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Study Objectives One purpose of this study is to evaluate the effectiveness and safety in long term treatment for patients who completed preceding phase I/II study. The other purpose is to evaluate the effectiveness and safety of patients who are re-treated with this drug in recommended dose. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: bortezomib Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Complete 6 cycles treatment in preceding phase I/II study * response (CR, PR, MR or NC) was obtained in 6 cycles treatment during the preceding phase I/II study and investigator considers that the patient is expected to have benefit such as antitumor effect, pain relief or improvement of performance state * Patients who did not have Grade >=3 non-hematologic toxicity or Grade 4 hematologic toxicity during the preceding phase I/II study or extension treatment of this study * Investigator considers that the patient is expected to have benefit of this drug such as antitumor effect, pain relief or improvement of performance state. Exclusion Criteria: * Patient is known to be HBs antigen positive, HCV antibody positive or HIV antibody positive (check is required for patients who received blood product during phase I/II study) * Patients who receive G-CSF product or blood transfusion within 7 days before the start of treatment * Disease progress was observed during the phase I/II or this study when patients receive recommended dose * Patients who suffer Grade >=2 peripheral neuropathy or Grade >=2 neuropathic pain * Patient has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, acute ischemia or active conduction system abnormalities.

Study Objectives Multicenter, open-label, phase 1, cohort dose escalation study to determine the maximum tolerated dose (MTD) of 3 intermittent OSI-906 dosing schedules. Conditions: Advanced Solid Tumors Intervention / Treatment: DRUG: OSI-906 Location: United States, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists * Patients with Eastern Cooperative Oncology Group (ECOG) performance status <= 2 * Predicted life expectancy >= 12 weeks * Patients may have had prior therapy, providing the following conditions are met: * Chemotherapy: A minimum of 3 weeks (4 weeks for carboplatin or investigational anticancer agents and 6 weeks for nitrosoureas and mitomycin C) must have elapsed between the end of treatment and registration into this study. Prior tyrosine kinase inhibitor therapy is permitted. Patients must have recovered from any treatment-related toxicities (except for alopecia, fatigue, and grade 1 neurotoxicity) prior to registration * Hormonal therapy: Patients may have had prior anticancer hormonal therapy provided it is discontinued prior to registration into this study. However, patients with prostate cancer with evidence of progressive disease may continue on therapy that produces medical castration (eg, goserelin or leuprorelin), provided this therapy was commenced at least 3 months earlier * Radiation: Patients may have had prior radiation therapy provided they have recovered from the acute, toxic effects of radiotherapy prior to registration. A minimum of 21 days must have elapsed between the end of radiotherapy and registration into the study unless the radiotherapy was palliative and nonmyelosuppressive * Surgery: Previous surgery is permitted provided that wound healing has occurred prior to registration * Fasting glucose <= 125 mg/dL (7 mmol/L) at baseline * Potassium, calcium, and magnesium must be within normal limits (WNL). Electrolyte abnormalities will be permitted if they are not clinically significant and if treatment for the abnormality is initiated prior to Day 1 * Adequate hematopoietic, hepatic, and renal function defined as follows: * Neutrophil count >= 1.5 x 10^9/L and platelet count >= 100 x 10^9/L * Bilirubin <= 1.5 x ULN or <= 3 x ULN if patient has Gilbert's disease * AST and/or ALT <= 2.5 x ULN or <= 5 x UNL if patient has documented liver metastases * Serum creatinine <= 1.5 x ULN * Patients must be accessible for repeat dosing and follow-up, including pharmacokinetic sampling * Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures (ie, barrier methods, eg, condom or diaphragm, with spermicide) throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration * Patients must provide written informed consent to participate in the study Exclusion Criteria: * Documented history of diabetes mellitus * History of significant cardiac disease unless the disease is well-controlled. Significant cardiac diseases includes second/third degree heart block; significant ischemic heart disease; QTc interval > 450 msec at baseline; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA)Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea) * Any type of active seizure disorder * Concurrent anticancer therapy (with the exception of hormonal therapy as described above) * Use of drugs with a risk of causing QT interval prolongation within 14 days prior to Day 1 and while on study * Use of glucocorticoids within 14 days prior to Day 1 dosing and while on study, with the exception of hormone replacement therapy or inhalers * History of any kind of stroke * Previously diagnosed brain metastases (includes active brain metastases) * Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study * History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent * Pregnant or breast-feeding females * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug

Study Objectives The realization of this project will generate an important advance in knowledge regarding one of the most important comorbidities in cancer patients: malnutrition. Currently, comprehensive treatments of cancer patients recognize the importance of the assessment of nutritional status, and the impact it has on the prognosis, quality of life and toxicity generated by cancer treatment. Due to this, it is imperative to offer diagnostic tools that identify patients in a timely manner and, in addition to this, offer therapeutic strategies for the improvement of nutritional status, in an adjuvant manner to their oncological treatment. It is widely recognized that the cachexia-anorexia syndrome (CACS) is present in 30 to 80% of cases in cancer patients and this proportion increases as the disease progresses, with weight loss being a powerful predictor of shorter survival. Unfortunately, current therapies available to treat anorexia and / or cancer-associated cachexia offer only partial results, mainly because the intervention is late and the development of an earlier and more effective intervention is still sought. Mirtazapine has recently gained attention not only because of its antidepressant effect, but also because of its potential benefit in patients with anorexia and weight loss, recently reported in a phase II study. Therefore, it is important to continue its evaluation through a randomized, double-blind clinical trial in which the effect of mirtazapine is compared and it is determined if it is superior compared to placebo to increase appetite in patients with NSCLC who present with anorexia. This type of strategy is a relevant therapeutic option in those patients in whom nutritional counseling by itself is not sufficient to counteract the damage caused by anorexia and to cope with or prevent the development of cachexia. Conditions: Anorexia, Non-small Cell Lung Cancer Intervention / Treatment: DRUG: Mirtazapine, DRUG: Placebo Oral Tablet Location: Mexico Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Outpatients over 18 years of age who are receiving care in INCan with histopathological diagnosis of advanced stage non-small cell lung cancer (IIIB or IV). * A score <= 32 on the cachexia anorexia scale or >= 5% weight loss in the last month. * Good performance status (ECOG 0-2) * That they are receiving chemotherapy as standard treatment or tyrosine kinase inhibitors or immunotherapy. * Have a life expectancy> 8 weeks. * Accept and sign informed consent letter. Exclusion Criteria: * Known allergy to mirtazapine * Patients who are treated with antidepressants * Patients who are under treatment with megestrol acetate * Patients with moderate hepatic and / or renal dysfunction (bilirubin level >= 1.5 x above normal limits (UNL), AST and ALT >= 5 x UNL, or creatinine >=5 x UNL). * Those unable to take medication orally. * Patients with mechanical obstruction of the gastrointestinal tract, ascites or generalized edema. * Patients with a history of phenylketonuria (preparation contains phenylalanine). * Patients with delirium.

Study Objectives Primary Objective 1. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL). Secondary Objectives 1. To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL. 2. To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment. Conditions: Untreated Mantle Cell Lymphoma Intervention / Treatment: DRUG: Bevacizumab, DRUG: Rituximab, DRUG: CHOP Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profile: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-) * Patient has not received any prior anti-cancer therapy for lymphoma * Laboratory parameters (unless considered by investigator to be due to lymphoma): Absolute neutrophil count > 1000 cells/mm3 Platelet count > 50,000 cells/mm3 Hemoglobin > 7 gm/dL Creatinine < 2.0 x ULN Total bilirubin < 2.0 x ULN * Patient has at least one tumor mass > 1.5 cm in one dimension * Available tumor tissue for correlative studies (rebiopsy to be performed if needed) * Patient is > 18 years old * Patient has KPS > 50% * Patient has signed IRB-approved informed consent * Patient agrees to use birth control for duration of study Exclusion Criteria: * Known central nervous system (CNS) involvement by lymphoma * Known hepatitis infection * Known HIV positivity * Known history of renal disease with proteinuria; urine protein:creatinine ratio ³1.0 at screening * Uncontrolled hypertension: blood pressure of >150/100 mmHg at screening * Unstable angina * History of myocardial infarction within 6 months * History of stroke within 6 months * Clinically significant peripheral vascular disease * New York Heart Association (NYHA) Grade II or greater congestive heart failure * Patient has ejection fraction < 50% * Patient is taking coumadin, or has known history of thrombosis within last 6 months * Evidence of bleeding diathesis or coagulopathy * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study * Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1 * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1 * Serious, non-healing wound, ulcer, or bone fracture * Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * Patient is pregnant or nursing * Patient is receiving other investigational drugs

Study Objectives In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori. Conditions: Helicobacter Pylori Infection, Family History of Stomach Cancer Intervention / Treatment: DRUG: Standard triple therapy, DRUG: Bismuth quadruple therapy Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Men and women aged 18 or more including following conditions * Family history of gastric cancer * Post endoscopic resection status for early gastric cancer or adenoma * Peptic ulcer disease (benign gastric ulcer and duodenal ulcer) * Chronic gastritis * Non-ulcer dyspepsia * Healthy adults who want to receive H. pylori treatment * H. pylori positive by urea breath test, histology, or rapid urease test Exclusion Criteria: * History of H. pylori eradication therapy * History of stomach operation * Other organ cancer within 5 years * Liver cirrhosis or Hepatic insufficiency * Renal insufficiency * Current treatment for serious medical condition which may hinder participation * Contraindication or allergy history for H. pylori treatment regimens * Mental incompetence to understand and sign informed consent * Incompatible conditions to be included into the trial by investigators' decision * Inability to provide an informed consent * History of treatment for peptic ulcer disease

Study Objectives This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients will be randomized to receive in a crossover design single oral doses of RO5185426 with or without food, with a 10-day washout period between doses. Following the crossover periods, patients will receive RO5185426 orally twice daily on a continuous basis until disease progression or unacceptable toxicity occurs. Conditions: Malignant Melanoma Intervention / Treatment: DRUG: RO5185426, DRUG: RO5185426, DRUG: RO5185426 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Adult patients, >= 18 years of age * Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer) * Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test * Previously treated patients must have failed at least one prior treatment regimen; if patients have received prior systemic treatments for metastatic melanoma, the time elapsed from previous therapy must be >= 28 days; patients must have recovered fully from toxicities of all prior therapy * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Evaluable disease (measurable for disease progression according to RECIST criteria) * Adequate hematological, renal and liver function Exclusion Criteria: * Active CNS lesions * History of or known spinal cord compression or carcinomatous meningitis * Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study * Previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix * Previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor * Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of any type of gastrointestinal surgery that would preclude adequate absorption of study drug

Study Objectives This is a single-arm, multicenter, Phase Ib study designed to describe the effect of GDC-0449 on the pharmacokinetics of rosiglitazone and oral contraceptives in patients with advanced solid tumors who are refractory to treatment or for whom no standard therapy exists. Conditions: Solid Cancers Intervention / Treatment: DRUG: Vismodegib, DRUG: Rosiglitazone, DRUG: Norethindrone/ethinyl estradiol 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: * Histologic documentation of incurable, locally advanced, or metastatic solid malignancy that has failed to respond to at least one prior regimen or for which there is no standard therapy * Documented negative serum pregnancy test for women of childbearing potential and use of two forms of contraception. Contraception must be used while the patient is enrolled in the study and for 12 months after the patient discontinues from the study. * For men with female partners of childbearing potential, agreement to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 3 months after their last dose of GDC-0449. * Agreement not to donate blood or blood products during the study and for at least 12 months after their last dose of GDC-0449 * For male patients, agreement not to donate sperm during the study and for at least 3 months after their last dose of GDC-0449 * Adequate hematopoietic capacity * Adequate renal function * Adequate hepatic function * At least 3 weeks since the patient's last chemotherapy, investigational agent, radiation therapy, or major surgical procedure and recovery to pre-treatment baseline or stabilization of all treatment-related toxicities Exclusion Criteria: * Active infection requiring intravenous (IV) antibiotics * Clinically important history of liver disease significantly impairing hepatic function, including active viral or other hepatitis, current alcohol abuse, or cirrhosis * Any medical condition or diagnosis that would likely impair absorption of an orally administered drug * Pregnant or lactating * Treatment with excluded medications, including strong CYP450 inhibitors and inducers, within 2 weeks of study entry * Male patients already receiving rosiglitazone * Male patients with a known contraindication to rosiglitazone * Female patients already receiving oral contraception < 14 days prior to Day 1 * Female patients with known contraindication to oral contraceptions

Study Objectives This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion in combination with paclitaxel (and pertuzumab, if applicable) in patients with human epidermal growth factor receptor 2-positive (HER2-positive), locally advanced or metastatic breast cancer. Conditions: Metastatic Breast Cancer Intervention / Treatment: DRUG: paclitaxel, DRUG: pertuzumab [Perjeta], DRUG: trastuzumab emtansine [Kadcyla], DRUG: paclitaxel, DRUG: trastuzumab emtansine [Kadcyla] Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically documented HER2-positive locally advanced or metastatic breast cancer * Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory HER2 status testing and other exploratory assessments * Prior trastuzumab in any line of therapy (Phase Ib patients only) * No prior T-DM1 or pertuzumab therapy * Measurable or evaluable disease * Cardiac ejection fraction >=50% by either echocardiogram or multigated acquisition scan * Life expectancy >= 90 days as assessed by the investigator Exclusion Criteria: * Fewer than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal or radiotherapy for the treatment of breast cancer, with the following exceptions: hormone-replacement therapy or oral contraceptives are allowed; palliative radiation therapy involving <=25% of marrow-bearing bone is allowed if completed within >= 14 days prior to first study treatment * History of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab, murine proteins, or any of the excipients that resulted in trastuzumab being permanently discontinued * Peripheral neuropathy of Grade >= 2 per NCI CTCAE, Version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (Phase Ib patients) * Peripheral neuropathy of Grade >=1 per NCI CTCAE, Version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (Phase IIa patients) * History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 500 mg/m^2; Liposomal doxorubicin > 900 mg/m^2; Epirubicin > 720 mg/m^2 * History of clinically significant cardiac dysfunction * Brain metastases that are untreated, or progressive, or have required any type of therapy (including radiation, surgery, or steroids) to control symptoms from brain metastases within 60 days prior to the first study treatment. * History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, basal cell carcinoma, or synchronous or subsequent HER2-positive breast cancer or other malignancy with a similar expected curative outcome

Study Objectives This study aims to show that 3-dimensional PET/CT imaging with a new novel PET tracer (called \[124I\]mIBG) can detect as many or more sites of neuroblastoma (a type of childhood cancer) compared to the recommended 1-dimensional routine scans (called \[123I\]mIBG planar scintigraphy). Conditions: Metastatic Neuroblastoma Intervention / Treatment: DRUG: [124I]meta-Iodobenzylguanidine Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically proven Stage 4 neuroblastoma as defined by the International Neuroblastoma Staging System (INSS). * Aged >= 1 year at the time that written informed consent is given. * Planned to undergo conventional [123I]mIBG planar scintigraphy for routine clinical care of neuroblastoma. * Life expectancy of at least 12 weeks. * World Health Organisation (WHO) performance status of 0, 1 or 2 for patients aged > 12 years old or Lansky play scale score of >= 50% for patients aged <= 12 years old. * Written (signed and dated) informed consent from patient >= 16 years old and/or parent or legal guardian for patients <16 years old and the patient be capable of co-operating with scanning requirements. (N.B. Written or verbal assent as appropriate should be sought from all patients who are under 16 years old). Exclusion Criteria: * Treatment with any medications contra-indicated with mIBG scanning as listed in Appendix 4 of the trial protocol. For example, decongestants containing pseudoephedrine, phenylpropalomine and phenylephrine, sympathomimetics, cocaine, antihypertensives, tricyclic antidepressants. These drugs should be stopped before administration as indicated in this list (usually for four biological half-lives to allow almost complete wash-out but refer to list). * Stage 4S neuroblastoma as defined by the INSS. * Any anti-cancer treatment planned between the routine [123I]mIBG imaging and the [124I]mIBG PET/CT scan on Day 2. Anti-cancer treatments can be started only after the Off-Study assessment on Day 3 to Day 7, see schedule of assessments in Section 7. N.B. Patients should not be enrolled in the study if their participation will delay their subsequent treatment for neuroblastoma. * Female patients who are pregnant or lactating. * At high medical risk because of non-malignant systemic disease including active uncontrolled infection. * Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV). * Patients with known hypersensitivity to mIBG. * Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical study. Clinical Criteria for [124I]mIBG imaging * One or more disease foci observed on conventional [123I]mIBG planar scintigraphy. Disease foci will initially be identified by a Nuclear Medicine physician at the investigational site. * >= 3kg at the time of the [124I]mIBG imaging to agree with the paediatric EANM guidelines. * Haematological and biochemical indices within the ranges below: For patients <=16 years old, haematological and biochemical indices within the following ranges: Haemoglobin >= 7.0 g/dl (N.B transfusions will be allowed); Absolute neutrophil count >= 0.2 x 10^9/L (N.B. G-CSF support will be allowed); Platelet count >= 10 x 10^9/L (N.B. transfusions will be allowed); Serum bilirubin <= 2.5 x upper limit of normal (ULN); Alanine amino-transferase (ALT), aspartate amino-transferase (AST), and/ or alkaline phosphatase (ALP) <= 5 x ULN; and Calculated creatinine clearance using revised Schwartz formula >= 60 mL/min/1.73m^2. For patients >16 years old, haematological and biochemical indices within the following ranges: Haemoglobin >= 8.0 g/dl (N.B transfusions will be allowed); Absolute neutrophil count >= 0.5 x 10^9/L (N.B. G-CSF support will be allowed); Platelet count >= 50 x 10^9/L (N.B. transfusions will be allowed); Serum bilirubin <= 2.5 x upper limit of normal (ULN); Alanine amino-transferase (ALT), aspartate amino-transferase (AST), and/ or alkaline phosphatase (ALP) <= 5 x ULN; and Estimated Glomerular Filtration Rate (eGFR) >= 60 mL/min/1.73m^2. * Menarchal female patients must have a negative serum or urine pregnancy test before administration of [124I]mIBG Solution for Injection on Day 1 and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom, have an intra-uterine device and condom, diaphragm with spermicidal gel and condom) to be effective from Day 1 and for 7 days afterwards. * Male patients with partners of child-bearing potential must agree to take measures not to father children by using one form of highly effective contraception [condom plus spermicide] from Day 1 and for 7 days afterwards. Male patients with pregnant or lactating partners must agree to use barrier method contraception (e.g. condom plus spermicidal gel) to prevent exposure to the foetus or neonate.

Study Objectives Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. The investigators will try following the original protocol making 2 randomized groups of patients, with cancer diagnosis, \>18 years old, with a GFR \<60 and \>30 ml/min/1,73m2 by MDRD formula and/or diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during and 6 hours before the injection. The primary end point will be the rise of 25% or more in creatinine or dialysis needed. Conditions: Radiographic Contrast Agent Nephropathy Intervention / Treatment: DRUG: sodium bicarbonate, DRUG: NaCl Location: Brazil Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * > 18 years old * cancer diagnosis * GFR < 60 and > 30 ml/min/1,73m2 by MDRD formula or diabetic * CT with contrast Exclusion Criteria: * dialysis needed * uncontrolled hypertension * changes in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours of procedure * recent exposure to radiographic contrast agents (within previous two days of the study) * administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study

Study Objectives Pancreatic cancer is a highly lethal disease. Patients with resectable or borderline resectable disease may benefit from preoperative radiochemotherapy. However, only a subset of patients will respond to this potentially toxic and expensive treatment. Therefore, novel predictive markers are needed to determine treatment efficacy at an early stage. Preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. Pancreatic cancers are heterogeneous tumors. The tumor microenvironment is often characterized by large amounts of stroma, hypovascularization, and hypoxia. As these three factors can all contribute to treatment resistance, a quantitative assessment of these markers may aid in the prediction of response to preoperative radiochemotherapy. Moreover, these assessments may have prognostic value. Finally, further insight into the interrelation of these aspects of the tumor microenvironment can contribute to the evaluation of new targeted treatment options. Tumor cellularity and extracellular matrix composition can be assessed non-invasively in vivo by diffusion weighted magnetic resonance imaging (DWI) and tumor vascularity can be assessed by dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). Finally, tumor hypoxia can be evaluated by T2\* MRI and PET-CT, using the 18F-labeled hypoxic marker HX4. Objective of the study: The primary aim of the study is to assess whether DWI, DCE-MRI, T2\*, and 18F-HX4-PET/CT predict overall survival in patients with pancreatic cancer treated with surgery and adjuvant chemotherapy or with neoadjuvant radiochemotherapy, surgery and adjuvant chemotherapy. Secondary aims of the study include the assessment of the predictive value of DWI, DCE-MRI, T2\*, and 18F-HX4-PET/CT for pathological response to neoadjuvant chemoradiation, the correlation of DWI, DCE-MRI, T2\*, and 18F-HX4-PET/CT with histopathological assessment of tumor stroma, vascularization, and hypoxia, and the assessment of the predictive value of these histopathological markers for overall survival. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Gadobutrol, DRUG: [F-18]HX4, DRUG: Gemcitabine, RADIATION: Radiotherapy, PROCEDURE: Pancreaticoduodenectomy Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with pancreatic tumors, with histological or cytological proof of adenocarcinoma or a high suspicion on CT imaging. * Tumor size >= 1cm. * WHO-performance score 0-2. * Scheduled for surgery or neo-adjuvant chemotherapy/radiation followed by surgery. For the reproducibility part of the study, patients who will not undergo surgery, may be included, too. * Written informed consent. Exclusion Criteria: * Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol. * Contra-indications for MR scanning, including patients with a pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; or a non-MR compatible aneurysm clip in their brain; patients with severe claustrophobia. * Renal failure (GFR < 30 ml/min) hampering safe administration of Gadolinium containing MR contrast agent. * For the reproducibility part of the protocol: surgery, radiation and/or chemotherapy foreseen within the timeframe needed for MR scanning.

Study Objectives This is a prospective, open-label, 2-arm, non-randomized study of CPI-100 in patients with advanced tumors. CPI-100 is administered via intravenous infusion in a 3 + 3 study design to identify the maximum tolerated dose (MTD). Conditions: Advanced Tumors Intervention / Treatment: DRUG: CPI-100, DRUG: Capecitabine 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: * Have a histologically or cytologically confirmed diagnosis of advanced solid tumor * Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy * Be reasonably recovered from preceding major surgery or no major surgery within 4 weeks prior to the start of Day 1 treatment * Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding * Be willing to abstain from sexual activity or practice physical barrier contraception from study entry to 6 months after the last day of treatment Exclusion Criteria: * Have peripheral neuropathy of Grade 3 or Grade 4 at screening * Have peripheral sensory neuropathy of Grade 2 or greater at screening * Have an interval from previous neurotoxic drugs less than 3 months unless reasonably recovered from all grades of neurotoxicity to grade 1 or lower as judged by the investigator * Have known hypersensitivity to chemotherapeutic agents * Have a history of thrombocytopenia with complications including hemorrhage or bleeding > Grade 2 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe * Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia * Is pregnant or breast-feeding

Study Objectives Ofatumumab is a drug that works by attaching to the CD20 molecule found on the surface of cancerous B cells, and then triggering the death of those cells. It is approved by the FDA for treatment of another B-cell cancer, chronic lymphocytic leukemia, and also has evidence of success in people who's B-cell lymphomas have relapsed after initial treatments. In this research study we are looking to see if ofatumumab is effective and safe in treating previously untreated B-cell NHL. Conditions: Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma Intervention / Treatment: DRUG: ofatumumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed indolent CD20+B-cell NHL of the following histologies: follicular lymphoma, grades 1-2; Marginal zone lymphoma (extranodal, nodal or splenic); small lymphocytic lymphoma; low-grade B-cell lymphoma not otherwise specified with CD20+ expression * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as 20mm or greater CT scan or MRI * No previous chemotherapy, antibody therapy or radioimmunotherapy for this disease. Patients previously treated with external beam radiation alone are eligible * 18 years of age or older * Life expectancy of greater than 3 months * ECOG Performance status of 0, 1 or 2 * Organ function as described in the protocol * Women of child-bearing potential and men must agree so use adequate contraception prior to study entry and for the duration of study participation Exclusion Criteria: * Prior chemotherapy, antibody therapy or radioimmunotherapy for lymphoma * Participants may not be receiving any other investigational agent * Participants with known brain metastases * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ofatumumab * Prior exposure to ofatumumab or other targeted anti-CD20 therapies including rituximab * Known HIV positivity * Positive serology for Hepatitis B * Positive serology for Hepatitis C * Participants who are candidates for curative radiotherapy, unless radiation therapy is considered too toxic (as in abdominal disease), or is refused by the patient * New York Heart Association Classification III of IV heart disease * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection that is not optimally treated with antibiotics, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or breastfeeding women * History of a different malignancy are ineligible except for the following circumstances: Individuals with a history of other malignancy are eligible if they have been disease-free for at least one year and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible even if diagnosed and treated within the past 1 year: localized prostate cancer, prostate cancer with elevated PSA but no measurable disease on CT scans or bone scan, cervical cancer in situ, breast ductal carcinoma in situ and non-melanoma skin cancers.

