal * Are >= 18 years * Are willing to keep a daily diary, engage in telephone follow up with a nurse every other day, and return for follow-up visit after 14 days of treatment * Have telephone access to be contacted by the research nurse. If patient is relocating within 5 weeks, patient will be asked to provide a new telephone number * Hemoglobin of greater than or equal to 8 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past 2 weeks, one will be done to determine the eligibility. Patients with a hemoglobin of less than 8 will be referred for treatment of their anemia * Able to understand the description of the study and give written informed consent. * Able to understand the description of assessments, and able to complete baseline assessment * Patients on no erythropoietin or stable dose. Exclusion Criteria: * Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics, glaucoma, severe angina pectoris, or hypertension, etc. * Currently on methylphenidate or has been on methylphenidate within the last 10 days. * Inability to complete the baseline assessment forms or do understand the recommendations for participation in the study * Major depression according to the Structured Clinical Interview (SCID) Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnostic criteria. These patients wil be referred immediately to psychiatry for assessment and management * Pregnant or lactating women * Requirement for Monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants or clonidine * Glaucoma, history of marked anxiety disorders * History of alcohol (CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale) or substance abuse including illegal drugs and/or medications. * Tourette's syndrome * Symptomatic tachycardia and uncontrolled hypertension. * Currently receiving oral anticoagulants (Coumadin/warfarin), anticonvulsants (Phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). * Patients with pacemakers * Patients with symptomatic cardiac arrhythmias

Study Objectives This study was to explore the efficacy of ALK-TKI in lung squamous cell carcinoma.Approximately 5% of lung adenocarcinomas have oncogenic fusions of EML-4 and ALK a mutation associated with tumorigenesis and migration. Several studies have shown that in patients with ALK-rearranged non-small cells, the use of ALK inhibitors can achieve better efficacy and significantly prolong overall survival. However few of them performed Fish or NGS tests. Our data demonstrates that lung squamous cell carcinoma with ALK rearrangement responds well to ALK-TKI, and correspondingly has a significant improvement in survival time and prognosis, providing a basis for the treatment of ALK-positive patients with lung squamous cell carcinoma. At the same time, we believe that genetic testing is also required for lung squamous cell carcinoma to achieve more accurate medication. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DRUG: Crizotinib Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * 18，Advanced Non-small Cell Lung Cancer Confirmed by Histopathology ALK Arranged Positive ALK Arranged Detection Method is NGS or FISH Treatment Plan is Crizotinib 250mg po bid Exclusion Criteria: * Patients with contraindication of chemotherapy Pregnant or breast feeding women

Study Objectives This study is done in patients having Breast Cancer with metastasis (patients with positive receptor HER2) whose disease progressed after receiving Trastuzumab. The primary objective of this study is to compare the time until disease progression between the Treatment Arm CAPECITABINE and the Treatment Arm CAPECITABINE + TRASTUZUMAB The study has also other secondary and tertiary objectives. Conditions: Breast Cancer Intervention / Treatment: DRUG: Capecitabine, DRUG: Trastuzumab Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements. * Pathologically confirmed carcinoma of the breast. * Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone. * HER2-overexpression of the primary or metastatic tumor tissue detected by immunohistochemistry (DAKO) 3+ or gene namplification detected by FISH. HER2-positive primary tumours with HER2-negative metastasis can be included. * Disease progression during or after previous chemotherapy and trastuzumab treatment as follows (Trastuzumab has to be given previously for at least 12 weeks, treatment free interval of trastuzumab for a maximum of 6 weeks): * Taxanes + trastuzumab given as adjuvant therapy * Taxanes + trastuzumab given as first line therapy for palliation * Trastuzumab given as first line therapy for palliation alone or in combination with chemotherapeutic agents other than capecitabine or taxanes * No more than 1 chemotherapy for palliation (max. Adriamycin dose < or = 400 mg/m²; Epirubicin < or = 600 mg/m²) * Patients must have either measurable or nonmeasurable target lesions according to the RECIST criteria (see Appendix 6) * At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease * At least 4 weeks since major surgery with full recovery. * Complete radiology and tumor measurement work up within 4 weeks prior to registration: * Karnofsky performance status evaluation > or = 60% * Age >18 years. * Absolute neutrophil count > or =1,500 cells/microL, platelet count > or =100,000 cells/microL. * Bilirubin < or = 2x the upper limit of normal for the institution (ULN); elevation of transaminases and alkaline phosphatase < 2.5x ULN or <5x ULN for patients with liver metastases. * Creatinine < or = 2.0 mg/dl. * Left ventricular ejection fraction (LVEF) by cardiac ultrasound of > or = 50%. * If of childbearing potential, pregnancy test is negative. In addition the patient agrees to use an effective method to avoid pregnancy for the duration of the study. Exclusion criteria: * Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency. * Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued. * Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and of all steroids. * Life expectancy of less than 3 months. * Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including severe pulmonary conditions, AIDS and serious active infection). * History of congestive heart failure or other significant uncontrolled cardiac disease. * History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer. * Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry. * Treatment with sorivudine or derivates e.g. brivudin * Pregnant or nursing women. * Male patients. * The patient must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre which could be the Principal or Co- investigator's site.

Study Objectives The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone. Conditions: Colorectal Cancer Intervention / Treatment: BIOLOGICAL: cetuximab, DRUG: oxaliplatin, DRUG: leucovorin, DRUG: 5-fluorouracil, DRUG: 5-fluorouracil, BIOLOGICAL: cetuximab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Documented colorectal cancer which is EGFR-positive and is metastatic. * Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease. Exclusion Criteria: * A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy. * Known dihydropyrimidine dehydrogenase (DPD) deficiency. * Known metastases in the central nervous system. * Symptomatic sensory or peripheral neuropathy. * More than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer. * Prior oxaliplatin therapy. * Prior cetuximab or other therapy which targets the EGF pathway. * Prior chimerized or murine monoclonal antibody therapy.

Study Objectives Determine the relapse-free, donor lymphocyte infusion (DLI)-free survival in patients receiving the investigational regimen.This is a randomized phase II clinical trial, comparing two different dosing schedules of mycophenolate mofetil for graft versus host disease (GVHD) prevention following allogeneic stem cell transplantation. Risk for relapse, GVHD and non-relapse mortality will be assessed. Adaptive randomization between two study arms will be performed based on T cell counts at day 60. Conditions: Hodgkin's Lymphoma, Lymphoid Leukemia, Lymphoma, Leukemia, Myeloma, Acute Lymphocytic Leukemia, Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Multiple Myeloma, Chronic Myelogenous Leukemia, Myelodysplastic Syndromes, Recurrent Acute Myeloid Leukemia, Adult, Recurrent Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Chronic Lymphocytic Leukemia, Recurrent Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia Intervention / Treatment: DRUG: mycophenolate mofetil, BIOLOGICAL: Sargramostim, BIOLOGICAL: Filgrastim Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria * Any of the following high risk or recurrent hematological malignancies: * Hodgkin lymphoma (HL) * Non-Hodgkin lymphoma (NHL) * Chronic lymphocytic leukemia (CLL) * Multiple myeloma (MM) * Acute myelogenous leukemia (AML) * Acute lymphocytic leukemia (ALL) * Chronic myelogenous leukemia (CML) * Myelodysplastic syndrome (MDS) *Note: Determination that the malignancy is high risk will be made by the investigator. * Investigator determination that the patient is an appropriate candidate for reduced intensity allogeneic SCT with the standard Massey Cancer Center-Virginia Commonwealth Health System Bone Marrow Transplant Massey Cancer Center Virginia Commonwealth University Health System Bone Marrow Transplant (MCC-VCUHS BMT) Program regimen employed in this trial * Patients with or without previous myeloablative autologous transplant * HLA-matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated (8/8 or 7/8 loci matched) *Note: Unrelated donors must be matched at HLA-A, -B, -C, and -DRB1 loci. However, a single locus mismatch will be acceptable in the event a more closely matched donor is not available. * Age >= 40 to < 75 years; patients 18 to 39 years of age will be eligible only if the investigator has determined that the patient has comorbidity(ies) precluding conventional allogeneic transplantation with full intensity myeloablative conditioning * Karnofsky Performance Status of 70-100% * Negative serology for HIV * Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard MCC-VCUHS BMT Program guidelines * Ability to understand and the willingness to sign a written informed consent document *Note: The consent form must be signed and dated prior to initiation of SCT preparative treatments. Exclusion Criteria * Previous therapeutic radiation therapy (RT) that exceeds critical structure tolerance doses as determined by a radiation oncologist * Uncontrolled viral, fungal, or bacterial infection * Active meningeal or central nervous system disease * Previous therapy with rabbit anti-thymocyte globulin (ATG); previous treatment with equine ATG is allowed if more than 3 months ago *Note: Previous myeloablative autologous transplant is permitted but not required. * Pregnancy or breastfeeding * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Study Objectives The aim of the study is to assess the restorative efficacy of the cosmetic product "Onco-Repair" vs placebo of the most affected palmer face in subject with grade 2 HFS induced by targeted therapies or conventional chemotherapy. Conditions: Grade 2 Hand-foot Syndrom Intervention / Treatment: OTHER: Onco-Repair/ Placebo Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Who suffers from grade 2 HFS * Subject under anti-tumor treatment known to cause this toxicity: targeted therapies or conventional chemotherapy: 5-Fluorouracile, Aflibercept, Axitinib, Bévacizumab, Capécitabine, Cediranib, Cytarabine, Dabrafenib, Docétaxel, Doxorubicine, Epirubicine, Pazopanib, Sorafenib, Sunitinib, Trastuzumab, Regorafenib, Vemurafenib and any other anti-tumor treatment that may lead to this toxicity * Subject 18 years old and more * Subject having been informed, having signed a free, informed and written consent * Woman of childbearing age using contraception deemed effective Non-Inclusion Criteria: * Pregnant or lactating women * Subject having a history of allergic contact dermatitis or irritation to any of the components of the investigational products * Subjects with another skin pathology that may interfere with the evaluation of a HFS (at the investigator's discretion) * Subject under anti-inflammatory treatment * Subject participating in another clinical study during the duration of the study, except in a study assessing one of the molecules listed in the section above * Subject who has already been treated for Grade 2 HFS or under other local treatment or cosmetic product * Subject refusing to interrupt the application of his/her usual care * Subject having a strongly altered general condition and / or non-autonomous subject (Karnofsky index <50%) * Subject in linguistic or psychic impossibility to understand and sign informed consent or in the impossibility of submitting to the medical follow-up of the study * Subject deprived of liberty by administrative or judicial decision, or under guardianship

Study Objectives This study is about Prostate Health Cocktail, a combination supplement that contains vitamin D3, vitamin E, selenium, green tea extract, saw palmetto, lycopene, and soy derivatives. This product is currently available on the market, as herb and vitamin supplements are not regulated by the FDA. Each ingredient has been studied in prostate cancer cells and/or in patients with prostate cancer. At the doses included in this supplement, no serious side effects have been reported. The purpose of this study is to find out whether Prostate Health Cocktail can lower your PSA. Additionally, we will be looking to see whether taking this treatment causes any unexpected side effects, and whether certain blood tests can inform us about your disease status in addition to your PSA Conditions: Prostate Cancer Intervention / Treatment: DRUG: Prostate Health Cocktail 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:: * Age greater than or equal to 18 * Histologically documented adenocarcinoma of the prostate * Initial treatment with radical prostatectomy or external beam radiation * Neoadjuvant/Adjuvant Androgen Deprivation therapy allowable, provided it was for a maximum of 24 months, with the last dose of medication at least 12 months previously * Neoadjuvant or adjuvant chemotherapy allowable, provided it was for a maximum of 6 months, with the last dose of medication at least 12 months previously * Adjuvant radiation after radical prostatectomy is allowed, provided at least 6 months have elapsed between completion of radiation and enrollment in study * PSA recurrence, with a rising PSA, as defined by: * Post Radiation Therapy: * Absolute PSA >2.0 ng/mL * PSA nadir <4 ng/mL after radiation * Absolute rise of at least 0.5 ng/mL total * At least 2 increases in PSA, separated by at least 2 weeks; these can be separated by a PSA value which declines provided the second rising value is higher than the first rising value. * Post Prostatectomy: * Absolute PSA >1.0 ng/mL * Absolute rise of at least 1 ng/mL total from nadir * At least 2 increases in PSA separated by at least 2 weeks; these can be separated by a PSA value which declines provided the second rising value is higher than the first value * PSA Doubling Time (PSA DT) more than 3 months and less than 36 months * PSA DT to be calculated using the web-based calculator at http://kevin.phys.unm.edu/psa/ with the following constraints: * At least 3 values, but no more than 6 * All values must be >0.2 * Values must be separated by at least 2 months * No radiographically evident bony or soft tissue metastases * Documented discussion between subject and physician about the option to pursue hormone therapy and/or salvage local therapy rather than enroll in this study * Patients who received treatment with androgen deprivation for biochemical recurrence are eligible provided: * They did not document castration resistance (defined as 2 rising PSA values while testosteron < 50 * They have been off androgen deprivation for at least 3 months and have recovered their testosterone (>150) * They have decided,in conjunction with their treating physician that they do not want to resume androgen deprivation * ECOG Performance Status 0-2 * Life expectancy > 12 months * Adequate hepatic function (AST, ALT, bilirubin <1.5 x ULN) * Adequate renal function (eGFR by Cockcroft-Gault or comparable calculation >50 ml/min) * Willing to discontinue all nutritional supplements and 5-alpha reductase inhibitors (finasteride, dutasteride) for the duration of study treatment, unless the medication is being used to control symptoms of BPH and the patient has been taking the medication for more than 6 weeks * Willing to discontinue all weight control medications for the duration of study treatment * Signed informed consent Exclusion Criteria: * Atypical prostate carcinoma histology (ex: small cell, adenoid cystic) * Evidence of bony or soft tissue metastatic disease on CT/MRI or bone scan or PET/CT * Other invasive malignancy within prior 3 years, except for fully treated basal cell or squamous cell carcinoma of the skin. * Full-dose anticoagulation therapy (warfarin or low molecular weight heparin) or antiplatelet therapy (clopidogrel or ticlopidine), with the exception of low-dose aspirin therapy (81 mg). * Significant cardiac disease, included but not limited to angina, myocardial infarction, cardiomyopathy, congestive heart failure, and coronary artery disease which has required bypass surgery, angioplasty or stent placement. * Significant uncontrolled comorbid condition which, in the opinion of the treating physician would compromise the subject's ability to comply with protocol requirements, or would pose undue risk for experiencing adverse events.

Study Objectives The investigators have recently demonstrated that argininosuccinate synthase 1 (ASS1) expression is silenced in 88% of all sarcomas (n=708), and that this loss is associated with a decreased overall survival. Using the extracellular arginine depleting enzyme PEGylated arginine deiminase (ADI-PEG20), an extracellular arginine depleting enzyme, the investigators demonstrated ADI-PEG20 induces a prosurvival metabolic reprogramming in ASS1-deficient sarcomas that redirects glucose into the serine/folate pathway directing the carbons from glucose into pyrimidine biosynthesis, thus sensitizing cells to death by the pyrimidine antimetabolite gemcitabine by using metabolomics. The synthetic lethality was increased by the addition of docetaxel. Therefore a phase II clinical trial of ADI with gemcitabine and docetaxel, a standard second line therapy for soft tissue sarcoma will be conducted to determine if the clinical benefit rate of gemcitabine and docetaxel is improved by the metabolic changes induced by ADI-PEG20. Recently published data shows that priming ASS1-deficient tumors with ADI-PEG 20 and docetaxel improves the effect of gemcitabine. Therefore, a cohort of patients consisting of ten patients diagnosed with either osteosarcoma or Ewing's sarcoma (ideally five of each), and five patients diagnosed with small cell lung cancer will be included as an exploratory cohort. Enrollment to Cohort 2 will occur concurrently with Cohort 1. Conditions: Soft Tissue Sarcoma Intervention / Treatment: DRUG: pegylated arginine deiminase, DRUG: Gemcitabine, DRUG: Docetaxel, PROCEDURE: Tumor biopsy, PROCEDURE: Research blood draw Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Cohort 1: Histologically or cytologically confirmed grade 2 or 3 soft tissue sarcoma that is unresectable or metastatic that would be standardly treated with gemcitabine or gemcitabine and docetaxel. For all others, please contact the principal investigator. Prior surgery for primary or metastatic disease after chemotherapy following a response is allowed. * Cohort 2: Histologically or cytologically confirmed osteosarcoma, Ewing's sarcoma, or small cell lung cancer that is unresectable or metastatic that have either failed standard of care therapy or would be standardly treated with gemcitabine or gemcitabine and docetaxel. * Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with CT scan, as >= 20 mm by chest x-ray, or >= 10 mm with calipers by clinical exam. * Treated with at least one line of systemic therapy. The allowable window between treatments is 21 days for chemotherapy or a TKI, or 5 ½ half-lives for a TKI (whichever is shorter), 21 days and progression by CT for immunotherapy, 21 days for RT, 21 days for surgery, or 28 days for an investigational agent. * Cohort 1: At least 16 years of age. * Cohort 2: Patients with osteosarcoma or Ewing's sarcoma must be at least 10 years of age. Patients with small cell lung cancer must be at least 18 years of age. * Cohort 2 (SCLC group ONLY): Must be amenable to biopsy * Eastern Cooperative Oncology Group (ECOG) performance status <= 2 * Normal bone marrow and organ function as defined below: * Leukocytes >= 3,000/mcL * Absolute neutrophil count >= 1,500/mcl * Platelets >= 100,000/mcl * Total bilirubin <= 2 x institutional upper limit of normal (IULN) * AST(SGOT)/ALT(SGPT) <= 3 x IULN (or <= 5 x IULN if liver metastases are present) * Creatinine <= 1.5 x IULN OR * Creatinine clearance >= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal * Serum uric acid <= 8 mg/dL (with or without medication control) * Women of childbearing 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 participating in this study, she must inform her treating physician immediately. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: * A history of other high grade malignancy <= 5 years previous. Exceptions include basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix, or other tumors discussed with the study PI * Currently receiving any other investigational agents. * Prior treatment with ADI-PEG 20, gemcitabine, or docetaxel. Patients treated > one year ago in the adjuvant/neoadjuvant setting with gemcitabine or docetaxel would be allowed to be enrolled on the trial. * Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial (except for patients with SCLC, see below) because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with SCLC are allowed to enroll with brain metastases provided they are stable and they are at least 3 months post-treatment for brain metastases. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, gemcitabine, pegylated compounds, or other agents used in the study. * 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 seizure disorder not related to underlying cancer. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. * Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study treatment. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Study Objectives To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies. Conditions: Neoplasms Intervention / Treatment: DRUG: ZSTK474 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Japanese males or females >= 20 years old * Advanced (metastatic or unresectable) solid tumor * ECOG performance status score of 0 or 1 and expected survival >12 weeks * Recovered from hematological toxicities of prior cancer therapies Exclusion Criteria: * Previous treatment with PI3K inhibitor * Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease. * Other investigational agent within previous 4 weeks * Participating in another clinical study

Study Objectives The goal of this clinical research study is to learn if clofarabine when given in combination with cytarabine can help to control myelodysplastic syndrome (MDS) after the disease could not be controlled with standard therapy. The safety of this treatment will also be studied. Clofarabine is designed to interfere with the growth and development of cancer cells. Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself. Conditions: Leukemia, Myeloproliferative Diseases Intervention / Treatment: DRUG: Clofarabine, DRUG: Cytarabine 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: * Age >= 18 years. * Diagnosis of MDS confirmed within 10 weeks prior to study entry according to World Health Organization (WHO) or French-American-British (FAB) criteria. Patients are either not eligible for or choose not to proceed with a stem cell transplant. * MDS classified as follows: refractory anemia with excess blasts (RAEB-1) (5%-9% BM blasts); RAEB-2 (10%-19% BM Blasts); chronic myelomonocytic leukemia (CMML) (5%-19% Bone Marrow (BM) blasts); RAEB-t (20%-29% BM blasts) AND/OR by International Prostate Symptom Score (IPSS): intermediate-2 and high risk patients. * No response, progression, or relapse (according to 2006 International Working Group (IWG) criteria; see section 8 for details) following at least 4 cycles of either azacitidine or decitabine, or following at least 2 cycles of SGI-110, which were completed within the last 2 years - AND/OR - intolerance to azacitidine, decitabine, or SGI-110 defined as drug-related >= grade 3 hepatic or renal toxicity leading to treatment discontinuation during the preceding 2 years. * Eastern Cooperative Oncology Group (ECOG) performance status of <= 2. * Willing to adhere to and comply with all prohibitions and restrictions specified in the protocol. * Patient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study. Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Active infection not adequately responding to appropriate antibiotics (i.e. ongoing temperatures of >= 38 degree Celsius). * Total bilirubin >= 1.5 mg/dL and not related to hemolysis or Gilbert's disease. Patients with total bilirubin >= 1.5 mg/dL to 3 mg/dL are eligible if at least 75% of the bilirubin is indirect. * Alanine transaminase (ALT/SGPT) or aspartate transaminase (AST/SGOT) >= 2.5 x the upper limit of normal. * Serum creatinine > 1.5 mg/dL. * Female patients who are pregnant or lactating. * Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine devices (IUD), double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) throughout the study. * Female patients with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening. * Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy. * No prior treatment with cytarabine or clofarabine. Prior hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (eg, G-CSF, Granulocyte-macrophage colony-stimulating factor (GM-CSF), procrit, aranesp, thrombopoietins) is allowed at any time prior to or during study if considered to be in the best interest of the patient. * Psychiatric illness or social situation that would limit the patient's ability to comply with study requirements.

