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Study Objectives RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer. PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment. Conditions: Brain Tumor, Central Nervous System Tumors, Cachexia, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Unspecified Childhood Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: cyproheptadine hydrochloride, DRUG: megestrol acetate Location: United States, Puerto Rico, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: NON_RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

INCLUSION CRITERIA: * Any cachectic patient with weight loss presumed secondary to cancer or cancer related therapy is eligible. Cachexia is defined as having one or more of the following: * documented history of weight loss > 5% * drop in growth rate two or more percentile ranks on standard growth charts, * weight for height less than the tenth percentile. * Patients with newly diagnosed or relapsed cancer of any type, including brain tumors. * Patients who are receiving active or palliative therapy are eligible. * If patients have completed treatment for cancer (surgery, chemotherapy, radiotherapy) within 8 weeks of study registration, they are also eligible. * Patients must be >= 2 years and < 21 years of age at the time of admission to this study. * Patients must have a predicted life expectancy of at least eight weeks. EXCLUSION CRITERIA: * Patients who are currently taking or who have taken Periactin and/or Megace during the past three weeks are not eligible. * Patients receiving corticosteroid or monoamine oxidase (MAO) inhibitor therapy. (Intermittent steroid use is permitted IF you anticipate it will not be administered for more than 7 days in a 4 week period. Calculate anticipated intermittent steroid use in 4-week intervals through the 8-week period during which study agent may be administered (4 weeks for Periactin and potentially 4 weeks for Megace. * Patients who have received parenteral nutrition or tube feedings within 1 week of starting this protocol or patients who are expected to require parenteral nutrition or tube feedings during the 4-week course of this study. * Patients taking dronabinol (Marinol) or other appetite-stimulating medications during the past three weeks or patients expected to be prescribed appetite-stimulating medications during the 4-week course of this study. * Patients with hormone sensitive tumors specifically meningiomas, breast cancer, ovarian cancer, and endometrial carcinoma.31, 32 * Children with neurofibromatosis, type I or II, are at risk for the development of meningiomas and are thus excluded from this study.32 * Children with glaucoma, chronic persistent asthma, or gastrointestinal (GI) or genitourinary (GU) obstruction. * Patients with recurrent and/or persistent hypertension, defined as blood pressure values >20% above normal. * Patients with thromboembolic disease, congestive heart failure, or peripheral edema. * Patients who are pregnant.

Study Objectives Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese). Conditions: Adenovirus, Anesthesia, Anxiety, Anxiolysis, Autism, Autistic Disorder, Bacterial Meningitis, Bacterial Septicemia, Benzodiazepine, Bipolar Disorder, Bone and Joint Infections, Central Nervous System Infections, Convulsions, Cytomegalovirus Retinitis, Early-onset Schizophrenia Spectrum Disorders, Epilepsy, General Anesthesia, Gynecologic Infections, Herpes Simplex Virus, Infantile Hemangioma, Infection, Inflammation, Inflammatory Conditions, Intra-abdominal Infections, Lower Respiratory Tract Infections, Migraines, Pain, Pneumonia, Schizophrenia, Sedation, Seizures, Skeletal Muscle Spasms, Skin and Skin-structure Infections, Treatment-resistant Schizophrenia, Urinary Tract Infections, Withdrawal, Sepsis, Gram-negative Infection, Bradycardia, Cardiac Arrest, Cardiac Arrhythmia, Staphylococcal Infections, Nosocomial Pneumonia, Neuromuscular Blockade, Methicillin Resistant Staphylococcus Aureus, Endocarditis, Neutropenia, Headache, Fibrinolytic Bleeding, Pulmonary Arterial Hypertension, CMV Retinitis, Hypertension, Chronic Kidney Diseases, Hyperaldosteronism, Hypokalemia, Heart Failure, Hemophilia, Heavy Menstrual Bleeding, Insomnia Intervention / Treatment: DRUG: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care: Location: Israel, Canada, United Kingdom, United States, Singapore Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * 1) Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver Exclusion Criteria: * 1) Failure to obtain consent/assent (as indicated) * 2) Known pregnancy as determined via interview or testing if available.