Study Objectives The Mother-Daughter Initiative (MDI) will test the feasibility and acceptability of a strategy to deliver comprehensive cervical cancer prevention services in Thailand and the Philippines by integrating the HPV vaccine for girls ages 9-13 into already successful screening and treatment programs for mothers. Conditions: Cervical Cancer Intervention / Treatment: BIOLOGICAL: HPV Vaccine (Gardasil) Location: Philippines, Thailand Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age 9-13 at first HPV vaccine dose * Mother/legal guardian and daughter are both interested and willing to have the girl receive the HPV vaccine * Mother/legal guardian and daughter both indicate that they would be able to return to clinic for the three vaccine doses Exclusion Criteria: * Girls with a known history of any allergies or severe reaction to any vaccines, food or medicine * Pregnant adolescents will be excluded. If a girl becomes pregnant after the first dose is administered, she will not be provided with the second or third dose * Girls with moderate or severe illnesses will be asked to postpone vaccination eg. Pneumonia. * Girls with a weakened immune system, cancer, leukemia, AIDS or other immune system problems * Girls with a bleeding disorder or currently taking anticoagulants * Girls that have received any other vaccinations in the past 4 weeks * Girls currently on steroids, such as cortisone, prednisone, or anti-cancer drug.

Study Objectives This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works in preventing cancer in patients with oral leukoplakia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate, a substance made from soy, may keep cancer from forming in patients with oral leukoplakia Conditions: Lip and Oral Cavity Cancer, Oral Leukoplakia, Oropharyngeal Cancer, Tongue Cancer Intervention / Treatment: DRUG: Bowman-Birk inhibitor concentrate, OTHER: placebo, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Histologically and clinically confirmed oral leukoplakia and/or erythroplakia * Bidimensionally measurable disease (>= 100 mm^2 for total area of all lesions) after biopsy * No presence of obvious head and neck aerodigestive tract cancer, carcinoma in situ, or previously treated head and neck cancer within the past 2 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergic reaction to soybeans, sorbitol, sucrose, artificial flavorings, aspartame, saccharin, or lidocaine * At least 6 months since prior Bowman-Birk inhibitor concentrate * At least 6 months since prior participation in another randomized clinical trail * At least 3 months since prior systemic steroids or topical oral steroid preparations * Topical nasal steroid sprays or cutaneous preparations with minimal systemic absorption for nasal or dermatologic disorders allowed * More than 6 months since prior beta carotene capsules * At least 2 years since prior retinoid or other beta carotene therapy, including > 25,000 IU of vitamin A for any reason * Up to 2 multivitamins per day allowed

Study Objectives In this open-label randomised phase I trial, bortezomib will be administrated to 2 groups of 10 patients with MM who have inclusion criteria use the extended 2nd line indication, either intravenously (group 1 = 10 patients) or subcutaneously (group 2 = 10 patients). The schedule of administration of bortezomib will be the following : 1.3 mg per square meter of body-surface area twice weekly for 2 weeks, followed by 1 week without treatment, for up to eight cycles, either IV (group 1) or SC (group 2). The primary objective is to characterize the pharmacokinetics of the 2 routes of administration. The secondary objectives are to characterize the pharmacodynamics (20S proteasome inhibition in whole blood), toxicity, including cardiac safety, and efficacy of the 2 routes of administration. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: bortezomib Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * diagnosis of MM according to the SWOG criteria (annex I) * symptomatic MM stage II or III according to Durie-Salmon staging system (annex II) or stage I with one symptomatic osteolytic lesion * with progressive disease after at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation * with measurable levels of paraprotein in the serum (> 1g/dl) or in the urine (> 0.2g/24h) * age < 75 years * able to understand and to given an informed consent * male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures. Men must agree to use an acceptable method of contraception (for themselves or female partners) for the duration of the study * no active systemic infection. In the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. Patients must be afebrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with Bortezomib. * Each subject will weigh ³50 kg and have a body mass index (BMI) of £30 kg/m2 (see annex V for BMI formula). Exclusion Criteria: * life expectancy < 2 months * ECOG performance status > 2 (annex III) * proven amyloidosis * positive HIV serology * antecedents of severe psychiatric disease * > NCI grade 2 peripheral neuropathy (Annex IV) * History of clinically relevant cardiac disease, including prior myocardial infarction, prior or existing heart failure, existing uncontrolled angina or clinically significant pericardial disease Evidence of arrhythmia, 2nd degree or greater AV block or prolonged QTc interval (>0.45 seconds in males, >0.47 seconds in females) on screening ECG * serum biochemical values as follow * creatinine level > 200mmol/l * bilirubin, transaminases or gGT > 3 the upper normal limit * potassium, calcium or magnesium outside of upper or lower normal limits * haematology values as follow * platelet < 70x 109 /L within 14 days of enrollment * absolute neutrophil count <1.0 x 109/L within 14 days of enrolment * concomitant use of drugs able to modify QTc interval within 1 week prior to the first dose of bortezomib and during Cycle 1 (Annex VI) * concomitant use of potent inhibitors or inducers of the cytochrome P450 (CYP) enzymes 3A and 2C19 within 1 week prior to the first dose of bortezomib and during Cycle 1 (see annex VII list of representative drugs). * use of any experimental drugs within 30 days of baseline * hypersensitivity to bortezomib, boron, or mannitol

Study Objectives Adequate quality of bowel preparation(BP) is essential for colonoscopy. In recently, Kang suggested that for low-risk patients, single dose of 2L PEG is an effective regimen for bowel preparation.However, due to the poor palatability, there still more than 30% patients with 2L regimen experienced nausea or vomiting in our center. Oral lactulose is a treatment for constipation. Several studies have compared the effectiveness between use PEG and lactulose for colonoscopy preparation in average-risk patients. However, the data in low-risk patients is vacant. The objective of current study was to compared the effectiveness of bowel preparation and patient tolerance using lactulose and 2L PEG regimen in low-risk patients. Conditions: Colonic Neoplasms Intervention / Treatment: DRUG: Lactulose oral solution, DRUG: PEG Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Patients over 18 years old and with low-risk were eligible. Patients were considered as low risk if they did not meet any of the following risk factors: age>70 years old, body mass index (BMI)>25Kg/m2, constipation, Parkinson's disease, diabetes, history of stroke or spinal cord injury, use of tricyclic antidepressant or narcotics. Exclusion Criteria: * (1) history of colorectal resection; (2) Known or suspected colonic stricture or obstructing tumor; (3) Known or suspected colonic perforation; (4) toxic colitis or megacolon; (5) use of prokinetic agents or purgatives within 7 days; (6) hemodynamic instability; (7) pregnancy or lactation; (8) inability to provide informed consent.

Study Objectives The purpose of this study is to see if giving high dose chemotherapy and total body irradiation before and repeating high dose chemotherapy after a bone marrow transplant could reduce the incidence of graft rejection and disease for patients with blood cancers Conditions: MDS, Leukemias, Lymphomas Intervention / Treatment: DRUG: Busulfan, DRUG: Cyclophosphamide, RADIATION: Total body irradiation 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: * Acute lymphocytic leukemia in high risk CR1 * Acute myeloid leukemia in CR1 * Therapy-related AML * RAEB with >5% and <20% bone marrow blasts * Chronic myelogenous leukemia beyond 1st chronic phase; Patients cannot be in blast crisis * CMMoL * JMML * Chemotherapy-resistant Hodgkins Lymphoma or intermediate or high grade Non-Hodgkins lymphoma (Less than a PR after standard or salvage chemotherapy) * Mantle cell lymphoma: chemotherapy refractory (Less than a PR after standard or salvage chemotherapy) or patients beyond CR1 with chemosensitive disease * Follicular Lymphoma, Grade 3 * Transformed indolent lymphomas Exclusion Criteria: * Poor cardiac function: left ventricular ejection fraction <45% as determined by MUGA or ECHO. For pediatric patients LVEF <45% or a shortening fraction below normal limits for age. * Poor pulmonary function: FEV1 and FVC <50% predicted for patients who have not received thoracic or mantle irradiation. For patients who have received thoracic or mantle irradiation, FEV1 and FVC <70% predicted or DLCO < 50 of predicted. For children unable to perform PFTs because of developmental stage pulse oximetry < 85% on RA * Poor liver function: bilirubin >2 mg/dl (not due to hemolysis, Gilbert's or primary malignancy) * Poor renal function: Creatinine >2.0mg/dl or creatinine clearance * HIV-positive * Positive leukocytotoxic crossmatch * Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception * Uncontrolled viral, bacterial, or fungal infections Patients with symptoms consistent with RSV, influenza A, B, or parainfluenza at the time of enrollment will be assayed for the above viruses and if positive are not eligible for the trial until they are no longer symptomatic (patients may have continued assay positivity for a period of time post resolution of symptoms secondary to the nature of the assay. * Indolent lymphomas (Follicular Grade 1 and 2, marginal zone, chronic lymphocytic leukemia, small lymphocytic lymphoma, MALT)

Study Objectives The purpose of the phase I/II clinical study is to determine the best dose of fractionated stereotactic radiation therapy (SBRT) given either with Avasopasem manganese (GC4419) or placebo to patients who have been diagnosed with locally advanced pancreatic cancer. Conditions: Pancreatic Cancer, Stereotactic Body Radiation Therapy Intervention / Treatment: DRUG: GC4419, DRUG: Placebo, RADIATION: Stereotactic Radiation Therapy (SBRT) 50 Gy, RADIATION: Stereotactic Radiation Therapy (SBRT) 55 Gy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Cytologic or biopsy confirmed adenocarcinoma of the pancreatic head, body or tail * Disease that is appropriate for SBRT by virtue of being: a. Locally advanced and technicallyunresectable, as determined by a pancreaticobiliary surgeon as part of a multidisciplinary review at the investigative site, including multi-phasic CT demonstrating: i.Greater than 180 degree tumor involvement of the superior mesenteric artery ii. Greater than 180 degree tumor involvement of the celiac axis, including major branches of the celiac axis that render it unresectable (e.g. common hepatic artery). iii. Tumor involvement of the first branch of the SMA that is not surgically reconstructible iv. Long segment involvement of the superior mesenteric vein/portal vein or hepatic artery that is not surgically reconstructible b. Potentially resectable, but patient is judged not a candidate for surgery, after multidisciplinary review at the investigative site; c. Potentially resectable, but the patients refuses surgery and is considered an acceptable candidate for SBRT after multidisciplinary review at the investigative site; d. "Borderline" resectable, as determined by multidisciplinary review, including absence of distant lymphadenopathy and the primary tumor characterized by one of more of the following: i. A tumor-vessel interface (TVI) with the mesenteric vein (SMV) or portal vein (PV) measuring >=180° of the circumference of either vein's wall or short-segment occlusion of either vein with a normal vein above or below the obstruction amenable to reconstruction; ii. Any TVI with the common hepatic artery (CHA) with normal artery proximal and distal to the TVI amenable to reconstruction; iii. A TVI with the superior mesenteric artery (SMA) measuring <180° of the circumference of the vessel wall * Pancreatic tumor size and limited bowel involvement by tumor must be judged acceptable for SBRT at the discretion of the treating investigator * No evidence of distant metastasis either prior to or after induction chemotherapy. * Completion of at least 3 months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX, gemcitabine or nab-paclitaxel or another standard combination of induction chemotherapy agents * Patient must have metal stent in place if duodenal stent is required. If patient has plastic stent, this must be replaced prior to radiation. * Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to <= 5mm. * Age >= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status <= 2 (0, 1 or 2) * Adequate hematologic function as indicated by i. Absolute neutrophil counts (ANC) >= 1,500/mm3 ii. Hemoglobin (Hgb) >= 8.0 g/dL iii. Platelet count >= 75,000/mm3 * Adequate renal and liver function as indicated by: i. Creatinine <= 1.5 x upper-normal limit (ULN) ii. Total bilirubin <= 1.5 x upper-normal limit (ULN) iii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN iv. Alkaline phosphatase <= 2.5 x ULN * Properly obtained written informed consent Exclusion Criteria: * Prior radiation therapy to the abdomen that would overlap with treatment field * Prior surgical resection of pancreatic tumor * Receiving any approved or investigational anti-cancer agent other than those provided for in this study * Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment * Visible invasion of tumor into the lumen of the bowel or stomach on endoscopy (Note: Radiological infiltration into bowel is allowed, unless deemed clinically unsafe.) * Residual or ongoing >= Grade 3 non-hematologic toxicity from chemotherapy * Contraindication to IV contrast * Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of study entry Note: Patients who are participating in non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment * Second primary malignancy within the last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator * Known history of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible) * Female patients who are pregnant or breastfeeding * Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for 30 days after the last dose of GC4419. This includes any woman who has experienced menarche but has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum FSH levels greater than 35 mIU/mL. A negative urine or serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential. * Male subjects who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 90 days after the last dose of GC4419 are excluded. * Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure. * Medical history that includes any condition, or requires the use of concomitant medications which, in the investigator's judgment, are associated with or create a risk of increased carotid sinus sensitivity, symptomatic bradycardia, or syncopal episodes.

Study Objectives The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients. Conditions: Pain, Cancer Intervention / Treatment: DRUG: OraVescent fentanyl (OVF) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Documented diagnosis of a malignant solid tumor or hematological malignancy causing cancer related pain * Currently taking around the clock opioid therapy for pain * Experience on average, 1-4 breakthrough pain episodes per day Exclusion Criteria: * Opioid or fentanyl intolerance * Sleep apnea or active brain metastases with increased intracranial pressure * COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease

Study Objectives The purpose of this study is to determine whether the bispecific T-cell engager (BiTE®) Blinatumomab (MT103) is effective in the treatment of ALL patients with minimal residual disease. Conditions: Acute Lymphoblastic Leukemia Intervention / Treatment: BIOLOGICAL: Blinatumomab (MT103) Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * B-precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within German Multicenter Study Group on Adult Acute Lymphoblastic Leukemia (GMALL) standards or at any time outside GMALL standards. * Patients must have a molecular marker for evaluation of minimal residual disease which is either Breakpoint cluster region/gene on human chromosome #9 (Bcr/abl) at any detection level or individual rearrangements of immunoglobulin or T-cell receptor (TCR)-genes measured by an assay with a sensitivity of minimum 10^-4: At least one individual marker at a quantitative level >= 10^-4. * Eastern Cooperative Oncology Group (ECOG) Performance Status < 2 * Ability to understand and willingness to sign a written informed consent * Signed and dated written informed consent is available Exclusion Criteria: * Current extra medullar involvement * History of or current relevant central nervous system (CNS) pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL) * Current infiltration of cerebrospinal fluid by ALL * History of or current autoimmune disease * Autologous stem cell transplantation within 6 weeks prior to study entry * Any prior allogeneic stem cell transplantation * Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, steroids) * Radiotherapy within 4 weeks prior to study treatment * Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment * Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation * Presence of human anti-murine antibodies (HAMA) * Abnormal bone marrow, renal or hepatic function * Indication for a hypercoagulative state * History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ * Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator * Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive) * Pregnant or nursing women * Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter

Study Objectives The standard or usual treatment for this disease is treatment with drugs and other treatments that may help to make a patient better or may improve their quality of life. This treatment is known as "best supportive care" (BSC). Although patients with best supportive care can feel better for some months, the cancer usually continues to grow. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: Tremelimumab, DRUG: Durvalumab, OTHER: Best Supportive Care Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Must have histologically or pathologically confirmed advanced (metastatic or locally advanced) colorectal cancer that is unresectable. * Received a prior thymidylate synthase inhibitor (e.g. 5-fluorouracil (5-FU), capecitabine, raltitrexed, UFT) for metastatic disease or as adjuvant therapy. A thymidylate synthase inhibitor may have been given in combination with oxaliplatin or irinotecan. * Received and failed an irinotecan -containing regimen (i.e. single-agent or in combination) for treatment of metastatic disease, OR relapsed within 6 months of completion of an irinotecan-containing adjuvant therapy, OR have documented unsuitability for an irinotecan-containing regimen. * Received and failed an oxaliplatin-containing regimen (i.e. single-agent or in combination) for treatment of metastatic disease, OR relapsed within 6 months of completion of an oxaliplatin-containing adjuvant therapy OR have documented unsuitability for an oxaliplatin-containing regimen. * For patients with colorectal cancer that is RAS-wild type: Received and failed a cetuximab or panitumumab-containing regimen (i.e. single-agent or in combination) for treatment of metastatic disease OR have documented unsuitability for a cetuximab or panitumumab-containing regimen * Patient prior treatment with VEGF targeting therapy, such as bevacizumab, aflibercept, ramucirumab, or regorafenib, is permitted but not mandatory. Reasons not used are to be documented. * Patient prior treatment with TAS-102 (an agent composed of a combination of trifluorothymidine (FTD) and tipiracil hydrochloride (TPI)), is permitted but not mandatory. * The only remaining standard available therapy as recommended by the Investigator, in consultation with the patient, is best supportive care. * Must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1). * Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease done within 28 days prior to randomization. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of >= 12 weeks at the time of study entry. * Must be >= 18 years of age. * Women/men of childbearing potential must have agreed to use a highly effective contraceptive method. * Patient must consent to provision of, and investigator(s) must confirm adequacy of tissue, and confirm access to and agree to submit within 4 weeks of randomization to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative marker assays may be conducted. * Patient must consent to provision of samples of blood in order that the specific correlative marker assays * Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French. Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient randomization. * The patient is not receiving therapy in a concurrent clinical study and the patient agrees not to participate in other clinical studies during their participation in this trial while on study treatment.

Study Objectives An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting. Conditions: Dupuytren's Contracture Intervention / Treatment: DRUG: Xiapex, PROCEDURE: surgery Location: Spain, Norway Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adults with a palpable cord eligible for the treatment of Dupuytren's contracture Exclusion Criteria: none

Study Objectives A prospective, multicenter, Phase-IV clinical trial to assess safety of Durvalumab in Indian adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) Conditions: Unresectable Non-small Cell Lung Cancer (NSCLC) Intervention / Treatment: DRUG: Durvalumab Location: India Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Provision of signed, written and dated informed consent prior to any study specific Procedures * Male or female aged >= 18 years * As per local prescribing information and in view of positive benefit-risk assessment, patient prescribed Durvalumab treatment as per independent clinical judgment of treating physician for either Exclusion Criteria: * Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study * Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed. * Prior exposure to any anti-PD-1 or anti-PD-L1 antibody including durvalumab. * For NSCLC cohort only: 1. Mixed small cell and non-small cell lung cancer histology 2. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy. 3. Patients with >=Grade 2 pneumonitis from prior chemoradiation therapy * Active or prior documented autoimmune disease within the past 2 years, inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), primary immunodeficiency, organ transplant that requires therapeutic immunosuppression, hypersensitivity to study drug or any excipient, leptomeningeal carcinomatosis, tuberculosis. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. * Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control * Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.

Study Objectives The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of weekly paclitaxel. This is a prospective single-center study that will investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative breast cancer that are candidate for receiving chemotherapy before surgery (neoadjuvant chemotherapy). Conditions: Breast Cancer Intervention / Treatment: DRUG: EndoTAG-1 Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * newly diagnosed histologically confirmed BC with breast infiltrating carcinoma of histological grade > 1 (either operable, or locally advanced or inflammatory) candidate for neoadjuvant chemotherapy * HER2-negative tumor, defined according to immunohistochemistry or using fluorescent in-situ hybridization (FISH) * ECOG performance status 0 or 1 * Gender: female * Age : >= 18 years old * Negative pregnancy test (females of childbearing potential) * Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment (females of childbearing potential) * Signed informed consent Exclusion Criteria: * Metastatic or relapsed disease * Major surgery < 3 weeks prior to enrollment * Severe pulmonary obstructive or restrictive disease * Uncontrolled inflammatory disease (autoimmune or infectious) * Clinically significant cardiac disease (NYHA stadium > 2) * Results of laboratory tests (hematology, chemistry) outside specified limits: * WBC <= 3 x 109/L * ANC < 1.5 x 109/L * Platelets < 100 x 109/L * Hb <= 9.0 g/dl (<= 5.6 mmol/l) * PTT/ INR > 1.5 x ULN * AST or ALT > 2.5 x ULN * Alkaline Phosphatase > 2 x ULN * Total Bilirubin > 1.5 x ULN * Pregnancy or nursing status * Known positive HIV testing * Known hypersensitivity to any component of the EndoTAG-1, paclitaxel or FEC formulations * History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally * History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial * Concurrent treatment with other experimental products. Participation in another clinical trial with any investigational product within 30 days prior to study entry

Study Objectives In this prospective pharmacokinetic we investigate the following topics: * The influence of grapefruit juice and orange juice on the steady-state pharmacokinetics of sunitinib in cancer patients * The influence of sunitinib on the pharmacokinetics of midazolam in cancer patients * The relationship between Cytochrome-P450-3A4 (CYP3A4) phenotype, as assessed using the midazolam clearance test, and the steady-state pharmacokinetics of sunitinib in cancer patients * The effect of grapefruit juice and orange juice on CYP3A4 metabolism Conditions: Healthy Intervention / Treatment: DRUG: Sunitinib, DRUG: Midazolam, OTHER: Orange juice, OTHER: Grapefruit juice Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with imatinib-resistant gastro-intestinal stromal cell tumor or metastatic renal cell carcinoma treated with sunitinib at a dose level of 25-50 mg sunitinib per day in a 4 weeks on/2 weeks off schedule. * Age at least 18 years * WHO performance status < 2. * At least 4 weeks since last chemotherapy, hormonal, or radiation therapy. * A life expectancy of at least 12 weeks. * Patients must have an adequate functional reserve as defined by: hemoglobin > 6.0 mmol/L, White Blood Count > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, creatinine clearance > 60 mL/min, bilirubin within normal limits, Alanine transaminase and aspartate transaminase < 2.5 times the upper limit of normal (unless due to liver metastases, then < 5 times the upper limit of normal. * Written informed consent. Exclusion Criteria: * Patients with hematological malignancies * Concurrent other chemotherapy, immunotherapy, or radiotherapy. * Concurrent use of other substances known or likely to interfere with the pharmacokinetics of sunitinib (e.g., ketoconazole, cyclosporine A). * Use of drugs, herbal preparations and/or dietary supplements known to influence the expression of CYP3A (e.g., phenytoin, rifampicin, St. John's wort, garlic supplements, milk thistle) within the preceding 2 weeks. * Present clinical signs of symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan. A patient with brain and/or leptomeningeal metastases may be included only if he/she is asymptomatic on neurological examination and is not receiving corticosteroid therapy to control symptoms. * Patients with uncontrolled infection. * Concurrent severe medical problems unrelated to the malignancy that would limit full compliance with the study or expose the patient to extreme risk. * Patients with pre-existing cardiac disease, including clinical congestive heart failure, cardiac arrhythmias requiring treatment, or a myocardial infarction within the preceding 3 months. * Patients who have received another investigational drug within 30 days or 5 half-lives prior to entry in the study (whichever is longer). * History of allergic reaction to compounds chemically related to sunitinib. * Patients who are pregnant or breastfeeding. * Patients of childbearing potential, not practicing adequate contraception. * Patients that are unable to ingest oral medication and/or are known with gastric emptying disorders.