Study Objectives It can be difficult to obtain the perspective of patients who have had bowel surgery. This study is being done because the investigators are trying to find out whether patient-reported outcomes, (results reported to investigators by the patient), on a regular basis, will help the investigators provide better patient care and symptom management. Therefore, the purpose of this study is to determine if it is possible and if it is useful to their medical care for patients who have had bowel surgery to complete surveys about their symptoms on a regular basis. In this study the surveys are completed from home, by web or by telephone, every month for 6 months. The results of this study will guide the design of large research studies on cancer-related bowel function. The purpose of this study is to develop a bowel function questionnaire for patients with colorectal cancer. The questionnaire will be used in future clinical trials to assess bowel function. Conditions: Colon Cancer, Rectal Cancer Intervention / Treatment: BEHAVIORAL: surveys, BEHAVIORAL: surveys, BEHAVIORAL: surveys, BEHAVIORAL: Surveys Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: Aim 1: * Stage I-III rectal cancer * Post sphincter preserving surgery with restoration of bowel continuity within last 4-6 weeks at MSKCC. * Access to web and email from home * Web avidity (>=2 uses of email/week) * Able to read and write in English * Age >= 18 Aim 2: * Stage I-III colon and rectal cancer * Post surgical resection of primary tumor at MSKCC * Access to web and email from home * Web avidity (>=2 uses of email/week) * Able to read and write in English * Age >= 18 Exclusion Criteria: Aim 1: * Metastatic disease - Auditory, visual or motor impairment that would preclude ability to use telephone and/or computer. * Stoma * Participated in Aim 2 * Definitive SPS = Transanal Excision (TAE) or Transanal Endoscopic Microsurgery (TEM) Aim 2: * Metastatic disease - Auditory, visual or motor impairment that would preclude ability to use telephone and/or computer. * Stoma * Participated in Aim 1

Study Objectives This study aimed to compare the efficacy of music therapy and midazolam 0,02 mg/kgBW in reducing preoperative anxiety on patients undergoing brachytherapy with spinal anesthesia Conditions: Cancer Intervention / Treatment: OTHER: Music therapy, DRUG: Midazolam Location: Indonesia Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Woman aged 18-65 years old * Undergoing one day care brachtherapy with spinal anesthesia * American Society of Anesthesiologist (ASA) physical status of I-III * Agreed to participate in this study and signed informed consent * Able to read, write, and speak in Indonesian language. Exclusion Criteria: * Subjects with severe hearing impairment * Subjects with cognitive/mental impairment based on medical record * Subjects with previous routine use of antipsychotic and benzodiazepine drug * Subjects with prior heart disease or uncontrolled hypertension.

Study Objectives To investigate the efficacy and safety of AK160 in patients with Dupuytren's Contracture. To determine plasma concentration after the first injection of AK160 in patients with Dupuytren's Contracture. Conditions: Dupuytren's Contracture Intervention / Treatment: DRUG: Collagenase Clostridium Histolyticum Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * At least 20 years old when written informed consent is obtained. * Having a diagnosis of Dupuytren's contracture and flexion contracture due to palpable cord in at least 1 non-thumb finger (20° to 100° in MP joint and 20° to 80° in PIP joint). * Positive tabletop test result (i.e., cannot simultaneously place affected finger and palm on a table). * Voluntary written informed consent is obtained. Exclusion Criteria: Patients meeting any of the following criteria will be excluded: * Is pregnant, may be pregnant, wishes to become or could become pregnant during the study (i.e., unless acceptable contraception is used, the patient has been sterilized, or the patient is postmenopausal [no menstrual period for at least 12 months without any other medical cause]), or is breastfeeding. * Has a coexisting chronic disease of the hand that could impact assessment (muscular disease, neurological disease, neuromuscular disease). * Has received another investigational product 30 or fewer days before first injection of the investigational product. * Has undergone aponeurectomy, aponeurotomy, needle aponeurotomy/fasciotomy, verapamil/interferon injection, or another Dupuytren's Contracture treatment of the primary joint 90 or fewer days before first injection of the investigational product. * Is allergic to collagenase or any of the excipients of AK160. * Has taken tetracycline derivative such as minocycline and doxycycline 14 or fewer days before first injection of the investigational product. * Has received a collagenase product 30 or fewer days before first injection of the investigational product. * Is currently taking or has taken, 7 or fewer days before first injection of the investigational product, an anticoagulant or antiplatelet drug (other than <=150 mg/day of aspirin). * Has suffered a recent stroke, hemorrhage, or other disease affecting the hands. * Has a serious disease unsuited for the study. * Receiving treatment for a malignancy. * History of drug or alcohol addiction within the past 5 years or history of drug or alcohol abuse within the past year. * Has received previously the investigational product (AK160, AA4500, XIAFLEX®, or XIAPEX®). * Otherwise found ineligible as a subject by the investigator.

Study Objectives The primary purpose of this study is to help answer the following research questions: * To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) remain free from disease and thus live longer. * To assess for any side effects that might be associated with enzastaurin and R-GEMOX . * To look at the characteristics and levels of certain genes and proteins to learn more about DLBCL and how enzastaurin works in the body. * To look at the level of enzastaurin in the body and how long it remains. Conditions: Lymphoma, Large Cell, Diffuse Intervention / Treatment: DRUG: enzastaurin, DRUG: gemcitabine, DRUG: rituximab, DRUG: oxaliplatin Location: Russian Federation, France, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of DLBCL or transformed (cluster differentiation 20 [CD20]+) indolent lymphoma * Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or participants who have not progressed after stable disease (SD) obtained in 1st- or 2nd-line. * Measurable disease (lymph node greater than 1.5 cm) * Adequate organ function * Greater than or equal to 60 years or less than 60 (but greater than or equal to 18 years) who are not eligible for high-dose chemotherapy high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT) Exclusion Criteria: * Prior Allogeneic transplantation * More than 2 prior anticancer treatment regimens * Pregnant or breastfeeding * Human-immunodeficiency-virus (HIV)associated lymphomas * Brain metastases

Study Objectives This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving trametinib is more effective than combination chemotherapy in treating patients with biliary or gallbladder cancer. Conditions: Adult Cholangiocarcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma, BCLC Stage D Adult Hepatocellular Carcinoma, Hilar Cholangiocarcinoma, Localized Non-Resectable Adult Liver Carcinoma, Recurrent Adult Liver Carcinoma, Recurrent Childhood Liver Cancer, Recurrent Extrahepatic Bile Duct Carcinoma, Recurrent Gallbladder Carcinoma, Stage II Gallbladder Cancer, Stage III Childhood Hepatocellular Carcinoma, Stage IIIA Gallbladder Cancer, Stage IIIB Gallbladder Cancer, Stage IV Childhood Hepatocellular Carcinoma, Stage IV Distal Bile Duct Cancer, Stage IVA Gallbladder Cancer, Stage IVB Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Carcinoma Intervention / Treatment: DRUG: Capecitabine, DRUG: Fluorouracil, OTHER: Laboratory Biomarker Analysis, DRUG: Leucovorin Calcium, DRUG: Trametinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * DISEASE RELATED CRITERIA * Patients must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease; patients with ampullary carcinoma are not eligible * Patients must have measurable disease; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) * PRIOR/CONCURRENT THERAPY CRITERIA * Patients must have completed any prior chemotherapy at least 21 days prior to registration and have recovered from any of the effects AND * Patients must have experienced progression to no more than 1 prior regimen of systemic chemotherapy for advanced biliary cancer OR * Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible; if patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing one regimen of systemic chemotherapy used to treat the (unresectable or metastatic) disease recurrence * Patients must not have been treated with prior MEK inhibitors; prior 5-FU or capecitabine treatment is allowed only if given as a radiosensitizer concurrently with radiation therapy at least 12 weeks prior to registration or if given as part of any adjuvant therapy regimen >= 12 months prior to study enrollment * Patients must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy (including herbal or natural supplements) for treatment of cancer while on this treatment protocol * For patients who have received prior cryotherapy, radiation therapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met: * 28 days have elapsed since that therapy (lesions that have not been treated with local therapy must be present and measureable) * CLINICAL/LABORATORY CRITERIA * Patients must have a Zubrod performance status of 0-1 * Absolute neutrophil count (ANC) > 1000/mcL * Platelets > 100000/mcL * Total bilirubin =< 2.0 x the institutional upper limit of normal limits (IULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 3 x IULN; if liver metastases are present, AST and ALT must be =< 5 x IULN * If the patient has had decompression of the biliary tree within the last 14 days, stability of the bilirubin level needs to be confirmed with two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to registration;) both the first and second measurement must be =< 2.0 x IULN; stability is defined as the second measurement being no more than one point higher than the first * Patients must have adequate kidney function as evidenced by at least ONE of the following: * Serum creatinine =< 1.5 x IULN within 28 days prior to registration * Calculated creatinine clearance >= 50 ml/min for patients with creatinine level of 1.0-1.5 x IULN; the serum creatinine value used in the calculation must have been obtained within 28 days prior to registration * Patients with known history or current evidence of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED) are not eligible: * History of RVO or RPED, or predisposing factors to RVO or RPED (e.g. such as uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes) * Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or RPED such as: * Evidence of new optic disc cupping * Evidence of new visual field defects * Intraocular pressure > 21 mmHg * NOTE: ophthalmic exam is required for all patients; this exam should not be performed until or unless it is very clear the patient is otherwise eligible for registration; this exam should not be performed until or unless it is very clear the patient is otherwise eligible for registration * Patients must have echocardiogram and left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (LLN) within 28 days prior to registration; this exam should not be performed until or unless it is very clear the patient is otherwise eligible for registration * Patients must not have uncontrolled or clinically significant cardiovascular disease including: myocardial infarction within past 6 months; uncontrolled angina within past 6 months; class II-IV New York Heart Association (NYHA) congestive heart failure; grade 3 cardiac valve dysfunction; cardiac arrhythmia not controlled by medication; history of stroke or transient ischemic attack within 6 months; history of arterial thrombotic event (ATE) of any type in the past 6 months; treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled with anti-hypertensive therapy; known intra-cardiac defibrillators; known cardiac metastases * Patients must have an electrocardiogram (ECG) within 28 days prior to registration; patients must have corrected QT interval (QTc) =< 500 msec; this exam should not be performed until or unless it is very clear the patient is otherwise eligible for registration * Must be able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels * Must not have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO) or other agents used in study * Must not have active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible) * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method while on study and for 4 months after discontinuation of study drug; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years * SPECIMEN SUBMISSION CRITERIA * Patients must submit paraffin-embedded tissue and blood for banking within 28 days after registration; paraffin-embedded tissue from prior surgical resection or from a diagnostic biopsy is acceptable * REGULATORY CRITERIA * Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Study Objectives The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive Airway Pressure (CPAP) patients. Conditions: Lung Cancer, Pulmonary Complications Intervention / Treatment: PROCEDURE: Cpap Location: Brazil Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: FACTORIAL Masking: NONE

Inclusion Criteria: * medical diagnosis of lung cancer and an indication for lung resection (lobectomy, bilobectomy and pneumonectomy) with posterolateral thoracotomy; * aged between 40 and 75 years. Exclusion Criteria: * Patients who refused to participate in the survey; * lung resection with incisions other than posterolateral; * patients who had contraindications to the use of noninvasive ventilation.

Study Objectives This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy. Conditions: Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: Atezolizumab, DRUG: Bevacizumab Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Life expectancy >= 10 months * Histologically or cytologically confirmed stage IIIB, IIIC, or IV non-squamous NSCLC. Patients with tumors of mixed histology are eligible if the major histological component appears to be non-squamous. * No prior treatment for Stage IIIB, IIIC, or IV non-squamous NSCLC, with the following exceptions: Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression or were intolerant to treatment with one or more EGFR TKIs. Patients who have progressed on or were intolerant to first-line osimertinib or other thirdgeneration EGFR TKIs are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, and who have no evidence of the EGFR T790M mutation after TKI therapy are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation must have also progressed on or were intolerant to osimertinib to be eligible. * TKIs approved for treatment of NSCLC discontinued >7 days prior to enrollment. * Measurable disease per RECIST v1.1. PD-L1 expression of >=1% as documented through central testing of a representative tumor tissue specimen either from previously obtained archival tumor tissue or tissue obtained from a biopsy at screening * ECOG Performance Status of 0-1 * Adequate hematologic and end-organ function * Negative HIV test at screening * Negative hepatitis B surface antigen (HBsAg) test at screening * Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test. * Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test. * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs. * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm. Exclusion Criteria: * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments * History of leptomeningeal disease * Prior chemotherapy or other systemic therapy for stage IIIB, IIIC, or IV disease * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Active tuberculosis * Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina * History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Prior allogeneic stem cell or solid organ transplantation * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab * Current treatment with anti-viral therapy for HBV * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies * Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment * Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment * History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulations * Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab, 6 months after the final dose of bevacizumab * Prior history of hypertensive crisis or hypertensive encephalopathy * Significant vascular disease within 6 months prior to initiation of study treatment * History of Grade >= 2 hemoptysis within 1 month prior to enrollment * Evidence of bleeding diathesis or coagulopathy. Current or recent use of aspirin, clopidogrel or treatment with dipyramidole, ticlopidine, or cilostazol * Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for > 2 weeks prior to enrollment * History of stroke or transient ischemic attack within 6 months prior to enrollment * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab * History of abdominal or tracheosphageal fistula or gastrointestinal perforation within 6 months prior to enrollment * History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to active peptic ulcer disease, diverticulitis,or colitis * Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding * Evidence of abdominal free air not explained by paracentesis or recent surgical procedure * Proteinuria * Clear tumor infiltration into the thoracic great vessels is seen on imaging * Clear cavitation of pulmonary lesions is seen on imaging

Study Objectives VELCADE has demonstrated marked activity in haematological cancers leading to registration (MM, MCL). Currently only biweekly or weekly regimens have been explored. Key signalling pathways which are aberrant in haematological cancers are also present in solid tumors. VELCADE covers a broad spectrum of proteins, which are pivotal in carcinogenesis.VELCADE as a single agent \& in combination with chemotherapy in solid cancers has shown modest and real anti-tumor activity but insufficient for Phase III development. VELCADE PK exposure may be inadequate in solid tumors compared to "liquid cancers." VELCADE daily low dose administration may allow a greater PK exposure to be achieved, which is tolerated Hypotheses: VELCADE daily dosing (5-days on, 2-days off) is tolerable at biologically active doses VELCADE daily dosing (5-days on, 2-days off) results in increased PK (AUC)/PD (20S proteasome inhibition) VELCADE daily dosing (5-days on, 2-days off) with increased PK/PD results in improved anti-tumor activity (Increased tolerable VELCADE AUC may potentially cross the threshold required for clinically significant anti-tumor activity in solid cancers). Some preclinical data suggest that: VELCADE daily dosing results in increased proteasome inhibition in tumor tissues Combination of VELCADE + XRT/other daily dosing agent may have increased anti-tumor activity compared to monotherapy alone. Conditions: Advanced or Metastatic Solid Tumors Intervention / Treatment: DRUG: Bortezomib Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed written informed consent * Target population * Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate * Ability to comply with visits/procedures required by the protocol * Life expectancy of at least 3 months * ECOG performance status score 0-1 * Subjects with Histologic or cytologic diagnosis of any solid tumor (nonhematologic malignancy). * A tumor paraffin tissue block or 20-30 unstained slides from the tumor tissue block or enough slides from an FNA to allow for biomarker and predictive marker analyses. (This biopsy need not be obtained fresh at the time of screening. Obtaining unstained slides from the original diagnostic biopsy will suffice to meet this requirement). * Measurable or evaluable disease * Prior anti-cancer treatments are permitted (i.e. chemotherapy, radiotherapy, hormonal, or immunotherapy) with the following exceptions: * Toxicity related to prior therapy must either have resolved, returned to baseline or been deemed irreversible but does not conflict with exclusion criteria. Peripheral pre-existent neuropathy of any grade related or not related to previous anticancer therapy is an exclusion criterion. * At least 3 weeks must have elapsed since the last chemo-therapy, immunotherapy or radiotherapy and the beginning of protocol therapy. At least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin. * At least 3 weeks must have elapsed since the last anti-cancer hormonal therapy or antibody targeted therapy (e.g. Bevacizumab, Cetuximab, Trastuzumab). Hormonal treatment by analog LHRH will be allowed for patients with prostate cancer For extended-release formulations, the washout period must extend 1 month beyond the duration of activity of the formulation (e.g., 3 months for the activity of a depot formulation + 1 month wash out). * Age and Sex * men and women 18 - 75 * Male and female patients of childbearing potential must use effective contraceptive measures during the study an d for at least 3 months after the end of the study treatment Exclusion Criteria: * Sex and Reproductive Status * Male and female patients of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to three months after the study. * Male and female patients of childbearing potential using a prohibited contraceptive method. * Women who are pregnant or breastfeeding. * Women with a positive pregnancy test on enrollment or prior to study drug administration. * Target Disease Exclusions: Subjects who have documented unstable or untreated brain metastasis for at least 4 weeks and who are still requiring steroids (Subjects with treated and stably controlled CNS metastases for at least 4 weeks and are no longer on steroids are eligible for this study). * Medical History and Concurrent Diseases * A serious uncontrolled medical disorder or active infection, which would impair the ability of the subject to receive protocol therapy * History of thromboembolic disease or bleeding diatheses within the last six (6) months. This includes those subjects with tumors that were known to have spontaneously bled in the past. * History or presence of the diffuse interstitial lung disease or pericardial disease * Previous history or current presence of neurological disorders, including epilepsy, Parkinson's disease, multiple sclerosis, stroke. * Pre-existent peripheral neuropathy of any grade, related or unrelated to previous anticancer therapy. However, asymptomatic infraclinical neuropathy with moderate measurable changes revealed by EMG will be allowed. * Uncontrolled or significant cardiovascular disease including * myocardial infarction within 12 months- uncontrolled angina within 6 months * congestive heart failure within 6 months * LVEF <= 45% at baseline, or <55% if prior exposure to anthracyclines * diagnosed or suspected congenital long QT syndrome. * any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or "Torsade de Pointes"). Controlled atrial fibrillation is not an exclusion criterion. * pericardial effusion * Subjects with concomitant other malignancies (except non-melanomatous skin cancers, early stage prostate or cervical cancers) are excluded unless a complete remission was achieved at least 5 years prior to study entry and no additional therapy is required or anticipated to be required during the study period * Subjects receiving any drugs or agents that inhibit (e.g., cimetidine, erythromycin, fluoxetine, ketoconazole, paroxetine) or induce (e.g., carbamazepine, glucocorticoids, phenobarbital, rifampin) CYP2C19 or CYP3A4 within 14 days before the first dose of VELCADE * Need for therapy with concomitant CYP 3A4 inhibitors (e.g., itraconazole,fluconazole,clarithromycin,erythromycin, norfloxacin, fluvoxamine, cimetidine, indinavir, ritonavir) or inducers (e.g., efavirenz, barbiturates, phenytoin, rifampin, glitazones) * Green tea consummation * Physical and Laboratory Test Findings (as confirmed by repeat test/results) * Inadequate bone marrow function defined as: * absolute neutrophil count < 1,500 cells/mm3. * platelet count < 100,000 cells/mm3. * hemoglobin < 9.0 g/dl * Inadequate hepatic function defined as: * total bilirubin > 1.5 times the institutional upper limit of normal (IULN) unless identified as a result of a confirmed genetic disorder of bilirubin metabolism (e.g., Gilbert's syndrome or familial benign unconjugated hyperbilirubinaemia). * alanine transaminase (ALT) and aspartate transaminase (AST) > 2.5 times the IULN * Inadequate renal function defined as serum creatinine >1.5 times the IULN * PT- INR/PTT >1.5 times the IULN is an exclusion criteria * If proteinuria >= 1+ then quantify by urinary protein in random urine sample; eligible if <1 g/l . * Allergies and Adverse Drug Reactions history of allergy to Velcade or chemically related compounds * Other Exclusion Criteria: prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Study Objectives This clinical trial studies fludarabine phosphate, low-dose total-body irradiation, and donor stem cell transplant followed by cyclosporine, mycophenolate mofetil, and donor lymphocyte infusion in treating patients with hematopoietic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and total body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also keep the patient's immune response from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Conditions: Acute Undifferentiated Leukemia, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Grade III Lymphomatoid Granulomatosis, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Myelomonocytic Leukemia, Cutaneous B-cell Non-Hodgkin Lymphoma, de Novo Myelodysplastic Syndromes, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Juvenile Myelomonocytic Leukemia, Mast Cell Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Myeloid/NK-cell Acute Leukemia, Nodal Marginal Zone B-cell Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Post-transplant Lymphoproliferative Disorder, Previously Treated Myelodysplastic Syndromes, Primary Systemic Amyloidosis, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, 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 Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, 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 Renal Cell Cancer, Recurrent Small Lymphocytic Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Refractory Multiple Myeloma, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Stage II Multiple Myeloma, Stage III Multiple Myeloma, T-cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Waldenström Macroglobulinemia Intervention / Treatment: RADIATION: total-body irradiation, DRUG: fludarabine phosphate, DRUG: cyclosporine, DRUG: mycophenolate mofetil, PROCEDURE: nonmyeloablative allogeneic hematopoietic stem cell transplantation, BIOLOGICAL: donor lymphocytes, PROCEDURE: peripheral blood stem cell transplantation, OTHER: laboratory biomarker analysis Location: United States, Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients aged > 49 years and < 75 years with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) and multiple myeloma who are not eligible for a curative autologous transplantation or who have failed prior autologous transplantation; patients with NHL and CLL must have failed prior therapy with an alkylating agent and/or fludarabine, or be at high risk of relapse; patients with multiple myeloma must have stage II or III disease and received prior chemotherapy * Patients < 50 years of age with NHL, CLL or multiple myeloma at high risk of regimen related toxicity through prior autologous transplant or through pre-existing medical conditions * Patients < 75 years of age with other malignant diseases treatable by allogeneic bone marrow transplant (BMT) whom through pre-existing chronic disease affecting kidneys, liver, lungs, and heart are considered to be at high risk for regimen related toxicity using standard high dose regimens; the following diseases are the likely candidates: * Myelodysplastic syndromes * Myeloproliferative syndromes * Acute Leukemia with < 10% blasts * Amyloidosis * Hodgkin's disease * Renal cell carcinoma * Patients with other malignancies declining standard allografts may be approved for transplant following presentation and approval by the Fred Hutchinson Cancer Research Center (FHCRC) chimerism group * DONOR: * Human leukocyte antigen (HLA) genotypically or phenotypically identical related donor * Donor must consent to granulocyte colony-stimulating factor (G-CSF) administration and leukopheresis * Donor must have adequate veins for leukopheresis or agree to placement of central venous catheter (femoral, subclavian) * Age < 75 years Exclusion Criteria: * Eligible for a high-priority curative autologous transplant * Patients with rapidly progressive aggressive NHL unless in minimal disease state * Active central nervous system (CNS) involvement with disease * Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment * Females who are pregnant * Patients who are human immunodeficiency virus (HIV) positive * Cardiac ejection fraction < 40% * Severe defects in pulmonary function testing (defects are currently categorized as mild, moderate and severe) as defined by the pulmonary consultant, or receiving supplementary continuous oxygen * Total bilirubin > 2 x the upper limit of normal * Serum glutamate pyruvate transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) 4 x the upper limit of normal * Karnofsky score < 50 * Patients with poorly controlled hypertension * Patients with renal failure are eligible, however patients with renal compromise (serum creatinine greater than 2.0) will likely have further compromise in renal function and may require hemodialysis (which may be permanent) due to the need to maintain adequate serum cyclosporine levels * DONOR: * Identical twin * Age less than 12 years * Pregnancy * Infection with HIV * Inability to achieve adequate venous access * Known allergy to G-CSF * Current serious systemic illness