Study Objectives The purpose of this study is to determine the feasibility and safety of administering CMV RNA-pulsed dendritic cells (DCs), also known as CMV-DCs, to children and young adults up to 35 years old with nWHO Grade IV glioma, recurrent malignant glioma, or recurrent medulloblastoma. Evidence for efficacy will also be sought. This will be a phase 1 study evaluating CMV-DC administration with tetanus toxoid (Td) preconditioning and Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) adjuvant in children and young adults up to 35 years old with WHO grade IV glioma, recurrent malignant glioma, or recurrent medulloblastoma. This safety study will enroll a maximum of 10 patients. Conditions: Glioblastoma, Malignant Glioma, Medulloblastoma Recurrent, Pediatric Glioblastoma Multiforme, Pediatric Brain Tumor, Recurrent, Pediatric Brain Tumor Intervention / Treatment: BIOLOGICAL: CMV-DCs with GM-CSF, BIOLOGICAL: Td (tetanus toxoid) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age requirements: 1. <= 35 years for patients with grade IV glioma or recurrent World Health Organization (WHO) grade IV glioma 2. 3-35 years old for patients with recurrent medulloblastoma * Newly diagnosed or recurrent WHO grade IV glioma, recurrent WHO grade III glioma, or recurrent medulloblastoma (multifocal/disseminated disease is eligible, at the discretion of the PI) * Patients with WHO grade IV glioma who received surgery and radiation are eligible even without recurrence or progression * Patients must have recovered from all previous treatments including chemotherapy, radiation therapy, surgery, and other immunotherapies, etc. a. If the patient was receiving bevacizumab at the time of enrollment, the treating oncologist has the discretion of administering and adjusting bevacizumab 10 mg/kg every 14 days. The rationale for continuing patients on bevacizumab is to prevent rebound cerebral edema commonly seen after stopping this agent. * Laboratory Studies: 1. Platelets >= 100,000 cells/mm3 2. Creatinine <= 1.2 x upper limit of normal (ULN) 3. Total bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase <= 2.5 x ULN 4. Neutrophil count >= 1000 cells/mm3 5. Hemoglobin >= 9 g/dl prior to biopsy (can be transfused) * Able to undergo brain MRI with and without contrast * Karnofsky Performance Status (KPS) >= 70 or Lansky Performance Status (LPS) >= 70 * A signed informed consent form approved by the Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients (if 18 years old or older) or their parent(s) or guardian(s) (if younger than 18 years old) must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study. * For females of childbearing potential, negative serum pregnancy test within 48 hours of leukapheresis * Females of childbearing potential must be willing to use acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug * Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug * Newly diagnosed WHO grade IV glioma patients only: must be expected to complete standard of care radiation (minimum ~54 Gray) Exclusion Criteria: * Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible) * Disease outside of the central nervous system (CNS) * Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositive * Known active infection requiring intravenous (IV) antibiotics or active immunosuppressive disease * Severe, active co-morbidity, defined as follows: 1. Unstable angina and/or congestive heart failure requiring hospitalization 2. Transmural myocardial infarction within the last 6 months 3. Acute bacterial or fungal infection requiring intravenous antibiotics at initiation of Radiation Therapy (XRT)/Temozolomide (TMZ) 4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at initiation of XRT/TMZ for newly diagnosed patients or at initiation of dose-intensified (DI) TMZ for recurrent patients 5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects 6. Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive 7. Patients with autoimmune disease requiring medical management with immunosuppressant(s) 8. Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy 9. Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity * Pregnant or lactating women * Prior allergy to TMZ, GM-CSF, gadolinium (Gd), or Td * Prior history of brachial neuritis or Guillain-Barré syndrome * Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry * Patients receiving > 0.1mg/kg or 4mg/day dexamethasone or equivalent * For recurrent patients only: Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy. Guidelines for this recovery period are dependent upon the specific therapeutic agent being used: * Patients who have received chemotherapy or bevacizumab <= 4 weeks [except for nitrosourea (6 weeks) or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)] prior to starting the study drug unless patients have recovered from the side effects of such therapy. If the patient was receiving bevacizumab at the time of enrollment, the treating oncologist has the discretion of administering and adjusting bevacizumab 10 mg/kg every 14 days. * Patients who have received immunotherapy <= 4 weeks prior to starting the study drug unless patients have recovered from the side effects of such therapy