Study Objectives This study will investigate the safety and efficacy of Relacorilant in combination with Pembrolizumab for Patients with Adrenocortical Carcinoma which Produces Too Much Stress Hormone (Cortisol). Conditions: Adrenocortical Carcinoma Intervention / Treatment: DRUG: Relacorilant, DRUG: Pembrolizumab 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 ACC (advanced unresectable and/or metastatic) * Measurable disease based upon RECIST v1.1 as determined by the Investigator. * Documented GC excess (too much cortisol). * For patients who have received mitotane within 3 months prior to screening, mitotane levels must be <4 mg/L at screening. * Eastern Cooperative Oncology Group (ECOG) performance status <=2. * Adequate organ and bone marrow function (determined through blood and urine tests) * Negative pregnancy test for patients of childbearing potential at the Screening and every 6 weeks (+ or - 7 days) in female patients of childbearing potential. Exclusion Criteria: * Major surgery within 4 weeks prior to enrollment. If the participant underwent major surgery, they must have recovered adequately prior to starting study treatment. * Have received and responded (complete response [CR] or partial response [PR]) to prior treatment with any prior checkpoint inhibitor or any other agents targeting T-cell stimulation pathways * Taking a concomitant medication that is a strong Cytochrome P450 3A (CYP3A) inducer, or that is a substrate of CYP3A with a narrow therapeutic index * Known untreated parenchymal brain metastasis or have uncontrolled central nervous system (CNS) metastases. Patients must not require steroids and must be neurologically stable without corticosteroids for a minimum of 3 weeks prior to the commencement of the study. Patients with neurologic symptoms must undergo a CT/MRI to rule out occult CNS metastases. * Requirement for chronic systemic GC treatment, such as active autoimmune disease requiring systemic treatment (corticosteroids or other immunosuppressive medication) * Patients requiring inhaled glucocorticoids but have no other alternative treatment option if their condition deteriorates during the study. * Clinically relevant toxicity from prior systemic cytotoxic therapies or radiotherapy that in the opinion of the Investigator has not resolved to NCI-CTCAE v5.0 Grade 1 or less prior to the first dose of relacorilant. * Treated with the following prior to the first dose of relacorilant: 1. Any investigational product, systemic anticancer therapy, or radiation therapy within 21 days 2. Antibodies or anticancer vaccines within 60 days 3. Mifepristone or other GR antagonists within 5 half-lives of these medications 4. Adrenostatic medications within 5 half-lives of these medications * History of severe hypersensitivity to another monoclonal antibody * Other concurrent cancer or a history of another invasive malignancy within the last 3 years that has a likelihood of recurrence of >30% within the next 5 years. Adequately treated basal and squamous skin cancers, ductal carcinoma in situ, cervical cancer, prostate cancer, non-muscle invasive urothelial cancer or other tumors curatively treated with no evidence of disease are permissible. * Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus including: Chronic or active hepatitis B as diagnosed by serologic tests. In equivocal cases, hepatitis B or C polymerase chain reaction may be performed and must be negative for enrollment. * Clinically significant uncontrolled condition(s) or a condition which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's participation, including but not limited to: 1. Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 3 months before study entry. 2. Active infection that requires parenteral antibiotics. 3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Study Objectives The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Melphalan, Prednisone and Thalidomide Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Allocation: RANDOMIZED Masking: NONE

Inclusion Criteria: * newly diagnosed of multiple myeloma. * Age > 65 years * ECOG <= 3 * Written informed consent given at the time of randomization * Patients with age <= 65 but not eligible for high dose treatment with stem cells support Exclusion Criteria: * ECOG > 3 * current neoplasm.. * contraindications to use thalidomide * peripheral neurophaty

Study Objectives The purpose of this study is to exploratorily examine efficacy and safety in the participants with chemotherapy-naïve unresectable, advanced/recurrent colorectal carcinoma of Kirsten rat sarcoma-2 virus (KRAS) wild-type who have been treated with 6 cycles (2 weeks/cycle) of first-line mFOLFOX6 + panitumumab combination therapy and then assigned to two groups i.e., a group receiving 5-FU/LV + panitumumab combination therapy and a group receiving mFOLFOX6 + panitumumab combination therapy. Conditions: Colorectal Carcinoma Intervention / Treatment: DRUG: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab, DRUG: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria for enrollment: * Participants with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer) * Participants with measurable lesion(s) according to the RECIST ver. 1.1 * Participants who have not received chemotherapy for colorectal cancer. Participants who experience relapse more than 6 months after the final dose of perioperative adjuvant chemotherapy with fluoropyrimidine agents may be enrolled. * Aged >= 20 years at the time of enrollment * Participants classified as KRAS wild-type. However, the criteria will be changed to all patients who are verified to be of KRAS and NRAS wild-type when the KRAS and NRAS tests come to be covered by National Health Insurance, and the tests become feasible at medical institutions. * Participants who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment 1. Neutrophil count >= 1.5 × 10^3/μL 2. White blood cell count >= 3.0 × 10^3/μL 3. Platelet count >= 10.0 × 10^4/μL 4. Hemoglobin >= 9.0 g/dL 5. Total bilirubin <= 2.0 mg/dL 6. AST <= 100 U/L (<= 200 U/L if liver metastases are present) 7. ALT <= 100 U/L (<= 200 U/L if liver metastases are present) 8. Serum creatinine <= 1.5 mg/dL * Participants who are assessed at Eastern Cooperative Oncology Group (ECOG) performance status (P.S.) of 0 or 1 * Life expectancy of >= 6 months after enrollment * Participants who have given written consent to take part in the study after detailed explanation of the study prior to enrollment Inclusion criteria for randomization: * Participants who have received 6 cycles of mFOLFOX6 + panitumumab combination therapy * Participants who are assessed at ECOG P.S. of 0-1 in the 6th cycle. * Participants for whom PD or not evaluable has been denied on the RECIST 1.1 based on imaging tests conducted after the day of administration in the 6th cycle within 14 days (2 weeks). Exclusion Criteria for enrollment: * Radiotherapy received for a measurable lesion * Radiotherapy received within 28 days (4 weeks) prior to enrollment for a lesion other than measurable lesions. However, treatment to relieve pain associated with metastatic bone tumors was allowed. * Known brain metastasis or strongly suspected of brain metastasis * Synchronous cancers or metachronous cancers with a disease-free period of <= 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.). * Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.) * Participants who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy * Active hemorrhage requiring blood transfusion * Disease requiring systemic steroids for treatment (excluding topical steroids) * Intestinal resection and colostomy within 2 weeks prior to enrollment * History or obvious and extensive CT findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.) * Serious drug hypersensitivity * Local or systemic active infection requiring treatment, or fever indicating infection * Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhea (incapacitating symptoms despite adequate treatment) * Active hepatitis B and/or active hepatitis C * Known human immunodeficiency virus infection * Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study Exclusion criteria for randomization: * Participants in whom interstitial pneumonia has been newly diagnosed during the period from registration to randomization * Participants who have received radiotherapy during the period from registration to randomization * Other Participants judged by the investigator or sub-investigator to be ineligible for enrollment in the study

Study Objectives This randomized phase II trial is studying how alvocidib, cytarabine, and mitoxantrone hydrochloride work compared to cytarabine and daunorubicin hydrochloride in treating patients with newly diagnosed acute myeloid leukemia. Alvocidib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, mitoxantrone hydrochloride, and daunorubicin hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving alvocidib, cytarabine, and mitoxantrone hydrochloride is more effective than giving cytarabine and daunorubicin hydrochloride in treating patients with acute myeloid leukemia. Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia Intervention / Treatment: DRUG: alvocidib, DRUG: daunorubicin hydrochloride, DRUG: mitoxantrone hydrochloride, DRUG: cytarabine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * All adults with established, pathologically confirmed diagnoses of newly diagnosed AML and adults with newly diagnosed AML, excluding newly diagnosed core-binding factor (CBF) AMLs and acute progranulocytic leukemia (APL, M3), will be considered eligible for study * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 * Patients >= 65 years of age must have ECOG PS =< 2 prior to developing leukemic symptoms * Serum creatinine <= 2.0 mg/dL * Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 5 times upper limit of normal (ULN) (unless leukemic infiltration) * Total bilirubin =< 2.0 mg/dL (unless Gilbert disease, hemolysis, or leukemia) * Left ventricular ejection fraction >= 45% * Newly diagnosed AML, subtypes M0, 1, 2, 4-7 but excluding M3 (APL), including those with the following poor risk features: * Antecedent hematologic disorder including myelodysplasia (MDS)-related AML (MDS/AML) and prior myeloproliferative disorder (MPD) * Treatment-related myeloid neoplasms (t-AML/t-MDS) * Myeloid sarcoma, myeloid proliferations related to Down Syndrome, and blastic plasmacytoid dendritic cell neoplasm * AML with multilineage dysplasia (AML-MLD) * Adverse cytogenetics (defined as -5/-5q; -7/-7q; abnormal 3q, 9q, 11q, 20q, 21q, or 17p; t(6;9); t(9;22); trisomy 8; trisomy 13; trisomy 21; and complex karyotypes (>= 3 unrelated abnormalities) * Patients who have received hydroxyurea alone or have received non-cytotoxic therapies previously for myelodysplasia (MDS) or myeloproliferative disorder (MPD) (e.g., thalidomide or lenalidomide, interferon, cytokines, 5-azacytidine or decitabine, histone deacetylase inhibitors, low-dose cyclophosphamide [cytoxan], tyrosine kinase [TK] or dual TK/src inhibitors) will be eligible for this trial * At least 24 hours since prior leukopheresis or hydroxyurea for cytoreduction Exclusion Criteria: * Any previous treatment with flavopiridol * Concomitant chemotherapy, radiation therapy, or immunotherapy * Hyperleukocytosis with >= 50,000 blasts/uL; leukopheresis or hydroxyurea may be used immediately prior to study drug administration for cytoreduction; must be stopped 24 hours before first dose of study chemotherapy * CBF AMLs associated with t(8;21) or M4eo subtype (inv[16] or t[16;16]), as diagnosed by morphologic criteria, flow cytometric characteristics, and rapid cytogenetics or FISH or molecular testing * Acute Progranulocytic Leukemia (APL, M3) * Active central nervous system (CNS) leukemia * Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible * Active, uncontrolled graft vs. host disease (GVHD) following allogeneic transplant for non-AML condition (e.g. MDS, lymphoid malignancy, aplastic anemia); patients with GVHD controlled on stable doses of immunosuppressants are eligible * Presence of other life-threatening illness * Patients with mental deficits and/or psychiatric history that preclude them form giving informed consent or from following protocol * Pregnant and nursing patients are excluded

Study Objectives To evaluate the efficacy and safety of preoperative olaparib monotherapy and preoperative olaparib plus pembrolizumab combination therapy in patients with untreated stage III, IV high-grade serous or Grade 3 endometrioid ovarian cancer with Homologous Recombination Deficiency (HRD) positivity. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Olaparib, DRUG: Pembrolizumab Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Has given signed informed consent to participate in the clinical trial of her own will. * Is aged >= 20 years on the day of signing the informed consent. * Has been diagnosed with histologically confirmed, Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer by the International Federation of Gynecology and Obstetrics (FIGO) staging system (2014), with a histological type of high-grade serous or Grade 3 endometrioid carcinoma. * Have measurable disease based on RECIST 1.1. * Is a candidate for debulking surgery. * Has an HRD-positive tumor. * Has an ECOG Performance Status of 0 or 1. * Laboratory test results within 21 days prior to enrollment have met the following organ function criteria. However, measurements within 14 days of blood transfusion or administration of granulocyte-colony stimulating factor (G-CSF) are excluded. * Neutrophil count >= 1,500/mm3 * Platelet count >= 100,000/mm3 * Hemoglobin >= 9.0 g/dL * Serum creatinine <= 1.5 × ULN, or creatinine clearance >= 50 mL/min * T-Bil <= 2.0 mg/dL * ALT and AST <= 100 U/L (<= 200 U/L if liver metastasis is present) * A woman of childbearing potential must agree to use contraception after signing the informed consent, throughout the study period, and until at least 120 days following the last dose of the study drug Exclusion Criteria: * Has received previous allogeneic bone-marrow transplantation. * Has concurrent interstitial lung disease/pneumonitis, or a history of (noninfectious) interstitial lung disease/pneumonitis that required treatment with steroids. Interstitial lung disease/pneumonitis includes radiation pneumonitis. * Has received prior antitumor therapy (e.g., chemotherapy, molecular-targeted therapy, therapeutic antibody, endocrine therapy, immunotherapy, and investigational therapy). * Has received surgery under general anesthesia within 28 days prior to enrollment. However, surgery to diagnose ovarian/fallopian tube/peritoneal cancer performed under general anesthesia is allowed. * Has received radiation or radioactive isotope therapy within 28 days prior to enrollment. * Has uncontrolled pericardial effusion, pleural effusion, or peritoneal effusion. * Has a history of cerebral infarction, cerebral hemorrhage, or transient cerebral ischemia within 180 days prior to enrollment. * Has a history of deep vein thrombosis or pulmonary embolism. * Is receiving systemic glucocorticoid therapy or systemic immunosuppressive therapy. * Has a history of autoimmune disease. * Is infected with human immunodeficiency virus (HIV). * Is infected with active* hepatitis B or hepatitis C. *: Active hepatitis B is defined as HBs antigen positive. * Has a symptomatic infection within 14 days prior to enrollment. * Has received a live vaccine within 28 days prior to enrollment. * Has clinically critical cardiac disease (has a history of myocardial infarction or angina pectoris within 180 days prior to enrollment or has New York Heart Association [NYHA] class II or higher cardiac failure, uncontrolled arrhythmia, or QTc prolongation defined as QTc > 470 msec). * Has active brain metastasis or a tumor causing spinal cord compression. * Is pregnant or breastfeeding. * Has a history of severe allergy, anaphylaxis, or hypersensitivity induced by humanized chimeric antibodies. * Is allergic to biologics produced from Chinese hamster ovary (CHO) cells, carboplatin, or paclitaxel. * Has a known or suspected active malignancy that is different from the disease of interest in the clinical trial or has a history of other malignancy within 3 years prior to enrollment. However, cutaneous basal cell carcinoma and cervical carcinoma in situ are not part of this exclusion criterion. * Is unwilling to or unable to comply with the protocol. * Is not eligible to enroll in the clinical trial based on the judgment by the Investigator or Sub-investigator.

Study Objectives Context: Approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. There are no proven therapies for treating chronic arsenic toxicity or for preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a variety of animal models. The investigators have recently shown in animals and humans that this effect is mediated by the formation of \[(GS)2AsSe\]- , the seleno-bis(S-glutathionyl) arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two Phase II studies in China and Bangladesh have suggested clinical benefit to selenium supplementation in arsenicosis patients. Objective: To assess whether daily selenium supplementation counters arsenic toxicity in patients exposed to drinking water arsenic. If proven effective, selenium supplementation might be safely and cost-effectively implemented in the worst-affected localities. Conditions: Arsenical Melanosis, Arsenical Keratosis, Arsenical Cancers, Arsenicosis, Arsenic Exposure, Arsenic Toxicity, Arsenic Poisoning Intervention / Treatment: DRUG: sodium selenite, DRUG: placebo Location: Bangladesh Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Resident of Bangladesh in an arsenic-affected region (Chandpur) * Age between 12 and 55 * Exposure to arsenic in home drinking water greater than 50 ug/L. * Arsenical melanosis on the torso confirmed by epiluminescence microscopy Exclusion Criteria: * Recent history or plans to consume selenium-containing supplements * Anticipated change in home drinking water supply during study period

Study Objectives This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST). Conditions: Gastrointestinal Stromal Tumor (GIST) Intervention / Treatment: DRUG: Nilotinib (AMN107), DRUG: imatinib (STI571) Location: Hungary, Canada, Turkey, Egypt, United States, Colombia, Taiwan, Austria, France, Poland, Israel, Venezuela, Thailand, Italy, Netherlands, United Kingdom, Denmark, Singapore, South Africa, Russian Federation, Bulgaria, Spain, Brazil, China, Sweden, Mexico, Norway, Germany, Czech Republic, Japan, Korea, Republic of, Romania, Slovakia, Hong Kong, Argentina Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either: * have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or * recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies. * At least one measurable site of disease on CT/MRI scan * Performance status <= 2 (capable of self-care but unable to carry out any work) * Normal organ, electrolyte and marrow function Exclusion Criteria: * Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study. * Disease progression during adjuvant therapy with imatinib * History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ. * Impaired cardiac function Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives No standard regimen currently exists for the treatment of AIDS-related lymphoma. Based on the encouraging NCI results with DA-EPOCH, the US AIDS Malignancy Consortium is currently administering a phase II randomized protocol comparing EPOCH with sequential versus concurrent rituximab (AMC protocol 034). In this AMC trial, the decision to co-administer cART is left to the discretion of the treating physician and the patient. While the AMC phase II study may establish an acceptable chemotherapy regimen suitable for further study in a phase III randomized trial, the results will not address adherence, pharmacokinetic interactions or the role of cART in AIDS-related lymphoma. The contribution of cART to the anti-lymphoma efficacy of any regimen needs to be formally studied. Our proposed trial to demonstrate the feasibility of co-administering cART with chemotherapy would justify the use of combined therapy in future AMC/International phase III protocols. Conditions: Lymphoma, AIDS Related, HIV Infections Intervention / Treatment: DRUG: R-EPOCH and cART Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * HIV seropositivity * Biopsy diagnosis of a CD20+ diffuse large B-cell lymphoma or variants (including mediastinal (thymic) large B-cell lymphoma and plasmablastic lymphoma), atypical Burkit/Burkitt-like lymphoma, or Burkitt lymphoma diagnosed according to the World Health Organization (WHO) classification * Age >= 18 years Exclusion Criteria * Performance status >=3 according to ECOG (Zubrod) scale (see Appendix I) * Known primary central nervous system lymphoma or parenchymal brain involvement with lymphoma * Non-measurable disease by physical examination or radiographic evaluation * Absolute CD4+ cell count <50 cells/mm3 within 3 months prior to trial initiation * Inadequate hepatic function (total bilirubin >=35 µmol/L, alkaline phosphatase >=2 xUL normal, AST/ALT >=2 xUL normal) unless directly attributable to lymphoma or known Hepatitis B or C co-infection. * Inadequate renal function (serum creatinine >=125µmol/L) unless directly attributable to lymphoma * Inadequate haematological function (haemoglobin <=85 g/L, absolute neutrophil count <=1000 cells/mm3, platelet count <=75,000 cells/mm3) unless directly attributable to lymphoma or autoimmune thrombocytopenia. * Evidence of left ventricular (LV) dysfunction (ejection fraction <= 50%) in patients over the age of 60 or in patients with a prior history of hypertension, congestive heart failure, peripheral vascular disease, cerebrovascular disease, coronary artery disease, or cardiac arrhythmia * Pregnant or lactating women who intend to breast-feed during the trial period * Men of reproductive potential and women of childbearing potential who are not using or not willing to use effective contraception * Known intolerance to the prescribed chemotherapy or antiretroviral drugs * Life-expectancy <= 3 months * Geographically inaccessible for follow-up

Study Objectives This trial will investigate the addition of an antibody (Ipilimumab) to conventional Carboplatin and Etoposide chemotherapy in extensive stage small cell lung cancer. The primary objective is to establish the progression free survival at 1 year. Conditions: Extensive Stage Small Cell Lung Cancer Intervention / Treatment: BIOLOGICAL: Ipilimumab Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Willing and able to give written informed consent. * Histological or cytological diagnosis of small cell lung cancer. * Adequate baseline laboratory tests. * No active or chronic infection with HIV, Hepatitis B, or Hepatitis C. * Performance status ECOG 0 or 1. * Men and women, 18 years of age and above. Exclusion Criteria: * Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation. * Symptomatic CNS metastases. * A history of prior malignant tumour, unless the patient has been without evidence of disease for at least 5 years, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix. * Clinically significant autoimmune disease. * Any underlying medical, neurological or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs. * Administration of any live vaccine for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab). * Previous chemotherapy for small cell lung cancer. * A history of prior treatment with immunostimulatory antibodies ipilimumab, prior CD137 agonist or CTLA 4 inhibitor or agonist. * Concomitant therapy with any of the following: Interleukin 2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids. * Women of childbearing potential (WOCBP), as defined in the protocol and who: * Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the duration of their participation in the study and for at least 8 weeks after cessation of study drug, or * Have a positive pregnancy test at baseline, or * Are pregnant or breastfeeding.

Study Objectives The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with suspected kidney cancer with the same accuracy as conventional ultrasound and contrast-enhanced magnetic resonance imaging (MRI) Conditions: Kidney Cancer Intervention / Treatment: DRUG: Perflutren lipid microsphere, DRUG: Sulfur hexafluoride lipid microspheres Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * A suspected diagnosis of kidney cancer with a solid or partially solid lesion and planned surgical nephrectomy within 3 months before surgery * Able to provide informed consent * Willing to comply with protocol requirements * At least 18 years of age Exclusion Criteria: * Critically ill or medically unstable or in an intensive care setting and whose critical course during a potential observation period would be unpredictable * Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®) or sulfur hexafluoride (Lumason®) * Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome * Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives * Unstable cardiopulmonary disease including any of the following: * Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association) * Unstable angina * Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation) * Myocardial infarction within 14 days prior to the date of proposed microbubble administration. * Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained the same day as the CEUS, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses) * Obesity that limits obtainment of acceptable images

Study Objectives To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus cisplatin combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy. Conditions: Biliary Tract Cancer Intervention / Treatment: DRUG: gemcitabine , cisplatin Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Biliary tract cancer (BTC) with more than stage IB * BTC undergoing R0 or R1 resection without major hepatectomy * >= 20 years years old * PS0 or 1 * No treatment other than surgery * No dysfunction of main organs * Possible oral intake * Treatment start; after 4 weeks and within 12 weeks after surgery * Obtained written informed consent Exclusion Criteria: * Patients with resection of major hepatectomy * Patients with double cancers * Patients having severe allergy * Patients with severe organ dysfunction * Patients with active infectious disease * Pregnancy * Patients with severe psychological disease * Patients seem inadequate for this study by investigators

Study Objectives Examining the analgesic effect of ultrasound guided Pectoral Blocks on analgesic opioid consumption after surgical removal of breast tissue. This study's uniqueness is in the quantification of the analgesic effect of regional anesthesia on its influence to reduce the use of opioid substances, and the variety of side effects associated with them, which has yet to been described in literature. Conditions: Malignant Neoplasm of Breast Intervention / Treatment: PROCEDURE: PECS Block, DRUG: Bupivacaine 0.25-0.5% Location: Israel Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: Women over 18 who undergo breast tissue resection under general anesthesia at Beilinson Hospital, and are able to comply with the study's protocol Exclusion Criteria: * Lack of patient's consent or lack of patient's ability to provide consent. * Known hypersensitivity to local anesthetic or to opioid, which will affect the nature of the pain management therapy in these patients. * Existing evidence of infection or gangrene on the thorax which prevents implementation of regional anesthesia - . * Known coagulation disorder.