Study Objectives The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp. Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has shown to be safe and effective for the treatment of AKs. Conditions: Actinic Keratosis Intervention / Treatment: DRUG: Imiquimod cream, DRUG: Placebo cream, DRUG: Imiquimod cream Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * In good general health. * Have 5 to 20 AKs on the face or balding scalp. * Negative pregnancy test (for women who are able to become pregnant). * Willing to make frequent visits to the study center during the treatment and follow-up periods. Exclusion Criteria: * Women who are pregnant, lactating or planning to become pregnant during the study. * Have had a medical event within 90 days of the first visit (such as: stroke, heart attack). * Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (such as: rosacea, psoriasis, atopic dermatitis, eczema). * Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.

Study Objectives A total of 200 women for elective abdominal myomectomy were randomly allocated into two groups. 100 women in experimental group were administered 400ug Misoprostol (2 tablets of Prosotec®) through the rectal route prior to surgery and 100 were in control group, in which no drug was administered. Conditions: Blood Loss, Surgical, Uterine Myoma Intervention / Treatment: DRUG: Misoprostol Location: Pakistan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: OTHER Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * ASA physical status class I-II * Intramural or subserosal fibroids - diagnosed on ultrasound * Candidates for elective abdominal myomectomy Exclusion Criteria: * Pre-operative Hemoglobin < 10 g/dl * Patient who received Danazol or GnRH analogues before surgery * No other systemic or metabolic disease

Study Objectives The purpose of this investigation is to evaluate the relationship between IOP fluctuation, RGC dysfunction, and optic nerve and retinal nerve fiber layer (RNFL) thickness changes in patients with glaucoma and ocular hypertension receiving latanoprost 0.005% versus placebo. Conditions: Glaucoma Intervention / Treatment: DRUG: latanoprost 0.005%, DRUG: Placebo Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: Inclusion Criteria - OHT: * Ocular hypertension defined as an IOP >= 24 mm Hg and <= 32 mm Hg in one eye and IOP >= 22 mm Hg and <= 32 mm Hg in the fellow eye * Normal optic disc * Normal visual field defined as follows: * Mean Deviation (MD) or Pattern Standard Deviation (PSD) of p>5% * Normal Glaucoma Hemifield Test (GHT) * Reliable visual field exam (less than 33% false positives or false negatives, and less than 20% fixation losses) Inclusion Criteria - POAG: * Glaucomatous visual field loss defined as a CPSD (p < 0.05), or GHT (p < 1%) outside normal limits with consistent with ONH or NFL defect * Early visual field loss defined as MD <= -6.0 dB * Untreated IOP <= 32 mmHg * ONH or NFL defect defined as either inter-eye CDR asymmetry > 0.2, rim thinning or notching, or NFL bundle defect visible on slitlamp biomicroscopy and stereo color fundus photography Exclusion Criteria: Exclusion Criteria - OHT: * Best-corrected visual acuity less than 20/40 either eye * Abnormal or unreliable VF * Untreated IOP > 32 mmHg * Age < 18 or >85 years * Refractive error of > +3.00 D or < -7.00 D * Previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation * Need for chronic ocular or systemic corticosteroid use * Narrow/closed angle (gonioscopy must show 75% or more of the angle to be Grade 2 or more by Shaffer's grading system) * Diabetic retinopathy * Other diseases that may cause VF loss or optic disc abnormalities * Life-threatening or debilitating illness making it unlikely patient could successfully complete the study * Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil * Refusal of informed consent or of commitment to the full length of the study * Contraindication to latanoprost or placebo vehicle Exclusion criteria - POAG: * Best-corrected visual acuity less than 20/40 * Untreated IOP > 32 mmHg * Age < 18 or >85 years * Refractive error of > +3.00 D or < -7.00 D * Previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation * Diabetic retinopathy * Other diseases that may cause VF loss or optic disc abnormalities * Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil * Inability to perform reliably on automated VF testing * Life-threatening or debilitating illness making it unlikely patient could successfully complete the study. * Refusal of informed consent or of commitment to the full length of the study * Contraindication to latanoprost or placebo vehicle

Study Objectives Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated. To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision). Conditions: Locally Advanced Rectal Cancer Intervention / Treatment: DRUG: Oxaliplatin, DRUG: Bevacizumab, DRUG: Capecitabine, RADIATION: radiotherapy Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Adenocarcinoma of rectum measurable (RECIST), locally advanced (defined by MRI - Tumour beyond mesorectal fascia (T4) or Tumour <= 2 mm from mesorectal fascia or T3 tumour < 5 cm from anal verge * Patient is at least 18 years of age * Good organ function Exclusion Criteria: * Evidence of distant metastases * Contraindication for bevacizumab * Pregnant or breastfeeding women.

Study Objectives This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn more about the disease and find better methods of treatment and on-going care. Conditions: Adult Diffuse Astrocytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Cognitive/Functional Effects, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment, Seizure Intervention / Treatment: PROCEDURE: cognitive assessment, PROCEDURE: magnetic resonance imaging, OTHER: laboratory biomarker analysis, OTHER: questionnaire administration, PROCEDURE: quality-of-life assessment Location: United States, Canada Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Central pathology confirmed diagnosis of supratentorial grade II oligodendroglioma, astrocytoma, or mixed oligoastrocytoma prior to step 2 registration * No multifocal disease, based upon the following minimum diagnostic work-up: * History/physical examination, including neurologic examination, within 84 days prior to step 2 registration * Brain MRI with and without contrast within 84 days prior to Step 2 registration (Note: MRI 70 days after surgery is preferred and highly encouraged) * The patient must be within one of the following categories: * Maximal safe resection with minimal residual disease defined as follows: * Removal of T2/fluid-attenuated inversion recovery (FLAIR) abnormalities thought to be primarily tumor, with a residual <= 2 cm maximal tumor diameter/T2 FLAIR abnormality on MRI to be done within 84 days post-operatively * If there is > 2 cm post-operative residual T2/FLAIR abnormality and the neurosurgeon believes this represents edema and not primarily tumor, the neurosurgeon is encouraged to repeat imaging within the allowed study period (up to 84 days post-operatively) to confirm resolution of edema * MRI at the time of enrollment must document a <= 2 cm residual maximal tumor diameter/T2 FLAIR abnormality * Patients who required a second surgery to obtain a maximal safe resection will be eligible if the second surgery is performed within 84 days of the initial diagnostic procedure * Age < 40 (any extent of resection) * Age < 50 and preoperative tumor diameter < 4 cm (any extent of resection) * Karnofsky performance status >= 80% * No 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) * Must be able to undergo MRI of the brain with gadolinium * No plans for adjuvant radiotherapy or chemotherapy after surgery * No more than 84 days (12 weeks) since prior surgery * No brain tumor recurrence * No prior brain tumor surgery, radiation therapy and/or chemotherapy

Study Objectives The study aims to explore the effects of silver spike point (SSP) treatment on common symptoms including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer patients. Conditions: Cancer Intervention / Treatment: DEVICE: SSP treatment Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Cancer patients * Competent with clear consciousness * With symptoms of pain, breathlessness, nause/vomiting, dry mouth, generalized discomfort * Expected life span of at least 1 week Exclusion Criteria: * With implanted devices * Not having clear consciousness * Expected life span less than 1 week * Foreigner

Study Objectives HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test DS-8201a (trastuzumab deruxtecan), a HER2-targeted antibody and topoisomerase I inhibitor conjugate. The safety and tolerability profile of DS-8201a will be assessed in Chinese patients with certain types of stomach and breast cancer that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics). Conditions: Adenocarcinoma, Gastric, Neoplasm, Breast Intervention / Treatment: DRUG: DS-8201a Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Has a pathologically documented unresectable or metastatic gastric or GEJ adenocarcinoma, or breast cancer, with HER2 expression [immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization (ISH) +] that is refractory to or intolerable with standard treatment, or for which no standard treatment is available * Has a left ventricular ejection fraction (LVEF) >= 50% * Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 Exclusion Criteria: * Has a medical history of myocardial infarction within 6 months before enrollment * Has a medical history of ventricular arrhythmias, other than rare occasional premature ventricular contractions * Has uncontrolled or significant cardiovascular disease * Has any other history or condition that might compromise: 1. Safety of the participant or offspring 2. Safety of study staff 3. Analysis of Results

Study Objectives The Wnt proteins belong to a family of proteins that have been demonstrated to play a role in the formation and dissemination of tumours. The present project focuses on the critical role of the Wnt-5a protein in the pathobiological processes that lead to metastatic cancer disease. WntResearch has identified a formylated 6 amino acid peptide fragment, named Foxy-5, which mimick the effects of Wnt-5a to impair migration of epithelial cancer cells and thereby acting anti-metastatic. The aim of the present clinical phase 1 trial is to establish the recommended dose for a clinical phase 2 study and thereby further develop Foxy-5 as a first in class anti-metastatic cancer drug. Foxy-5 is designed to inhibit the development of metastasis by reducing the motility of cancer cells and should thereby increase the survival rates of patients with solid malignant tumours. Conditions: Metastatic Breast Cancer, Colorectal Cancer, Prostate Cancer Intervention / Treatment: DRUG: Foxy-5 Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Males and females of at least 18 years of age * Histologically/cytologically documented diagnosis of metastatic breast, colon or prostate cancer, refractory to standard therapy or for which no curative therapy exists * Loss of or reduced Wnt-5a protein expression in primary or metastatic tumour cells, characterised by IHC analysis * Eastern Cooperative Oncology Group (ECOG) performance status of <= 1 * Life expectancy of at least 3 months * Unresectable disease, i.e. the metastases cannot be surgically removed with a curative intent * >= 4 weeks must have elapsed since the patient has received any other IMP * >=4 weeks must have elapsed since the patient has received any anti cancer treatment; including radiotherapy (except for single dose of palliative radiotherapy), cytotoxic chemotherapy, biologic agents or targeted therapy * >= 2 weeks must have elapsed since any prior surgery or therapy with bone marrow stimulating factors * Adequate haematological functions as defined by: * Absolute neutrophil count >= 1.5 10E9/L * Platelets >= 100 10E9/L * Hemoglobin >= 5.6 mmol/L * Adequate hepatic function as defined by: * Total bilirubin <= 1.5 x the upper limit of normal (ULN) * Aspartate aminotransferase (AST) <= 2.5 x ULN* * Alanine aminotransferase (ALT) <= 2.5 x ULN* * For patients with liver metastasis adequate hepatic function is defined by AST <= 5 x ULN and ALT <= 5 ULN. * Adequate renal function as defined by Serum creatinine <= 1,5 x ULN * Provision of written informed consent * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures * Sexually active males and females of child-producing potential, must use adequate contraception (intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release) or diaphragm always with spermicidal jelly and a male condom) for the study duration and at least six months afterwards Exclusion Criteria: * Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease) * Any active infection requiring antibiotic treatment * Known infection with human immunodeficiency virus (HIV) or hepatitis virus * Active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or symptomatic arrhythmias currently requiring medication * Known or suspected active central nervous system (CNS) metastasis. (Patients stable 8 weeks after completion of treatment for CNS metastasis are eligible) * Impending or symptomatic spinal cord compression or carcinomatous meningitis * Requiring immediate palliative surgery and/or radiotherapy * Pre-existing neuropathy, i.e., Grade >2 neuromotor or neurosensory toxicity * Participation in other clinical studies within 4 weeks of first dose of study treatment * History of severe allergic or hypersensitive reactions to excipients * Pregnant or breastfeeding women * Chronic immunosuppressant use (e.g. systemic steroids for treatment of autoimmune disease) * History of second malignancy, including histologically confirmed diagnosis of malignant melanoma except for carcinoma in situ or basal cell carcinoma * Severe or uncontrolled chronic or uncontrolled systemic disease (e. g. severe respiratory or cardiovascular disease) * Other medications or conditions that in the Investigator's opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results

Study Objectives Fifteen women with recurrent ovarian cancer will be treated by an intraperitoneal chemotherapy with cisplatin and doxorubicin in three escalating dosage schedules. The aim of the study is to evaluate the safety and tolerability of doxorubicin and cisplatin every 4 weeks for three courses using a three-group, dose-escalation protocol with fixed dose-density. The time Frame for the assessment of the Primary outcome is therefore 12 weeks. Predefined toxicity criteria will be applied using CTCAE version 4.0 criteria. The study hypothesis is that local and systemic toxicity will increase with increasing dosage of cisplatin and doxorubicin during three repeated PIPAC courses with no CTCAE grade 4 and 5 events in any treatment group. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Cisplatin and doxorubicin, PROCEDURE: Cisplatin and doxorubicin Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * clinical and/or radiological evidence of PC, * age between 18 and 85 years with a diagnosis of recurrent ovarian cancer with disease progression after at least one line of previous intravenous chemotherapy with a platinum compound, * blood and electrolyte counts, liver, and renal function parameters within 10% of the normal range established in the respective laboratory of the study institution, * provision of written informed consent, and * postmenopausal status. Exclusion Criteria: * extraabdominal metastatic disease, with the exception of isolated pleural carcinomatosis/effusion, * chemotherapy or surgery within the last four weeks prior to the first PIPAC application, * previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones, * a history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin, * severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction or severe cardiac arrhythmia, * immunocompromised status such as immunosuppressive therapy or a known disease of the immune system, * previous enrolment in the present study, and * previous intraabdominal chemotherapy or intraabdominal antibody therapy.

Study Objectives The purpose of the study is to test 18F-BMS-986229 positron emission tomography (PET) imaging a practical and safe way to check the status of esophageal, stomach, and gastroesophageal junction cancer. Conditions: Esophagogastric Cancer, Esophagus Cancer, Esophageal Cancer, Gastric Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Gastroesophageal Junction Squamous Cell Carcinoma Intervention / Treatment: DRUG: 18F-BMS-986229 Injection, DRUG: IV 18F-BMS-986229, DIAGNOSTIC_TEST: PET/CT Scan Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Participant must have pathologically or cytolofically confirmed (at MSK) esophageal, gastric, or gastroesophageal junction adenocarcinoma or squamous cell carcinoma * PD-L1-positive expression in >=1% of the tumor or stromal cells. PD-L1 expression will be reviewed by MSK pathologist, scored and recorded using the combined positive score (CPS) formula (number of PD-L1 positive tumor cells, lymphocytes, and macrophages divided by the number of tumor cells x 100). * Participants must have disease that can be evaluated radiographically. This may be measurable disease or nonmeasurable disease according to RECIST 1.1. * Concurrent therapy is allowed. * Age >= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours before receiving the first dose of the study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Adequate organ function, as defined in Table 1. All screening labs should be performed within 14 days of initiation of treatment. Hematological Absolute neutrophil count: >=1,000/mCL Platelets: >=90,000/mCL Hemoglobin: >=8 g/dL Renal Serum creatinine: <=2.0 x upper limit of normal (ULN) Hepatic Serum total bilirubin: <=2.5 x ULN (1.5 mg/dL or 25.65 umol/L) OR (except patients with Gilbert's disease [<=3 x ULN]) AST (SGOT) and ALT (SGPT): <=2.5 x ULN OR <=5 x ULN for subjects with liver metastases Exclusion Criteria: * Known diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment * History of active tuberculosis (Bacillus tuberculosis) * Active or documented autoimmune or inflammatory disorder (including inflammatory bowel disease, systemic lupus erythematous, Wegener syndrome [granulomatosis with polyangitis], myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis) within the 3 years before the start of treatment. The following are exceptions to this criterion: * Subjects with vitiligo or alopecia * Subjects with hypothyroidism (e.g., following Hashimoto syndrome) who are stable with hormone replacement therapy or with psoriasis not requiring systemic treatment

Study Objectives The pharmacist, as a specialist of medications, occupies a strategic position: he participates in a global care of their patients. Dispensation is the pharmaceutical act which associates with the dispensing of medications "the pharmaceutical analysis of the medical prescription if it exists, the possible preparation of the doses to be administered and the provisions of the information and advices necessary for the proper use of medications". The pharmacist ensures that the quality and safety of the dispensation is guaranteed at all times by limiting as far as possible the risks associated with an error in delivery, prescription, drug interactions or undetected contraindications, inadequate dosages or non-compliance with treatment. The longer the patient feels satisfied with the stage of delivery of his treatment, the better his adherence to treatment is, and the less he will encounter poor compliance. Oncology has particularly benefited in recent years from the introduction of numerous drugs with the aim of extending the duration of response in a growing number of indications. Traditionally in oncology, chemotherapy treatments are administered intravenously by trained personnel and rarely managed by the patient at home. Recently, there has been a growing choice of oral formulations, whether for conventional hormonal, anticancer therapies or targeted therapies. These specialties are now widely available in community pharmacies. Oral administration puts the patient at the center of his therapeutic management. He must take his medication alone. Adherence and compliance are therefore particularly important here for an optimal risk-benefit ratio. This study project is designed to evaluate the satisfaction of patients undergoing oral chemotherapy treated for a cancer pathology and whose treatment is provided by their community pharmacies. It also needs to provide information about the reasons for their poor adherence to treatment (personal factors, factors attributable to treatment, factors attributable to the care system). Patients will be recruited and interviewed by contacting several departments of the Clermont-Ferrand University Hospital (CHU de Clermont-Ferrand), who are used to caring for patients with cancerous diseases (hematology, urology, respiratory, gastro-enterology). The data collected in this study may be used for subsequent studies evaluating new management strategies or therapeutic education to improve adherence to patient treatment. Conditions: Cancer Intervention / Treatment: DRUG: Oral anticancer medications Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patient (or helping people) receiving oral cancer chemotherapy or oral hormone therapy delivered in community pharmacy for the treatment of cancer * Non-opposition to participation in the study Exclusion Criteria: * Patient unable to understand or respond to questionnaires * Age < 18 * Legal incapacity (person deprived of liberty or under guardianship)