Study Objectives Chronic myeloid leukemia (CML) is a hematopoietic neoplasm characterized by the reciprocal translocation t(9;22). The resulting oncoprotein, bcr-abl is an essential trigger for growth and survival of leukemic cells. In the past decade, the bcr-abl tyrosine kinase inhibitor (TKI) imatinib (IM or Glivec©) has been the standard of care for patients with CML, inducing durable responses. However, requiring continuing IM indefinitely and the ability of IM to eradicate the CML clone was uncertain. In a small proportion of patients, IM can induce complete molecular response (CMR) defined by the disappearance of the bcr-abl transcript in conventional quantitative RT-PCR. The question whether or not these patients are cured and can discontinue drug therapy has been assessed by Mahon and coll, in the STIM study. He demonstrates that IM can be safely discontinued in patient with a CMR of at least 2 year duration and all patients who relapsed after IM discontinuation mainly did it in the first 6 months and responded to reintroduction of imatinib. Nilotinib is a rationally designed second generation tyrosine kinase inhibitor with improved target specificity over imatinib. Its efficacy and safety in the treatment of patients who are resistant or intolerant to imatinib as well as patients with newly diagnosed CML-CP led to the registration in second and first line treatment of CML-CP patients. Nilotinib produces even faster and deeper responses with more occurrence of CMR than does Imatinib. Consequently, one can assume that a more potent drug such nilotinib could induce deeper and sustained CMR allowing longer period off treatment than IM. The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in molecular relapse after IM discontinuation and to provide an estimation about duration of CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of stable CMR with nilotinib. Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive Intervention / Treatment: DRUG: Nilotinib Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male and female patients * Patient participating to the STIM trials (including STIM, STIM2 et EURO-SKI) and with confirmed molecular relapse on two consecutive RQ PCR, after imatinib discontinuation * Still in chronic phase * Not yet treated for this relapse * At least 18 years old (no upper age limit) * SGOT and SGPT < 2.5 UNL * Serum creatinin < 2 UNL * No planned allogeneic stem cell transplantation * Signed informed consent * ECOG score 0 to 2 Exclusion Criteria: * Pregnancy, lactation * Prior or concurrent malignancy other than CML (exceptions to be mentioned) * Serious uncontrolled cardiovascular disease * Severe psychiatric/neurological disease (previous or ongoing) * Ongoing treatment at risk for inducing "torsades de pointe" * QTcF > 450ms despite correction of predisposing factors (i.e electrolytes...) * Congenital long QTcF * No health insurance coverage

Study Objectives This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive 800mg daily of LDE225 and two separate doses of either bupropion or warfarin. Conditions: Advanced Solid Tumor Intervention / Treatment: DRUG: LDE225, DRUG: Wafarin, DRUG: Bupropion Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Adults * Patients with cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists or patients with locally advanced or metastatic basal cell carcinoma who are not amendable or eligible for standard therapy. * Protocol-defined renal , liver and bone marrow function Exclusion Criteria: * CNS (Central Nervous System) tumors as well as history of brain metastases * Systemic anticancer treatment (including biologic therapy/antibodies) within 2 weeks before first dose of study treatment (6 weeks for nitrosourea, mitomycin, and monoclonal antibodies). * Radiation therapy within 4 weeks before first dose * Investigational agents within 4 weeks before start of study therapy * Patients with known allergy/hypersensitivity to warfarin or bupropion and/or related compounds * Patients with a history of/or active bleeding disorders * Patients receiving treatment with vitamin K, Coumadin or other agents containing warfarin and heparin. Heparin flush to maintain patency of a central venous access device is allowed. * Patients receiving treatment with bupropion. * Patients who have neuromuscular disorders that are associated with elevated CK (Creatine phosphokinase) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy). * Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B or C (testing is not mandatory for study entry) * Patients currently receiving systemic corticosteroids Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back. Conditions: Acute Myeloid Leukemia, Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Untreated Adult Acute Myeloid Leukemia Intervention / Treatment: PROCEDURE: Autologous Bone Marrow Transplantation, PROCEDURE: Autologous Hematopoietic Stem Cell Transplantation, DRUG: Busulfan, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Decitabine, DRUG: Etoposide, BIOLOGICAL: Filgrastim, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study 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: * Unequivocal histologic diagnosis of AML (> 20% blasts in the bone marrow based on the World Health Organization [WHO] and/or French American British [FAB] classifications), excluding M3 (acute promyelocytic leukemia); patients with antecedent myelodysplasia are eligible for treatment on this trial only if there were no bone marrow biopsy showing myelodysplastic syndrome (MDS) > 3 months prior to enrollment; patients with therapy-related AML are eligible if they have been free of their primary disease and have not received any chemotherapy for at least 2 years * No prior 5-azacitidine or decitabine therapy * No prior treatment for leukemia or myelodysplastic syndrome with four permissible exceptions: * Emergency leukapheresis * Emergency treatment for hyperleukocytosis with hydroxyurea * Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only) * Growth factor/cytokine support