Study Objectives The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet. Conditions: Cathartic Colon, Colonic Neoplasms Intervention / Treatment: PROCEDURE: Diet, DRUG: Faecal Tagging, DRUG: Bowel cleansing, PROCEDURE: CT colonography Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Asymptomatic patients (Screening Patients) * Symptomatic patients unwilling to undergo optical colonoscopy (Symptomatic Patients) * Patients with a previous incomplete optical colonoscopy. Exclusion Criteria: * Allergy to Macrogol * Cognitive behavioral deficits

Study Objectives This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer. Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Denosumab, DRUG: Zoledronic acid, DRUG: Placebo to Denosumab, DRUG: Standard Chemotherapy, DRUG: Placebo to Zoledronic Acid Location: Canada, Germany, Italy, Netherlands, United Kingdom, United States, Australia, Greece, Czechia, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Histologically or cytologically confirmed stage IV non-small cell lung carcinoma (NSCLC), according to 7th Tumor/Node/Metastasis (TNM) classification (cytological specimens obtained by bronchial washing or brushing, or fine-needle aspiration are acceptable) * Subject has available and has provided consent to release to the sponsor (or designee) a tumor block with confirmed tumor content (or approximately 20 unstained charged slides [a minimum of 7 slides is mandatory]) and the corresponding pathology report * Planned to receive 4 to 6 cycles of pemetrexed or gemcitabine in combination with cisplatin or carboplatin * For subjects to receive pemetrexed, planned to receive vitamin B12 and folate per pemetrexed approved labeling * Radiographically evaluable (measurable or non-measurable) disease (according to modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria * Other inclusion criteria may apply Exclusion Criteria: * Known presence of documented sensitizing epidermal growth factor receptor (EGFR) activating mutation or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) translocation (screening following local standards, but strongly encouraged in non-squamous histology) * Known brain metastases (systematic screening of patients not mandatory) * Any prior systemic therapy (before randomization) for the treatment of NSCLC (including chemoradiation), except if for non-metastatic disease and was completed at least 6 months prior to randomization * Planned to receive bevacizumab * Significant dental/oral disease, including prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw, or with the following: * Active dental or jaw condition which requires oral surgery * Non-healed dental/oral surgery * Planned invasive dental procedures for the course of the study.

Study Objectives The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC) treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant radiotherapy in elderly patients. Conditions: Non Small Cell Lung Cancer Intervention / Treatment: DRUG: Cisplatin IV, DRUG: Vinorelbine, RADIATION: Radiotherapy Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age >= 70 years * Independent patients (based on the score of geriatric frailty: IADL = 0, ADL = 0, no geriatric syndrome, low comorbidity (comorbidity index of Charlson to 3 or 4), depression score 0-1) * Performance Status (ECOG) <= 1 * Weight loss <10% of usual weight in the last 3 months * Life expectancy greater than 12 weeks * Hematologic function: neutrophils> 1.5 x 10**9 / l, hemoglobin> 9.5 g / dl, platelets > 100 x 10**9 / l) * Renal function: creatinine clearance >= 50 ml / min calculated by the formula of MDRD * Normal liver function: bilirubin < Limit of Normal (ULN), SGOT and / or SGPT <2.5 x UNL * Respiratory Function: FEV >= 40% predicted, PaO2 >= 60 mm Hg, KCO >= 60% predicted * Patient affiliated to a social security regimen or beneficiary of such regimen * Informed consent signed The disease * Pathological anatomy: CBP non-small cell (squamous cell carcinoma, adenocarcinoma, large cell carcinoma, undifferentiated carcinoma) histologically or cytologically proven * Stage IIIAN2 considered inoperable stage IIIB * Presence of at least one measurable target * Delay at least three weeks between surgery and initiation of treatment * No prior treatment with chemotherapy or radiotherapy for lung cancer Exclusion Criteria: * Age < 70 years * Performance Status (ECOG) >= 2 * Hematologic function: neutrophils <1.5 x 10**9 / l, hemoglobin <9.5 g / dl, platelets <100 x 10**9 / l) * Renal function: creatinine clearance <50 ml / min calculated by the formula of MDRD * Hepatic: bilirubin> Upper Limit of Normal (ULN), SGOT and / or SGPT> 2.5 x ULN * Respiratory Function: FEV <40% predicted, KCO <60% predicted, PaO2 <60 mmHg * Peripheral neuropathy grade> 1 * Unstable cardiac pathology requiring treatment (heart failure, angor of effort, arrhythmia) or previous myocardial infarction older than 12 months * Deafness not paired or deafness requiring major achievement of an audiogram-cons may indicate taking cisplatin * Neurological or psychiatric disorders prohibiting the understanding of the test * Previous history of cancer except basal cell cancer, carcinoma in situ of the cervix treated or any other cancer treated with surgery alone or radiotherapy alone extra-thoracic recurrence-free 5 years * Significant malabsorption syndrome or disease affecting the functioning of the gastrointestinal tract The disease * Pathological anatomy: Bronchioloalveolar carcinoma, neuroendocrine carcinoma, small cell carcinoma * Metastatic disease * Pleural drain * Carcinomatous lymphangitis * Operable Cancer * Previously treated for lung cancer disease: radiotherapy, chemotherapy, hormonal therapy, endobronchial suctioning older less than eight days

Study Objectives The goal of this clinical research study is to learn if the drug ZD1839 (Iressa) can shrink or slow the growth of cancer in participants with recurrent and/or metastatic squamous cell cancer (SCC) of the skin. The safety of this drug will also be studied. Conditions: Skin Cancer Intervention / Treatment: DRUG: Iressa 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: * Provision of written informed consent. * Pathologically confirmed locoregional recurrence and/or metastatic SCC of the skin not amenable to curative therapy (i.e., surgery or radiation). * Evaluable and/or measurable disease. (Based on Union for International Cancer Control (UICC)/World Health Organization (WHO) Criteria) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Adequate hematologic function as defined by an absolute neutrophil count >= 1,500/mm3, a platelet count >= 100,000/mm3, a white blood count (WBC) >= 3,000/ mm3, and a hemoglobin level of >= 9 g/dl. * Up to one prior chemotherapy regimen. * At least a 2-week recovery from prior therapy toxicity. * Age >= 18 years. * Disease free from a previously treated malignancy, other than the disease under study, for greater than 3 years. Patients with a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix, completely resected breast cancer will not be excluded. * Women of childbearing potential and men must be willing to practice acceptable methods of birth control to prevent pregnancy. Exclusion Criteria: * Prior ZD1839 or other Epidermal growth factor receptor (EGFR) inhibiting agents. * Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ. * Any unresolved chronic toxicity greater then Common Terminology Criteria (CTC) grade 2 from previous anticancer therapy. * Incomplete healing from previous oncologic or other major surgery. * Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, St John's Wort. Patients taking anticoagulants must have coagulation parameters followed (i.e., Prothrombin time (PT) or Partial thromboplastin time (PTT)). * Absolute neutrophil count (ANC) less than 1,500/mm**3 or platelets less than 100,000/mm**3. * Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR). * In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease). * Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the Upper Limit of the Reference Range (ULRR) in the presence of liver metastases. * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial. * Pregnancy or breast feeding (women of child-bearing potential) * The patient has an uncontrolled seizure disorder or active neurological disease. * The patient has received any non-approved or investigational agent(s) within 30 days before Day 1 of study treatment. * Known, severe hypersensitivity to ZD1839 or any of the excipients of this product. * Any evidence of clinically active Interstitial Lung Disease (ILD) (patients with chronic, stable radiographic changes who are asymptomatic need not be excluded).

Study Objectives Observational, longitudinal (retrospective cohort), multicenter, national study aiming to evaluate the proportion of women with HR+/HER2- advanced breast cancer treated with ribociclib plus non-steroidal aromatase inhibitors who were alive and without disease progression at 1 year. Conditions: Breast Cancer Intervention / Treatment: DRUG: Ribociclib Location: Brazil Study Design and Phases Study Type: OBSERVATIONAL

Inclusion criteria * Female patient >= 18 years of age. All the patients must have at least one year of follow-up * Patients at an age not consistent with postmenopausal status could only participate if they had oophorectomy surgery or being on treatment with goserelin for ovarian suppression Post-menopausal women defined as age >= 60 years old or < 60 years old and amenorrhea for 12 months or more (in the absence of chemotherapy, tamoxifen, toremifene or goserelin use for ovarian suppression) * Confirmed diagnosis of HR+/HER2- locally advanced or metastatic BC * Never in use of CDK 4/6i Exclusion criteria * Patients in menopause status other than postmenopausal (young patients must have undergone oophorectomy being on treatment with goserelin for ovarian suppression to be characterized as postmenopausal) * Previous use, at any time, of CDK 4/6i * The patient received any previous systemic therapy for advanced breast cancer Patients who have received (neo)adjuvant therapy for breast cancer are eligible. If previous (neo) adjuvant therapy has included letrozole or anastrozole, the disease- free interval should be longer than 12 months from completion of treatment until entry in this trial Patients who received <=28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible * Uncontrolled heart disease and/or clinically significant cardiac repolarization abnormalities

Study Objectives The purpose of this research study is to determine whether we can purify and grow a population of cells from the participants blood (iNKT cells) and then safely give them back to the participant in increased numbers, and whether these cells will then stimulate the bodies own immune response against the cancer. These iNKT cells have been used in laboratory studies and information from these and other research studies suggest that increasing the number of these cells in the blood can stimulate the immune response against tumors. Conditions: Malignant Melanoma Intervention / Treatment: BIOLOGICAL: INKT, DRUG: GM-CSF 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: * Stage IV melanoma * ECOG Performance Status 0-1 * Estimated life expectancy of 6 months or greater * 18 years of age or older * Adequate renal, hepatic and hematological function as outlined in protocol * Adequate pulmonary and cardiac function as outlined in protocol * Prior therapies must be discontinued at least 4 weeks prior to the leukopheresis to obtain iNKT cells. This does not include palliative surgery or radiation therapy, which may be used prior to leukopheresis or during the interval between leukopheresis and iNKT cell reinfusion * Melanoma patients must not have brain metastases based on a negative MRI obtained within 4 weeks prior to screening, and must not have a history of brain metastases * No other significant medical, surgical or psychiatric condition that, in the judgment of the PI, would interfere with compliance to the protocol regimen Exclusion Criteria: * Pregnant or nursing women * Active systemic infection, positive HIV, HBV, or HCV serology, or immune deficiency disease * Autoimmune disease that currently requires systemic therapy with immunosuppressive agents * Known hypersensitivity to GM-CSF or DMSO * Other active malignancy other than squamous cell or basal cell of the skin

Study Objectives The purpose of this study is to learn what effects digoxin (DIG) may have on human breast cancer tissue. Conditions: Breast Cancer Intervention / Treatment: DRUG: Digoxin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: BASIC_SCIENCE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Female sex * 18-70 years of age at time of consent. * Histologically confirmed infiltrating carcinoma of the breast (Stage I-III) * Unresected disease that meets scheduled to undergo definitive surgery; tumor size >= 1cm; grade 2 or 3 tumor or Ki-67 proliferation index of >= 10%; and, any estrogen receptor (ER), progesterone receptor (PR) or human epidermal growth factor receptor 2 (HER2) status * Patients must not have received any prior treatment of any kind to treat the current breast cancer. * Prior use of hormone contraceptives and replacement therapy is allowed, but must have been discontinued at least 30 days prior to the diagnostic biopsy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky 80%-100%) * Patients must have normal organ and marrow function: absolute neutrophil count (ANC) >= 1,500/mm3; platelet count >= 100,000/mm3; bilirubin (total) less than or equal to the upper limit of normal; creatinine <= 1.5 times the upper limit of normal with creatinine clearance >= 50 mL/min using the Modified Cockcroft-Gault method; and, all of the following within normal limits: thyroid stimulating hormone (TSH), magnesium, potassium, sodium, calcium. * Heart rate > 60 beats/minute and < 100 beats/minute (clinical exam). * Not pregnant or nursing * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Current use of any investigational agents * Radiological evidence of metastatic disease * History of allergic reactions attributed to compounds of similar chemical or biologic composition to digoxin * Concomitant use of these drugs at baseline and for the duration of digoxin administration (if randomized to receive it): the calcium channel blockers diltiazem or verapamil; cardiac arrhythmic agents (such as quinidine, amiodarone); indomethacin (Indocin); alprazolam (Xanax); diuretics (such as furosemide, spironolactone, itraconazole); beta-blockers (such as atenolol, metoprolol); calcium carbonate antacids (e.g., Maalox, Tums, Rolaids); proton pump inhibitors; antidiarrheal adsorbents (kaolin and pectin); antibiotics; other P450 inducer/inhibitors. Note: Patients already receiving digoxin are also excluded. * Presence of any of the following on electrocardiogram (ECG): atrial arrhythmias, including atrial fibrillation and flutter; AV block; heart rate < 60 beats/minute and > 100 beats/minute; ventricular Fibrillation; ventricular tachycardia; premature ventricular contractions; Wolff-Parkinson-White syndrome. Note: Any questions on cardiac eligibility should be reviewed by the Study Cardiologist for approval in advance of enrollment. * History of any of the following, unless approval is given by the Protocol Chair: heart disease, including acute myocardial infarction; cardiac arrhythmias, including sick sinus syndrome; pulmonary disease with a known forced expiratory volume (FEV) of <1.5 or on oxygen; gastrointestinal disease, surgery or malabsorption that could potentially impact the absorption of the study drug; patients requiring the use of a feeding tube; inability to swallow tablets * 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 will limit compliance with study requirements * Any medical condition which in the opinion of the investigator puts the patient at risk of potentially serious complications while on this therapy

Study Objectives The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World Health Organization (WHO) classification of lymphoid neoplasms. Conditions: Lymphoma, T-Cell, Peripheral Intervention / Treatment: OTHER: No Intervention Location: Spain Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Participants diagnosed with PTCL in the six years between 01/01/2008 and 31/12/2013. * Availability of initial tumor biopsy diagnosis in paraffin block (node or core biopsy of 16-18mm). * PTCL subtypes permitted by WHO 2008 classification of lymphoid neoplasms: * Natural killer/ T-lymphocytes (NK /T-cell) lymphoma extranodal nasal type * Enteropathic T-cell lymphoma * Hepatosplenic T-cell lymphoma * Peripheral T-cell lymphoma, not otherwise specified * Angioimmunoblastic T-cell lymphoma * Anaplastic large cell lymphoma, Anaplastic lymphoma kinase positive (ALK)+ * Anaplastic large cell lymphoma, ALK- Exclusion Criteria: * Participants with an unavailable history (lost, empty or not recoverable).

Study Objectives The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with cancer receiving chemotherapy, and to investigate possible quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production. Conditions: Anemia, Multiple Myeloma, Lymphoma, Breast Cancer, Ovarian Cancer, Carcinoma, Small Cell Lung, Esophagus Cancer, Prostate Cancer, Neoplasm Intervention / Treatment: DRUG: epoetin alfa Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Confirmed diagnosis of multiple myeloma, lymphoma, breast cancer, ovarian cancer, small-cell lung cancer, esophagus cancer, or prostate cancer * receiving treatment with chemotherapy, with at least 3 additional months of chemotherapy planned * a self-care performance score of 0 (fully active, no disease restriction) to 3 (capable of only limited self-care, confined to bed or chair more than 50% of waking hours) * life expectancy of at least 6 months * baseline hemoglobin <12 grams per deciliter and baseline count of <100,000 microliter for developing red cells Exclusion Criteria: * Clinically significant disease other than cancer * evidence of uncontrolled hypertension or history of seizure * transfusion within 1 week of the study * radiotherapy within 2 weeks of study start * use of corticosteroid or steroid drugs during the study.

Study Objectives The purpose of the study is to determine the safe and tolerable doses of sunitinib given together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients who have advanced gastric cancer who have not received prior chemotherapy for their advanced cancer Conditions: Stomach Neoplasms Intervention / Treatment: DRUG: capecitabine, DRUG: oxaliplatin, DRUG: sunitinib malate, DRUG: capecitabine, DRUG: cisplatin, DRUG: sunitinib malate Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * confirmed diagnosis of stomach cancer * advanced stomach cancer of stage IV * adequate blood chemistry, blood counts and kidney function * willing to participate to study requirements and sign an informed consent document Exclusion Criteria: * prior chemotherapy for the stomach cancer in its advanced stage * excessive toxicities related to prior therapies * pregnant or breastfeeding patients

Study Objectives This is a phase Ib, open-label, single-arm, single-center study conducted in Canada. Subjects with NMIBC (Ta, T1, and/or Tis) who are not candidates for or have refused radical cystectomy will be eligible for participation in the study. Bacillus Calmette-Guerin (BCG) intolerance or refractory disease are defined as inability to tolerate or failure to achieve a tumour-free state after at least one induction (a minimum of 5 instillations) followed by either a second induction (a minimum of 5 instillations) or at least 2 maintenance instillations. Subjects experiencing disease relapse within 12 months or less after finishing the second course of BCG therapy are also considered refractory. The study will consist of 2 phases. In the first phase, 3 subjects will receive PDT (TLC-3200 System) employing 0.35 mg/cm\^2 (maximum recommended starting dose) TLD1433. If treatment with the maximum recommended starting dose does not raise significant safety concerns as determined by the safety monitoring committee, an additional 6 subjects will receive PDT with 0.70 mg/cm\^2 (therapeutic dose) TLD1433. Conditions: Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG Intervention / Treatment: DRUG: TLD1433 infusion and photodynamic therapy (PDT) treatment Location: Canada 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. * Have histologically confirmed NMIBC (T1, Ta, and/or Tis) according to the 2004 World Health Organization (WHO) classification within 8 weeks prior of treatment initiation. Participants with tumours of mixed transitional / non-transitional cell histology are eligible, but urothelial carcinoma must be the predominant histology. Participants with predominant or exclusively non-urothelial histology are not eligible. Confirmation of histology, grade and stage will be performed by local review and must be completed prior to enrolment. * For participants with Ta and T1, they must have undergone complete TURBT defined as absence of resectable disease after at least 2 cystoscopy / TURBT procedures. The most recent cystoscopy must have been performed no longer than 8 weeks prior to the first dose of trial treatment. * Have been considered intolerant or refractory to first-line BCG therapy defined as inability to tolerate or failure to achieve a tumour-free state after at least one induction (minimum of 5 instillations) followed by at either a second induction (minimum of 5 instillations) or at least 2 maintenance instillations. Participants experiencing disease relapse within 12 months or less after finishing the second course of BCG therapy are also considered refractory. * Are not candidates for cystectomy on medical grounds or refuse radical cystectomy. * Have a performance status of 70 or more on the Karnofsky Performance Status Scale as assessed within 28 days prior to treatment initiation. * Have no evidence of upper urothelial carcinoma (involving the upper urinary tract or the urethra) (confirmed by staging to exclude extravesical disease, which may include radiological imaging and/or biopsy) within 3 months of treatment initiation. If previous work up occurred more than 3 months prior to treatment initiation, staging for extravesical disease must be repeated prior to enrolment in order to determine eligibility. * Have satisfactory bladder function. Ability to retain instillate for a minimum of 1 hour, even with premedication. * Are available for the duration of the study including follow-up (approximately 12 months). * Female participants of childbearing potential must have a negative urine or serum pregnancy test 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 participants of childbearing potential must be willing to use 2 methods of birth control (oral contraceptive, pills, diaphragm, or condoms) 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. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >1 year. Male participants must agree to use an adequate method of contraception (oral contraceptive, pills, diaphragm, or condoms) starting with the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria: * Past or current muscle invasive (i.e., T2, T3, T4) or metastatic urothelial carcinoma. * Has concurrent extravesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium. * Have 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 that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable, provided that the following criteria are met: Stage T2N0M0 or lower; Prostate-Specific Antigen undetectable for 5 years while off androgen deprivation therapy. * Have a known psychiatric or substance abuse disorder that would interfere with meeting the requirements of the trial. * Have a history or current evidence of any condition, therapy, surgery or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the participant's participation in the trial, or is not in the best interest of the participant to participate. * Currently receiving any photosensitizing medications. * Have a known hypersensitivity to ruthenium. * Currently receiving treatment with a prohibited concomitant therapy (refer to 12.2.1, Prohibited Medications). * Participated in a study with an investigational agent or device within 3 months from the first dose of current study treatment. * Prior treatment with an intravesical chemotherapeutic agent within 3months of the first dose of current study drug, with the exception of a single perioperative dose of chemotherapy immediately post-TURBT (not considered treatment). * Have an active infection requiring systemic therapy, including active or intractable urinary tract infection (UTI), in the last month. * Has any contraindication to general or spinal anesthesia. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. * Known history of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies). * Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., hepatitis C virus (HCV) RNA [qualitative] is detected). * Received a live virus vaccine within 30 days of planned start of trial treatment. * Have a diagnosis of psoriasis.

Study Objectives TACE is considered the standard treatment for unresectable HCC and is widely used as a palliative treatment. However there is no consensus of the protocol of TACE.One of the variation is does the stability of the suspension by emulsified the lipiodol and the contrast medium used to dissolve the anticancer agents really effect the survival.Thus the investigators conduct this prospective,randomized controlled study to find out if the different method of preparing chemotheraputic drugs can cause a different survival benefit. Conditions: Hepatocellular Carcinoma Intervention / Treatment: OTHER: Solvent with specific gravity less than lipiodol, OTHER: Solvent with specific gravity equivalent to lipiodol Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Male or female patients > 18 years and <=70 years of age with a diagnosis of HCC * BCLC B stage disease * Not amendable to surgical resection ,local ablative therapy and any other cured treatment. * Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. The lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation. * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Not pregnant or breast-feeding patients * No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis * The following laboratory parameters: * Platelet count >= 60,000/µL * Hemoglobin >= 8.5 g/dL * Total bilirubin <= 1.5 mg/dL Serum albumin >= 35 g/L * ASL and AST <= 5 x upper limit of normal * Serum creatinine <= 1.5 x upper limit of normal * INR <= 1.5 or PT/APTT within normal limits * Absolute neutrophil count (ANC) >1,500/mm3 * Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug * Serious non-healing wound, ulcer, or bone fracture * Known central nervous system tumors including metastatic brain disease * severe Arterioportal Shunts or Arteria vein Shunts

Study Objectives This pilot clinical trial studies cesium Cs 131 brachytherapy in treating patients with head and neck cancer that has come back (recurrent) and can be removed by surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Radioactive drugs, such as cesium Cs 131, may carry radiation directly to tumor cells and not harm normal cells. Permanently implanting cesium Cs 131 into the wound bed after surgery may help treat microscopic cancer cells that may be in the tissue after surgical removal of the tumor. Conditions: Recurrent Head and Neck Carcinoma Intervention / Treatment: RADIATION: Brachytherapy, DRUG: Cesium-131, PROCEDURE: Conventional surgery Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis: Subjects with a diagnosis of recurrent head and neck cancer * Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively * Age: Subjects must be >= 18 years of age and <= 90 years old * Informed Consent: All subjects must be able to comprehend and sign a written informed consent document Exclusion Criteria: * Subjects who are pregnant or may become pregnant * Unresectable tumor * Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study

Study Objectives Phase II trial to study the effectiveness of interleukin-12 in treating patients with previously treated non-Hodgkin's lymphoma or Hodgkin's disease. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill lymphoma cells. Conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent 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 Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia Intervention / Treatment: BIOLOGICAL: recombinant interleukin-12, OTHER: laboratory biomarker analysis 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: * Previously treated non-Hodgkin's lymphoma (all histologies except lymphoblastic and Burkitt's lymphoma) or Hodgkin's disease * Maximum of 4 previous treatment regimens * Measurable disease * No CNS involvement * Performance status - Zubrod 0-1 * Performance status - Karnofsky 80-100% * At least 12 weeks * Platelet count at least 75,000/mm^3 * Absolute neutrophil count greater than 1500/mm^3 * Lymphocyte count greater than 500/mm^3 * Hemoglobin at least 8.0 g/dL * Bilirubin less than 1.5 mg/dL * SGOT/SGPT less than 2 times normal * Creatinine no greater than 1.6 mg/dL * Creatinine clearance at least 60 mL/min * No severe cardiovascular disease including active ischemic heart disease, congestive heart failure, or major arrhythmias * No severe pulmonary disease including dyspnea with moderate to severe exertion * HIV negative * No active infection * Not pregnant or nursing * Fertile patients must use adequate contraception * No clinically significant autoimmune disease (e.g. rheumatoid arthritis) * No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer * No prior allogeneic bone marrow or stem cell transplant * At least 3 weeks since prior biologic therapy for lymphoma * At least 3 weeks since prior chemotherapy for lymphoma * No concurrent steroid therapy * At least 3 weeks since prior endocrine therapy for lymphoma * At least 3 weeks since prior radiotherapy for lymphoma * At least 2 weeks since prior surgery

Study Objectives Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients. Once the examining physician has decided on the therapeutic approach and if the selection criteria are fulfilled, he will propose the patient to participate in the study. An informed consent form will be collected for all participants in the study. There are 2 possible study visits that coincide with a routine consultation, namely visit 1 (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment benefit of the patient. Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both visits, if available. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Depo-Eligard® Location: Belgium Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients having been prescribed Depo-Eligard® 7.5 mg - 22.5 mg - 45 mg in accordance with the terms of the marketing authorization.