Study Objectives This phase II trial studies how well ramucirumab works in treating patients with previously treated biliary cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Conditions: Cholangiocarcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Stage III Gallbladder Cancer AJCC v7, Stage III Intrahepatic Cholangiocarcinoma AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7, Stage IIIB Gallbladder Cancer AJCC v7, Stage IV Gallbladder Cancer AJCC v7, Stage IVA Gallbladder Cancer AJCC v7, Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7, Stage IVB Gallbladder Cancer AJCC v7, Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7, Unresectable Gallbladder Carcinoma Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, BIOLOGICAL: Ramucirumab 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: * Patient must have cholangiocarcinoma, gallbladder cancer or adenocarcinoma on liver biopsy with clinical features consistent with biliary primary/cholangiocarcinoma * Metastatic or unresectable disease documented on diagnostic imaging studies * Must have received at least one regimen containing gemcitabine chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Total bilirubin =< 1.5 mg/dL (25.65 mol/L) * Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 times the upper limit of normal ([ULN]; or 5.0 times the ULN in the setting of liver metastases) * Absolute neutrophil count (ANC) >= 1000/uL * Hemoglobin >= 9 g/dL (5.58 mmol/L) * Platelets >= 100,000/uL * The patient does not have: * Cirrhosis at a level of Child-Pugh B (or worse) or * Cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis; clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis * Serum creatinine =< 1.5 times the ULN or * Creatinine clearance (measured via 24-hour urine collection) >= 40 mL/minute (that is, if serum creatinine is > 1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed * The patient's urinary protein is =< 1 positive (+) (=< 30-100 mg/dl) on dipstick or routine urinalysis (urinary analysis [UA]; if urine dipstick or routine analysis is >= 2+ (>=100-300 mg/dl), a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in this protocol) * The patient must have adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 and * Partial thromboplastin time (PTT) (PTT/activated partial thromboplastin time [aPTT]) < 1.5 x ULN) * Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin; if receiving warfarin, the patient must have an INR =< 3.0 and no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices) * The patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods) * Female patients of childbearing potential must have a negative serum pregnancy test within 7 days * Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved * In the ten patient expanded cohort, patients diagnosed with deoxyribonucleic acid (DNA) repair or FGFR genetic aberrations will be enrolled Exclusion Criteria: * The patient has experienced any grade 3-4 gastrointestinal (GI) bleeding within 3 months prior to enrollment * Prior therapy with any agent targeting the vascular endothelial growth factor receptor (VEGFR) pathway to include bevacizumab, pazopanib, and other anti-angiogenesis inhibitors * The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism, including portal venous thrombosis (venous port or catheter thrombosis, incidental pulmonary embolism diagnosed on imaging studies or superficial venous thrombosis are not considered significant) during the 3 months prior to randomization * The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment * The patient has uncontrolled or poorly-controlled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management * The patient has a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment * The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment * The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs ([NSAIDs], including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted * The patient has elective or planned major surgery to be performed during the course of the clinical trial * The patient is pregnant or breast-feeding

Study Objectives The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer. Conditions: Prostate Cancer Intervention / Treatment: DRUG: 68Ga RM2, DRUG: 68Ga-PSMA-11, DEVICE: Investigational PET scanner coils and software Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Suspected prostate cancer * Planned prostate biopsy * Able to provide written consent * Karnofsky performance status of 50 (or ECOG/WHO equivalent) Exclusion Criteria: * Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam * Metallic implants (contraindicated for MRI)

Study Objectives This study evaluates the combination of entacapone and imatinib in the treatment of gastrointestinal stromal Tumors who have progressed on the setting of at least Imatinib and Sunitinib. 5 participants will be included in this open-label observatory study. Conditions: Gastrointestinal Stromal Tumor, Malignant Intervention / Treatment: DRUG: Entacapone, DRUG: Imatinib Mesylate Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Able to provide written informed consent and can understand and comply with the requirements of the study and the schedule of assessments. * Age >= 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place). * Expected life span > 12 weeks. * Histologically confirmed disease which is currently metastatic/unresectable gastrointestinal stroma tumor(GIST) of c-KIT E11 mutation genotype. * Patients received imatinib as the first-line treatment and no progression within the first 6 months(no primary resistance to imatinib ). With disease progression following treatment with at least imatinib and sunitinib. * Patients must be able to provide archival tumor tissues (approximately 4 [at least 2] unstained Formalin Fixed and Paraffin Embedded Tissues （FFPET）slides) for biomarker analysis to assess the expression of FTO and c-KIT protein. * At least 1 measurable lesion (the longest diameter>= 10mm). Note: Computed Tomography（CT） abdomen and pelvis with contrast including peritoneum, or positron emission tomography/computed tomography(PET/CT) performed skull base to knees or whole body before the first day of entacapone. * Eastern Cooperative Oncology Group-performance status(ECOG PS) <= 2,or 3(the symptoms were definitely caused by GIST itself). * Adequate hematologic and end-organ function, as defined by the following laboratory results (obtained <= 28 days prior to the first day of entacapone): * Absolute neutrophil count (ANC) >= 1.5 × 10 9 /L, hemoglobin >= 80 g/L and platelets >=80 × 10 9 /L. * Total serum bilirubin <= 2.5 × upper limit of normal (ULN); Aspartate and alanine aminotransferase (AST and ALT) <= 2.5× ULN. * Estimated creatinine clearance rate>= 60 mL/min（According to the formula of Cockcroft-Gault）. * Females of childbearing potential must be willing to practice highly effective method of birth control for the duration of the study, and at least 120 days after the last dose of entacapone or imatinib. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and at least 120 days after the last dose of entacapone or imatinib. Exclusion Criteria: * Age < 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place). * Progression within the first 6 months of first-line imatinib treatment (primary imatinib resistance). * Patients with active/symptomatic carrier or chronic hepatitis B virus (HBV) whose HBV DNA >= 1×104 copies/mL should be excluded. Note: Patients with detectable hepatitis B surface antigen(HBsAg) or HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at screening should have been treated for >=2 weeks prior to written informed consent and should continue treatment for 6 months after study drug treatment discontinues. Note: Patients with active hepatitis C may enroll and those with detectable hepatitis C virus(HCV) RNA who are receiving antiviral therapy at time of screening should remain on continuous, effective antiviral therapy during the study. * A known history of human immunodeficiency virus(HIV) infection. * Malignancy other than GIST and still under the active treatment. * Was administered a live vaccine <= 4 weeks before written informed consent. * Any of the following medical conditions may threaten the safety of patients or affect the trial obedience including symptomatic heart failure requiring systematic treatment, unstable angina , acute myocardial infarction and severe chronic or active infections (including tuberculosis infection) requiring systemic antibacterial, antifungal, or antiviral therapy. * History of severe hypersensitivity reactions to any ingredient of entacapone and imatinib. * Pheochromocytoma or history of neuroleptic malignant syndrome(NMS) and/or non-traumatic rhabdomyolysis (NRML). * Female in pregnancy or lactation(Urine or serum pregnancy test and documented as negative within 7 days prior to the first dose of entacapone for the female with fertility expectation or sexual intercourse.

Study Objectives This phase IV trial studies how well influenza vaccination works in preventing infections such as influenza in patients with plasma cell disorders. Influenza infections may theoretically support the growth of tumor cells and improving protection against influenza may improve the status of patients' plasma cell disorder. Giving influenza vaccination may reduce influenza-related complications including infections, hospitalizations, and deaths, and improve the status of plasma cell disorders. Conditions: Plasma Cell Neoplasm Intervention / Treatment: BIOLOGICAL: Pneumococcal 13-valent Conjugate Vaccine, BIOLOGICAL: Trivalent Influenza Vaccine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patient must have a plasma cell dyscrasia that fits in the International Myeloma Working Group (IMWG) diagnostic criteria. * Both men and women of all races and ethnic groups are eligible for this study. * Eastern Cooperative Oncology Group (ECOG) performance status <= 3 (Karnofsky >= 30%) is required for eligibility. * Patient must be eligible to receive standard of care influenza vaccination. If the patient has a history of egg allergy with symptoms more severe than urticaria, e.g. angioedema, respiratory distress, lightheadedness, or recurrent emesis, they remain eligible to receive influenza vaccination but must receive the vaccine in a facility able to recognize and manage severe allergic reactions. Persons who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic, although egg-allergic persons might tolerate egg in baked products. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have already received the seasonal influenza vaccine in the current season. * History of Guillain-Barré syndrome. * Patients with a previous severe allergic reaction to influenza vaccination or pneumococcal 13-valent conjugate vaccine (PCV13). * Expected survival < 9 months. * Prisoners.

Study Objectives This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate cancer undergoing surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). Many patients with benign lesions must undergo biopsy to test the lesion. Cu-64-TP3805 is a radioactive substance that attaches to cancer cells but not normal cells. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body where the radioactive substance is lighting up. Using Cu-64-TP3805 PET/CT scans and comparing them with cancer tissue obtained from surgery may help doctors learn whether Cu-64-TP3805 PET/CT can accurately detect prostate lesions and determine whether they are cancerous or benign, which may minimize the need for prostate biopsies. Conditions: Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer Intervention / Treatment: RADIATION: Copper Cu 64 TP3805, PROCEDURE: Positron Emission Tomography, PROCEDURE: Computed Tomography, PROCEDURE: Radical Prostatectomy, OTHER: Laboratory Biomarker Analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Ability to provide signed informed consent and willingness to comply with protocol requirements * Biopsy confirmed presence of adenocarcinoma of the prostate gland * Have intermediate or high-risk PC as defined by >= T2b disease, or Gleason score >= 7 or prostate-specific antigen (PSA) >= 10 ng/dL * Scheduled to undergo radical prostatectomy with pelvic lymph node dissection (either open or robotic) * Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection Exclusion Criteria: * Participating would significantly delay the scheduled standard of care therapy * Administered a radioisotope within 10 physical half-lives prior to study drug injection * Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study

Study Objectives In this phase I study we will characterize the safety, tolerability, maximum tolerated dose and dose-limiting toxicity of weekly bolus topotecan when administered in combination with two different dosing schedules of carboplatin. We will also evaluate any antitumor activity of these combination regimens. Conditions: Cancer Intervention / Treatment: DRUG: Topotecan, DRUG: Carboplatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: To be included in this study, you must meet the following criteria: * Adult patients at least 18 years old * Advanced solid tumors refractory to conventional therapy * ECOG performance status must be 0 or 1 * Patients may have received no more than 3 prior chemotherapy regimens * Adequate bone marrow, liver and kidney function * Able to understand the nature of the study and give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: * Active concurrent infections or serious underlying medical conditions * Known HIV positivity * Female patients who are pregnant or lactating * Received both topotecan and carboplatin Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Objectives The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma. Conditions: Lymphoma, Large B-Cell, Diffuse Intervention / Treatment: DRUG: Chidamide, Rituximab, Gemcitabine,Oxaliplatin Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * biopsy proved CD20+ DLBCL; * relapse or refractory DLBCL# * previously received systemic chemotherapy with anthracycline# * not eligible for autologous hematopoietic stem cell transplantation# * at least one evaluable lesion# * ECOG PS 0-1; * 18-75 years; without other malignancy; * proper functioning of the major organs. Exclusion Criteria: * double-hit lymphoma; * previously received treatment of HDAC inhibitor; * plan to receive autologous stem cell transplantation; * involvement of central nervous system; * previously received gemcitabine within the past 6 months; * patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;

Study Objectives The KOHDIAK study is a prospective, three-armed, randomised, double-blind study to evaluate the efficacy and safety of the treatment of mild and moderate actinic keratosis with a 5% potassium hydroxide solution (Solcera, medical device) versus placebo and investigator-blinded comparison with 3% diclofenac gel (Solaraze, medicinal product). It is performed in accordance with both the laws in force for clinical trials with medical devices and those with medicinal products. Conditions: Actinic Keratosis Intervention / Treatment: DEVICE: Solcera, DEVICE: Placebo, DRUG: Solaraze Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Age >= 18 years and < 90 years * Actinic keratosis grade I (mild) or II (moderate) according to the definition by Olsen with palpable or clinically/dermatoscopically apparent keratosis * Either lesions being well accessible/treatable by the patient or presence of a second person to do the daily applications * Written informed consent by the patient Exclusion Criteria: * Number of initial lesions to be treated >= 6 * Overall size of the area to be treated > 25 cm2 * Size (maximum diameter) of single lesion to be treated > 20 mm * Lesions in close proximity to the eyes, eyelids, nostrils, mouth or mucosal tissue * Need for topical treatment of cancerous area * Presence of a relapsing, persistent, indurated, thickened, painful, bleeding, ulcerated and/or rapidly growing lesion * Existing skin cancer (all forms of skin cancer incl. basal-cell carcinoma and squamous cell carcinoma) in the area to be treated in this study * Dermal injuries, skin infection or exfoliative dermatitis in the area to be treated in this study * Other skin diseases in the area to be treated in this study that affect the diagnostic assessment * Pharmacological or physical local therapy of actinic keratosis (or application of the active ingredients used in the pharmacological therapy) in the area to be treated in this study during the last 4 weeks * Primary or secondary immunodeficiency * Treatment with interferons, interferon inducers, immunomodulators or systemic corticosteroids during the last 4 weeks * Treatment with oral isotretinoin during the last 6 months * Intracranial bleeding in the medical history or generally increased primary bleeding tendency * Known intolerance/hypersensitivity to one of the ingredients of the investigational products, especially to diclofenac, parabens or benzyl alcohol as well as to NSAIDs, in particular acetylsalicylic acid * Pregnancy and lactation * Women of child-bearing potential either wishing to become pregnant or without effective contraception * Other serious diseases, which are (according to the investigator's assessment) in conflict with the study participation (i.a. also in view of risk factors for a severe course of a potential COVID-19 disease in case of a SARS-CoV-2 infection) * Obvious unreliability or lack of cooperation * Known addiction to alcohol, medicinal products or drugs * Dependency on the sponsor or an investigator * Participation in a clinical trial during the last 30 days * Previous participation in the present clinical trial * Participation of a family member (in the same household) in the present clinical trial

Study Objectives Phase II trial of combination therapy with S-1, irinotecan, and bevacizumab (SIRB) in patients with unresectable or recurrent colorectal cancer Conditions: Colorectal, Cancer Intervention / Treatment: DRUG: S-1, Irinotecan, Bevacizumab Location: Japan 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 colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy * Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) * Patients with no previous treatment (radiotherapy or chemotherapy). Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment. Preoperative or postoperative irradiation (<30 Gy) for rectal cancer is possible * Age >20 years * Life expectancy of at least 3 months * ECOG PS of 0 or 1 * Adequate function of major organs as defined below: 1. Hemoglobin >9.0 g/dL 2. White blood cell count >3,000/mm3 3. Neutrophil count >1,500/mm3 4. Platelet count >100,000/mm3 5. Total bilirubin <1.5 mg/dL 6. AST and ALT <100 U/L (<200 U/L in patients with liver metastasis) 7. Serum creatinine <1.2 mg/dL 8. Creatinine clearance estimate by the Cockcroft-Gault method >50 mL/min (reduce initial dosage by one step if >=50 but <80 mL/min) * Able to take capsules orally. * No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator. * Voluntary written informed consent. Exclusion Criteria: * Serious drug hypersensitivity or a history of drug allergy * Active double cancer * Active infections (e.g., patients with pyrexia of 38℃ or higher) * History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year. * Uncontrolled hypertension * Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes) * Moderate or severe ascites or pleural effusion requiring treatment * Watery diarrhea * Treatment with flucytosine or atazanavir sulfate * Metastasis to the CNS * Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children. * Severe mental disorder * Continuous treatment with steroids * Urine dipstick for proteinuria should be <2+ * Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism * Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks * Long-term daily treatment with aspirin (>325 mg/day) * History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding * Judged ineligible for participation in the study by the investigator for safety reasons.

Study Objectives The purpose of this study is to evaluate the safety and efficacy of nano drug（Gemzar® mix with Compound Glycyrrhizin Injection） interventional therapy using digital subtraction angiography（DSA） for liver cancer. Conditions: Liver Cancer Intervention / Treatment: PROCEDURE: interventional therapy Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age:18-80 * Karnofsky performance status >60 * Diagnosis of liver cancer based on histology or the current accepted radiological measures. * Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ * Will receive interventional therapy * Life expectancy: Greater than 3 months * Patients' routine blood test, liver function and kidney function have no obvious abnormalities * Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: * Patients with other primary tumor except liver cancer * History of coagulation disorders or anemia

Study Objectives This randomized phase III trial is studying tacrolimus, methotrexate, and sirolimus to see how well they work compared to tacrolimus and methotrexate in preventing graft-versus-host disease in young patients who are undergoing donor stem cell transplant for intermediate-risk or high-risk acute lymphoblastic leukemia in second complete remission and high risk acute lymphoblastic leukemia in first remission. Giving chemotherapy, such as thiotepa and cyclophosphamide, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, methotrexate, and sirolimus after the transplant may stop this from happening. It is not yet known whether tacrolimus and methotrexate are more effective with or without sirolimus in preventing graft-versus-host disease. Conditions: B-cell Childhood Acute Lymphoblastic Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Graft Versus Host Disease, L1 Childhood Acute Lymphoblastic Leukemia, L2 Childhood Acute Lymphoblastic Leukemia, T-cell Childhood Acute Lymphoblastic Leukemia Intervention / Treatment: DRUG: thiotepa, DRUG: cyclophosphamide, DRUG: tacrolimus, DRUG: methotrexate, DRUG: sirolimus, RADIATION: total body irradiation Location: United States, Australia, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed acute lymphoblastic leukemia (ALL) in second complete remission (CR2) (M1 bone marrow, < 5% blasts by morphology) meeting the following criteria: * Intermediate risk relapsed ALL in CR2 (may receive matched sibling transplantation only) meeting 1 of the following criteria: * B-lineage ALL in CR2 after a late first bone marrow (BM) relapse (>= 36 months after the initiation of primary chemotherapy) with or without associated extramedullary disease * B-lineage ALL in CR2 after a very early isolated extramedullary relapse (<18 months from the initiation of primary chemotherapy) * High risk relapsed ALL in CR2 (may receive other related donor, unrelated donor, or matched sibling transplantation) meeting 1 of the following criteria: * In CR2 after an early first BM relapse (< 36 months from initiation of primary chemotherapy) * T-lineage ALL in CR2 after a first BM relapse occurring at any time after initiation of primary chemotherapy * Philadelphia chromosome-positive ALL in CR2 after a first BM relapse occurring at any time after the initiation of primary chemotherapy * T-lineage ALL in CR2 after a very early isolated extramedullary relapse (<18 months from the initiation of primary chemotherapy) * High risk de novo ALL in CR1 (may receive matched sibling, other related/unrelated BM/PBSC or unrelated CB transplantation) meeting 1 of the following criteria: * Patients with the presence of t(9;22) translocation (Ph+) detected by cytogenetic or PCR analysis at initial diagnosis. For patients on AALL0622, the criteria for transplant are 1) any patient with Ph+ ALL with an available matched sibling donor or 2) any patient with Ph+ ALL that is defined as high risk (MRD > 1% Day 29 or MRD > 0.01% end-Consolidation Block 2) with any available donor, related or unrelated. Patients enrolled on AALL0622 are only eligible if they follow this algorithm. * Patients with the presence of extreme hypodiploidy (< 44 chromosomes or DNA index of < 0.81) detected by cytogenetic/ploidy analysis at initial diagnosis. * Patients with the presence of 11q23 (MLL) rearrangements detected by cytogenetic or PCR analysis at initial diagnosis who are slow early responders (M2/M3 at Day 14 or MRD > 0.1% at Day 29). * Enrolled on an appropriate COG relapsed ALL clinical trial after completing the required study therapy (i.e., minimum 1 re-induction course (4-6 weeks) and 1 round of intensive consolidation chemotherapy (3-6 weeks). Patients with high risk ALL in CR1 are eligible as soon as they have achieved a CR. * Patients not on a COG relapsed ALL clinical trial are eligible provided they have received >= 1 round of re-induction lasting 4-6 weeks and 1 round of intensive consolidation chemotherapy lasting 3-6 weeks * No B-cell ALL L3 morphology with evidence of myc translocation by molecular or cytogenetic technique * No Down syndrome * No evidence of active CNS or other extramedullary disease (i.e., no CNS2) * Karnofsky performance status (PS) 60-100% (for patients > 16 years of age) OR Lansky PS 60-100% (for patients <= 16 years of age) * Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by radionuclide angiogram * ALT or AST < 5 times upper limit of normal * Bilirubin < 2.5 mg/dL (unless an increase is attributable to Gilbert's syndrome) * Creatinine clearance OR radioisotope glomerular filtration rate >= 70 mL/min * FEV_1 >= 60% by pulmonary function tests (PFTs) * FVC >= 60% by PFTs * DLCO >= 60% by PFTs * For children who are unable to cooperate for PFTs all of the following criteria must be met: * No evidence of dyspnea at rest * No exercise intolerance * No requirement for supplemental oxygen therapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No HIV or uncontrolled fungal, bacterial, or viral infection * Fungal infection acquired during induction therapy allowed provided there is a significant response to antifungal therapy with minimal or no evidence of disease by CT scan * Other concurrent immunosuppressants allowed * No prior allogeneic or autologous stem cell transplantation * No prior or concurrent voriconazole unless prior voriconazole therapy is completed or a different agent is substituted for voriconazole prior to study entry * No concurrent grapefruit juice during sirolimus administration