Study Objectives The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone. Conditions: Bladder Cancer, Transitional Cell Carcinoma, Metastasis Intervention / Treatment: DRUG: Vinflunine, DRUG: Gemcitabine, OTHER: Placebo Location: Indonesia, Canada, Korea, Republic of, Thailand, Italy, Spain, United Kingdom, Denmark, United States, Belgium, Australia, Greece, Philippines, Russian Federation, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic * Ineligible for cisplatin-based therapy because of at least one of the following two medical conditions: * Calculated creatinine clearance <=60 mL/min: OR * New York Heart Association Classification Stage III-IV Congestive Heart Failure * Measurable disease documented by imaging with at least one uni-dimensional lesion * Adequate performance status (ECOG 0, 1, or 2) * Men and women >=18 years of age Exclusion Criteria: * Patients in whom radiation or surgery is indicated * Current neuropathy >= CTCAE grade 3 * Prior radiation to >= 30% of bone marrow * Inadequate renal function: serum creatinine clearance <= 20 mL/min * Prior allergy to any vinca alkaloid

Study Objectives Currently, there are no telemedical visits between patients and/or their relatives and a palliative physician for the evaluation of symptom and progress monitoring. This is done during visits of the patient by the coordinators and palliative physicians of the palliative network/PKD Münster (PKD = Palliative Care Consultation Service) and/or the general practitioners. Upon enrollment in the Palliative Network/PKD Münster, patients receive a 24-hour emergency telephone number. This is staffed by a caregiver who coordinates the deployment of other caregivers / palliative care physicians according to the information provided by the patient / family members. If patients are randomized to the "telemedicine" group, they have the option of using ELVI (ELVI = electronic visit) in addition to conventional care, and thus the possibility of televisits with physicians or nurses. In this case, they receive access data for ELVI, i.e., an access code for a virtual waiting room. In addition, patients will be given questionnaires at discharge to be completed on the day of discharge and on days 7, and 14. The primary objective of this randomized trial is to demonstrate that telemedically managed patients are not relevantly inferior to conventionally managed patients in terms of change in Integrated Palliative care Outcome Scale (IPOS) from the day of discharge (non-inferiority question), although the possibility of televisiting may result in less frequent physician visits to the patient's home. Conditions: Cancer, Chronic Heart Failure, Chronic Obstructive Pulmonary Disease, Palliative Care Intervention / Treatment: OTHER: Telemedicine Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with indications to receive specialized palliative care for advanced malignant and non-malignant diseases * Minimum age 18 years * Signed informed consent * Inpatient care in a normal ward or the palliative care unit at University Hospital Muenster * Planned discharge to home environment * Consent to participate in randomized study * Residence in the area of responsibility of the palliative care network/PKD Münster and consent to the Connection to the palliative care network/PKD Münster * At least one cell phone (or comparable device with camera and microphone) with wireless network connection or long data evolution (LTE) flat rate * Basic willingness to use new media * Disease phase "stable" / "unstable" / "deteriorating" (patients who are in the dying phase are not included in the randomized part of the study, as they will in all likelihood not be discharged home). Exclusion Criteria: * Pregnant or breastfeeding patients * minors * Language difficulties (lack of German language skills), if these cannot be compensated by family members or interpreters can be compensated * Dependency or employment relationship to the project management or the including physician * Persons who have been placed in an institution by court or official order

Study Objectives The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) five elements music therapy improving quality of life for patients with advanced cancer, as well as establishing the standard operating procedures (SOP) for it. Conditions: Cancer Intervention / Treatment: OTHER: music Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Eligible participation will be enrolled based on diagnostic criteria. * Advanced cancer patient with more than 50 scores of Karnofsky Performance Score (KPS). * Diagnosis of advanced cancer * Patients who are willing to be subject with taking part in this research voluntarily. * No prior experience with TCM music therapy. * Newly admitted to TCM oncology department for 3 weeks treatment course. Exclusion Criteria: * Complicated diagnose or one who don't consistent with inclusion criteria. * Patients suffering from psychosis or diagnosis, or psychiatric diagnoses (e.g., schizophrenia). * Suffering from acute organ prostration or other condition of demanding to rescue，inability for accepting music therapy. * One don't read or fill in diary owing to some causes, such as state of the art or acuity of vision * One suffering from hearing disturbance * Accepted TCM five elements music therapy in the past.