Study Objectives The aim of the study is to evaluate the efficacy and safety of Bemiparin, a second-generation LMWH, in the prophylaxis of VTE (using a postoperative regimen, i.e. administering the first dose 6 hours after finishing the surgical procedure) for 28 days compared to 8 days, in oncological surgery. Conditions: Cancer, Venous Thromboembolism Intervention / Treatment: DRUG: Bemiparin Location: Portugal, Russian Federation, Romania, Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Patients of 40 years of age or older, of either sex, who have given their informed consent to participate in the study. * Patients with a malignant neoplastic process (primary or metastasic) of the gastrointestinal tract (except the oesophagus), genitourinary tract or female reproductive organs, previously diagnosed and documented, and who are programmed to undergo elective, open, curative or palliative surgery directly related to that disease. * Patients undergoing surgery with general or spinal anaesthesia, with an estimated duration of surgery of over 30 minutes. * Patients with a life expectancy of at least 3 months. Exclusion Criteria: * Curative or palliative surgery of a malignant neoplastic process in liver, biliary tract or pancreas. * Women who are pregnant or breast-feeding, or women with child-bearing potential who are not using effective contraceptive methods. * Patients with macrohaematuria, active haemorrhage within the past two months, organ lesions at risk of bleeding (e.g. active peptic ulcer, haemorrhagic cerebrovascular accident, aneurysms), a history of episodes of clinically evident haemorrhage, major surgery in the previous month or an increase in the risk of bleeding due to any disturbance of haemostasis which would contraindicate the anticoagulant therapy, with the exception of bleedings episodes directly caused by tumour subjected to the surgical intervention. * Patients with known hypersensitivity to the LMWHs, to heparin or to substances of porcine origin. * Patients with known hypersensitivity to radiological contrast media. * Patients with known hypersensitivity to anaesthetic drugs or pre-anaesthetic drugs. * Patients with a congenital or acquired bleeding diathesis (confirmed by hematological test), with or without haematuria. * Lesions or surgical interventions of the central nervous system, eyes or ears within the previous 6 months, including hemorrhagic or ischemic cerebro-vascular accident, cerebral thrombosis and/or known cerebral metastasis. * Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced thrombocytopenia. * Acute bacterial endocarditis and slow endocarditis. * Patients on treatment with oral or parenteral anticoagulants within 5 days before the operation. * Patients with a history of thrombocytopenia associated with heparin or with a current platelet count <75,000/mm3. * Patients with renal failure (defined as a serum creatinine over 2 mg/dL), hepatic insufficiency (with AST and/or ALT values > 5 times over normal values established by the reference range of the local laboratory of the hospital). * Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg). * One or more documented episodes of DVT and/or PE (confirmed by a ventilation-perfusion gamma scan or helical CT) in the previous 3 months. * Patients with suspected or confirmed inability to comply with the study treatment and/or follow-up. * Patients who are participating in another clinical trial or who have done so in the past 30 days. * Patients with a cava vein filter in place. * Patients needing the use of unallowed concomitant treatments or medications such as more than 125mg/day aspirin, NSAIDs with long half-life of significant anti-aggregation activity, metformin, or any anticoagulant compound (please refer to section of the protocol "Concomitant medications and treatments" for details)

Study Objectives This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers. The subjects administer 240mg of lazertinib of different formulations on the fasted status on each period and have a wash-out period for 14-21 days between the first and second period. Conditions: Healthy Adult Volunteers Intervention / Treatment: DRUG: Lazertinib(G001), DRUG: Lazertinib(G002) Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Male, over 19 years of age * Male participants must agree to use an adequate contraception method from the first to the third month after the last dose. * Participants must have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive(BMI = weight/height2), and body weight not less than 50 kg. * Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis. * Participants must be healthy on the basis of clinical laboratory tests performed at screening. * Informed of the investigational nature of this study and voluntarily agree to participate in this study. Exclusion Criteria: * Clinically significant medical or psychiatric illness. * Hypotension (SBP <= 90 mmHg or DBP <= 50 mmHg) or hypertension (SBP >= 150 mmHg or DBP >= 100 mmHg). * A marked baseline prolongation of QTc. * Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications * Participants who are planning COVID-19 vaccine within 14 days before the first intake of study drug and to the end of the trials.

Study Objectives A phase 1/2, open-label, study to determine the safety and preliminary efficacy of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups. Conditions: Bladder Cancer, Gastric Cancer, Non Small Cell Lung Cancer, NSCLC, Urothelial Carcinoma, Advanced Solid Tumor Intervention / Treatment: DRUG: APR-246 (eprenetapopt) + Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Signed informed consent form (ICF) and ability to comply with protocol requirements. * Known tumor TP53 mutation status from recent or archival sample. * Histologically and/or cytologically confirmed solid tumor malignancy 1. Safety lead in- Advanced non-central nervous system (CNS) primary tumors that have progressed after first line treatment, who are intolerant to first line treatment, or who are unable to receive first line treatment, and for whom pembrolizumab, or pembrolizumab-based therapy is considered appropriate 2. Expansion 1- Patients with a confirmed diagnosis of advanced gastric or gastroesophageal junction (GEJ) tumors that have progressed after first line treatment, who are intolerant to first line treatment, or who are unable to receive first line treatment 3. Expansion 2- Patients with a confirmed diagnosis of advanced bladder/urothelial tumors that have progressed after first line treatment, or who are intolerant to first line treatment, or who are unable to receive first line treatment with cisplatin-based chemotherapy. 4. Expansion 3- Confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) previously treated with anti-PD-1 or anti-PD-L1 therapy. * Adequate organ function 1. Creatinine clearance > 30 mL/min 2. Total serum bilirubin < 1.5 × upper limit of normal (ULN) unless due to Gilbert's syndrome, tumor involvement, hemolysis or considered an effect of regular blood transfusions 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 × ULN, unless due to involvement by the underlying malignancy. * Projected life expectancy of >= 12 weeks. * Age >= 18 years at the time of signing the ICF. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * In the expansion portion, measurable disease meeting the following criteria: 1. At least 1 lesion of >=10 mm in the longest diameter (LD) for a non-lymph node or >=15 mm in the short-axis diameter for a lymph node that is serially measurable according to RECIST 1.1. 2. Lesions that have had external beam radiotherapy or loco-regional therapies such as radiofrequency ablation must show subsequent evidence of substantial size increase (ex. 20% increase in LD) to be deemed a target lesion. * Negative serum or urine pregnancy test prior to study treatment initiation in female subjects of childbearing potential. * Women of childbearing potential and men with female partners of childbearing potential must be willing to use an effective form of contraception Exclusion Criteria: * Known history of untreated human immunodeficiency virus (HIV)/HIV with a detectable viral load or active hepatitis B or active hepatitis C infection. * Cardiac abnormalities * Concomitant malignancies or previous malignancies with less than a 1-year disease-free interval at the time of signing consent. * Pregnancy or lactation. * Active uncontrolled systemic infection. * An autoimmune condition requiring >= 10 mg (or equivalent corticosteroid) prednisone daily, or any other systemic immunosuppressive treatment within 28 days of first dose of study therapy. * Known history of active tuberculosis. * Current (non-infectious) pneumonitis, or a history of pneumonitis that required steroids. * A live vaccine administered within 30 days of the first dose of study treatment. * Receipt of any investigational product within 14 days or 5 half-lives prior to study treatment initiation, whichever is shortest. * Prior intolerance to pembrolizumab or other anti-PD-1/PD-L1 agents.

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

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

Study Objectives The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923 (XL139) when orally administered on a once daily schedule. Conditions: Cancer Intervention / Treatment: DRUG: BMS-833923 (XL139) Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment * Men and woman, 20 years of age and above Exclusion Criteria: * Subjects with symptomatic brain metastasis or active brain metastasis requiring treatments * Inability to swallow oral medication * Uncontrolled or significant cardiovascular disease * Inadequate bone marrow function * Inadequate hepatic function * Inadequate renal function * Pancreatitis

Study Objectives In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high expression of Notch1. Conditions: Hepatocellular Carcinoma, TACE, Notch1, Rg3 Intervention / Treatment: PROCEDURE: TACE, DRUG: Rg3, OTHER: TACE + Rg3, PROCEDURE: protective therapy Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Pathologically confirmed hepatocellular carcinoma. * High expression of Notch1 in tumor tissues. Exclusion Criteria: no pathological evidence of HCC

Study Objectives The purpose of this study is to find out what effects, good and/or bad, intermittent dosing of the drug Selumetinib will have on subjects with uveal melanoma. Selumetinib is a drug that blocks (or turns off) methyl ethyl ketone (MEK), a protein activated in some uveal melanoma cells. Selumetinib is a MEK inhibitor. Blocking MEK may stop the cancer from growing. Conditions: Uveal Melanoma Intervention / Treatment: DRUG: Selumetinib, 100mg, DRUG: Selumetinib, 125mg, DRUG: Selumetinib, 150mg, DRUG: Selumetinib, 175mg, DRUG: Selumetinib, 200mg, DRUG: Selumetinib, 225mg Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Histopathologically confirmed diagnosis of metastatic or unresectable uveal melanoma. Note - Documentation of mutation status for uveal melanoma will not be required prospectively given the high rate of GNAQ/11 mutations (>90%) in this population * Able to provide informed consent prior to initiation of study * Age >= 18 years old * Measurable indicator lesion by RECIST v1.1 * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >=20 mm with conventional techniques or as >=10 mm with spiral CT scan, MRI, or calipers by clinical exam. * Karnofsky Performance Status >= 60% or Eastern Cooperative Oncology Group (ECOG) <=2 * Ability to take oral medications * All clinically significant toxicities from prior therapy must be <= grade 1 (with the exception of alopecia) * Organ and marrow function and laboratory values as follows: * Adequate marrow function * absolute neutrophil count (ANC) >1500 cells/mm3 * platelet count >100,000/mm3 * hemoglobin >9.0g/dL * Adequate hepatic function * Angiotensin Sensitivity Test/alternative (AST/ALT)<2.5x upper limit of normal if no documented liver disease or <5x upper limit of normal if documented liver disease * Total bilirubin <1.5X upper limit of normal unless known diagnosis of Gilbert's disease * Alkaline phosphatase <2.5x upper limit of normal if no documented liver disease or <6x upper limit of normal if documented liver or bone disease * Creatinine clearance >=60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. * Negative pregnancy test (serum or urine) for women of child bearing potential * The effects of selumetinib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 4 weeks after study discontinuation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of selumetinib administration. Exclusion Criteria: * Patients who have had chemotherapy or immunotherapy within 4 weeks or radiation therapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Patients who are receiving any other investigational agents concurrently. Palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteria. * Have had recent major surgery within a minimum 4 weeks prior to starting study treatment, with the exception of surgical placement for vascular access. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib * Every effort must be made to avoid the use of a concomitant medication that can prolong the corrected QT (QTc) interval while receiving selumetinib (hyd-sulfate AZD6244). If the patient cannot discontinue medications that prolong QTc interval while receiving selumetinib, close cardiac monitoring should be performed. * Patients with QTc interval >450 msecs or other factors that increase the risk of QTc prolongation or arrhythmic events (ex. Heart failure, hypokalemia, family history of long QT syndrome) including heart failure that meets New York Heart Association (NYHA) class III and IV definitions (see Appendix A) are excluded. * Prior or current cardiomyopathy including but not limited to the following: known hypertrophic cardiomyopathy, known arrhythmogenic right ventricular cardiomyopathy, previous moderate or severe impairment of left ventricular systolic function (LVEF <45% on echocardiography or equivalent on MuGA) even if full recovery has occurred. * Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest * Baseline Left ventricular ejection fraction (LVEF) below the LLN or <55% measured by echocardiography or institution's lower limit of normal (LLN) for MUGA * Severe valvular heart disease * Uncontrolled Angina - Canadian Cardiovascular Society grade II-IV despite medical therapy * Acute coronary syndrome within 6 months prior to starting treatment * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because selumetinib may be teratogenic or have abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with selumetinib, breastfeeding should be discontinued if the mother is treated with selumetinib. * HIV positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with selumetinib. * Prior treatment with a MEK, Ras or Raf inhibitor * History of current evidence/risk of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED) in the eye unaffected by uveal melanoma; intraocular pressure (IOP) >21mmgHG or uncontrolled glaucoma * History of interstitial lung disease or pneumonitis * Patients with known Hepatitis B or C * Refractory nausea and vomiting, active gastrointestinal disease (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption * Patients taking vitamin E supplements while on study * Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and / or radiation, and has been stable for at least 4 weeks prior to the first dose of study medication * Any unresolved toxicity >= CTCAE Grade 2 from previous anti-cancer therapy, except for alopecia * Have evidence of any other significant clinical disorder or laboratory finding that, as judged by the investigator, makes it undesirable for the patient to participate in the study. * Patients being actively treated for a secondary malignancy

Study Objectives PD1-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer Conditions: Castrate-Resistant Prostate Cancer Intervention / Treatment: DRUG: PD1-PSMA-CART cells Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Fully understand and voluntarily sign informed consent. * Aged 18 to 75 years old. * Expected survival > 6 months. * CRPC patients:Serum testosterone reached castration level (<50ng/dl or<1.7nmol/L) and: prostate specific antigen (PSA) increased more than 50% at intervals of one week or three consecutive times, with PSA>2 ng/ml; or imaging scans revealed two or more new lesions or enlargement of soft tissue lesions that met the criteria for evaluating solid tumor response. * CRPC patients received abiraterone or chemotherapy for 3 months or more, and were ineffective or progressive (PSA continued to rise for 3 months, or bone scan/whole-body imaging showed local recurrence or new metastasis). * Immunohistochemical staining of repetitive biopsy tissues showed the expression of PSMA in tumor cells was more than 50%. * Eastern Cooperative Oncology Group (ECOG) score <=2. * Virological examination was negative. * Hematological indexes: hemoglobin > 100 g/L, platelet count > 100×10^9/L, absolute neutrophil count > 1.5×10^9/L. Exclusion Criteria: * Prior treatment with any CART therapy targeting any target. * Prior treatment with any PSMA targeting therapy. * Need steroid therapy, except physiological replacement therapy. * Prior treatment with any immunotherapy, including tumor vaccine therapy, radium-223, checkpoint inhibitors and others. * Subjects with severe mental disorders. * Subjects with other malignant tumors. * Subjects with severe cardiovascular diseases: a, New York Heart Association (NYHA) stage III or IV congestive heart failure; b, history of myocardial infarction or coronary artery bypass grafting (CABG) within 6 months; c, clinical significance of ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or dehydration; d, history of severe non-ischemic cardiomyopathy; e, the left ventricular ejection fraction (left ventricular ejection fraction< 55%) was decreased by echocardiography or multiple gated acquisition scan (within 8 weeks before peripheral blood mononuclear cell (PBMC) collection), and abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis. * Patients with ongoing or active infection. * Organ function: a, Alanine aminotransferase or Aspartate aminotransferase >2.5*Upper limit of normal (ULN); Creatine kinase>1.5*ULN; Creatine kinase isoenzyme >1.5*ULN; Troponin T >1.5*ULN; b, Total bilirubin >1.5*ULN; c, Partial prothrombin time or activated partial thromboplastin time or international standardized ratio > 1.5*ULN without anticoagulant treatment. * History of participation in other clinical studies within 3 months or treatment with any gene therapy product. * Intolerant or allergic to cyclophosphamide or fludarabine. * Subjects not appropriate to participate in this clinical study judged by investigators.

Study Objectives The proposed study is aimed at examining mitochondrial function as a potential target of action of vitamin D on muscle metabolism, size, and strength in preventing the progression of cachexia. This is the first clinical trial designed to understand the effects of vitamin D on muscle metabolic dynamics driving dysfunction in cachectic muscle. Our preliminary data suggest that vitamin D promotes lipid partitioning and muscle metabolic function, which the investigators hypothesize, will mitigate cachexia via improved muscle health and quality that translates into reduced fatigue, and improved patient resilience to multimodal cancer therapy. Conditions: Cancer Cachexia, Vitamin D Deficiency Intervention / Treatment: DIETARY_SUPPLEMENT: Vitamin D, DIETARY_SUPPLEMENT: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: Patients must have histologically or cytologically confirmed stage II-IV lung cancer and be planned for definitive non-surgical therapy. Patients may have a history of prior malignancy. Mild cancer cachexia, defined by the miniCASCO score of 0-25 points Vitamin D insufficiency, defined as 25(OH)D < 32 ng/ml Aged 45 to 75 years. Stratified randomization by age ECOG performance status <= 2 (see Appendix A). Life expectancy of greater than 3 months Patients must have normal renal and liver function as defined below: AST(SGOT)/ALT(SGPT) <=2.5 × institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance >=60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. Able to swallow thin liquids No uncontrolled illness including, but not limited to, any of the following: * Ongoing or active serious infection * Symptomatic congestive heart failure * Unstable angina pectoris * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Psychiatric illness or social situation that would preclude compliance with study requirements Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Patients with untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with treated brain metastasis are eligible for this trial, providing they have completed treatment at least one day prior to registration. History of allergic reactions to whey or milk proteins. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients with a history of calcium oxalate nephrolithiasis are excluded. Patients with a significant history of malabsorption (e.g. celiac sprue, short bowel syndrome, IBD or other, as determined by the treating physician) are excluded. Patients will not be eligible if actively receiving treatment for vitamin D deficiency and have had recent (3 month) history of vitamin D supplementation (>1000 IU) or calcium supplementation (>800mg). The following exclusion criteria will avoid the possibility of preexisting muscle impairment: history of congenital myopathies; neurologic disorder involving sequelae of spinal derangement; disk disease or vascular disease; tremor and rigidity. Patients will also be excluded if they report lower extremity (LE) surgery or injury to the LE in the past 3 months or a past medical history of primary hyperparathyroidism; or rhabdomyolysis. Additional exclusion criteria include participation in a scheduled resistance exercise program 1 month; * metal implants or other contraindications for the MRI; * diabetes, * advanced renal disease, * uncontrolled hypertension; * a vitamin D status (25(OH)D) of > 32ng/mL.

Study Objectives This study is an open-label, single center, nonrandomized study, consisting of a dose-escalating phase I study in advanced solid cancer and a subsequent phase II study in metastatic gastric cancer. In phase I study, we aim to determine the MTD and the recommended dose of S-1 combined with docetaxel given every 3 weeks. Dose level and escalating schedule are followings * S-1(level 0, 1/2, 3/4, 5: 60, 70, 80, 90 mg/m2/day) q 12 hours po Days 1-14) * Docetaxel (level 0/1,2/3, 4/5: 25, 30, 35 mg/m2) mixed in d5w 200 ml iv over 60 min: Days 1, 8with dexamethasone 8 mg po q 12hr for 3 days (total 6 doses: D0-2)and parenteral pheniramine maleate 1 ample (45.5mg) before docetaxel Conditions: Stomach Neoplasms Intervention / Treatment: DRUG: S-1, Docetaxel Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * In phase I:histologically or cytologically confirmed advanced solid Cancer In phase II:histologically or cytologically confirmed metastatic gastric adenocarcinoma * Age: over 18 years * No prior chemotherapy or radiotherapy (including any adjuvant hemotherapy) in phase II portion Previous chemotherapy up to two regimens (including adjuvant chemotherapy) is allowed in phase I portion; patients are required to have discontinued chemotherapy, immunotherapy, and radiotherapy for at least 4 weeks before entry into phase I portion * Disease status must be that of measurable disease defined as: Lesions that can be accurately measured in at least one dimension >10 mm with spiral CTscan and palpable LN (including supraclavicular LN) in physical examination. * Performance status: ECOG 0-2 * Adequate major organ function including the following Hematopoietic function: WBC>4,000/mm3 or ANC> 2,000/mm3, Platelet count ³ 100,000/mm3Hepatic function: Bilirubin UNL (Upper normal limit), AST/ALT levels 2.5X UNL Renal function: Creatinine UNL * Patients should sign an informed consent Exclusion Criteria: * Inadequate cardiovascular function: New York Heart Association class III or IV heart disease Active angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significantconduction system abnormality * Other malignancy within the past 3 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix * Pregnant or nursing women * Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy * Psychiatric disorder that would preclude compliance * Patients receiving a concomitant treatment with drugs interacting with S-1 or docetaxel: flucytosine, phenitoin, warfarin et al.

Study Objectives RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. 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. Giving bevacizumab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with several chemotherapy drugs (combination chemotherapy) works in treating patients with peripheral T-cell lymphoma or natural killer cell neoplasms. Conditions: Lymphoma Intervention / Treatment: BIOLOGICAL: bevacizumab, DRUG: cyclophosphamide, DRUG: doxorubicin, DRUG: prednisone, DRUG: vincristine 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: * Diagnosis of peripheral T-cell or natural killer cell neoplasm * Any stage disease allowed * HTLV-positive tumors allowed * At least one objective measurable disease parameter. Abnormal positron emission tomography scans are not considered evidence of measurable disease unless results are confirmed by CT scan or other appropriate imaging techniques * Age 18 and over * ECOG Performance status 0-2 * Absolute neutrophil count >= 1,000/mm^3(500/mm^3 if due to bone marrow involvement with lymphoma) * Platelet count >= 100,000/mm^3(50,000/mm^3 if due to bone marrow involvement with lymphoma) * Bilirubin <= 2.0 mg/dL (<= 3 times upper limit of normal [ULN] if due to hepatic involvement with lymphoma) * AST <= 2 times ULN (5 times ULN if due to hepatic involvement with lymphoma) * PT, INR, and PTT <= 1.5 times normal * Creatinine <= 2.0 mg/dL * Urinary protein:creatinine ratio <= 1 * History of deep venous thrombosis allowed provided patient is on a stable dose of anticoagulants for at least 2 weeks prior to study entry * LVEF >= 50% * History of pulmonary embolism allowed provided patient is on a stable dose of anticoagulants for at least 2 weeks prior to study entry * One prior cycle of CHOP for PTCL allowed * More than 4 weeks since prior major invasive surgery or open biopsy * At least 7 days since prior minor surgery. Peripheral lymph node core biopsy, bone marrow biopsy, fine needle aspiration, skin biopsy, or central line placement are not considered minor surgical procedures * More than 7 days since prior and no concurrent anti-platelet drugs (e.g., ticlopidine, clopidogrel, or cilostazol) except aspirin or other nonsteroidal anti-inflammatory drugs * Concurrent anticoagulants allowed provided patient is on a stable dose * INR must be stable for at least 2 weeks prior to study entry * PT/INR and/or PTT must be closely monitored and levels kept within acceptable range for underlying thrombotic disease * Concurrent heparin flush for maintenance of central line patency allowed EXCLUSION CRITERIA: * Anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma. ALK-negative T-cell large cell lymphoma allowed * Cutaneous T-cell lymphoma * History of or current radiographic evidence of CNS metastasis, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement * Evidence of bleeding diathesis or coagulopathy * Cerebrovascular accident within the past 6 months * Myocardial infarction within the past 6 months * Unstable angina within the past 6 months * New York Heart Association class II-IV congestive heart failure * Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg) * Other clinically significant cardiovascular or peripheral vascular disease * Abdominal fistula within the past 6 months * Gastrointestinal perforation within the past 6 months * Intra-abdominal abscess within the past 6 months * Concurrent major surgery * Pregnant or nursing. Female patients must have negative pregnancy test. Fertile patients must use effective contraception * History of active seizures * Significant traumatic injury within the past 4 weeks * Non-healing ulcer (unless involved with lymphoma) * Bone fracture * Active infection requiring parenteral antibiotics * HIV positivity * Other active malignancy within the past 6 months except carcinoma in situ of the cervix or basal cell carcinoma of the skin