Study Objectives This is a multicenter, non-randomized, Phase II study of patients with previously untreated NSCLC not amenable to radiotherapy or surgical treatment. The planned enrollment for this trial is 78 patients (including a 10% rate for inevaluable patients). There will be a total of 39 patients in each cohort (Cohorts A and B). Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Ixabepilone, DRUG: Carboplatin, DRUG: Bevacizumab 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 non-small-cell bronchogenic carcinoma (squamous carcinoma, adenocarcinoma, or large cell carcinoma). Cytologic specimens obtained by brushings, washings, or needle aspiration of the defined lesion are acceptable. Mixed tumors with small-cell anaplastic elements are not eligible. * Patients who have newly diagnosed unresectable stage III or IV disease are eligible. Patients with stage III disease should be ineligible for combined modality therapy * Patients must not have received any prior antineoplastic chemotherapy for metastatic lung cancer prior to study entry. * Patients who have had previous radiotherapy as definitive therapy for locally advanced non-small-cell are eligible as long as the recurrence is outside the original radiation port. Radiation therapy must have been completed greater than 4 weeks prior to registration. * Male or female patients >=18 years of age. * Life expectancy of at least 3 months. * ECOG performance status of <=1. * Measurable disease by RECIST criteria (see Section 7). * Laboratory values as follows: * ANC >=1500/mm3 (7 days prior to treatment); * Hemoglobin >=8 g/dL; * Platelets >=100,000 mm3 (7 days prior to treatment) * Bilirubin <=1 x ULN for institution * AST/SGOT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases and * ALT/SGPT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases * Creatinine <=2.0 mg/dL or * Calculated (measured) GFR >=40 mL/min * PT/INR and PTT <=1.5 x ULN * Peripheral neuropathy <= grade 1. Exclusion Criteria: * A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure of > grade 2 per New York Heart Association (NYHA) criteria (see Appendix B), myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias. * Metastatic brain or meningeal tumors. * Uncontrolled intercurrent illness. * Chemotherapy, investigational drug therapy, or major surgery <= 4 weeks prior to starting study drug, or patients who have not recovered from side effects of previous therapy. * Patient is <=5 years free of another primary malignancy, except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if the other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Exclusion Criteria for Enrollment on Bevacizumab (Cohort B): * Patients with squamous cell histology NSCLC. * Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury within 1 month of beginning bevacizumab. * Patients who have had primary thoracic radiation within 3 months of beginning bevacizumab. * Fine needle aspiration, core biopsy, mediastinoscopy or other minor surgical procedure within 7 days of beginning bevacizumab. * Patients receiving thrombolytic therapy within 10 days of starting bevacizumab. * Patients with serious non-healing wound, ulcer, or bone fracture. * Patients with evidence of bleeding diathesis or coagulopathy. * Patients with history of hemoptysis (defined as bright red blood of ½ teaspoon or more per episode) within 3 months prior to study enrollment. * Patients with proteinuria at screening, as demonstrated by either: * Urine protein : creatinine (UPC) ratio >=1.0 or * Urine dipstick for protein >=2+ (patients discovered to have >=2+ proteinuria on dipstick at baseline should undergo a 24-hour urine collection, and must demonstrate <1 g of protein in 24 hours to be eligible). * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.

Study Objectives This randomized phase II trial studies how well afimoxifene works in reducing the risk of breast cancer in women with mammographically dense breast. Estrogen can cause the growth of breast cancer cells. Hormone therapy using afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells. Conditions: Mammographically Dense Breast Intervention / Treatment: DRUG: Afimoxifene, OTHER: Laboratory Biomarker Analysis, OTHER: Placebo, OTHER: Questionnaire Administration Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Women age 40-69 years, or less than 40 years if 5-year breast cancer Gail risk is >= 1.66%. * Mammographically dense breast (heterogeneously dense [C] or extremely dense [D], based on American College of Radiology [ACR] BIRADS fifth edition classification or heterogeneously dense [3] or extremely dense [4], based on ACR BIRADS fourth edition classification) in either breast * Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) * White blood cells >= 3,000/microliter * Absolute neutrophil count >= 1,500/microliter * Platelets >= 100,000/microliter * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 × institutional upper limit of normal (ULN) * Creatinine within normal institutional limits * Participant must have a gynecology examination within the last 3 years, with no atypical hyperplasia and no cancer * Premenopausal women taking non hormonal intra-uterine device (IUD) birth control method will be eligible, if they have been on the same IUD for at least 3 months prior to enrollment and plan to continue using the same method throughout the study * Women of child-bearing potential must agree to use a reliable nonhormonal contraceptive method during the study and for 2 months after completing study medications; reliable nonhormonal methods of contraception include barrier contraception and an intra-uterine device (IUD); Note: women who had tubal ligation or had a partner who had undergone a vasectomy (and are monogamous) are eligible for the study and are not required to use barrier contraception * If the participant is of childbearing potential, she must have a documented negative urine pregnancy test within 7 days prior to randomization * Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of the study * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * History of allergic reactions attributed to compounds of similar chemical or biologic composition to 4-OHT gel * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, thromboembolic disease, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant, or had given birth, or nursed at any time during the last 12 months * Women with a previous history of invasive breast cancer or bilateral ductal carcinoma in situ (DCIS) or current untreated DCIS; women with a history of cancer within the last 3 years, except for non-melanoma skin cancer; women with unilateral DCIS (with or without radiation therapy) are eligible as long as they have an unaffected breast * Prior bilateral breast surgery (mastectomy, segmental mastectomy, or breast augmentation surgery including breast implants or breast reductions) * Women with "mosaic mammographic screening views", i.e., whose larger breast size precludes being imaged within a single mammographic screening view * Women with active liver disease, abnormal uterine bleeding, or prior diagnosis of endometrial hyperplasia * Prior use of selective estrogen receptor modulators (SERMS) and aromatase inhibitors (AIs) for prevention or therapy * Skin lesions on the breast that disrupt the stratum corneum (e.g., eczema, ulceration) * Treatment with any investigational drug or investigational biologic within 30 days of initiating study treatment or during the study

Study Objectives This phase I clinical trial studies the side effects and best dose of CD19-specific T-cells in treating patients with lymphoid malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment. Sometimes researchers change the deoxyribonucleic acid (DNA) (genetic material in cells) of donated T-cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves drawing blood from the patient, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject the changed T-cells into the body of the patient. Injecting modified T-cells made from the patient may help attack cancer cells in patients with advanced B-cell lymphoma or leukemia. Conditions: Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Blasts 5 Percent or More of Bone Marrow Nucleated Cells, CD19 Positive, Minimal Residual Disease, Non-Hodgkin Lymphoma, Small Lymphocytic Lymphoma, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia Intervention / Treatment: DRUG: Cyclophosphamide, DRUG: Fludarabine Phosphate, OTHER: Laboratory Biomarker Analysis, BIOLOGICAL: Tisagenlecleucel 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 with a history of CD19+ lymphoid malignancy defined as acute lymphoblastic leukemia, acute biphenotypic leukemia, non-Hodgkin's lymphoma, small lymphocytic lymphoma, or chronic lymphocytic leukemia with active disease defined by presence of > 5% malignant blasts in bone marrow and/or peripheral blood, and/or minimal residual disease by flow cytometry or molecular analysis for fusion proteins, and/or positive imaging for extramedullary disease; patients must have measurable disease at time of study treatment * Confirmed history of CD19 positivity by flow cytometry for malignant cells * Lansky/Karnofsky performance scale > 60% * Patient able to provide written informed consent; parent or guardian of minor patient able to provide written informed consent * Patient able to provide written informed consent for the long-term follow-up gene therapy study: 2006-0676; parent or guardian of minor patient able to provide written informed consent for the long-term follow-up gene therapy study: 2006-0676 Exclusion Criteria: * Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females * Patients with known allergy to bovine or murine products * Positive serology for human immunodeficiency virus (HIV) * Active hepatitis B or active hepatitis C * Has received donor lymphocyte infusion (DLI) product within 6 weeks of CAR T cell infusion * Has received allogeneic hematopoietic stem cell transplant within 3 months of CAR T cell infusion; hematopoietic stem cell transplant (HSCT) > 3 months from CAR T cell infusion eligible

Study Objectives The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage groups. Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to assess anti-SR29142 antibody production in patients with malignant lymphoma and acute leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the results of efficacy and safety evaluations. Conditions: Hyperuricemia, Leukemia, Lymphoma Intervention / Treatment: DRUG: Rasburicase (SR29142) Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: Patient suffering from: * acute leukemia with white blood cell (WBC) count>= 20,000/mm3 without regard to uric acid level ; or * lymphoma,Stage >= III without regard to uric acid level; or * lymphomas, Stage II with bulky disease; or * lymphoma or leukemia, without regard to classification or morphology, with uric acid level >= 8.0 mg/dL, and lactate dehydrogenase (LDH) level >= twice the upper limit of normal (ULN).

Study Objectives The purpose of this study is to compare the outcomes between hospitalized cancer patients with high blood sugar receiving the current standard of care of administering insulin, and hospitalized cancer patients receiving a new, individualized method of insulin administration. Conditions: Hyperglycemia Intervention / Treatment: DRUG: Insulin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Provide race and ethnicity information * Male or female, aged 18 years or greater * Diagnosed with cancer * Hospitalized at MCC in the medical, hematologic, or bone marrow transplant units * Having in-hospital hyperglycemia with or without a pre-existing diagnosis of DM, with 2 measurements of BG > 180 mg/dL and/or 1 measurement of BG > 350mg/dL within the first 72 hours of admission, detected by bedside point-of-care testing and/or basic metabolic panel laboratory data. * Participants enrolled in other clinical trials are admissible to this trial. Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: * Participants < 18 years of age * Participants at the end of life and/or with limited life expectancies (< 6 months) * Participants without cancer diagnoses * Surgical patients and patients admitted directly to the intensive care unit, other than those in the Bone Marrow Transplant Unit, who are included * Participants treated and discharged in outpatient settings (ie, direct referral center, infusion center, or clinical research unit) or those admitted for observation only (hospitalized less than 24 hours) * Participants on total parenteral nutrition * Participants on insulin pumps * Participants admitted with diabetic ketoacidosis and hyperglycemic hyperosmolar syndrome * Pregnant Participants based on medical history * Participants being followed by endocrinology for hyperglycemia or hypoglycemia

Study Objectives Study Design: This is a pragmatic study on the management strategy for patients with metastatic colorectal cancer (CRC) who are candidates for CT, independently of any previous adjuvant therapy received. The aim of this study is to define the role of new target molecules in combination with CT in first- and second line treatment. First line study: Eligible patients were randomized to either treatment: Arm A: FOLFIRI or FOLFOX + Bevacizumab, cycle to be repeated every 2 weeks * BEVACIZUMAB: Day 1,1st cycle 5 mg/kg IV infusion of 90 min Day 1, 2nd cycle if well tolerated, 5 mg/kg IV infusion of 60 min Day 1, 3rd cycle and subsequent cycles if well tolerated, 5 mg/kg IV infusion of 30 min after 5-Fluorouracile (FU) bolus * FOLFIRI Day 1: Irinotecan 180 mg/m2 IV infusion 30-90 min Day 1,2: L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus 5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours - FOLFOX Day 1: Oxaliplatin 85 mg/m2 IV infusion of 2hours Day 1,2: L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus 5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours Arm B: FOLFIRI or FOLFOX, cycle to be repeated every 2 weeks If FOLFIRI: FOLFIRI as specified in arm A without Bevacizumab If FOLFOX: FOLFOX as specified in arm A without Bevacizumab Duration of Therapy For both arms, CT was repeated until progressive disease (PD) or unacceptable toxicity occurs. If unacceptable CT-related toxicity occurs in ARM A, in the absence of PD patients stopped CT and continued with only bevacizumab 5 mg/kg as a 30-min infusion every 2 weeks until progression or intolerable toxicity occurred. Second line - it is divided in two different studies (2A and 2B): Study 2A: Patients from arm A and Kras Wild Type were randomized to: * Arm C: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as defined in arm B) * Arm D: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as described in arm B) plus CETUXIMAB CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hrs before CT infusion 1st cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1 hr before CT infusion Patients from arm A and Kras Mutant were treated according to arm C. Study 2B: Patients from arm B and Kras Wild Type were randomized to: * Arm E: FOLFIRI or FOLFOX (the CT schedule not received in the 1st line trial, as defined in arm B) plus BEVACIZUMAB * Arm F: FOLFIRI or FOLFOX (the CT schedule not received in the first-line trial, as defined in arm B) plus BEVACIZUMAB and CETUXIMAB; cycle to be repeated every 2 weeks, whilst cetuximab will be administered weekly. * BEVACIZUMAB 2nd day of 1st cycle 5 mg/kg IV infusion of 90 min 2nd day of 2 nd cycle if well tolerated, 5 mg/kg IV infusion of 60 min 2nd day of 3 rd cycle and subsequent cycles if well tolerated, 5 mg/kg IV infusion of 30 min after the end of 5-FU bolus on the 2nd day * CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hr before CT infusion 1st cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1 hr before CT infusion If cetuximab will be stopped for any of the reasons specified in this protocol, bevacizumab will be administered as defined in arm A of the 1st line study Patients from arm B and Kras Mutant were treated according to arm E. Objectives of study The primary objective of the 1st line study is to determine whether the addition of bevacizumab to a poly-chemotherapy (polyCT) regimen (FOLFIRI or FOLFOX) improves efficacy in terms of progression-free survival (PFS). The secondary objectives of the 1st line study are to determine the Overall Response Rate (ORR) and the safety profile of the treatments administered. The primary objective of the 2nd line studies is to determine, separately for each study, whether the addition of cetuximab to a polyCT schemes (FOLFOX or FOLFIRI), or to polyCT schemes plus bevacizumab, improves efficacy in terms of PFS.The secondary objectives of the 2nd line studies are to determine the ORR, the overall survival (OS) and the safety profile of the treatments administered. Conditions: Metastatic Colorectal Cancer Intervention / Treatment: DRUG: Arm A: FOLFIRI or FOLFOX + Bevacizumab, DRUG: Arm B: FOLFIRI or FOLFOX, DRUG: Arm D: FOLFIRI or FOLFOX plus CETUXIMAB, DRUG: Arm F: FOLFIRI or FOLFOX plus BEVACIZUMAB and CETUXIMAB Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed untreated metastatic or locally advanced, non resectable CRC; previous adjuvant chemotherapy for CRC or neoadjuvant/adjuvant chemoradiotherapy for rectal cancer is permitted but must have been completed at least 6 months prior to enrolment; * Resected CRC patients who have developed metastases do not require separate histological or cytological confirmation unless > 5 yrs have elapsed between primary surgery or primary tumor stage I; * Evaluation of Kras status from the primary tumor or metastases * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria) * Age >= 18 years and < 70 years with Performance Status (ECOG) <= 2 or age > 70 years with ECOG <= 1; * Estimated life expectancy of at least 12 weeks; * Adequate hematological, hepatic and renal function, as follows: hemoglobin >= 9 g/dl,absolute neutrophil count >=1,500/μL, platelets >=100,000/μL, total bilirubin <=1.5 x upper limit of normal (ULN),alkaline phosphatase, aspartate aminotransferase (AST(SGOT)) and alanine aminotransferase (ALT(SGPT)) <= 2.5 x ULN (<= 5 x ULN if liver metastases present), serum creatinine <= 1.5 x ULN or calculated creatinine clearance >50 mL/min (calculated on the basis of Standard Cockcroft and Gault Formula, urinary excretion (if protein > 30 mg/dL or +1, patients must have <= 1 g of protein/24 hours) * Either international normalized ratio (INR) or activated partial thromboplastin time (APTT) < 1.5 x ULN and D-dimer within normal range (if abnormal, thromboembolic events must be excluded); * Negative pregnancy test no more than 7 days before randomization; test pregnancy can be omitted only in women without any reproductive potential (e.g.: postmenopausal women, i.e. amenorrhoea >=2 years or with previous hysterectomy or bilateral ovariectomy). Women of child-bearing potential and men must agree to use adequate contraception at the time of randomization and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician and coordinating centre (CC) immediately; women in lactation period must be excluded; * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Prior treatment with cetuximab, bevacizumab or other anti Epidermal Growth Factor Receptor (antiEGFR) or anti-angiogenesis agents; * Prior chemotherapy or immunotherapy for metastatic or advanced disease; * Participation in another clinical trial with any investigational agents <= 30 days prior to study randomization; * Contraindications or hypersensitivity to study drugs; * Treatment with other concomitant antineoplastic drugs; * Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix); * Symptomatic brain or central nervous system metastases or clinically relevant central nervous diseases (for example: primary brain tumor, uncontrolled convulsions with medical therapy, carcinomatous meningitis); * Grade > 1 peripheral neuropathy (as defined by the National Cancer Institute - Common Toxicity Criteria for Adverse Effects (NCI CTCAE) v3.0); * Clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents <= 6 months prior to randomization), myocardial infarction (<= 1 year prior to randomization), uncontrolled hypertension whilst receiving chronic medication, unstable angina, New York Heart Association (NYHA) grade II or more congestive heart failure,or serious cardiac arrhythmia requiring medication; * Malabsorption syndrome or lack of physical integrity of the gastrointestinal tract. Diverticulitis. Patients with colostomy or ileostomy may enter at the investigator's discretion. History of trachea-oesophageal fistula or any other type of fistula (e.g. abdominal), gastrointestinal perforation, intra-abdominal abscess; * Interstitial pneumonia or extensive symptomatic fibrosis of the lungs; * Serious, non-healing wound, ulcer, or bone fracture; significant traumatic injury in the 4 weeks prior to enrolment (complete recover must have occurred); * Major surgery (e.g. laparotomy) in the 4 weeks prior to study randomization; * Minor surgery in the 2 weeks prior to study randomization. Insertion of a central vascular access device for chemotherapy infusion must be done at least 2 days prior to the start of treatment. Patients will be randomized only if they have recovered from all surgery related toxicities; * Bleeding diathesis or coagulopathy; * Pulmonary embolism or any arterial thromboembolism; * Deep vein thrombosis or other significant thromboembolic event; * Clinically significant peripheral vascular disease; * Previous organ transplantation that requires immunosuppressive therapy; * Need for chronic oral steroid use ( >=10 mg/day of methylprednisolone or equivalent) for the treatment of a nonmalignant condition other than intermittent prophylactic use as an antiemetic and inhaled steroid use; * Chronic use of aspirin (> 325 mg/day) or other non steroidal anti-inflammatory agents (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases); * In treatment with antiplatelets agents (i.e clopidogrel > 75 mg/day, ticlopidine,dipyridamole); * Undergoing treatment with sorivudine or its chemically-related analogues (such as brivudine); * Full-dose oral or parenteral anticoagulants or thrombolytic treatment for therapeutic purposes <=10 days prior to study randomization; * Geographic inaccessibility; * Any radiation therapy completed <= 4 weeks prior to study randomization. If the radiated lesion/s is/are the only site of disease, and if it/they show progression after the radiotherapeutic procedure, the patient will become eligible for the study; * Previous embolization or thermoablation of metastases <= 30 days prior to study randomization. If these lesions are the only site of disease, and if they show progression after the embolization or thermoablation procedure, the patient will become eligible for the study; * Laboratory abnormality or medical or psychiatric disorders that would interfere with informed consent or compliance, or which could indicate a contraindication to patient enrolment into the study (also known dihydropyrimidine dehydrogenase deficit); * HIV-positivity, whether or not symptomatic.