Study Objectives The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Degarelix, DRUG: Degarelix, DRUG: Leuprolide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * >= 18 years. * Raising PSA after prior treatment failure of localized prostate cancer. * Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy. * Has a screening testosterone within normal range (>=1.5 ng/mL). * Has Eastern Cooperative Oncology Group score of <=2. * Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs. * Life expectancy of at least 15 months. Exclusion Criteria: * Taken hormone therapy in the last 6 months prior to entering this study. * Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial. * Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema. * Has hypersensitivity towards any component of the study drug. * Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last five years. * Has abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial. * Has a clinically significant medical condition (other than prostate cancer) including but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator. * Has an intellectual incapacity or language barriers precluding adequate understanding or co-operation. * Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial. * Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit. * Has previously participated in any Degarelix trial. * Is part of an ongoing trial.

Study Objectives Primary Objective: * To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4). * To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses. Secondary Objectives: * To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1 * To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2 * To determine antitumor activity in Segment 2 Conditions: Solid Tumor Intervention / Treatment: DRUG: SAR302503, DRUG: omeprazol, DRUG: metoprolol, DRUG: midazolam Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion criteria : * Histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist * Signed informed consent Exclusion criteria: * Less than 18 years of age. * Limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale) * Inability to follow study requirements and schedule * Treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other anti-cancer therapy * Serious medical illness at same time of study and/or significantly abnormal lab reports * Lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding. * Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug * Continued toxic effects of prior chemotherapy * Evidence of other concurrent active malignancy * Other concurrent serious illness or medical condition * Cardiac abnormalities include bradycardia, AV block or other conduction defect on ECG, and patients taking a beta blocker. * Patients with Insulin-Dependent Diabetes Mellitus. * Patients with known active (acute or chronic) hepatitis A, B, C, and hepatitis B and C carries. Prior history of chronic liver disease (e.g., chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH]). * Inadequate organ function * History of partial or total gastrectomy, or, if in the opinion of the investigator, have any other disorder that would inhibit absorption of oral medications. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives This phase I/II trial studies the side effects and best dose of cetuximab when given together with pembrolizumab in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body (metastatic) or that cannot be removed by surgery. Monoclonal antibodies, such as cetixumab and pembrolizumab, may block tumor growth in different ways by targeting certain cells. Conditions: Recurrent Colorectal Carcinoma, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer Intervention / Treatment: BIOLOGICAL: Cetuximab, OTHER: Laboratory Biomarker Analysis, BIOLOGICAL: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Have a pathologically confirmed diagnosis of colorectal cancer, which is metastatic or otherwise unresectable * Have received at least 1 prior systemic therapy in the metastatic or unresectable disease setting; patients who have recurred within six months of adjuvant chemotherapy are not required to have received an additional line of chemotherapy * Retrovirus-associated deoxyribonucleic acid (DNA) sequence (RAS) wild-type; v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) testing must be completed, with full KRAS and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) testing strongly advised; the presence of known mutations in KRAS or NRAS is exclusionary; primary tumor or metastatic tumor may be tested; (note: in the case of multiple genomic evaluations with conflicting results - e.g. KRAS mutant in one sample, but wild-type in another - the patient may be included as RAS wild-type, if clinically justified, after review with the principal investigator [PI]) * Appropriate for anti-EGFR therapy: Naive to anti-EGFR therapy (cetuximab or panitumumab) or a candidate for rechallenge by virtue of the following: 1. the investigator deems anti-EGFR retreatment with cetuximab to be a reasonable standard of care option AND 2. outcome of prior anti-EGFR therapy was not rapid progression (i.e. <= 3 months on therapy) AND 3. prior anti-EGFR therapy was administered > 6 months prior to the start of protocol therapy * Have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2 * Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present * Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 30 days prior to initiation of treatment on day 1 * Hemoglobin >= 8 g/dL (performed within 14 days of treatment initiation) * Absolute neutrophil count >= 1000/mm3 (performed within 14 days of treatment initiation) * Platelet count >= 100,000/mm3 (performed within 14 days of treatment initiation) * Serum creatinine =< 2 upper limit of normal (ULN) or, >= 15 mL/min for participants with creatinine levels > 2 ULN (performed within 14 days of treatment initiation) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 ULN or, =< 5 ULN for participants with liver metastases (performed within 14 days of treatment initiation) * Female participants of childbearing potential are to have a negative serum pregnancy test * Female participants of child-bearing potential must agree to use an acceptable method of birth control, 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; 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 * Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy * Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Participants who have had chemotherapy, targeted therapies, radiotherapy, or used an investigational device within 2 weeks prior to the first dose of treatment or those who have not recovered from adverse events (i.e., =< grade 1 or at baseline) due to agents administered more than 2 weeks earlier; note: participants with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment * Has a known history of active TB (Bacillus Tuberculosis) * Hypersensitivity to pembrolizumab or any of its excipients * Prior severe infusion reaction to cetuximab * Has a known additional malignancy that requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment * Has known history of, or any evidence of active, non-infectious pneumonitis * Uncontrolled clinically significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness, substance abuse disorders or social situations that would limit compliance with study requirements * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment * Has a known history of human immunodeficiency virus (HIV or HIV 1/2 antibodies); testing not required * Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected); testing not required * Has received a live vaccine within 30 days of planned start of study therapy (note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and shingles are not allowed) * Received an investigational agent within 30 days prior to starting study treatment * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator * Unwilling or unable to follow protocol requirements