Study Objectives The purpose of this study is to investigate if an investigational drug called AT13387 is active against Gastrointestinal Stromal Tumor (GIST) that is resistant to other treatments, and to understand more about the safety of AT13387. Most subjects in the study will receive AT13387 along with another drug called imatinib (Gleevec). Imatinib is a standard (approved) drug for treating patients with GIST. Some patients may receive AT13387 on its own. As a result, we shall begin to understand the effects of AT13387 given on its own and when combined with imatinib.We shall also find out more about the side-effects of AT13387, and more about how the body breaks down (metabolizes) AT13387. Conditions: Gastrointestinal Stromal Tumor (GIST) Intervention / Treatment: DRUG: AT13387 and Imatinib 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: * Ability to understand the risks of the study and to provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations). * Age >= 18 years. * Unresectable and/or metastatic malignant GIST with objective progression of disease following treatment with a maximum of 3 tyrosine kinase inhibitors (TKIs) including imatinib. To clarify, it is the number of TKIs - up to a maximum of three agents, including imatinib - that is the criterion for entry, not the number of prior courses of TKI treatment. * Measurable disease. * ECOG performance status 0 or 1. * Negative blood or urine pregnancy test (within 7 days prior to commencing treatment), or documented evidence of surgical sterility, or natural or treatment-induced post-menopausal status with last menses >1 year ago. * Willing to provide a tissue block or unstained slides of archived tumour for central pathology review and genotyping, or a full pathology report and results of genotyping of a previous tumour sample, or willing to undergo a new tumour biopsy for central pathology review and genotyping during the screening period of the study (prior to dosing) Exclusion Criteria: * Pregnancy or lactation (women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to commencing treatment ). Male and female patients of childbearing potential must use appropriate birth control (abstinence, barrier methods, oral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records). * Impaired liver function, as evidenced by prior liver segmentectomy or hemi-hepatectomy; or alanine or aspartate aminotransferase (ALAT/ASAT) >2.5x ULN; or alkaline phosphatase >2.0x ULN; or bilirubin >2.0x ULN. * Abnormal clotting, as evidenced by PT or PTT >1.5x ULN, or therapeutic/prophylactic anticoagulation. * Renal impairment, defined as either serum creatinine higher than the institution ULN,or estimated creatinine clearance lower than LLN (i.e. patients should have both normal serum creatinine, and normal estimated creatinine clearance) * Impaired marrow function, defined as haemoglobin <9.0 g/dL, neutrophils <1.5 x10^9/L, or platelets <100 x10^9/L. Patients may receive a blood transfusion for anaemia to allow entry to the study but should not be transfusion-dependent. * Left ventricular ejection fraction <50% on echocardiography or MUGA scan. * Known metastases of the central nervous system. * Prior anticancer therapies including tyrosine kinase inhibitors (other than imatinib) not completed within 2 weeks or 5 half-lives of the agent (including known active metabolites) prior to treatment with study drug. Patients receiving imatinib should continue to receive imatinib (400 mg daily) throughout the screening period. * Clinically important intolerance or safety concerns with prior use of imatinib 400 mg daily. * Prior treatment with an HSP90 inhibitor. * Major surgery within 14 days prior to treatment with study drug, or failure to recover from the effects of such surgery. * Wide field radiotherapy within 4 weeks prior to treatment with study drug, limited field radiation within 2 weeks, or failure to recover from such therapies. * History of an ischaemic cardiac event or unstable cardiac disease within 3 months of study entry. * QTc >450 ms using Fredericia's correction. * Previous malignancy, except for basal cell and squamous cell skin carcinomas or carcinoma of the uterine cervix, unless treated with curative intent more than 2 years prior to study entry. * Evidence of severe or uncontrolled systemic medical conditions which make it undesirable for the patient to take part in the study, or which could jeopardize protocol compliance. Patients with multiple comorbidities and/or requiring multiple concomitant medications (especially conditions/medications which may impair renal function or predispose to renal impairment) should be discussed with the Astex Medical Monitor at the discretion of the Investigator before enrollment. * Prior history of infection with HIV, or known active hepatitis B or C viral infection (active screening for viral infections is not required for study entry). * Significant visual impairment such that in the opinion of the investigator, further minor deterioration would have unacceptable consequences (eg. loss of ability to drive or live at home. * The Safety Monitoring Committee may add other specific exclusion criteria to enhance the safety of the patients based on emerging safety data.

Study Objectives This study involves the administration of a hypoxia marker, pimonidazole hydrochloride, taken orally approximately 24 hours before surgical resection of a pancreatic tumor in order to identify areas of lower oxygen content on tumor samples. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Pimonidazole hydrochloride Location: Canada Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * age > 18 * provisional diagnosis of pancreatic cancer * scheduled resection at UHN * consented to ICGC Pancreatic Cancer Genome Project * surgery planned for >2 days away (drug administration has to be 16-20hrs before surgery) Exclusion Criteria: * not participating in ICGC * contraindications to pimonidazole (allergy) * surgery scheduled for same or next day (not enough time to arrange for drug administration)

Study Objectives The purpose of this study is to determine the effectiveness of TLK286 in treatment of metastatic breast cancer. Conditions: Breast Neoplasms Intervention / Treatment: DRUG: TLK286 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: * Histologic diagnosis of breast cancer * Metastatic disease * Measurable or evaluable disease * No prior chemotherapy regimens * Age at least 18 years * Adequate liver and kidney function * Adequate bone marrow function Exclusion Criteria: * Pregnant or lactating women * Unstable medical conditions * Chemotherapy within 14 days of TLK286 * Radiation therapy within 14 days of TLK286 * Hormonal therapy within 14 days of TLK286 * Immunotherapy within 14 days of TLK286 * CNS metastasis unless controlled by treatment

Study Objectives This is an open-label Phase 1 trial of MM-111 in combination with Herceptin. Conditions: Breast Neoplasms Intervention / Treatment: DRUG: MM-111 + Herceptin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically or cytologically confirmed advanced breast cancer that is amplified for HER2, based on archived tumor biopsy (IHC 2+ or greater) * Patients must have histologically or cytologically confirmed advanced breast cancer that is heregulin positive based on fresh tumor tissue biopsy * The patient's cancer must have recurred, progressed or not responded to standard chemotherapy or other standard treatment. Prior therapies may include but are not limited to Herceptin, Tykerb (lapatinib), anthracyclines, and taxanes * Patients must be >= 18 years of age * Patients or their legal representatives must be able to understand and sign an informed consent * Patients may have measurable (per RECIST 1.1) or non-measurable tumor(s) (for Phase 1) * Patients should have ECOG Performance Score (PS) 0, 1 or 2 (for Phase 1). * Patients should have a life expectancy of at least 12 weeks * Patients must have adequate bone marrow reserves * Patients must have adequate hepatic function * Patients must have adequate renal function * Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. * Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-111. Exclusion Criteria: * Patients who are pregnant or lactating * Patients with an active infection or with an unexplained fever > 38.5°C (101.3° F) during screening visits or on the first scheduled day of dosing. * Patients with untreated and/or symptomatic metastatic CNS malignancies. * Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies, including Herceptin. * Patients who have received other recent antitumor therapy including: * Treatment with Herceptin within the 28 days prior to the first scheduled day of dosing with MM-111 * Investigational therapy administered within the 28 days prior to the first scheduled day of dosing MM-111 (Dosing in less than 28 days' since receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent has passed.) * Any standard chemotherapy, Tykerb (lapatinib) or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of MM-111 * Patients who have previously received MM-111 * Patients with NYHA Class III or IV congestive heart failure or LVEF < 50% * Patients with a history of allogeneic transplant * Patients with known HIV, hepatitis B or C (if patients have previously been treated for hepatitis C and have undetectable viral loads, they can be considered eligible for the trial) * Patients with any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

Study Objectives Glioblastomas represent 40% of all tumors of the central nervous system (CNS) and are among the most lethal tumors. Temozolomide (TMZ) combined with radiotherapy was the first substance to significantly improve the overall survival (to 14.6 months) as compared to surgery and radiotherapy alone and increased the proportion of patients surviving more than 2 years to 26%. TMZ showed the best efficacy in patients with a methylated O6-methylguanine-DNA methyltransferase (MGMT) promoter in part by eliminating stem cell-like tumor cells. Among patients with a methylated MGMT promoter, the median survival after treatment with combined radio-chemotherapy was 21.7 months, as compared to 15.3 months among those who were assigned to radiotherapy only. In the absence of methylation of the MGMT promoter, there was a smaller and statistically insignificant difference in survival between the treatment groups. Doxorubicin is one of the most effective substances in vitro against cells derived from glioblastoma. However, it has no significant effect in vivo due to poor blood-brain-barrier penetration. In a tumor model, tissue and CSF-concentrations of doxorubicin were substantially increased when sterically stabilized liposomes were used resulting in a comparable clinical response using approximately half of the dose of stabilized liposomes compared to conventional doxorubicin. A pegylated formulation (PEG-liposomal Doxorubicin) even further improved the penetration of the blood-brain barrier. Case series and two phase II-studies in patients with recurrent glioblastoma have shown modestly promising results for PEG-Dox. In this study, the investigators treated patients with recurrent glioblastoma with 20 mg/m2 PEG-Dox on days 1 and 15 of each 28-day cycle. To determine the dose limiting toxicity of PEG-Dox combined with prolonged administration of TMZ, the investigators performed a phase I part ahead of the phase II study. To investigate, by means of a historical control analysis, if the addition of PEG-Dox to TMZ and radiotherapy improves the survival of patients, the investigators chose similar inclusion criteria and identical TMZ and radiotherapeutic regimes as in the EORTC26981/NCIC-CE.3 study. Conditions: Glioblastoma Intervention / Treatment: DRUG: Pegylated Liposomal Doxorubicine Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * newly diagnosed glioblastoma * centrally confirmed histology * Karnofsky performance score (KPS) > 70% * stable corticosteroids within 2 weeks before inclusion * leucocytes > 3/ul, thrombocytes > 100/ul, Hb > 10 g/dl * additional standard criteria Exclusion Criteria: * other tumor in history * pretreatment with radiotherapy to the brain

Study Objectives The study is designed to investigate the influence of parenteral nutrition (PN) with low nitrogen and calorie supply on the clinical outcome of patients after an operation compared to that of traditional PNs. Conditions: Gastrointestinal Neoplasms, Postoperative Complications Intervention / Treatment: DRUG: low calorie, low nitrogen parenteral nutrition for patient with NRS score 3 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients undergone resection of stomach, intestine, or rectum, having the indication of nutrition * Nutrition risk screening scores around 3 * The age of the patients must be between 18 to 80 * The patients sign the confirmed consent letter * Weight falls in the range of either 45-56 kg or 60-75 kg Exclusion Criteria: * Pregnant or breast feeding * Contraindication of fluid infusion, acute pulmonary edema, brain edema and functional insufficiency of the heart * Hypersensitive to the ingredient of the trial product nutrient * Chemotherapy within 7 days before the beginning of this trial * Unstable angina pectoris * Diabetes mellitus * Disorder of lipid metabolism: triglycerides, cholesterol increased by 1.5 times above the reference value * Abnormal renal function: serum creatinine or BUN 1.5 times above normal reference value * Abnormal liver function: ALT or serum total bilirubin 1.5 times above normal reference value * Having severe drug allergy history and/or asthma * On operation day, blood loss above 800 ml * Contraindication to parenteral nutrition * Receiving regular parenteral nutrition within 7 days before the trial

Study Objectives This study compares manipulative therapy to steroid injection in the treatment of Morton's Neuroma. Conditions: Morton Neuroma Intervention / Treatment: DRUG: methylprednisolone, PROCEDURE: manual manipulation Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * clinical diagnosis of morton's neuroma * over 18 years of age * presenting VAS score > 30mm Exclusion Criteria: * diabetes, * rheumatoid arthritis * fibromyalgia. * Those currently taking Statins or analgesics * previous neuroma surgery

Study Objectives The purpose of the study is to evaluate the efficacy of Iocide oral rinse as a treatment for Oral Candidiasis in any patient including but not limited to patients receiving radiation therapy or who have previously received radiation therapy for head and neck cancer, or patients positive for HIV/AIDS or are transplant patients. Conditions: Candidiasis, Oral, Thrush, Candidiasis Intervention / Treatment: DRUG: Frio Oral Rinse Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Males or non-pregnant females currently receiving or post radiation therapy for head and neck cancer; * 18 years of age; * With signs and symptoms of oral candidiasis as determined by investigator(s); * Females using an effective contraception method during study. * Patients must be able and willing to comply with study requirements, and have full understanding of all elements of, and signature and dating of, informed consent prior to initiation of protocol specified procedures. * Participating female subjects must agree to use adequate contraceptive measures during the trial. Before entering the study, women of childbearing age will be tested for pregnancy with a urine pregnancy test. Exclusion Criteria: * History, or current evidence, of any significant acute or chronic medical or psychiatric condition that would render examination difficult or invalid or prevent the subject from active study participation; * Inability to use an oral rinse; * Use of concomitant medication that, in the opinion of the Study Director, might interfere with the outcome of the study (e.g. anabolic steroids or excessive corticosteroids, large doses of aspirin (no more than one 325 mg tablet per day), phenytoin, lithium, coumadin or Iodine containing preparations [use of iodized table salt is acceptable]). Steroids, therapeutic doses of non-steroidal anti-inflammatory agents, estrogen therapy agents and oral contraceptives are OK to use as long as the baseline dose remains steady through the end of the study; * Use of antifungal medication in the last 30 days, purported sensitivity or allergy to iodine; * Pregnant or nursing patients as the effect of Iocide in the fetus or infant are not established; * History thyroid disease.

Study Objectives This research study aims to explore the effectiveness of human erythropoietin versus placebo in promoting the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for clinically localized prostate cancer. Pre-clinical studies have shown erythropoietin potently promoted recovery of erectile function in rats and humans have similar receptors on penile tissues and the periprostatic neurovascular bundles. A clinical non-randomized study conducted in men undergoing radical prostatectomy demonstrated a benefit to recovery of erectile function. Therefore, the hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy and results in a reduced degree of erectile dysfunction and also an improved rate of erection recovery following surgery. Conditions: Prostate Cancer, Erectile Dysfunction Intervention / Treatment: DRUG: Placebo, DRUG: Erythropoietin (EPO) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Patient eligibility consists of men 40 to 65 years of age * Localized prostate cancer * clinical stage T2a or lower * Gleason grade of 3+4 or 3+3 * prostate specific antigen (PSA) < 10 * Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function * International Index of Erectile Function-5 (IIEF-5) score of 22-25. * The patient has a sexual partner, of at least 6 months. * The patient's pre-surgical hematocrit is <= 48. * The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery. Exclusion Criteria: * The patient has known penile deformity or a history of Peyronie's disease. * The patient has planned pre or post operative androgen therapy. * The patient has planned pre or post operative radiation therapy. * The patient is on anticoagulation therapy. * The patient has a history of sickle cell anemia. * The patient has a history of high or low blood pressure that is not controlled. * The patient is taking medications called "nitrates" * The patient has a history of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction * The patient has a history of history of drug or alcohol abuse. * The patient currently smokes or has a 20 pack/year history of cigarette smoking. * The patient has a history of acute or chronic depression * The patient has a history liver problems, or kidney problems. * The patient has a history of retinitis pigmentosa or severe vision loss, including a condition called NAION, Nonarteritic Anterior Ischemic Optic Neuropathy. * The patient has a history of spinal trauma or surgery to the brain or spinal cord. * The patient has contraindications to the use of phosphodiesterase type 5 (PDE 5) inhibitors. * Patient is currently participating in another clinical investigation that would serve as a contraindication to administering erythropoietin.

Study Objectives To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides). Conditions: Cutaneous T-Cell Lymphoma Intervention / Treatment: DRUG: SGX301 (synthetic hypericin), DRUG: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage IB, or Stage IIA. * Subjects must have a minimum of three (3) evaluable, discrete lesions. * Subjects must be willing to refrain from sunbathing for the duration of the study. Exclusion Criteria: * History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions or radiation therapy within 30 days of enrolling. * Pregnancy or mothers who are breast feeding. * Males and females not willing to use effective contraception. * Unhealed sunburn. * Subjects receiving topical steroids or other topical treatments for CTCL within 2 weeks. * Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment. * Subjects with significant history of systemic immunosuppression due to drugs or infection with HIV or HTLV 1. * Subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.

Study Objectives The primary objective for this study is to determine the safety profile of radiotherapy and durvalumab, a PD-L1 inhibitor. Primary endpoint: Toxicity, drug pharmacokinetics (PK), maximum tolerated dose (MTD) and recommended phase two dose (RPTD) of simultaneous radiotherapy plus durvalumab in patients with relapsed or refractory DLBCL or FL. Secondary endpoints: * ORR * Progression-free survival * Overall survival Exploratory endpoints include description of biological effects of combination radiotherapy plus durvalumab (Imaging results, immune function, PK and PD-see 'research methodologies') and in the PET-Sub-Study, biodistribution of 89Zr Durvalumab and 89Zr-IAB22M2C. Conditions: Diffuse Large B Cell Lymphoma, Follicular Lymphoma Intervention / Treatment: DRUG: Durvalumab, RADIATION: Radiotherapy, RADIATION: Radiotherapy (cohort 6 only) Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Male or Female subjects aged 18 years weighing more than 30 kg * Histologically proven CD20-positive relapsed or refractory diffuse large B cell non-Hodgkin lymphoma (DLBCL) either de novo or DLBCL transformed from any indolent B-non-Hodgkin lymphoma (including Richter's transformation) Or follicular lymphoma grade 1-3A, or Grade 3B, according to the current World Health Organization classification on tissue biopsy. Archived tissue is permitted however must have been obtained after the last known therapy. The Trial Management Group retains the option to limit the number of participants enrolled with a specific histology. * At least 1 line of previous treatment for lymphoma which must include a CD20 monoclonal antibody such as rituximab, with no curative option as determined by the investigator. Prior radiotherapy is permitted. * Patients with DLBCL must not be eligible or willing to receive high-dose (myeloablative) chemotherapy (HDC) and autologous stem cell transplant (ASCT) OR has received prior ASCT. * Eastern Collaborative Oncology Group performance status 0, or 1, unless attributable to lymphoma in which case patients of performance status 2 are also eligible. * Patients must have measurable disease (at least one bi-dimensionally measurable site of disease that has not been previously irradiated OR has progressed after radiotherapy: nodal disease >1.5 cm or an extranodal lesion > 1.0 cm in longest perpendicular diameter). At least three disease sites must be FDG-avid on PET imaging AND amenable to radiotherapy according to local radiation oncology investigator review. * One site of disease must be amenable to biopsy. It is preferable that this is a site not planned for radiotherapy, but not mandated. A fresh tumor biopsy collected during screening and /or archival tumor tissue collected after the last relapse/disease progression (material which has been collected before the last line of treatment is not accepted). In addition, a sufficient amount of the material is required for acceptance of the archival material. If neither condition occurs, a fresh tumor biopsy needs to be performed as stated above. * Adequate bone marrow function with platelets > 50 x109/l; neutrophils > 1.0x109/l at the time of study entry unless attributed to bone marrow infiltration by lymphoma. * Adequate renal function defined by an estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method). * Adequate hepatic function defined by a total bilirubin level <= 2 × the upper limit of normal (ULN) range (excluding Gilbert's disease where a level of <= 3 ×ULN is acceptable) and AST and alanine aminotransferase (ALT) levels <= 2.5 × upper limit of institutional normal range unless attributed to lymphoma. * No concurrent uncontrolled medical condition as determined by the investigator. * Life expectancy > 3 months. * Negative blood pregnancy test at screening for women of childbearing potential. Effective contraception for both male and female subjects if the risk of conception exists. (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use effective contraception, defined as 2 barrier methods, or 1 barrier method with an intrauterine device, or use of oral female contraceptive. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately. Effective contraception at least 30 days prior and up to 3 months after treatment is required for all women of childbearing potential and male subjects will be advised not to father a child during the 3 months after treatment completion. Male subjects will be requested to seek advice on conservation of sperm prior to treatment.) n) Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management. Exclusion Criteria: * T-cell lymphoma, Hodgkin lymphoma. * Central nervous system, meningeal or spinal cord involvement by lymphoma. * Prior therapy with any antibody or drug targeting T-cell coregulatory proteins (immune checkpoints) such as PD-1, PD-L1, or cytotoxic T-lymphocyte antigen-4 (CTLA-4). * Patients with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent: i) Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible ii) Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses <= 10 mg or 10 mg equivalent prednisone per day iii) Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is acceptable. e) Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: i. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) ii. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisolone or its equivalent iii. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) .iv.Patients requiring steroids for symptom control during the screening period may receive a single course of prednisolone at a dose of up to 100mg daily (or equivalent) for a maximum of 5 days at the discretion of the local PI. Steroids must not be given within 5 days of radiotherapy. Note that steroids are optimally avoided due to the potential for reduction in durvalumab activity f) Known severe hypersensitivity reactions to monoclonal antibodies (Grade >= 3 NCI-CTCAE v 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma) g) Past history of interstitial lung disease. h) Prior organ transplantation, including allogeneic stem-cell transplantation i) Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. j) Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment and/or if the subject has not fully recovered from the surgery within 4 weeks of enrolment k) Any other serious active disease, including but not limited to; i) clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina pectoris, congestive heart failure (New York Heart Association Classification Class >= II), or serious cardiac arrhythmia requiring medication (including QTc prolongation of > 470 ms and/or pacemaker) or prior diagnosis of congenital long QT syndrome. ii) uncontrolled active infection, iii) uncontrolled diabetes (e.g., haemoglobin A1c >= 8.5%) l) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive) m) Medical or psychiatric conditions that compromise the patient's ability to give informed consent. o) Subject is pregnant, lactating or unwilling/unable to use adequate contraception p) Subject weighs less than 30kg

Study Objectives The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone. Conditions: Endometrial Neoplasms Intervention / Treatment: DRUG: Paclitaxel, DRUG: Sapanisertib, DRUG: MLN1117 Location: Norway, Germany, Canada, Italy, Netherlands, Spain, United Kingdom, United States, Belgium, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologic or cytologic diagnosis of endometrial carcinoma (including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma). * Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy or established treatments. * At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior chemotherapeutic regimens, for management of endometrial carcinoma. Prior treatment may include chemotherapy, chemotherapy/radiation therapy, and/or consolidation/maintenance therapy. Chemotherapy administered in conjunction with primary radiation as a radio-sensitized therapy will be considered a systemic chemotherapy regimen. * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded). Each lesion must be greater than or equal to (>=) 10 millimeter (mm) in long axis when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam. Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI. * Tumor accessible and participant consents to undergo fresh tumor biopsies. * Female participants >= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Female participants who: * Are postmenopausal for at least 1 year before the screening visit, OR * Are surgically sterile, OR * If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [example, United States Prescribing Information (USPI), Summary of Product Characteristics (SmPC), etc.]) after the last dose of study drug, OR * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) * Clinical laboratory values as specified below within 4 weeks before the first dose of study drug: * Bone marrow reserve consistent with absolute neutrophil count (ANC) >= 1500 per micro liter (/mcL); platelet count >= 100,000/mcL; hemoglobin A1c (HbA1c) less than (<) 6.5 percent (%). * Total bilirubin must be less than or equal to (<=) 1.5 * the upper limit of normal (ULN). * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be <= 2.5 * the upper limit of the normal range. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of metastatic disease in liver. * Creatinine clearance >= 50 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) based either on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection. * Fasting serum glucose < 130 milligram per deciliter (mg/dL) and fasting triglycerides <= 300 mg/dL. * Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and suitable venous access for the study-required blood sampling. * Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. Exclusion Criteria: * Positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug. Women who are lactating and breastfeeding are not eligible. * Previous treatment with any weekly taxane regimen. * History of severe hypersensitivity reactions to paclitaxel or any of its excipients. * Previous treatment with phosphoinositide 3-kinase (PI3K), serine/threonine-specific protein kinase (AKT), dual PI3K/ mammalian (or mechanistic) target of rapamycin (mTOR) inhibitors, target of rapamycin complex 1/2 (TORC1/2) inhibitors or TORC1 inhibitors. * Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers) within 1 week before administration of the first dose of study drug (participants already receiving erythropoietin on a chronic basis for >=4 weeks are eligible). * Participants who are taking proton pump inhibitors (PPIs) within 7 days of the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drug. * A prothrombin time (PT) or activated partial thromboplastin time (aPTT) above the ULN or a history of a coagulopathy or bleeding disorder. * Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection. * Sensory or motor neuropathy >= Grade 2. * Central nervous system (CNS) metastasis, endometrial leiomyosarcoma, or endometrial stromal sarcoma. * Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal disease, or for some other reason that may alter the absorption of sapanisertib or MLN1117. In addition, participants with enteric stomata are also excluded. * Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, active infection, or any other condition that could compromise participation of the participant in the study. * Known human immunodeficiency virus infection. * History of any of the following within the last 6 months before administration of the first dose of study drug: * Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures. * Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures. * Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia). * Placement of a pacemaker for control of rhythm. * New York Heart Association Class III or IV heart failure. * Pulmonary embolism. * Significant active cardiovascular or pulmonary disease before administration of the first dose of study drug, including: * Uncontrolled hypertension (that is, either systolic blood pressure > 180 millimeter of mercury [mm Hg] or diastolic blood pressure > 95 mm Hg). * Pulmonary hypertension. * Uncontrolled asthma or oxygen saturation < 90% by arterial blood gas analysis or pulse oximetry on room air. * Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement. * Medically significant (symptomatic) bradycardia. * History of arrhythmia requiring an implantable cardiac defibrillator. * Baseline prolongation of the rate-corrected QT interval (QTc; example, repeated demonstration of QTc interval > 480 millisecond [ms], or history of congenital long QT syndrome, or torsades de pointes). * Diagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. * Participants with endometrioid histology and histologically confirmed expression of estrogen receptors (ER) and/or progesterone receptors (PgR) who have not received prior endocrine therapy and for whom endocrine therapy is currently indicated.