Study Objectives Colonoscopy is a common screening method to detect polyps and CRC. With the early detection of CRC through screening colonoscopy, patients could have better therapeutic effects and outcomes. In population screening programs, an increase in completed colonoscopies is related to a decrease in mortality from CRC. However, the miss rate for detecting colorectal neoplastic polyps of colonoscopy is 5-28%. The reluctance of participants to undergo bowel preparation results in the relatively low rate of detection of polyps and CRC, because poor preparation interferes with successful colon mucosa examination during a colonoscopy. Low-volume bowel preparations provide equivalent cleansing effect compared with standard 4 liter polyethylene glycol. However, studies comparing the superiority between low-volume bowel preparations are rare, and results are controversial. This study aimed to compare the bowel cleansing quality and tolerability between split-dose sodium picosulfate/magnesium citrate and polyethylene glycol with ascorbic acid. Conditions: Colorectal Cancer, Colon Adenoma Intervention / Treatment: DRUG: PEG-Asc, DRUG: SPMC 2 Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Male or female patients, aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study Exclusion Criteria: * patients who had chronic kidney disease, severe heart failure(New York Heart Association [NYHA] class III or IV), uncontrolled hypertension (systolic pressure >=170 mm Hg, diastolic pressure >=100 mm Hg), severe constipation, any bowel resection, significant gastroparesis, or suspected bowel obstruction or perforation.

Study Objectives This is a multicenter phase 2b study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer, suitable for treatment with a taxane. Conditions: Prostate Cancer Metastatic, Castration-resistant Prostate Cancer Intervention / Treatment: DRUG: Docetaxel in Parenteral Dosage Form, DRUG: ModraDoc006/r Location: Hungary, Germany, United States, Czechia, Russian Federation, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age >= 18 years * Histologically or cytologically proven prostate cancer with evidence of progressive mCRPC, defined as: 1. Castrate levels of testosterone, defined as <= 50 ng/dL (or <= 0.50 ng/mL or 1.73 nmol/L) 2. Evidence of progressive metastatic disease as defined by radiographic disease progression or Prostate Specific Antigen (PSA) progression 3. With an indication for systemic treatment with docetaxel according to the standard of care * Measurable tumour lesions, defined as pelvic and/or extra-pelvic nodal lesions >=1.5 cm in the short axis or visceral lesions >=1.0 cm in the longest dimensions and measurable according to RECIST v1.1, bone metastasis as evaluated with 99mTc-methylene diphosphonate (MDP) radionuclide bone scintigraphy * Resolution of toxicity of prior therapy to < grade 2 (except for alopecia), as defined by CTCAE v5.0 * Adequate haematological, renal and hepatic functions: 1. Hemoglobin >= 6.0 mmol/l (>9.6 g/dL) 2. Absolute Neutrophil Count (ANC) >= 1.5 x 109 /L 3. Platelet count >= 100 x 109 /L 4. Hepatic function defined by serum bilirubin <= Upper Limit of Normal (ULN), Alanine Amino Transferase (ALAT) and Aspartate Amino Transferase (ASAT) <= 1.5 x ULN concomitant with alkaline phosphatase <= 2.5 × ULN. 5. Renal function defined by serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula, or MDRD). * World Health Organisation Performance Status (WHO-PS) of 0-2 * Estimated life expectancy of at least 12 weeks * Able and willing to swallow oral medication * Able and willing to undergo radiologic scans (CT scan) * Able and willing to give written informed consent according to local guidelines Exclusion Criteria: * Any treatment with investigational drugs, chemotherapy or immunotherapy within 4 weeks prior to receiving the first dose of investigational treatment. Palliative radiotherapy (1x8 Gy dose) is allowed before and during the study, but not in the week prior to start of study treatment. * Subjects who have had prior treatment with taxanes. * Subjects with symptomatic brain metastases. Subjects asymptomatic in the absence of corticosteroids and anticonvulsant therapy for >=6 weeks are eligible. Radiotherapy for brain metastasis must have been completed >=6 weeks prior to start of trial. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening, demonstrating no current evidence of progressive brain metastases). Subjects are not permitted to receive anti-epileptic drugs or corticosteroid treatment indicated for brain metastasis. Subjects with a history of leptomeningeal metastases are not eligible. * Current malignancies other than mCRPC with exception of adequately treated basal or squamous cell carcinoma of the skin, or adequately treated non-muscular invasive bladder cancer. * Absence of highly effective method of contraception as of cycle one day one (C1D1). Men enrolled in this trial must agree to use a highly effective contraceptive method throughout the study. * Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) * Unresolved (>grade 0 as defined by CTCAE version 5.0) gastrointestinal toxicities (pre-existing mucositis, diarrhea or nausea/vomiting) * Grade >= 2 motor >= 2 motor or sensory neuropathy symptoms (as defined by CTCAE version 5.0) * Known hypersensitivity to any of the study drugs or excipients or taxanes * Concomitant use of P-glycoprotein (P-gp , MDR), Cytochrome P450 (CYP)3A, Organic Anion-Transporting Polypeptide (OATP)1B1, OATP1B3 and Multidrug resistance-associated protein 2 (MRP2) modulating drugs such as Ca+- entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine and grapefruit juice, concomitant use of HIV medications, other protease inhibitors, (non) nucleoside analogues, or St. John's wort * Bowel obstruction or motility disorder that may influence the resorption of drugs as judged by the treating physician * Major surgical procedures within 21 days prior to providing informed consent * Active acute or chronic infection, which is not controlled by appropriate medication (at the discretion of the treating physician) * Known positivity for Human Immunodeficiency Virus HIV-1 or HIV-2 type * Patients with known active infection of hepatitis B/C (HBC), or E (patients who are anti-HBC positive but HBsAg negative are eligible to participate in this study) * Clinically significant (i.e. active) cardiovascular disease defined as stroke, transient ischemic attack (TIA), myocardial infarction, unstable angina, or congestive heart failure within <= 6 months prior to first trial treatment * Evidence of any other medical conditions (such as treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, or pulmonary embolism within 4 weeks of randomization, or psychiatric illness, drug or alcohol abuse, physical examination or laboratory findings) that may interfere with the planned treatment, affect subject compliance or place the subject at high risk of treatment-related complications * Legal incapacity

Study Objectives The majority of breast cancer patients receive radiotherapy as part of their treatment. Radiotherapy improves both locoregional control and overall survival. In most patients with breast cancer the locoregional recurrence rate (LRR) is low, however still high LRRs are found in certain patient groups, especially in locally advanced, inflammatory and triple negative breast cancer. Olaparib is a potent PARP inhibitor developed as an anti-cancer drug for homologous recombination (HR) defected tumors and as a dose intensifier for chemo- and radiotherapy. The combination of olaparib and radiotherapy is expected to improve locoregional control and thereby overall survival in both breast cancer patients with a high probability of locoregional recurrence and patients with HR deficient tumors. However, this combination treatment has never been tested in humans before. The purpose of this study is to determine the safety and tolerability of radiotherapy to the breast and regional lymph nodes with concurrent olaparib. Conditions: Locally Advanced Malignant Neoplasm, Inflammatory Breast Carcinoma, Triple-Negative Invasive Breast Carcinoma Intervention / Treatment: RADIATION: radiotherapy, DRUG: olaparib Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * >=18 years of age * Histological proven breast cancer or local recurrence of breast cancer which is inoperable or/and metastatic, including inflammatory breast cancer * No participation in trial with neoadjuvant systemic treatment, except for previous contralateral breast cancer * Tumor in breast accessible for biopsy * WHO performance 0-2 * Life expectancy of at least 6 months * Adequate hematological, renal and hepatic functions * Hemoglobin 6.2 mmol/l * Leucocytes 3.0 x 10E9/l * Absolute neutrophil count 1.5x10E9/l * Platelet count 100 x 10E9/l * Total bilirubin <= 1.5 x ULN * ASAT/ALAT <= 2.5 x ULN; or in the presence of liver metastases <= 5 x ULN * Creatinine clearance 50 ml/min; measured or calculated * Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 21 days of study treatment. Non-childbearing potential or postmenopausal is defined as: * Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments * LH and FSH levels in post menopausal range for women under 50 years of age * Radiation-induced oophorectomy with last menses > 1 year ago * Chemotherapy-induced menopause with > 1 year interval since last menses * Surgical sterilisation (bilateral oophorectomy or hysterectomy) * Patients of reproductive potential must agree to practice two effective medically approved contraceptive method during the trial and 3 months afterwards * Signed written informed consent Exclusion Criteria: * Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within 3 weeks prior to start of therapy (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin ornitrosourea). Patient may continue the use of tamoxifen, aromatase inhibitor and LHRH agonists for cancer; bisphosphonates for bone disease and corticosteroids. The use of denosumab for bone disease is not allowed. * Major surgery within two weeks of starting study treatment. * Participation in other trial with investigational drug or treatment modality * Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. * Prior ipsilateral radiotherapy to the chest or breast. * Blood transfusion in the four weeks prior to study entry * Persistent toxicities (CTC >= grade 2) with the exception of alopecia, caused by previous cancer therapy * QT-interval > 470 msec * Significant cardiovascular disease as defined by * History of congestive heart failure defined as NYHA class III * History of unstable angina pectoris or myocardial infarction up to 3 months prior to trial entry; * Presence of severe valvular heart disease * Presence of a ventricular arrhythmia requiring treatment; * Uncontrolled hypertension * Patients considered a poor medical risk due to: * non-malignant systemic disease * active, uncontrolled infection requiring parenteral antibiotics * a serious, uncontrolled medical disorder; examples include, but are not limited to: * uncontrolled major seizure disorder * unstable spinal cord compression * superior vena cava syndrome * extensive bilateral lung disease on HRCT scan * any psychiatric disorder that prohibits obtaining informed consent. * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. * Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy. * Patients with known active hepatic disease (i.e. Hepatitis B or C) * Patients with myelodysplastic syndrome/acute myeloid leukaemia or features suggestive of MDS/AML on peripheral blood smear. * Gastrointestinal disorders that may interfere with absorption of the study drug or patients who are not able to take oral medication * Concomitant medications: * Any previous treatment with a PARP inhibitor, including Olaparib * Patients receiving the following classes of inhibitors of CYP3A4 (see Section 6.4.2 for guidelines and wash out periods) * Azole antifungals * Macrolide antibiotics * Protease inhibitors * Patients with a known hypersensitivity to olaparib or any of the excipients of the product * Breast-feeding women

Study Objectives The purpose of this study is to determine the recommended phase II dose (RP2D) of rosuvastatin that can be given in combination with standard erlotinib treatment in patients with advanced incurable squamous cell cancer and NSCLC. Conditions: Squamous Cell Carcinoma, Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Erlotinib + Rosuvastatin Location: Canada 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 documented advanced and/or metastatic incurable tumor (especially squamous cell carcinoma or NSCLC). * Clinically or radiologically documented (measurable or evaluable)disease. * >= 18 years and less than 70 years of age. * ECOG performance status: 0, 1 or 2 * No previous therapy with EGFR inhibitor (monoclonal antibody or TKI). * Must have recovered from any treatment related toxicities prior to registration. * Curative radiotherapy must be completed at least 3 months prior to registration * Palliative radiotherapy is permitted providing a minimum of 14 days have elapsed between the end of radiotherapy and registration onto the study and patients have recovered from any acute toxic effects from radiation prior to registration. * Previous surgery is permitted provided wound healing has occurred and at least 14 days have elapsed prior to registration if surgery was major. * Adequate hematopoietic, hepatic and renal function defined as follows: hemoglobin >= 90g/L, platelets > 100 x 10^9/L, bilirubin <1.5 x ULN, ALT or AST <1.5 x ULN, proteinuria < grade 1, normal thyroid function (normal TSH or free T4 level after correction), serum creatinine institution normal limits or calculated creatinine clearance > 60 mls/min (except for patients with cervical cancer who require a creatinine clearance of 72 mls/min.) * Women must be post menopausal, surgically sterile or use two reliable forms of contraception. Women of childbearing potential must have a serum or urine pregnancy test taken and proven negative within 7 days prior to registration. Men must be surgically sterile or use a barrier method of contraception * Accessible for repeat dosing and follow-up Exclusion Criteria: * Asian ethnicity (Filipino, Chinese, Japanese, Korean, Vietnamese, or South Asian origin) * History of other malignancies, except adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for > 5 years. * Untreated brain or meningeal metastases. Patients with treated and radiologic or clinical evidence of stable brain metastases are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 4 weeks prior to registration). * Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction. * Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. * Concurrent treatment with other experimental drugs or anti-cancer therapy. * Patients who require oral anticoagulants (coumadin, warfarin) are eligible provided there is strict vigilance with respect to monitoring INR. The investigator should consider switching these patients to LMW heparin or an oral anti-platelet agent such as aspirin * Patients who are taking concomitant medications, which are highly protein bound, nephrotoxic, or which are known strong inhibitors or inducers of the hepatic p450 (especially CYP3A4) system, which have not been discontinued prior to study registration. Caution should be exercised, and patients monitored closely, for patients taking concomitant drugs with the potential to inhibit or induce the hepatic p450 (especially CYP3A4) system. * Any use of hypocholesterolemia agent such as niacin, fibrates or any statin should be discontinued at least 7 days prior to study registration. * Personal or family history of hereditary muscular disorders * Previous history of muscular toxicity with another HMG-CoA reductase inhibitor * Alcohol abuse * Any condition that could affect absorption of study oral drugs (erlotinib and rosuvastatin) * Inflammatory bowel disease * Uncontrolled hypothyroidism * Chronic liver disease (ex: biliary sclerosis) * Suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis * Inability to give written, informed consent prior to study participation.

Study Objectives The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 30mg (100µCi) dose of \[14C\] HQP1351 given as a suspension. For further clinical development, human mass balance data are required to elucidate the absorption, metabolism, and excretion of HQP1351. Conditions: Chronic Myeloid Leukemia (CML) Intervention / Treatment: DRUG: [14C] HQP1351 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: A subject will be eligible for study participation if he meets the following criteria: * Healthy male volunteers between the ages of 18 to 50 years old, inclusive; * Body weight >=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive); * Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant; * Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 1 year after discontinuing treatment with the investigational product. * Must understand, and voluntarily sign the informed consent, comply with the requirements of the study. Exclusion Criteria: A subject will not be eligible for study participation if he meets any of the exclusion criteria: * History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder; * Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody; * Abnormality in blood pressure, including hypertensive BP (SBP>=140 mmHg, or DBP >=90 mmHg), or hypotensive BP (SBP<90 mmHg, or DBP <=55 mmHg), Pulse rate<55 bpm or >100 bpm; * Long-QT syndrome or family history of it, or QTcB interval > 450 ms; intraventricular blocks or left/right bundle branch block or QRS>120ms; frequent ventricular ectopic beats (any 10s ECG ventricular premature beat >= 1 in screening period); or abnormal resting heart rate (> 100 bpm) * The following abnormal clinical laboratory values 1. HGB < LLN or HGB>ULN, and is judged as clinically significant by the investigator； 2. Abnormal ALB, TP, CRE, ALT, AST, BIL, BUN, GLU value, and is judged as clinically significant by the investigator; * Received any drug within 14 days before taking the investigational drug, including any prescription drug, OTC drug, herbal drug or health care product with medicinal effect; * Received any other investigating products or participated in any clinical trails three month before screening or within 10 t1/2 after receiving other investigating products; * History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs; * Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease or history of gastrointestinal surgery and cholecystectomy; * Hemorrhoids or perianal disease with regular/perianal bleeding; * Allergies, have allergies to two or more drugs or foods; or have known allergies to the components of the drug (microcrystalline cellulose, stearic acid, croscarmellose sodium); * Have donated 400ml or more of blood or plasma 3 months prior to the study drug administration, or more than 50ml within 2 weeks prior to administration; * Vaccination was administered within 6 months prior to screening or during screening; * History of drug or alcohol abuse; * Smoking (> 10 cigarette / day), drinking (> 15 g, pure alcohol / day, equivalent to 450 ml beer, 150 ml wine or 50 ml low-alcohol liquor), or abusing drugs within last 3 months; * Subject with mentally ill and could not understand the property, scope and possible consequences of the study; * subject in prison or whose freedom is restricted by administrative or legal issues; * Failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study; * Abnormal coagulation function or known severe bleeding tendency; * Subjects who have participated in radiolabeled clinical study prior to drug administration; * Significant radiation exposure within one year prior to drug administration (more than one exposure from chest X-ray, CT scan, or barium meal examination and radiation-related occupations). * Investigators think that subjects are not suitable to participate in the study.

Study Objectives The present trial is designed as a phase II study that aims at estimating the efficacy of the combination of bendamustine, bortezomib and dexamethasone in relapsed/refractory multiple myeloma (MM). The response rate, i.e. the rate of the patients achieving a Complete Response or Partial Response at cycle 4, divided by the total intent to treat patient number is chosen as primary efficacy endpoint. The estimation of the efficacy rate is to be based on an explorative pilot study, since immediate embarking on a large-scale comparative efficacy trial would not be acceptable from the point of view of resources. Moreover, this would induce ethical objections, as it does not seem to be justifiable to expose a large number of patients to an experimental approach without sufficient exploratory indications of an improved risk-benefit ratio. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Bendamustine, Velcade and Dexamethasone Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Symptomatic multiple myeloma (MM) patient at the time of diagnosis (but not necessarily at the time of relapse), according to International Myeloma Working Group criteria. * Patient having received conventional chemotherapy in 1st line treatment because of age 65 years or over, or younger than 65 years and ineligible to high-dose therapy plus stem cell transplantation. * Measurable disease (>=10g/L monoclonal gammapathy and/or >= 200 mg/24h proteinuria or involved serum free light chain >= 100mg/L with abnormal FLC ratio < 0.26 or > 1.65) * Patient in 1st relapse or refractory to 1st line therapy. Relapse is defined by M-component increase of >=25% from baseline, in serum and/or urine (the absolute increase in serum must be >= 5 g/l - the absolute increase of BJ proteins in urine must be >=200 mg/24 h). (It is recommended to treat only symptomatic or rapidly evolutive relapses) * Life expectancy of at least 3 months * ECOG performance status <= 2 at study entry * Laboratory test results within these ranges: * Absolute neutrophil count >= 1.5 x 109/L * Platelet count >= 100 x 109/L * Serum creatinine <= 250 umol/l * AST (SGOT) and ALT (SGPT) <= 3 x ULN * Disease free of prior malignancies for >= 5 years, with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast * Able to adhere to the study visit schedule and other protocol requirements * Using effective contraceptive methods during and for 6 months after study treatment (for fertile men, women of childbearing potential). * Provision of informed consent. * A period of at least 15 days must be respected between the last treatment of myeloma and the beginning of the study. Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Any comorbidity which places the subject at unacceptable risk if he/she were to participate in the study. * Patients treated with high-dose therapy plus stem cell transplantation in 1st line therapy * Any prior use of bortezomib (Velcade) or bendamustine (Ribomustin) * Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan * Use of any other experimental drug or therapy within 28 days prior to the start of study treatment. * Known hypersensitivity to the study drugs * Positive HIV serology, positive hepatitis C serology, active infection hepatitis A, active infection hepatitis B. * Severe cardiovascular disorders within 12 months prior to the start of study treatment (e.g. myocardial infarct, ischemic episodes, arrhythmias) * Previous major surgery less than 30 days before start of treatment * Active infection, * Pregnant or lactating women.

Study Objectives Objective of this study is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs Progression-free survival (by at least 9 months). Conditions: Myeloma Intervention / Treatment: DRUG: Lenalidomide, Bortezomib, DRUG: Lenalidomide, Bortezomib Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria for registration : (with labs performed within 21 days of initiation of protocol therapy): * Patients diagnosed with multiple myeloma based on International Myeloma Foundation 2003 Diagnostic Criteria. * Patients must have symptomatic myeloma with myeloma-related organ damage. * Patients must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains. * Age between 18 and 65 years at the time of signing the informed consent document. * ECOG performance status <2 (Karnofsky >= 60%) * Negative HIV blood test Exclusion Criteria for registration (section 4.2): * Participants must not have been treated with any prior systemic therapy for multiple myeloma. Treatment by localized radiotherapy is not an exclusion criterion if an interval of at least two weeks between the end of radiotherapy and initiation of protocol therapy entry in the study is observed. Similarly, the dose of corticosteroids received by the participant should not exceed the equivalent of 160 mg of dexamethasone over a two-week period before initiation of protocol therapy. * Primary amyloidosis (AL) or myeloma complicated by amylosis. * Participants may not be receiving any other study investigational agents. * Participants with known brain metastases * Poor tolerability or known allergy to any of the study drugs or compounds of similar chemical or biologic composition to study agents * Platelet count < 50,000/mm3 per µLwithin 21 days of initiation of protocol therapy. Transfusion within 7 days of screening is not allowed to meet platelet eligibility criteria. * ANC < 1,000 cells/mm3 within 21 days of initiation of protocol therapy. Growth factor within 7 days of screening is not allowed to meet ANC eligibility criteria. * Hemoglobin < 8.0 g/dL within 21 days of initiation of protocol therapy. Transfusion may be used to meet hemoglobin eligibility criteria. * Hepatic impairment, defined a bilirubin > 1.5 x institutional upper limit of normal (ULN) > 2 mg/dL (Patients with benign hyperbilirubinemia (e.g., Gilbert's syndrome) are eligible) and or AST (SGOT), or ALT (SGPT), or alkaline phosphatase > 2 x ULN * Renal insufficiency, defined as serum creatinine > 2.5 mg/dl and/or creatinine clearance < <40 60 ml/min (actual or calculated). The Cockgroft-Gault formula should be used for calculating creatinine clearance values, and may be located in Section 4.2 * Respiratory compromise, defined as ventilation tests and with DLCO < 50% * Participant must not demonstrate with clinical signs of heart or coronary failure, or evidence of LVEF < 40%. Participant must not have with myocardial infarction within 6 months prior to enrollment or have New York Heart Association (NYHA Appendix VII) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant. * Intercurrent illness including, but not limited to ongoing or active severe infection, known (active or not) infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements. * Participant with previous history of another malignant condition, except for basal cell carcinoma and stage I cervical cancer * Female participant who is pregnant or breast-feeding * Inability to comply with an anti-thrombotic treatment regimen * Peripheral neuropathy >= Grade 2 peripheral neuropathy on clinical examination within 21 days of initiation of protocol therapy * Mental illness likely to interfere with participation in the study and Adults under juridical protection

Study Objectives The primary objective of this study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. This study will also include assessment of response in untreated bystander lesions following intralesional injection of PV-10 into targeted lesions. Additional objectives are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection. Conditions: Melanoma Intervention / Treatment: DRUG: PV-10 (10% rose bengal disodium) Location: United States, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Men or women, age >= 18 years. * Histologically or cytologically confirmed metastatic melanoma, AJCC (2002) Stage III (regional lymph node metastasis, in-transit metastasis or satellite metastasis) or Stage IV (distant metastasis). * Measurable disease in at least one lesion >= 0.2 cm in diameter that can be accurately measured by ruler/caliper or ultrasound. Target, Non-Target and Bystander Lesions selected by discretion of Investigator. * Performance Status: ECOG 0-2. * Life Expectancy: At least 6 months. * Hematopoietic: * White blood cell count (WBC) no less than 2500/mm3 (2.5 x 10E9/L). * Absolute neutrophil count (ANC) no less than 1,000/mm3 (1.0 x 10E9/L). * Platelet count no less than 90,000/mm3 (90 x 10E9/L). * Blood Chemistry: * Creatinine no greater than 1.5 times the upper limit of normal (ULN). * Total bilirubin no greater than 1.5 times the upper limit of normal (ULN). * AST/ALT no greater than 3 times the upper limit of normal (ULN). * Thyroid Function: * Total T3 or free T3 (serum triiodothyronine), total T4 or free T4 (serum thyroxine) and THS (serum thyrotropin) within normal limits. * Cardiovascular Function: * No clinically significant cardiovascular disease. * Respiratory Function: * No clinically significant respiratory disease. * Immunological Function: * No known immunodeficiency disease. Subjects must have adequate immune system function in the opinion of the Investigator. Exclusion Criteria: * Radiation therapy within 4 weeks of study treatment or to any Study Lesion within 12 weeks of study treatment. * Chemotherapy: * Chemotherapy or other systemic cancer therapy within 4 weeks of study treatment (6 weeks for nitrosoureas or mitomycin). * Regional chemotherapy (limb infusion or perfusion) within 12 weeks of study treatment. * Local treatment (e.g., surgery, cryotherapy, radiofrequency ablation) to the treatment area within 4 weeks of study treatment. * Investigational agents within 4 weeks (or 5 half-lives) of study treatment. * Photosensitizing agents within 5 half-lives of study treatment. * Anti-tumor vaccine therapy within 6 weeks of study treatment. * Concurrent or Intercurrent Illness: * Severe diabetes. * Extremity complications due to diabetes. * Significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise their safety or compliance or interfere with interpretation of study results. * Thyroid disease (subclinical or ongoing), goiter, partial thyroidectomy, previous radioiodine- or surgically-treated Graves' hyperthyroidism or cystic fibrosis, or taking thyroid hormone medication. * Pregnancy: * Female subjects who are pregnant or lactating. * Female subjects who have positive serum ßHCG pregnancy test taken within 7 days of PV-10 treatment. * Fertile subjects who are not using effective contraception.

Study Objectives The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma Conditions: Diffuse Large B-Cell Lymphoma Intervention / Treatment: DRUG: rituximab, DRUG: vinorelbine, DRUG: ifosfamide, DRUG: Mitoxantrone, DRUG: Prednisone Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Both genders, between 18 and 75 years old * CD 20+ large cell lymphoma * In first relapse * No previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation * Ann Arbor stage I, II, III ou IV * ECOG 0,1 or 2 * Signed informed consent Exclusion Criteria: * age: before 18 and more than 75 years old * other type of lymphoma * Informed consent not signed

Study Objectives To study the tolerance and toxicity of the combination of tumor necrosis factor (TNF) and interferon gamma (IFN-G) or as single agent TNF or IFN-G in HIV infected patients. To selectively monitor the immune system of AIDS related complex (ARC) patients who receive either combination therapy or TNF or IFN-G alone. To obtain information on the effectiveness of combination therapy or TNF or IFN-G alone against HIV in ARC patients. Recombinant TNF and recombinant IFN-G have been shown to be effective against the virus which causes AIDS and ARC in some laboratory studies, but may increase virus replication in other laboratory studies. Previous studies in humans showed no increase in virus cultures and some decrease in measurements of virus. Extensive preclinical data show that TNF and IFN-G are more effective together than separately in laboratory and animal studies. As single agents, both TNF and IFN-G have modest effect against HIV. Studies have demonstrated that TNF and IFN-G, in combination, can not only inhibit HIV infection of previously uninfected cells, but also can selectively induce the destruction of acutely infected target cells. Conditions: HIV Infections Intervention / Treatment: DRUG: Tumor Necrosis Factor, DRUG: Interferon gamma-1b Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Masking: DOUBLE

Inclusion Criteria Patients who have a primary diagnosis of AIDS related complex (ARC) including lymphadenopathy syndrome (LAS), who are positive for HIV antibody, have a minimum life expectancy of 3 months, and have one or more of the following symptoms for = or > 30 days: * Fever. * Night sweats. * Fatigue. * Oral thrush. * Hairy leukoplakia. * Diarrhea. * Weight loss < 10 percent. * Patients must be able to sign a written informed consent form, which must be obtained prior to treatment. Concurrent Medication: Allowed: * Acetaminophen for temperature rise of > 38.5 degrees C - 650 mg by mouth every 4 hours on an as needed basis. Severe rigors may be treated (or prevented) with meperidine 50 mg IV on an as needed basis in the absence of systolic hypotension < 80 mm Hg. * Exclusion Criteria Co-existing Condition: Patients with the following are excluded: * Clinically significant cardiac disease - New York Heart Association Class II, III, or IV. * Hemorrhagic diathesis (including hemophilia) or active bleeding disorder (e.g., genitourinary, gastrointestinal). * Clinically apparent vascular disease (including a prior history of pulmonary embolus, deep venous thrombosis, or peripheral arterial occlusive disease). Concurrent Medication: Excluded: * Medications required for the treatment of active cardiac disease including cardiac glycosides, antiarrhythmics and antianginal agents. * Anticoagulants. * Thrombolytic agents. * Nonsteroidal anti-inflammatory drugs. * Ongoing therapy with vasodilators. * Aspirin. * Corticosteroids. * Antihistamines. * Barbiturates. * Excluded within 4 weeks of study entry: * Antiviral chemotherapy. * Immunotherapy. * Excluded within 12 weeks of study entry: * Suramin. Patients with the following are excluded: * AIDS-associated opportunistic infection. * Lipoprotein disorders. * Hemophilia. Prior Medication: Excluded: * Interferon gamma. * Tumor necrosis factor.

Study Objectives You are invited to participate in a research study to develop new ways to look for abnormal areas/tissues of the esophagus. The current endoscopes used to look at the esophagus are very good, but if the area doesn't look different to the naked eye, then the endoscope can't improve on that. The investigators are looking at using special fluorescent stains in addition to special endoscopes designed to see abnormal areas that are not obvious to the naked eye. Currently specialized microscopes and fluorescent stains are used in clinical laboratories but it takes several days of processing to get results. It may be very helpful to look for areas to sample for abnormal tissue during the endoscopy procedure. You are being asked to let us use "fluorescent peptides" with a special endoscope that allow us to "see" your esophagus with both fluorescent and white light during your upper GI endoscopy procedure to help target your biopsies. Peptides are small chains of amino acids (the building blocks that make up proteins) linked together. Our peptide is a chain of 7 amino acids attached to a fluorescent dye called FITC (like the one used by your eye doctor). The investigators have prepared special "fluorescent peptides", that will "glow" when a special light is used that should help us separate normal tissue from abnormal tissue. In this study, the investigators will apply the special fluorescent peptides by a spray catheter to your esophagus to help us target you biopsies. Both routine and targeted biopsies will be taken as your endoscopist feels is indicated. This is a phase 1b study. This means that although the investigators have applied the peptide to 25 people in our first research study, the investigators still need to learn more about "fluorescent peptide" in people. The Food and Drug Administration (FDA) has not approved this agent, but is allowing us to test it in this study. The main goal of this study is to see if the peptide "glows" well and if the investigators can take pictures of the areas that do glow. This is a research study of the peptide and our ability to see it "light up or fluoresce". Being in this study and applying this peptide won't change how your biopsies are taken nor how your endoscopy is done. Conditions: Barrett's Esophagus Intervention / Treatment: DRUG: GI heptapeptide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects with Barrett's Esophagus or esophageal adenocarcinoma with or without confirmed Barrett's Esophagus * Subjects who are scheduled for a clinically-indicated upper endoscopic evaluation and/or intervention (e.g. esophagogastroduodenoscopy (EGD) with biopsies) * All subjects who are medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) who meet the inclusion/exclusion will be included. Standard practice guidelines for safely proceeding with the procedure will be sufficient for our study * Adults aged 18 years to 100 * Willing and able to sign informed consent Exclusion Criteria: * Subjects with known allergy or negative reaction to fluorescein or derivatives * Subjects who have had an esophagectomy * Subjects who are also prepped for colonoscopy with the EGD * Subjects on active chemotherapy or radiation treatment

Study Objectives Breast carcinoma is the most frequent cancer in women, affecting an estimated 207,090 in 2010 leading to 39,840 cancer related deaths. Fludeoxyglucose F 18 Injection (FDG) Positron Emission Tomography, (PET) or PET-CT has become the a standard method for isolating the tumor. However, FDG is insensitive in small breast tumors and certain histologic types such as lobular, certain types of breast carcinoma. In addition, FDG uptake can be nonspecific since inflammatory some benign lesions may also evidence have accumulation of this radiotracer. Hence there is a need for a tracer/imaging tool that increases the ability to characterize detect breast carcinoma and to detect locoregional spread, as well as monitor therapeutic treatment response. anti-3-\[18F\]. anti-1-amino-3-\[18F\]fluorocyclobutyl-1-carboxylic acid (FACBC) is an amino acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell culture experiments,FACBC has shown uptake in the breast tumor cell line. The primary aim of this study is to determine if FACBC PET-CT demonstrates uptake within breast carcinoma (primary site and/or locoregional lymph nodes) and to study uptake kinetics via time-activity curves from dynamic imaging characteristics. The investigators will enroll 12 patients who have a breast mass or masses and/or lymph nodes naïve to therapy about to undergo biopsy or post-biopsy pre-therapy. All patients will undergo standard of care imaging as appropriate such as mammography, ultrasound, MR, and/or FDG PET-CT scanning. The investigators will then compare findings to determine if this radiotracer is worthy of further study in a more comprehensive experiment. Conditions: Breast Cancer Intervention / Treatment: DRUG: FACBC Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must be 18 years of age or older. * Patients will have a breast mass and/or lymph nodes naïve to therapy about to undergo biopsy or post-biopsy pre-therapy. Patients with known or suspected recurrent disease will be eligible for this protocol. * Ability to lie still for PET scanning * Patients must be able to provide written informed consent Exclusion Criteria: * Age less than 18. * Inability to lie still for PET scanning. * Cannot provide written informed consent. * Current therapy for breast carcinoma. * Positive serum or urine pregnancy test within 24 hours of study.

Study Objectives This is a pain survey study that will compare the level of discomfort experienced by breast cancer patients after injection of either technetium-labeled sulfur colloid or technetium-labeled tilmanocept, both FDA-approved agents used for sentinel lymph node biopsy (SLNB). Breast cancer patients who are already scheduled for SLNB as part of their original surgical plan will be asked to participate in this study and be randomized to receive either technetium-labeled sulfur colloid or technetium-labeled tilmanocept. After injection, patients will complete pain questionnaires to measure the amount of discomfort they are feeling during and after they receive the injection. There will be no change to the patient's treatment plan other than the addition of pain questionnaires. The investigators' hypothesis is that patients will feel less discomfort after injection of tilmanocept versus sulfur colloid. Conditions: Breast Cancer Intervention / Treatment: DRUG: Tilmanocept, DRUG: Sulfur Colloid Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * The patient has a diagnosis of biopsy-proven primary breast cancer or a diagnosis of pure ductal carcinoma in situ (DCIS) who will be undergoing intraoperative lymphatic mapping as part of their standard surgical plan. * The patient has provided written informed consent before participating in the study, as has his/her responsible caregiver, if applicable. * The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan. * The patient is greater than 18 years of age at the time of consent. * The patient has an performance status of Grade 0 - 2. * The patient has a clinical negative node status at the time of study entry. * If the patients is of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of radiopharmaceutical, has been surgically sterilized, or has been postmenopausal for at least 1 year. Exclusion Criteria: * The patient is pregnant or lactating. * The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes

Study Objectives The combination of paclitaxel and carboplatin in a three weeks schedule has emerged as the current standard approach for the adjuvant treatment of ovarian cancer. Based on a phase I study now a multi-center phase II-trial was conducted. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Paclitaxel, DRUG: Carboplatin Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * histologically-confirmed epithelial ovarian cancer of FIGO stage IIB - IV * life expectancy of more than three months * ECOG performance status less than 3 * laboratory parameters within the normal range, including a glomerular filtration rate (GFR) greater than 60 ml/min, serum creatinine levels below 1.6 mg/dl, liver transaminases less than two times the normal levels, bilirubin concentrations below 1.5 mg/dl, adequate bone marrow function as indicated by a neutrophil count greater than 1,500/µl, and a platelet count greater than 100,000/µl. * written informed consent Exclusion Criteria: * suffering from secondary malignancy or underlying serious, uncontrolled concurrent medical or psychiatric disease * radiotherapy within 4 weeks for study entry

Study Objectives This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer. Conditions: Non-Small-Cell Lung Carcinoma Intervention / Treatment: DRUG: Gefitinib, DRUG: Vinorelbine Location: Germany, Czech Republic, Korea, Republic of, Italy, Brazil, United Kingdom, Australia, Taiwan, South Africa, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed NSCLC and willing to provide paraffin embedded tumour tissue * NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy chemonaïve, life expectancy of 12 weeks * WHO Performance status <= 2 Exclusion Criteria: * Newly diagnosed CNS metastases * Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity. * Hypersensitivity to ZD1839 or intravenous vinorelbine * Prior treatment with EGFR inhibitors * Other co-existing malignancies * ALT/AST >2.5 x ULRR * ANC < 2.0 x 10^9/L or platelets < 100 x 10^9/L

Study Objectives This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with a targeted agent such as gefitinib, erlotinib and icotinib. Conditions: Stage IV Non-small Cell Lung Cancer Intervention / Treatment: RADIATION: SBRT+TKI, DRUG: TKI Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must have biopsy proven metastatic NSCLC (Stage IV). * Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response. * Patients receiving first-line erlotinib, gefitinib, or icotinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response or completely response. * Age 18 to 75 years old. * Patients must have measurable disease at baseline. * The amount of metastatic focus <5. * ECOG score 0-2 * Adequate normal organ and marrow function for TKI treatment and radiotherapy. * Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R) * Patients must provide written informed consent to participate in the study. Exclusion Criteria: * Patients who previously received radiotherapy to the primary site. * Patient can't tolerate radiotherapy or targeted therapy; * Pregnant or nursing women

Study Objectives This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases. Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: PF-04449913, DRUG: Low dose ARA-C (LDAC), DRUG: PF-04449913, DRUG: Decitabine, DRUG: PF-04449913, DRUG: Daunorubicin, DRUG: Cytarabine, DRUG: PF-04449913, DRUG: Daunorubicin, DRUG: Cytarabine, DRUG: PF-04449913, DRUG: Low dose ARA-C (LDAC) Location: Germany, Canada, Italy, Spain, United States, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Masking: NONE

Inclusion Criteria: * Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the WHO 2008 Classification and previously untreated. * Patients with AML (arising from an antecedent hematologic disease [AHD]) or MDS who may have had one prior regimen with commercially available agents for the treatment of their prior hematologic disease. The patients may not have had a prior therapy for their AML. * AML patients include de novo AML, AML evolving from MDS or other AHD and AML after previous cytotoxic therapy or radiation (secondary AML) * For a diagnosis of AML, a bone marrow blast count of 20% or more is required. * For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have 10-19% bone marrow blasts * Adequate Organ Function * ECOG Performance Status 0, 1, or 2 Exclusion Criteria: * AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic translocation. * Patients with known active uncontrolled central nervous system (CNS) leukemia.

Study Objectives The purpose of this study is to compare the drug gemcitabine to two drugs, gemcitabine and docetaxel, to find out which treatment is better for people with sarcomas. Conditions: Sarcoma, Soft Tissue Intervention / Treatment: DRUG: Gemcitabine, DRUG: Docetaxel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically proven soft tissue sarcoma (except the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's Sarcoma, mesotheliomas * Age >= 10 years * Recurrent or progressive disease defined as an increase in size of any existing tumor mass, or the development of new tumor mass or masses, which is not amenable to definitive surgical therapy. * Patients may have had another cancer but there must be convincing clinical evidence that the sarcoma is the disease requiring therapeutic intervention. (ie. Several sarcoma patients have had had a prior cancer (Hodgkin's disease or breast cancer) treated years previously and then developed a clinically active sarcoma.) * Patients may have failed no more than 3 prior chemotherapy regimens. * Measurable disease as defined by RECIST. Measurable disease is the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. A measurable lesion is one that can be accurately measured in at least one dimension with longest diameter >20 mm using conventional techniques or >10 mm with spiral CT scan. * Karnofsky performance status of greater than or equal to 60% * Peripheral neuropathy, if present, must be < or = to grade 1 * At least 3 weeks since prior chemotherapy (10 days if the patient was on imatinib, thalidomide, or an interferon) * At least 3 weeks since prior radiation therapy * Absolute neutrophil count > 1,500/mm3 * Hemoglobin > 8.0 g/dl * Platelet count > 100,000/mm3 * Total Bilirubin < upper limit of normal (ULN). * ALT (SGOT) or AST (SGPT) <5 x ULN. * Alkaline Phosphatase < 2.5 x ULN. * Serum creatinine < or equal to 2.0 mg/dL * Women of child-bearing potential must have a negative serum pregnancy test * Men and women of child-bearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter (approximately 3 months) * If the patient is >= 18 years, the patient must be capable of providing written, informed consent. If the patient is younger than 18, written and voluntary informed consent from patient's parents or legal guardians and the patient's assent are required. Exclusion Criteria: * Soft tissue sarcomas with the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's sarcoma, mesotheliomas * Active or uncontrolled infection (on antibiotic therapy for acute or chronic infection) * Prior treatment with gemcitabine or docetaxel * Peripheral neuropathy > or = grade 2 * History of known hypersensitivity reaction to agents formulated in polysorbate 80, the solubilizing agent for docetaxel [e.g. interferon alpha-2a, children's ibuprofen suspension (Advil), terconazole (Terazol), lamivudine (Epivir), etoposide, amiodarone, vaccines (DtaP, influenza), bupropion (Wellbutrin), Vitamins B12, C+zinc+selenium]. * Uncontrolled, central nervous system metastases