Study Objectives The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer. Conditions: Carcinoma, Renal Cell Intervention / Treatment: DRUG: RAD001 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: * Metastatic renal cancer refractory to sorafenib or sunitinib therapy * At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. * 18 years of age or older * Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior standard systemic anticancer therapy and adequately recovered from the acute toxicities of any prior therapy. * World Health Organization (WHO) performance status <= 2 * Adequate bone marrow function * Adequate liver function * Adequate creatinine clearance * Signed informed consent Exclusion Criteria: * Prior treatment with any investigational drug within the previous 4 weeks * Chronic treatment with systemic steroids or another immunosuppressive agent * Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases * Patients who have a history of another primary malignancy <= 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study * A known history of HIV seropositivity * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) * Patients with an active, bleeding diathesis or on oral anti-vitamin K medication * Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control from enrollment through 6 months following the end of treatment * Patients who have received prior treatment with an mTOR inhibitor. * Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients * History of noncompliance to medical regimens * Patients unwilling to or unable to comply with the protocol

Study Objectives Excision repair cross complementing 1 (ERCC1) ribonucleotide reductase M1 (RRM1) and thymidylate synthase(TS) are molecular determinants that predict sensitivity or resistance to platinum agents 、 gemcitabine and pemetrexed respectively. Tailored therapy using these molecular determinants suggested patient benefit in a previously reported phase 2 trial. Here, we designed a study for an individual patient analysis of prospectively accrued patients who were treated with the "personalized therapy" approach versus other standard approaches. Conditions: Lung Cancer, Carboplatin Adverse Reaction Intervention / Treatment: DRUG: carboplatin, gemcitabine , pametrexed Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed non-small cell lung cancer * age from 18 years to 75 years * ECOG Performance Status no more than 2 * at least one appraisable lung focus of diameter>= 10 mm by lung CT * Haemoglobin >=10.0 g/dl, Absolute neutrophil count >=(ANC) 1.5 x 109/L, platelets >=100 x 109/L * Total bilirubin <=1.5 x upper limit of normal (ULN) * ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases * Creatinine clearance >=60ml/min (calculated according to Cockcroft-gault formula) * Informed consent should be obtained before treatment. Exclusion Criteria: * Mixed non-adenocarcinoma cell lung cancer histology * Previous treatment for Systemic chemotherapy or local radiotherapy * Be allergic to chemotherapy drugs * second active primary malignancy or serious concomitant medical disease * difficulties with adequate follow-up

Study Objectives The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: nab-paclitaxel, DRUG: trastuzumab, DRUG: Doxorubicin, DRUG: cyclophosphamide, BIOLOGICAL: Growth Factor Support, PROCEDURE: Surgery 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: * Female patient >= 18 years of age * Histologically proven stage II or III adenocarcinoma of the breast * Must be candidate for neoadjuvant treatment (Tumor size >= 2 cm, T2, T3, T4 and/or clinical N1 or N2). * HER-2/neu 1+ or 2+ by immunohistochemistry * Must have operable tumor. * Performance status of 2 or better per SWOG criteria * LVEF >= 55% by echocardiogram performed within 4 weeks prior to treatment initiation * If patient of childbearing potential, pregnancy test is negative * Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial. * Adequate bone marrow function: ANC > 1500/mm3, platelet count > 100,000/mm3, and hemoglobin > 9 g/dL * Adequate kidney function: serum creatinine of < 1.5mg/dl and/or creatinine clearance of > 60 mL/min * Adequate hepatic function: transaminases < 2.5 x upper limit of normal and total bilirubin < 1.5 mg/dL * Must be informed of the investigational nature of the study and must sign an informed consent in accordance with the institutional rules. * Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies (with the exception of mammogram) must be performed within 30 days of patient registration. EXCLUSION CRITERIA: * Patient with metastatic breast cancer. * Women with tumors that are HER-2 neu 0+ or 3+ by immunohistochemistry * Women with HER 2 FISH amplified tumors (FISH ratio >2.2) * Patients who have had prior endocrine therapy for > 4 weeks or chemotherapy for this breast cancer will be excluded. * Locally advanced, inoperable tumors will be excluded. * The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications. * History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias * Ejection fraction < 55% * Pregnancy or lactation * Patients with inadequate laboratory values (as defined above) are excluded from study. * Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study. * Patients with active infection are excluded from study. * Patients with concomitant or previous malignancies within the last 5 years, are excluded from the study. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS). * Patients with emotional limitations are excluded from study.

Study Objectives The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy. Conditions: Prostatic Neoplasms Intervention / Treatment: DRUG: enzalutamide, DRUG: bicalutamide Location: Canada, Germany, Romania, United Kingdom, Denmark, United States, Belgium, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features * Ongoing androgen deprivation therapy with a Luteinizing Hormone Receptor Hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of randomization or bilateral orchiectomy (i.e., surgical or medical castration) * Metastatic disease documented by one of the following: * At least two bone lesions on bone scan, or * Soft tissue disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI), or * Unequivocal pelvic adenopathy short axis > 2.0 cm in diameter by CT/MRI * Progressive disease at study entry defined as one or more of the following three criteria occurring in the setting of castrate levels of testosterone: * Prostate Specific Antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of >= 1 week between each determination. The PSA value should be >= 2 µg/L (2 ng/mL); * Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; * Bone disease progression defined by two or more new lesions on bone scan * Asymptomatic or mildly symptomatic from prostate cancer (i.e. the score on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 must be < 4); no use of opiate analgesics for prostate cancer-related pain currently or anytime within 4 weeks prior to randomization * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, including subjects with decreased performance status not attributed to progressive and symptomatic prostate cancer * Estimated life expectancy of >= 12 months * Able to swallow the study drug and comply with study requirements * A male subject and his female spouse/partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period, and for 3 months after final study drug administration. Two acceptable forms of birth control include: 1. Condom (barrier method of contraception), AND 2. In addition to a condom, one of the following acceptable forms of contraception is required: * Established use of oral, injected or implanted hormonal methods of contraception. * Placement of an intrauterine device (IUD) or intrauterine system (IUS). * Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. * Tubal ligation for at least 6 months prior to Screening * Vasectomy or other surgical castration at least 6 months prior to Screening Exclusion Criteria: * Prior cytotoxic chemotherapy for prostate cancer * Severe concurrent disease, infection, or comorbidity that would make the subject inappropriate for enrollment * Known or suspected brain and/or skull metastasis or active epidural disease * History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer * Current or prior treatment with estrogens and/or drugs with anti-androgenic properties such as spironolactone > 50 mg/day, or progestational agents for the treatment of prostate cancer within 6 months prior to randomization * Current or prior use of ketoconazole for the treatment of prostate cancer * Use of antiandrogens within 6 weeks prior to randomization * Documented prior disease progression while receiving antiandrogens. Disease progression defined as PSA progression, radiographic progression and/or clinical deterioration. * Current or prior treatment with 5-α reductase inhibitors or anabolic steroids within 6 months prior to randomization * Prior use of systemic glucocorticoids (the equivalent of 10 mg of prednisone) within 3 months prior to randomization or expectation of their use during the study * Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to randomization * Major surgery within 2 months prior to randomization * History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). Also, current or prior treatment with anti-epileptic medications for the treatment of seizures or history of loss of consciousness or transient ischemic attack within 12 months prior to randomization * Clinically significant cardiovascular disease including myocardial infarction within past six months or uncontrolled angina within past three months

Study Objectives The purpose of this study is to evaluate the activity of RO4929097 in renal cell carcinoma patients that have failed therapy with VEGF/VEGFR directed agents. Conditions: Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer Intervention / Treatment: DRUG: Gamma-Secretase Inhibitor RO4929097, OTHER: Laboratory Biomarker Analysis Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically or cytologically confirmed predominant clear cell, renal cell carcinoma, NOS, that is recurrent or metastatic * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan; scans must be completed within 4 weeks prior to starting study treatment * Patients must have had one prior therapy for non-resectable renal cell carcinoma with a VEGF/VEGFR targeted therapy (e.g. sunitinib, sorafenib, other VEGFR tyrosine kinase inhibitor, or bevacizumab) * Prior treatment with mTOR inhibitors (Everolimus, Temsirolimus, or rapamycin) for non-resectable disease is permitted * Prior immunotherapy is permitted * Only one line of prior VEGF/VEGFR is permitted * Life expectancy of greater than 3 months * ECOG performance status =< 2 (Karnofsky >= 60%) * Patients must have normal organ and marrow function as defined below (within 7days prior to starting study treatment): * Hemoglobin >= 90 g/L * Absolute granulocyte count >= 1.5 x 10^9/L * Platelets >= 100 x 10^9/L * Total bilirubin =< 1.25 x ULN * AST (SGOT)/ALT (SGPT) =< 1.5 x institutional upper limit of normal (=< 5 x ULN for patients with liver metastases) * Creatinine =< within institutional normal limits OR creatinine clearance >= mL/min/1.73 m^2 for patients with creatinine levels above institutional (using Cockcroft-Gault formula) * Patients must have no serious medical conditions such as myocardial infarction within 6 months prior to entry, congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders, serious infections, active peptic ulcer disease, psychiatric illness, or any other medical conditions that might be aggravated by treatment or limit compliance * Patients must have no active malignancy at any other site * Patients must be able to take oral medication and have no evidence of bowel obstruction * The effects of RO4929097 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because Notch signal pathway inhibitors are known to be teratogenic, if women of childbearing potential do not abstain from sexual activity (documentation that they have been abstinent from sexual activity at least 4 weeks prior to study entry) they must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry; women of childbearing potential be can either be abstinent or use two forms of contraception for the duration of study participation, and be either abstinent or use two forms of contraception for at least 12 months post-treatment; men must use condoms when sexually active with women for the duration of study participation and at least 12 months post-treatment * Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study and for 12 months after study participation, the patient should inform the treating physician immediately * Pregnancy Testing; women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) within 10-14 days and within 24 hours prior to the first dose of RO4929097 (serum or urine); a pregnancy test (serum or urine) will be administered every 4 weeks if their menstrual cycles are regular or every 2 weeks if their cycles are irregular while on study within the 24-hour period prior to the administration of RO4929097; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing RO4929097, the investigator or clinical staff must confirm and document the patient's use of two contraceptive methods or abstinence, dates of negative pregnancy test, and confirm the patient's understanding of the teratogenic potential of RO4929097 * Female patients of childbearing potential are defined as follows: * Patients with regular menses * Patients, after menarche with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding * Women who have had tubal ligation * Female patients may be considered to NOT be of childbearing potential for the following reasons: * The patient has undergone total abdominal hysterectomy with bilateral salpingo-oophorectomy or bilateral oophorectomy * The patient is medically confirmed to be menopausal (no menstrual period) for 24 consecutive months * Pre-pubertal females; the parent or guardian of young female patients who have not yet started menstruation should verify that menstruation has not begun; if a young female patient reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forward * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients must not have had major surgery, chemotherapy, or radiation therapy within 4 weeks of starting the study treatment (6 weeks for nitrosoureas or mitomycin C); prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that had not been irradiated; patients must have recovered from the toxic effects from any prior therapy to =< grade 1, except alopecia * Patients may not be receiving any other investigational agents concurrently * Patients with controlled brain metastases (no radiographic progression following radiation and/or surgical treatment and no neurological signs or symptoms) that are clinically and radiologically stable for at least 6 months will be allowed but must NOT be currently taking corticosteroids (e.g. dexamethasone) to control neurologic symptoms of brain metastases * Patients with unstable or symptomatic brain metastases, spinal core compression, or carcinomatosis meningitis, or evidence of brain or leptomeningeal disease on screening CT or MRI scan are excluded * History of allergic reactions attributed to compounds of similar chemical or biologic composition to RO4929097 or other agents used in the study * Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®) are ineligible * Preclinical studies indicate that RO4929097 is a substrate of CYP3A4 and inducer of CYP3A4 enzyme activity; caution should be exercised when dosing RO4929097 concurrently with CYP3A4 substrates, inducers, and/or inhibitors; furthermore, patients who are taking concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4 should be switched to alternative medications to minimize any potential risk; if such patients cannot be switched to alternative medications, they will be ineligible to participate in this study * Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption; patients must be able to swallow tablets * Patients who are serologically positive for Hepatitis A, B or C, or have a history of liver disease, other forms of hepatitis or cirrhosis are ineligible * Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because RO4929097 is a Notch pathway-inhibiting agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with RO4929097, breastfeeding should be discontinued if the mother is treated with RO4929097; these potential risks may also apply to other agents used in this study * Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with RO4929097; 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 * Cardiovascular: baseline (within 7days prior to starting study treatment) QTc > 450 msec (male) or QTc > 470 msec (female) * History of risk factors for QT interval prolongation, including, but not limited to family or personal history of long QT syndrome, recurrent syncope without known etiology or sudden unexpected death * History of Torsades de Pointes or other significant cardiac arrhythmias or the need for concomitant meds with known potential to prolong QT interval or antiarrhythmics

Study Objectives The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every week in the treatment of patients with advanced ovarian cancer that is resistant to platinum-based chemotherapy. Conditions: Ovarian Neoplasms Intervention / Treatment: DRUG: TLK286 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 * Histologic diagnosis of ovarian cancer * Recurrent or persistent disease following primary therapy * Measurable disease * Prior treatment with at least one but no more than three prior chemotherapy regimens * Resistant or refractory to platinum-based chemotherapy * At least 18 years of age * Good performance status (ECOG 0 to 1) * Adequate liver, renal and bone marrow function Exclusion criteria * Pregnant or currently breast feeding * Treatment with chemotherapy or immunotherapy within four weeks * Prior radiation to the whole pelvis

Study Objectives This Phase II study is designed to evaluate the antitumor efficacy and pharmacokinetics of crenolanib (CP-868,596) in patients with D842-related mutant metastatic GIST. Conditions: D842-related Mutant GIST Intervention / Treatment: DRUG: Crenolanib besylate (CP-868,596-26), Dose: 140mg BID 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 * Male or female, of any racial or ethnic group * Age >= 18 years * Life expectancy of greater than 12 weeks * Patient able and willing to provide informed consent * Normal liver function, defined as AST and ALT <=2.5x ULN, and Total Bilirubin <= 2x ULN. * Total creatinine <= 1.5x ULN * ECOG Performance Status 0 - 2 (Appendix II) * Patients must have histologically or cytologically confirmed GIST with a D842-related mutation or deletion on the PDGFRA gene * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See Section 10.1.2 for the evaluation of measurable disease. * Patients must have recovered from any prior therapy and completed the minimum of, either 5 half-lives of prior therapy or 2 weeks must have elapsed since prior treatment Exclusion Criteria * Patient unable to provide informed consent * ECOG Performance status > 2 * Any concurrent anticancer therapy, immunotherapy, or hormonal therapy. * Any other investigational agents taken within 2 weeks of start of study drug or if study drug will commence within 5 half-lives of prior therapy * Patients with known or active Hepatitis B or C; liver cirrhosis. * Patients with active fungal, viral, and bacterial infections * Positive serum pregnancy test * Pregnant or lactating women * Patients on concomitant medications that induce or inhibit CYP3A4 (Appendix III) * Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs

Study Objectives The purpose of this study is to find out if the experimental drug pralatrexate with the vitamins folic acid and vitamin B12 might be an effective treatment for head and neck cancer. The reason we are doing this study is because another drug called methotrexate has been used for a long time to treat head and neck cancer patients. Pralatrexate was designed by scientists to be a new drug that works better than methotrexate. Laboratory studies have shown that pralatrexate works better than methotrexate at killing cancer cells. Pralatrexate has already been studied in patients with other types of cancers, such as lymphoma and lung cancer. The results from those studies were promising. Pralatrexate was recently approved by the Food and Drug Administration (FDA) as a new treatment for a cancer called peripheral T cell lymphoma. Conditions: Head and Neck Cancer Intervention / Treatment: DRUG: Pralatrexate With Vitamin B12 and Folic Acid Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histopathologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck, including unknown primary squamous cell carcinomas of the neck. Confirmation of biopsy/diagnosis will be performed at MSKCC or at participating sites (NYU Cancer Institute/NYU Medical Center/ Bellevue Hospital Center). * Patients must be at least 18 years of age. * ECOG performance status must be >= 0 or 1. * Disease must be measurable by RECIST version 1.1 criteria. * Patients must have been previously treated with systemic chemotherapy (i.e., chemotherapy and/or targeted therapies such as cetuximab for recurrent/metastatic HNSCC,. * At least four weeks must have elapsed from previous radiation therapy. Patients must have recovered from the acute toxic effects of treatment prior to study enrollment. * Patients must have adequate organ function, as follows: Adequate bone marrow reserve: absolute neutrophil count (ANC) > 1,000 cells/mm3, platelets > 100,000 cells/mm3, and hemoglobin > 9 g/dL Hepatic: AST and ALT <= 3 X upper limit of normal (ULN); AST and ALT <= 5 X ULN if liver metastasis present; Total bilirubin <= 1.5 x ULN unless Gilbert's disease is present Renal: Serum creatinine <= 1.5 mg/dL or creatinine clearance (by either 24 hour urine collection or Cockcroft-Gault equation) > or = to 55 ml/min * Both women and men and members of all races and ethnic groups are eligible for this trial. * Women of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Both men and women must agree to use a reliable method of birth control until 30 days following the last dose of study drug. Exclusion Criteria: * History of any brain metastases unless resected with no evidence for > 12 weeks and not on steroids * Women who are lactating * Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis * Patients who have undergone an allogeneic stem cell transplant

Study Objectives The goal of this clinical research study is to find out if 1% chlorhexidine gluconate gel will decrease the amount of bacteria that causes tooth decay. Whether the gel is acceptable to patients will also be studied. Conditions: Head and Neck Cancer Intervention / Treatment: DRUG: 1% Chlorhexidine Gluconate Gel, BEHAVIORAL: Surveys Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Inclusion: * Patients who have undergone radiation treatment to the head and neck at U.T. M. D. Anderson Cancer Center for oral cavity or oropharyngeal cancer (base of tongue and tonsil) and have recent documented caries, within 8 weeks, on routine oral examination. * Patients with >= 10 teeth. * Patients with >= 100,000 CFU/ ml S. mutans in the baseline microbiological sample (i.e., supragingival curette sampling). Exclusion Criteria: * Patients using antibiotics in the past 4 weeks. (Note: A subject may have antibiotics administered during the study evaluation period, for unforeseen medical reasons. The patients will not be removed from the study and the plaque samples will be evaluated for descriptive assessment with the concomitant medication(s) recorded to determine if changes between the subject's samples were globally outside the range of changes for the population as a whole.) * Patients using chlorhexidine gluconate or antimicrobial rinses in past 2 weeks. * Patients under the age of 18. * Patients unable to return to dental clinic over the 20-week study period. * Patients with a known allergy to Chlorhexidine.

Study Objectives In this study participants with relapsed/refractory leukemia will be given MK-0457 in sequential cohorts and with varying treatment duration to determine the maximum tolerated dose (MTD) for MK-0457. Conditions: Chronic Myelogenous Leukemia in Blast Crisis, Lymphocytic Leukemia, B Cell, Acute, Myelodysplastic Syndromes, Myelogenous Leukemia, Chronic Intervention / Treatment: DRUG: MK0457 Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Part 1: * Patients with relapsed/refractory acute myelogenous leukemia (AML), poor risk myelodysplastic syndrome (MDS), B-cell acute lymphocytic leukemia (ALL), myeloproliferative diseases, or chronic myelogenous leukemia (CML) in blast crisis Part 2: * Acute myelogenous leukemia (with FLT-3 mutation ), and myeloproliferative diseases only * At least 2 weeks since the last cytotoxic therapy * Acceptable renal and hepatic function * Ambulatory, capable of all self-care, and out of bed for more than 50% of waking hours * More than 2 months since autologous bone marrow or peripheral blood stem cell transplantation Exclusion Criteria: * Not fully recovered from previous anti-leukemia therapy * Previous allogeneic bone marrow transplant * Uncontrolled congestive heart failure * Myocardial infarction within the last 3 months * Active or uncontrolled infection * Pregnancy or lactation * Currently active second malignancy, other than non-melanoma skin cancer * History of hepatitis B or C, known HIV positivity, or AIDS related illness

Study Objectives The primary objective was to determine the maximum tolerated dose of carfilzomib given twice weekly in combination with cyclophosphamide and dexamethasone for patients with newly diagnosed multiple myeloma. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Carfilzomib, DRUG: Cyclophosphamide, DRUG: Dexamethasone 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: * Newly diagnosed multiple myeloma * Measurable disease, as defined by 1 or more of the following * Serum M-protein >= 0.5 g/dL, or * Urine M-protein >= 200 mg/24 hours, or * In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ( κ/λ) ratio * Males and females >= 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Adequate hepatic function * Left ventricular ejection fraction (LVEF) >= 40% * Absolute neutrophil count (ANC) >= 1.0 × 10^9/L * Platelet count >= 50 × 10^9/L * Calculated or measured creatinine clearance (CrCl) of >= 15 mL/min Exclusion Criteria: * Planned autologous hematopoietic stem cell transplantation (HSCT) for the initial therapy of newly diagnosed multiple myeloma * Multiple myeloma of immunoglobulin M (IgM) subtype * Prior systemic treatment for multiple myeloma * Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds the equivalent of dexamethasone 160 mg * Known amyloidosis * Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to enrollment. * Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (subjects with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B are allowed) * Significant neuropathy (Grades >= 2) within 14 days prior to enrollment * Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Study Objectives To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer. Conditions: Stomach Neoplasms Intervention / Treatment: DRUG: Cisplatin, DRUG: S-1, DRUG: Sunitinib Location: Japan 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 diagnosis of gastric cancer * Chemonaive patients * Adequate organ function Exclusion Criteria: * Patients who meet the contra-indications of S-1 and Cisplatin. * Prior chemotherapy failure patients

Study Objectives The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and to determine the composite complete remission (CRc) rate for participants who either discontinued the study or completed 2 cycles of gilteritinib given in combination with atezolizumab. This study also evaluated pharmacokinetics (PK), response to treatment, remission and survival. Adverse events (AEs), clinical laboratory results, vital signs, electrocardiograms (ECGs), and Eastern Cooperative Oncology Group (ECOG) performance status scores were also assessed. Conditions: Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation Intervention / Treatment: DRUG: gilteritinib, DRUG: atezolizumab 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: * Subject is considered an adult according to local regulation at the time of signing informed consent form (ICF). * Subject has defined AML by the World Health Organization (WHO) criteria (2017) and fulfills one of the following: * Refractory to at least 1 cycle of induction chemotherapy * Relapsed after achieving remission with a prior therapy * Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject's last interventional treatment. * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status <= 2 at screening. * Subject must meet the following criteria as indicated on the clinical laboratory tests: * Serum Aspartate aminotransferase (AST) and Alanine Aminotransferease (ALT) <= 2.5 x upper limit of normal (ULN) * Serum total bilirubin (TBL) <= 1.5 x ULN * Serum creatinine <= 1.5 x ULN or an estimated glomerular filtration rate of > 50 mL/min as calculated by the Modification of Diet in Renal Disease equation. * Subject is suitable for oral administration of study drug. * A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 180 days after the final study drug administration. * Female subject must agree not to breastfeed starting at screening and throughout the study period, and for at least 180 days after the final study drug administration. * Female subject must not donate ova starting at screening and throughout the study period, and for at least 180 days after the final study drug administration. * A male subject must not donate sperm starting at screening and throughout the treatment period, and for at least 120 days after the final study drug administration. * A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period, and for at least 120 days after the final study drug administration. * Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the treatment period, and for 120 days after the final study drug administration. * Subject agrees not to participate in another investigational study while on treatment. Exclusion Criteria: * Subject was diagnosed as acute promyelocytic leukemia. * Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis). * Subject has AML secondary to prior chemotherapy for other neoplasms (except for myelodysplastic syndrome). * Subject has clinically active central nervous system leukemia. * Subject has uncontrolled or significant cardiovascular disease, including: * A myocardial infarction within 12 months * Uncontrolled angina within 6 months * History of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes) or any history of arrhythmia * Uncontrolled hypertension * Subject has baseline left ventricular ejection fraction that is >= 45%. * Subject has mean triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading. * Subject has congenital or acquired Long QT Syndrome at screening. * Subject has hypokalemia and/or hypomagnesemia at screening. * Subject has been diagnosed with another malignancy that requires concurrent treatment or hepatic malignancy regardless of the need for treatment. * Subject has clinically significant coagulation abnormality unless secondary to AML. * Subject is receiving or plans to receive concomitant chemotherapy or immunotherapy. * Subject has had major surgery within 4 weeks prior to the first study dose. * Subject has radiation therapy within 4 weeks prior to the first study dose. * Subject requires treatment with concomitant drugs that are strong inducers of Cytochrome P450 (CYP3A). * Subject has known pulmonary disease with diffusion capacity of lung for carbon monoxide <= 65%, forced expiratory volume in the first second (FEV1) <= 65%, dyspnea at rest or requiring oxygen or any pleural neoplasm. * Subject with systemic fungal, bacterial, viral or other uncontrolled infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. Subject needs to be off pressors and have negative blood cultures for 48 hours. * Subject has not recovered from any prior therapy related toxicities. * Subject is known to have human immunodeficiency virus infection. * Subject has active hepatitis B or C or other active hepatic disorder. * Subject has previously been treated with gilteritinib, quizartinib or crenolanib (will only apply to subjects enrolled in the phase 2 portion of the study). * Subject has active clinically significant graft-versus-host disease (GVHD) or is on treatment with systemic corticosteroids for GVHD. * Subject has relapsed after allogeneic hematopoietic stem cell transplant (HCST). * Subject has an active autoimmune disorder that makes the subject unsuitable for study treatment or participation. * Subject has any condition that makes the subject unsuitable for study participation.