Study Objectives The dose-confirming part of this study, comprising at least 10 patients is designed as a single center, prospective, single arm, open label in patients who have failed or are unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with at least 44 patients; the objective of the whole study being to assess the safety, efficacy, pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in low and intermediate-1 risk myelodysplastic syndrome (second and third line Lower risk MDS). Conditions: Myelodysplastic Syndrome Intervention / Treatment: DRUG: OPN-305 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: * Written informed consent * Age >= 18 years * Diagnosis of MDS (de novo or secondary) by bone marrow aspirate based on the World Health Organization (WHO) classification - Low and Intermediate-1 risk categories MDS using the IPSS (International Prognostic Scoring System) * AZA/decitabine (this applies to standard of care and investigational drugs) failure (Dose confirming and Dose expansion parts): * defined as discontinuation due to any of the following: * Lack of response after at least 4 cycles * Loss of response (patient must have received therapy for at least 4 cycles) * Progressive disease * Adverse events Note: Patients are eligible if additionally they have failed an ESA * HMA Naïve group: * Never received a hypomethylating agent for MDS * Failed or ceased to respond to ESA(s) * ESA ineligible; defined as endogenous serum erythropoietin level > 200 U/L for subjects not previously treated with ESAs * Red blood cell transfusion dependent defined as >= 2 Red blood cells (RBC) units required in the 8 weeks prior to starting in the study. In addition, there should be no 8 consecutive weeks without red blood cell transfusions in the 16 weeks prior to enrolment. * Life expectancy >= 3 months * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-2 * Serum bilirubin levels <=2 x upper limits of normal (ULN) * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels <=2.5 x ULN * Del 5q patients who have failed or are not eligible for Revlimid * Creatinine clearance >30 ml/min calculated by the Cockcroft-Gault formula * Willingness to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations * Negative urine β-human chorionic gonadotropin (β-HCG) pregnancy test for fertile women at screening and confirmed by serum pregnancy test in the 48 hours prior to OPN-305 administration * If sexually active female, patient must be/have one of the following: * Post-menopausal defined as the absence of menses for at least one year (serum Follicle-stimulating hormone (FSH) >=20IU/L can also be measured according to local practice),OR * Surgically sterile defined as a bilateral tubal ligation at least 6 months prior to administration of study drug, bilateral oophorectomy, or complete hysterectomy, OR * Using an effective means of contraception that is planned to continue for the duration of treatment and for a further 3 months. * If sexually active male, patient must: Agree to use an effective means of contraception (per site-specific guidelines) that is planned to continue until 6 months after the last dose of OPN-305.Agree not to donate sperm until 6 months after the last dose of OPN-305 Exclusion Criteria: * Diagnosis of MDS by bone marrow aspirate of Intermediate-2 and High risk category MDS based on the World Health Organization (WHO) classification using the IPSS (International Prognostic Scoring System) * Patients with 5q deletion (del) MDS eligible for Revlimid (lenalidomide) * Hypomethylating agent (HMA) Naïve group: * Have received a hypomethylating agent for MDS * Have not failed or ceased to respond to an ESA * Are not ESA ineligible as defined in inclusion criteria * Prior history of acute leukemia or AML * Unable/unwilling to undergo bone marrow sampling * Prior history of bone marrow transplantation * Prior malignancy (other than non-invasive malignancy including in situ cervical cancer, Bowen's disease, basal cell cancer of the skin and non-invasive or excised skin squamous cell carcinoma) unless treated with curative intent and without evidence of disease for 3 years before randomization * Active viral or bacterial infections: this includes any infections that are being actively treated even if the signs and symptoms appear to have resolved. Courses of antibiotics or anti-viral treatment should be completed before the patients is enrolled * Unstable angina, congestive heart failure [NYHA (New York Heart Association) >class II], uncontrolled hypertension [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction, uncontrolled diabetes mellitus * Clinical Evidence of Central Nervous System (CNS) disease * Less than 4 weeks since any therapy for MDS * Prior history of anaphylaxis to similar products * History or presence of a medical condition or disease or substance abuse that in the investigator's assessment would place the patient at an unacceptable risk for study participation * Lactating or pregnant woman

Study Objectives Efficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in Germany. Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. Conditions: Soft Tissue Sarcoma Intervention / Treatment: DRUG: trabectedin Location: Germany Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients must comply with all of the following criteria in order to be enrolled into the study: * Histologically diagnosed advanced STS * Female or male aged 18 years or above * Signed written informed consent * Suitable to undergo treatment with trabectedin according to SmPC * Progress after therapy with anthracyclines and ifosfamide has failed, or if patients are unsuited to receive these agents Exclusion Criteria: * Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.

Study Objectives Sodium zirconium cyclosilicate (SZC) has been demonstrated for its serum potassium-lowering efficacy and safety in hyperkalemia hemodialysis patients. However, the effects of SZC during the perioperative period remained unknown. This experiment aimed to determine whether using SZC would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (PTX). Conditions: Sodium Zirconium Cyclosilicate, Hyperkalemia, Hyperparathyroidism, Secondary Intervention / Treatment: DRUG: Sodium zirconium cyclosilicate Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Secondary Hyperparathyroidism (SHPT) is a common and severe manifestation of chronic kidney disease (CKD), especially in end-stage renal disease (ESRD) patients. ESRD MHD with SHPT patients were recruited into this study Exclusion Criteria: * Patients with severe cardiovascular disease who cannot tolerate general anesthesia surgery were not included in this study.

Study Objectives GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of trastuzumab, and within the SC by the administration through the vial or device self-administration in patients with disseminated breast cancer HER2. Conditions: Breast Cancer Intervention / Treatment: DRUG: Trastuzumab Injectable Solution, DRUG: Trastuzumab Injectable Product, DRUG: Trastuzumab Injection Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Woman, 18 years old or upper. * Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are: 1. immuno-histochemistry (IHC) 3+ (>10% of tumor cells with complete and intense membrane staining) 2. IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (*) 3. FISH / CISH / SISH + for HER 2 amplification (*) (*) Defined as the ratio of copies of HER 2/neu and copies of centromere of chromosome 17 (CEP17)> 2.2, or a number of copies of HER 2/neu> 6, as per local laboratory criteria. * Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months. * No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months. * Adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2. * Adequate bone marrow function, liver and kidney * Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA). * The patient must have been informed of the study and must sign and date informed consent document for entry into the trial. * The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires. Exclusion Criteria: * Patients with no advanced breast cancer. * Breast cancer patients with tumors HER 2-negative. * The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 5 years without evidence of disease could be included. * The patient has uncontrolled brain metastases. * Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment. * Known hypersensitivity to trastuzumab or to any of its components. * Patients with severe dyspnea at rest or requiring supplemental oxygen. * Heart disease or serious medical pathological prevent trastuzumab administration: documented history of congestive cardiac insufficiency (CCI), high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled. * Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator). * The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment.

Study Objectives MEK113583 is a Phase II open-label, multi-site study to investigate the objective response rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent and highly selective inhibitor of MEK activation and kinase activity. Conditions: Cancer Intervention / Treatment: DRUG: GSK1120212 Location: United States, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Metastatic cutaneous melanoma that was previously treated with: (Cohort A) a BRAF inhibitor either with or without other prior therapy. (Cohort B) at least 1 prior chemotherapy or immunotherapy, without treatment with a BRAF inhibitor. * Documented positive BRAF mutation (V600E, V600K, or V600D). * Subjects must provide archived tumor tissue or undergo fresh tumor biopsy prior to enrollment. * The subject must have a radiographically measurable tumor. * The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1). * Able to swallow and retain oral medication. * Sexually active subjects must use acceptable methods of contraception during the course of the study. * Adequate organ system function and blood cell counts. Exclusion Criteria: * The subject has had major surgery or received certain types of cancer therapy within 21 days before starting the study. * Previous treatment with a MEK inhibitor. * Current use of a prohibited medication listed in the protocol. * Uncontrolled glaucoma. * Brain metastasis, unless previously treated with surgery or stereotactic radiosurgery, and the disease has been stable for at least 2 months prior to enrollment. * Current severe or uncontrolled systemic disease. * History of clinically significant heart, lung, or eye/vision problems. * Significant unresolved side effects from previous anti-cancer therapy. * The subject is pregnant or breastfeeding.

Study Objectives RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) scan and computated tomography (CT) scan, may help doctors predict a patient's response to treatment and may help plan the best treatment. Drugs used in chemotherapy, such as doxorubicin and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying how well PET scan combined with CT scan predicts response in patients undergoing chemotherapy and surgery for soft tissue sarcoma. Conditions: Sarcoma Intervention / Treatment: BIOLOGICAL: pegfilgrastim, DRUG: doxorubicin hydrochloride, DRUG: ifosfamide, DRUG: pegylated liposomal doxorubicin hydrochloride, PROCEDURE: conventional surgery, RADIATION: fludeoxyglucose F 18 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically confirmed, high grade, soft tissue sarcoma including * malignant fibrous histiocytoma, * liposarcoma, * fibrosarcoma, * leiomyosarcoma, * synovial carcinoma, * malignant peripheral nerve sheath tumor (MPNST), * epithelioid sarcoma, and * sarcomas-not otherwise specified. NOTE: Ewings sarcoma, primitive neuroectodermal tumor, extraskeletal, osteosarcoma, extraskeletal chondrosarcoma, alveolar soft part sarcoma, rhabdomyosarcoma, carcinosarcoma, Kaposi's sarcoma, angiosarcoma, and mesothelioma patients are ineligible for this study. * Measurable disease using traditional cross section measurements with the primary site's largest diameter > 5 centimeters by positron emission tomography/computated tomography (PET/CT), CT or magnetic resonance imaging (MRI) scan. Patients with either localized (primary or locally recurrent) or metastatic disease at presentation are eligible for study if they are to receive neoadjuvant treatment prior to excision of the primary (stage IIC, III, IVA, IVB.) * Age >= 16 years, Karnofsky >= 70% * Adequate organ function for receiving chemotherapy as determined by the treating physician. * Women of childbearing potential and sexually active males are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study. Exclusion Criteria: * Previous treatment with chemotherapy or radiation therapy * Females known to be pregnant or breast-feeding are excluded because PET/CT scan in pregnant women is not FDA approved. * Serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study. Patients with PET-CT as an indicator of disease survival in soft tissue sarcoma untreated or symptomatic CNS metastases or uncontrolled diabetes will not be eligible. Patient must give written informed consent indicating the investigational nature of the study and its potential risks.

Study Objectives This randomized pilot clinical trial studies sildenafil citrate before surgery in improving kidney function in patients with kidney cancer. Sildenafil citrate may help protect the kidney from the side effects of surgery and improve kidney function after surgery. Conditions: Kidney Tumor Intervention / Treatment: DRUG: sildenafil citrate, OTHER: placebo, PROCEDURE: therapeutic conventional surgery Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients who are scheduled to undergo robotic partial nephrectomy for suspected renal malignancy * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients with a history of coronary artery disease (including history of myocardial infarction or cardiac stents) or a history of inducible ischemic changes on any prior cardiac stress testing * History of adverse reactions to any phosphodiesterase (PDE) inhibitor (PDE type 5 inhibitor [PDE5i]) * Any patient currently taking a PDE5i will be asked to refrain from use for one week prior to their surgery; patients who have used a PDE5i within 72 hours of surgery will be excluded * Pregnant women are excluded from this study * Patients with only one kidney

Study Objectives Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data \[PMA P020016\] Conditions: Arthroplasty Intervention / Treatment: DEVICE: Biomet TMJ Replacement System Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients requiring total joint reconstruction due to: Arthritis (osteoarthritis, rheumatoid, traumatic) malignancy Ankylosis functional deformity Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints * Patients who are skeletally mature. * Patients must have at least one of the following criteria for surgical TMJ treatment. 1. Presence of considerable pain and/or limited function in the joint area. 2. Clinical and imaging evidence consistent with anatomic joint pathology 3. Previous failure of non-surgical treatment/therapy or a failed implant. 4. High probability of patient improvement by surgical treatment. * Patients must be able to return for follow-up examinations. * Patients without serious compromising general medical conditions. Exclusion Criteria: * Patients with active infection. * Patient conditions where there is insufficient quantity or quality of bone to support the device * Patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component. * Patients with mandibular and/or zygomatic arch screw holes compromising component fixation * Patients requiring partial joint reconstruction or other TMJ procedures not listed as an indication. * Patients who are NOT skeletally mature. * Patients who are incapable or unwilling to follow postoperative care instructions. * Patients who are unable to return for follow-up examinations. * Patients with severe hyper-functional habits * Patients on chronic steroid therapy.

Study Objectives Poor health, and its treatment, has impact beyond the healthcare system into wider society. A person's productivity, taxable earnings, benefit payments and community contribution may all be adversely affected by poor health. Family members living with or caring for a patient may suffer equally, or sometimes more than the patient themselves, but this familial burden has gone largely unrecognised by healthcare systems. The Family-Reported Outcome Measure (FROM-16) is the first generic questionnaire designed to measure the impact of any chronic disease on the quality of life of family members or partners of patients with a health condition. Advance Therapy Medicinal Products (ATMPs) are a novel \& ground-breaking therapeutic approach for curative treatment of disease and/or injury where conventional treatments have been ineffective. Such disease/injury generally has an extremely high impact on the patient's quality of life, and also the quality of life of the patient's family, in particular those family members who take on the role of 'informal carer'. ATMPs usually have very high costs and this can limit their usage, especially in the context of low prevalence disease and publicly-funded healthcare systems, where healthcare providers may be reluctant to take on the cost burden of the ATMP therapy. As a result, there is a particular focus on the 'value' of ATMPs. An important component of value is 'Societal Value', where a treatment leads to societal contributions, and considering Societal Value may justify the high cost of ATMPs despite the relatively few patients cured. In this study, we will validate the FROM-16 for use as one measure of the Societal Value of very high cost, potentially curative treatments such as ATMPs. Conditions: Family Members, Cancer Intervention / Treatment: OTHER: FROM-16 Questionnaire, OTHER: Semi-structured two-part interview Location: United Kingdom Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: Patients: * Patients of any age * Ability to read English or Welsh (where age-appropriate). * Capacity to give written informed consent, or assent for their family member to participate * Attending ATMP treatment centre with a family member/carer. * Being considered for, or have recently received, ATMP therapy for any diagnosed condition. Family Members: * Considered by the patient to be the person most affected by the patient's condition * Adult family members aged >= 18 years. * A family member or partner, living with or caring for, a patient who is being prepared to receive ATMP treatment or has recently received ATMP therapy for any diagnosed condition. * Have capacity to give written informed consent and complete the interview and questionnaires. Exclusion Criteria: Patients: * Adult patients: Lacking capacity, or unwilling to give written informed consent for their family member to participate. * Gillick competent paediatric patients: unwilling to give written informed assent and/or consent for their family member to participate. * Non-Gillick competent paediatric patients: patient's parent/guardian refuses to give consent or is unable to give consent on their behalf. * Not being prepared for ATMP therapy, or is currently receiving ATMPs. Family Members: * Family members under 18 years of age. * Not considered by the patient to be a family member or carer. * Lacking capacity or willingness to give informed written consent to participate * Having a severe handicap or disability that prevents the completion of interview and questionnaires.

Study Objectives The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck. Conditions: Squamous Cell Carcinoma, Carcinoma of Head and/or Neck Intervention / Treatment: DRUG: Taxotere, DRUG: Cisplatin, DRUG: 5-Fluorouracil, DRUG: Leucovorin 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: * Histologic documentation of squamous cell carcinoma of head and neck * Patients will previously untreated stage III or IV squamous cell carcinoma. * Patients with locally recurrent disease after surgery. * Life expectancy of longer than 3 months. * Kidney function: 1.5 or a 24 hour creatinine clearance of > 30ml/min * Liver function: SGOT < 1.5 X upper normal limit and alkaline phosphatase of < 2.5 X upper normal limit. * WBC greater than or equal to 4,000/mm * Platelet count greater than or equal to 100,000/mm * Hemoglobin greater than or equal to 10gm/dl * Patients of child-bearing age must use effective methods of contraception. Exclusion Criteria: * Patients treated with previous chemotherapy or radiotherapy for head and neck cancer. * Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix. * Pregnant or breast-feeding women

Study Objectives This phase III trial is studying how well combination chemotherapy works when given before radiation therapy and/or additional chemotherapy in treating young patients with newly diagnosed Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) and giving them together with radiation therapy may kill more cancer cells. Conditions: Childhood Favorable Prognosis Hodgkin Lymphoma, Childhood Lymphocyte Depletion Hodgkin Lymphoma, Childhood Mixed Cellularity Hodgkin Lymphoma, Childhood Nodular Sclerosis Hodgkin Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage II Childhood Hodgkin Lymphoma Intervention / Treatment: RADIATION: radiation therapy, DRUG: doxorubicin hydrochloride, DRUG: vincristine sulfate, DRUG: prednisone, DRUG: cyclophosphamide, DRUG: ifosfamide, DRUG: vinorelbine tartrate, DRUG: dexamethasone, DRUG: etoposide phosphate, DRUG: cisplatin, DRUG: cytarabine, BIOLOGICAL: filgrastim Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed Hodgkin's lymphoma meeting the following criteria: * Newly diagnosed disease * Stage IA OR stage IIA without bulky disease * No lymphocyte-predominant histology * Staging on this study will be determined by the clinical stage; surgical staging is strongly discouraged, except for the rare situation of equivocal imaging studies below the diaphragm * Patients may not have received any previous chemotherapy or radiation therapy; patients may not have received systemic corticosteroids within 30 days of enrollment on this protocol; steroids used for treatment of contrast agent allergy required for computed tomography (CT) scans are acceptable * Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^3 * Total bilirubin =< 1.5 x normal * Alanine (ALT) =< 2.5 x normal * Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by multi-gated acquisition (MUGA) * No pathologic prolongation of QTc interval on 12-lead electrocardiography (ECG) * Female patients of childbearing potential must have a negative pregnancy test * Lactating females must agree that they will not breastfeed a child while on this study * Fertile patients must use effective contraception * Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * 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

Study Objectives This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane. Conditions: Neoplasms, Breast Intervention / Treatment: DRUG: Tykerb Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients. * Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity. * Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control. Exclusion Criteria: * Patients with certain heart problems.

Study Objectives The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults. Conditions: Advanced Solid Tumor Intervention / Treatment: DRUG: Fluzoparib, DRUG: Omeprazole Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age 18 to 50 years (including both ends), male; * Male volunteers have a body weight >= 50.0 kg and a body mass index (BMI) between 19 and 28 kg/m2 (including both ends); * Male volunteers are willing to have no birth plans in the next 6 months and voluntarily take effective contraceptive measures; * Volunteers voluntarily sign written informed consent. Exclusion Criteria: * Previous or currently suffering from circulatory system (myocarditis, coronary heart disease, pathological arrhythmia, stroke, etc.), endocrine system, nervous system, digestive system (peptic ulcer, colitis, pancreatitis, etc.), respiratory system (Invasive lung disease, pneumonia, dyspnea, etc., urogenital system (chronic kidney disease, renal insufficiency, renal anemia), hematology, immunology, psychiatry and metabolic abnormalities, etc. Result of any other disease; * A history of allergies to drugs, foods or other substances; allergies, including a history of severe drug allergies or drug allergies; a history of allergies to Fluzoparib capsules or omeprazole magnesium enteric-coated tablets * Those who have undergone surgery within 4 weeks prior to the trial or who plan to undergo surgery during the study; * Those who have taken any drugs or health care products (including Chinese herbal medicines) within 14 days before the test; * Any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg, inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor - SSRI resistance) Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines; * Those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial; * Donate blood or massive blood loss (>=200 mL), receive blood transfusion or use blood products within 3 months before enrollment; * One or more non-pharmaceutical contraceptives cannot be used during the volunteer trial; * Those who have special requirements for diet and cannot follow the unified diet; * Drink excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day; * smokers or smokers with more than 5 cigarettes per day for the first 3 months of the trial or who cannot stop using any tobacco products during the trial period; * Alcoholics or those who regularly drink alcohol within 6 months prior to the test, ie drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or during the test period Stop using any alcoholic products; * Drug abusers or soft drugs (eg marijuana) 3 months prior to the trial or hard drugs (eg cocaine, phencyclidine, etc.) 1 year prior to the trial; and nicotinic positive volunteers * Abnormal vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg; pulse <50 bpm or >100 bpm) or physical examination, electrocardiogram, laboratory examination, imaging examination abnormalities Clinically significant (subject to the judgment of the clinical research doctor); * have a history of dysphagia or any history of gastrointestinal disease that affects drug absorption; * Those who have undergone any surgery within the first 6 months of screening; have previously undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, stomach reduction surgery, etc.); * The volunteer refused to discontinue any beverage containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any juice, 48 hours before the study drug was administered until the end of the study; * Creatinine clearance (CLCr) <80 mL/min, or creatinine above the upper limit of normal; * Volunteers may not be able to complete the study for other reasons or those the investigator believes should not be included.

Study Objectives The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML. Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: Lintuzumab (SGN-33), DRUG: Low dose cytarabine, DRUG: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder. * After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML. * At least 20% blasts in blood or marrow. * Must have a minimum of 50% leukemic blasts that express CD33. * ECOG performance status score of 0 to 2. * WBC less than 30,000/µL Exclusion Criteria: * No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia. * No other active systemic malignancies treated with chemotherapy within the last 12 months. * Must not have received previous chemotherapy (except hydroxyurea) for AML. * Must not have significantly abnormal kidney or liver disease. * Must not have known human immunodeficiency virus (HIV).