Study Objectives The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time. Conditions: Prostatic Neoplasm, Prostate Cancer, Prostatic Adenocarcinoma Intervention / Treatment: BIOLOGICAL: sipuleucel-T, DRUG: leuprolide acetate Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Hormone-sensitive prostate cancer * Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis * ECOG performance status <= 1 * Histologically documented prostate cancer * Prior primary therapy for prostate cancer * Rising PSA with a PSADT of <= 12 months * Testosterone >= 200 ng/dL <= 28 days of registration * Adequate hematologic, renal, and liver function * Must live in a permanent residence within a comfortable driving distance (round-trip within one day) to the clinical research site Exclusion Criteria: * Requires systemic ongoing immunosuppressive therapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF * Prior sipuleucel-T therapy * Prior ADT therapy <= 6 months prior to registration or >= 6 months duration in total * If subject has a history of any other stage III/IV malignancy, the subject must be disease free and off any malignancy-related treatment for at least 10 years. If the subject has a history of any stage I-II malignancy, the subject must be disease free and off any malignancy-related treatment for at least 5 years. * Prior experimental immunotherapy or on an experimental clinical trial within 1 year * Received denosumab or XRT <= 6 months prior to registration * Received chemotherapy or GM-CSF <= 90 days prior to registration * Received any of the following medications or interventions <= 28 days prior to registration * major surgery requiring general anesthesia * systemic immunosuppressive therapy * other prescription treatment for prostate cancer * Active infection within 1 week of registration * Likely to receive XRT or surgery for prostate cancer during the study period * Any medical intervention, any other condition, or any circumstances that could compromise the study.

Study Objectives Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. Conditions: Advanced Cancer Intervention / Treatment: DRUG: anlotinib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * late malignant tumor patients diagnosed with the pathological and/or cytological; * lack of the standard treatment or treatment failure; * 18-65years, ECOG:0-1,Expected survival period >3 months; * stop medicine > 30 days if any other chemotherapy drugs be used. * HB>=90g/L,ANC(Absolute Neutrophil Count) >=1.5×109/L；PLT >=100×109/L ,BIL/ALT/AST(aspartate aminotransferase )/Cr in normal range,or CCR>=60ml/min,TG<= 3.0mmol/L，cholesterol<=7.75mmol/L; LVEF>=LLN. * Female should be agreed to use contraceptive during the study and after 6 months (such as intrauterine device(IUD), the pill or a condom); The serum or urine pregnancy test negative before take ALTN, and is out of non-lactation period. Male should be agreed to use contraceptive during the study and after the period of 6 months. * Volunteer, informed consent form (ICF) signed, compliance. Exclusion Criteria: * Subject was diagnosed with other malignant tumors previously or meanwhile; * Participated in other clinical trials in four weeks; * Has influence of oral drugs(such as unable to swallow, gastrointestinal tract after resection); * Already diagnosed with brain metastases, spinal cord compression, cancerous meningitis, or screening CT or MRI findings of the brain or soft meningeal disease patient; * Hypertension * Urine protein: ++, and urinary in 24 hours > 1.0g; * Coagulant function abnormality: subject with bleeding tendency (such as active peptic ulcer) or are receiving thrombolysis or anticoagulant therapy; * Subject with psychiatric drugs abuse history and can't get rid of, or mental disorder; * With artery/venous thrombotic before oral ALTN; * With history of anticoagulant, vitamin K antagonists(such as warfarin or heparin) or other analogues treatment; * With Abnormal thyroid function; * With history of psychiatric drugs abuse or a mental disorder; * Viral hepatitis B or hepatitis c patients (including hepatitis b, hepatitis c virus carriers); * Have immunodeficiency history; * According to the researcher's judgment,there are concomitant diseases which will seriously endanger the patients or obstruct the patients to complete the clinical trial.

Study Objectives A Phase Ia/Ib Safety and Tolerability Evaluation of Low-dose Radiation in Combination with CS1001 in relapsed SCLC patients Conditions: Relapsed Small Cell Lung Cancer Intervention / Treatment: DRUG: CS1001 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histologically or cytologically confirmed LS-SCLC or ES-SCLC and experienced progression since first-line standard platinum containing dual-drug chemotherapy. * Patients whose initial diagnosis was limited must undergo radical chest radiotherapy and the time of tumor progression is not less than 3 months from the end of radiotherapy, or cannot receive radical chest radiotherapy due to specific reasons * At least one extracranial measurable lesion (RECIST v1.1), and for a lesion that has received radiotherapy, progression of the lesion after radiotherapy must be confirmed. * Patients with brain metastases are allowed to receive previous radiotherapy and their condition is stable, but the time to the end of radiotherapy must not be less than 3 months. * No radiotherapy contraindications were judged by the radiologist * ECOG performance status of 0 or 1. * Patients with life expectancy >= 3 months. * Patients must have adequate organ function. * Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 6 months after last study drug administration. Exclusion Criteria: * Subjects known to have primary CNS tumors or meningeal metastases or unstable CNS metastases. * Patients with active autoimmune diseases or history of autoimmune diseases should be excluded. * Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment. * Known history of HIV infection. * Subjects with active chronic hepatitis B or active hepatitis C . * Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma. * Known history of alcoholism or drugs abuse. * Subjects with history of radiation pneumonitis of grade 3 or above, regardless of recovered or not.

Study Objectives Phase I exploratory, open-label, single arm, multicenter study to assess safety, tolerability and antitumor activity of ONCOFID-P-B™ therapy in adult patients with histologically confirmed diagnosis of bladder carcinoma in situ (CIS), who were unresponsive or intolerant to Bacillus Calmette-Guérin (BCG)-therapy. Patients are initially treated with 12 weekly intravesical instillations of ONCOFID-P-B™ (intensive treatment phase). Patients who achieve a complete response (CR) after the 12 weekly instillations entered the maintenance phase of the study, during which ONCOFID-P-B™ is furtherly administered once a month for 12 months. Conditions: Bladder Carcinoma in Situ (CIS) Intervention / Treatment: DRUG: ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) Location: Italy, Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histologically confirmed CIS of the bladder. A portion of patients up to 30% could have concomitant Ta and/or T1 lesions. * Complete resection of papillary lesions before entering the trial in patients with concomitant CIS and papillary tumors. * Patients were to be unresponsive or intolerant to BCG, had to have refused radical cystectomy or were not clinically suitable for cystectomy. Patients unresponsive to BCG were defined as patients for whom further BCG would be unlikely to be of benefit. This included all patients treated with an adequate course of induction plus maintenance BCG who either had persistent disease or who relapsed within 6 months of their last BCG treatment. * Age >=18 yrs. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Female in non-reproductive years (defined as surgically sterile or one year postmenopausal). Female of childbearing potential had to agree to practice complete abstinence or to use an effective contraceptive method. * Able and willing to comply with scheduled visits, therapy plans, and laboratory tests required in the protocol. * Signed and dated Independent Ethics Committee (IEC)-approved Informed Consent. Exclusion Criteria: * Any of the following in the previous 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart enrolled cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis. * Known hypersensitivity to paclitaxel or any of its constituents. * Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment start. * Muscle-invasive disease T2-T4. * Previous or concomitant cancer of the upper urinary tract or the prostatic urethra. * Prior (within the previous 3 years) or concurrent malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri. * Last intravesical immunotherapy dose administration <8 weeks prior to study entry. Patients had to have documentation of persistent or recurrent disease. * Previous intravesical chemotherapy < 28 days prior to study entry with the exception of patients who underwent transurethral resection (TUR) < 7 days. * Bladder capacity lower than 150 ml. * Presence of significant urologic disease interfering with intravesical therapy. * Concurrent enrollment or participation in another therapeutic clinical trial within 4 weeks preceding treatment start. * Patients with known active substances and/or alcohol abuse. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patients inappropriate for entry into the study or, in the opinion of the Investigator and/or the Sponsor, could compromise protocol objectives.

Study Objectives This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Docetaxel, DRUG: Androgen Hormonal Suppression and Radiation, DRUG: Androgen Suppression Therapy and Radiation Therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Biopsy proven prostate cancer * Clinical Tumor Category T1b, T1c, T2a and PSA greater than (>) 10 or Gleason score equal or greater than 4+3=7 or PSA velocity > 2.0 ng/ml per year and also eligible patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal Vesicle Invasion); Gleason = or > 3+4=7 with 50% or more cores positive * Negative bone scan * Lymph node assessment by CT or MR * Adequate hematologic function (Blood Counts) * Adequate liver functions (blood tests) * ECOG performance Status 0 or 1 * Peripheral neuropathy must be =< grade 1 * PSA obtained within 3 months of entry Exclusion Criteria: * Prior history of malignancy that are < 5 years except for cancers found to be "in-situ" and would not likely impact a patient's life expectancy with appropriate medical management. * Prior pelvic radiation therapy * Prior hormonal therapy (up to 4 weeks prior to enrollment allowed) * Individuals unable to tolerate lying still 5 - 10 minutes * Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 90.

Study Objectives The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ). Conditions: Melanoma Intervention / Treatment: DRUG: Sorafenib (Nexavar, BAY43-9006), DRUG: Carboplatin/Paclitaxel, DRUG: Placebo Location: Germany, Canada, Netherlands, United Kingdom, United States, Australia, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Subjects who have a life expectancy of at least 12 weeks * Subjects with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma * Subjects must have progressed after receiving at least one cycle of DTIC or TMZ containing regimen * Subjects who have an ECOG PS of 0 or 1 * Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria Exclusion Criteria: * Primary ocular or mucosal melanoma * Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"]& T1 [Tumor invades subepithelial connective tissue]) or any cancer curatively treated < 5 years prior to study entry * History of cardiac disease * Known history of human immunodeficiency virus (HIV) infection

Study Objectives The purpose of this study is to determine the safety and tolerability of ruxolitinib (INCB018424) sustained release (SR) formulation in participants with primary myelofibrosis (PMF), post-polycythemia vera MF (PPV-MF), and post-essential thrombocythemia MF (PET-MF). Conditions: Myelofibrosis Intervention / Treatment: DRUG: Ruxolitinib 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: * Participants 18 years of age or older. * Participants must be diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia myelofibrosis (PPV-MF), or post-polycythemia vera myelofibrosis (PET-MF). * Participants with myelofibrosis requiring therapy must be classified as high risk (3 or more prognostic factors), intermediate risk level 2 (2 prognostic factors), or intermediate risk level 1 (1 prognostic factor)defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT). * Participants must have a palpable spleen measuring 5 cm or greater below the costal margin. Exclusion Criteria: * Participants with a life expectancy of less than 6 months. * Participants of childbearing potential who are unwilling to take appropriate precautions to avoid pregnancy or fathering a child. * Participants with inadequate bone marrow reserve. * Participants with history of platelet counts < 50,000/μL, platelet transfusion(s), or an absolute neutrophil count < 500/μL in the month prior to Screening. * Participants with inadequate liver or renal function at Screening and Baseline visits.

Study Objectives In this retrospective study, the investigators assessed the application of radiofrequency-assisted liver resection in intractable liver cancer resection, and plan to analysis the different factors. Conditions: Liver Cancer Intervention / Treatment: PROCEDURE: radiofrequency, PROCEDURE: TACE, PROCEDURE: TACE+radiofrequency Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Ultrasound-guided fine-needle aspiration pathology or postoperative pathology was confirmed to be liver cancer, no pathological results according to China 's 2017 version of the hepatocarcinoma (HCC) diagnosis and treatment specifications, in line with the standard clinical diagnosis of liver cancer * According to Barcelona Clinic Liver Cancer (BCLC) staging criteria, it is stage C (stage C: single tumour> 5 cm or more than three tumours, and at least one tumour> 3 cm, liver function Child-Pugh A or B, with lymph node metastasis or distant metastasis or portal vein or Venous liver trunk is invaded, penance Status (PST) score 1-2 points) Exclusion Criteria: * HCC patients with other malignant tumours * Metastatic liver tumour * Patients with liver abscess * Patients with organ dysfunction

Study Objectives This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison. Approximately 544 participants, at least 18 years of age, with Child-Pugh score \< 7 and diagnosed with hepatocellular carcinoma will be randomized. Participants must have received sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have discontinued sorafenib prior to entering the study. Hypothesis: This sample size will allow differentiation of the expected increase in median overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab arm. Upon registration and completion of screening procedures, eligible participants with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo. The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision. Conditions: Hepatocellular Carcinoma Intervention / Treatment: BIOLOGICAL: Placebo, BIOLOGICAL: Ramucirumab DP (IMC-1121B), OTHER: BSC Location: Hungary, Canada, Portugal, United States, Taiwan, Austria, Philippines, France, Israel, Thailand, Italy, Netherlands, Bulgaria, Finland, Spain, Brazil, Belgium, Sweden, Norway, Germany, Czech Republic, Japan, Korea, Republic of, Romania, Switzerland, Australia, Hong Kong Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 * Child-Pugh score of <7 (Child-Pugh Class A only) * Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC stage B not amenable to locoregional therapy or refractory to locoregional therapy * Diagnosis of HCC (excluding fibrolamellar carcinoma) in the absence of histologic or cytologic confirmation * There are either clinical, laboratory, or radiographic findings consistent with a diagnosis of liver cirrhosis * Has a liver mass measuring at least 2 centimeters (cm) with characteristic vascularization seen on either triphasic computed tomography (CT) scan or magnetic resonance imaging (MRI) with gadolinium * At least 1 measurable or evaluable lesion that is viable [that is (i.e.), is vascularized], and has not been previously treated with locoregional therapy. A lesion that has been previously treated will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy * Previously treated with sorafenib and has discontinued sorafenib treatment at least 14 days prior to randomization. Participants may have experienced: * Radiographically documented disease progression during sorafenib therapy or after discontinuation of sorafenib therapy, or * Discontinuation of sorafenib due to an adverse drug reaction, despite dose reduction by 1 level and BSC * The participant has received sorafenib as the only systemic therapeutic intervention. Any hepatic locoregional therapy that has been administered prior to sorafenib is allowed, but not following sorafenib. Radiation to metastatic sites [for example (e.g.), bone] following sorafenib therapy is permitted. * Resolution of clinically significant toxicity of any anti-cancer therapy to Grade <=1 by the National Cancer Institute Common Terminology Criteria for Adverse Events volume 4.0 (NCI-CTCAE v. 4.0). Adequate Organ Function defined as: * Total bilirubin <3.0 mg/dL [51.3 micromole/liter (µmol/L)], aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=5 × upper limit of normal (ULN) * Serum creatinine <=1.2 × ULN or calculated creatinine clearance >50 milliliters/minute (mL/min) * Absolute neutrophil count (ANC) >=1.0 × 10^3/microliter (μL) (1.0 × 10^9/liter (L)]), hemoglobin >=9 grams/deciliter (g/dL) [5.58 millimoles/liter (mmol/L)], and platelets >=75 × 10^3/µL (75 × 10^9/L) * International Normalized Ratio (INR) <=1.5 and partial thromboplastin time (PTT) <=5 seconds above ULN. Participants receiving prophylactic low-dose anticoagulant therapy are eligible provided that INR <=1.5 and PTT <=5 seconds above the ULN * The participant's urinary protein is <=1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates >=2+ proteinuria, then a 24-hour urine must be collected and must demonstrate <1000 milligrams (mg) of protein in 24 hours to allow participation in the study Exclusion criteria: * Major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to randomization * Hepatic locoregional therapy within 28 days prior to randomization * Radiation to any nonhepatic (e.g., bone) site within 14 days prior to randomization * Sorafenib within 14 days prior to randomization * Received any investigational therapy or non-approved drug within 28 days prior to randomization * Received any previous systemic therapy with vascular endothelial growth factor (VEGF) inhibitors or vascular endothelial growth factor receptor (VEGFR) inhibitors (including investigational agents) other than sorafenib for treatment of HCC * Fibrolamellar carcinoma * Received any transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony-stimulating factors (G-CSF) within 14 days prior to randomization * Therapeutic anticoagulation with warfarin, low-molecular-weight heparin, or similar agents. Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters defined in the inclusion criteria (INR <=1.5 and PTT <=5 seconds above the ULN) are met * Receiving ongoing therapy with nonsteroidal anti-inflammatory agents (NSAIDs, e.g., indomethacin, ibuprofen, naproxen, nimesulide, celecoxib, etoricoxib, or similar agents) or other antiplatelet agents (e.g., clopidogrel, ticlopidine, prasugrel, dipyridamole, picotamide, indobufen, anagrelide, triflusal). Aspirin (ASA) at doses up to 100 milligrams/day (mg/day) is permitted * Symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia * Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization * Uncontrolled arterial hypertension systolic >=150 / diastolic >=90 millimeters of mercury (mm Hg) despite standard medical management * Grade 3-4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to randomization requiring transfusion, endoscopic or operative intervention (participants with any bleeding episode considered life-threatening during the 3 months prior to randomization are excluded, regardless of transfusion or intervention status) * Esophageal or gastric varices that require immediate intervention (e.g., banding, sclerotherapy) or represent a high bleeding risk. Participants with evidence of portal hypertension (including splenomegaly) or any prior history of variceal bleeding must have had endoscopic evaluation within the 3 months immediately prior to randomization. Participants with evidence of portal hypertension are eligible for study participation if endoscopic evaluation does not indicate esophageal or gastric varices that require immediate intervention or represent a high bleeding risk; however, these eligible participants must receive supportive therapy (e.g., beta blocker therapy) according to institutional standards and clinical guidelines during study participation * Central nervous system (CNS) metastases or carcinomatous meningitis * History of or current hepatic encephalopathy or current clinically meaningful ascites

Study Objectives This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lymphoma. Conditions: Lymphoma Intervention / Treatment: DRUG: IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen) Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Subjects with NHL to be included: * Any subject with NHL that had relapsed or progressed following initial therapy with an anthracycline-based chemotherapy regimen and has achieved a subsequent partial remission (PR) or a complete remission (CR) following a salvage chemotherapy regimen. * Any subject with NHL that was initially refractory to an anthracycline-based chemotherapy regimen but who has achieved a PR or CR following a salvage chemotherapy regimen. * Any subject with an initial International Prognostic Index (IPI) score 4-5 who achieved a PR or any CR following an anthracycline-based chemotherapy regimen except subjects with Mantle cell, T cell and Natural Killer (NK) cell pathologies. * Subjects with Mantle cell, T cell and NK cell lymphoma may be enrolled if they have PR or CR after initial therapy. * Any subject that has relapsed or progressed following previous autologous HSCT. Subjects with HL to be included: * Any subject with HL that had relapsed or progressed following initial therapy with an multi-drug chemotherapy regimen and has achieved a subsequent PR or a CR following a salvage chemotherapy regimen. * Any subject with HL that is initially refractory to a multi-drug chemotherapy regimen but who has achieved a PR or CR following a salvage chemotherapy regimen. * Any subject that has relapsed or progressed following previous autologous HSCT. Exclusion Criteria: * Any subject with chemoresistant disease by demonstration of less than PR to most recent chemotherapy, and any subject with prior treatment history of autologous HSCT or high-dose chemotherapy with stem cell rescue for any medical reason will be excluded. Excluded will also be subjects with existing or active central nervous system lymphoma or human immunodeficiency virus related lymphoma, unacceptable organ function, or uncontrolled infections.

Study Objectives This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with cervical cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of \[cancer/tumor\] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells. Conditions: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IB Cervical Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7, Stage IIB Cervical Cancer AJCC v6 and v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IVA Cervical Cancer AJCC v6 and v7 Intervention / Treatment: RADIATION: Brachytherapy, DRUG: Carboplatin, DRUG: Cisplatin, RADIATION: External Beam Radiation Therapy, DRUG: Paclitaxel, OTHER: Quality-of-Life Assessment Location: Canada, United States, Singapore, Saudi Arabia, China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Eligible patients will have locally advanced cervical cancer suitable for primary treatment with chemoradiation with curative intent, in addition to: * Federation of Gynecology and Obstetrics (FIGO) 2008 stage IB1 & node positive, IB2, IIA, IIB, IIIB, or IVA disease * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix * White blood cells (WBC) >= 3.0 x 10^9/L * Absolute neutrophil count (ANC) >= 1.5 x 10^9/L * Platelet count >= 100 x 10^9/L * Bilirubin =< 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN (if both tests are done, both results need to be =< 2.5 x ULN) * Creatinine =< ULN (Common Toxicity Criteria [CTC] grade 0) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 60 mL/min OR >= 50 mL/min by ethylenediaminetetraacetic acid (EDTA) creatinine clearance * Written informed consent Exclusion Criteria: * Any previous pelvic radiotherapy * Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive, or >= 15 mm short-axis diameter on computed tomography [CT]) * FIGO 2008 stage IIIA disease * Patients assessed at presentation as requiring interstitial brachytherapy treatment * Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria * Previous chemotherapy for this tumor * Evidence of distant metastases * Prior diagnosis of Crohn's disease or ulcerative colitis * Peripheral neuropathy >= grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4) * Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomy * Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years * Patients who are pregnant or lactating * Any contraindication to the use of cisplatin, carboplatin, or paclitaxel chemotherapy * Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients who are known to be human immunodeficiency virus (HIV) positive