Study Objectives This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This study will be activated at the UT Southwestern Medical Center, comprised of The Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland Memorial Hospital System. Advanced HCC is defined as disease that is not amenable to surgical resection or orthotopic liver transplantation or is metastatic in nature. Conditions: Hepatocellular Carcinoma, Liver Cancer Intervention / Treatment: DRUG: bavituximab (0.3 mg/kg) and sorafenib, DRUG: bavituximab (1.0 mg/kg ) and sorafenib, DRUG: bavituximab (3.0 mg/kg) and sorafenib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below: * Histologically confirmed. * MRI or CT consistent with liver cirrhosis and at least one solid liver lesion >2 cm with early enhancement and delayed enhancement washout regardless of AFP. * AFP >400 ng/ml and evidence of at least one solid liver lesion >2 cm regardless of specific imaging characteristics on CT or MRI. * Locally advanced or metastatic disease. * Patients with locally advanced disease must have disease deemed to be unresectable or not eligible for hepatic transplantation. Determination will occur in the weekly GI DMT meeting by surgical oncologists and transplant surgeons. * Measurable disease, as defined as lesions that can accurately be measured in at least one dimension (longest diameter to be measured) according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at least 2 cm with conventional techniques or at least 1 cm with spiral computed tomography. * Child-Pugh Score A. * Age >= 18 years. * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. * Absolute neutrophil count >= 1,500 cells/mm3. * Platelet count >= 75,000 cells/mm3. * Total bilirubin <= 3.0 mg/dl. * Hemoglobin >= 8.5 g/dl. * AST and ALT <= 5.0 times upper limit of normal. * D-dimer <= 3 times upper limit of normal. * INR <= 1.8 (therapeutic anticoagulation allowed as long as medically indicated. Exclusion Criteria: * History of bleeding diathesis or coagulopathy. * Symptomatic or clinically active brain metastases. * Major surgery within previous 4 weeks. * History of thromboembolic events (including both pulmonary embolisms and deep vein thrombosis); central venous catheter-related thrombosis > 6 months prior is allowed. * Prior adjuvant therapy with sorafenib or other Raf/MEK/RAS or VEGFR inhibitors. Prior adjuvant therapy is allowed provided it was completed > 6 months ago and there is documented recurrence of hepatocellular carcinoma.

Study Objectives Advanced colorectal cancer (ACRC) is a heterogeneous disease and classification of patients is nowadays inefficient. Roughly twenty per cent of patients present with favorable figures (less than 4 liver nodules and less than 5 cm) and are suitable for local treatments (surgery or local-ablative therapies). Additionally, 10-15% of patients have poor performance status (PS \>2) or are severe disabled due to geriatric syndromes or/and co-morbid diseases that preclude any treatment strategies than best supportive care alone. The rest of patients (fit patients not suitable for radical treatments) constitute the population of patients treated with palliative therapies. Despite of it not all these patients have the same prognosis. Patients with PS 0,1 and levels of LDH \<ULN (Intermediate-risk patients) have better PFS and OS irrespective of therapy in all randomized clinical trials (de Gramont et al, JCO 2000; Douillard et al, Lancet 2000; Koopman et al, 2007). CRYSTAL trial shows a benefit in PFS (1.5 months) in RASWT of FOLFIRI plus cetuximab compared with FOLFIRI alone. Nowadays the selection of patients for cetuximab treatment is based on mutational status of KRAS, which allow to select those patients who will not respond to therapy. Other surrogate markers of activity should be also evaluated. Our hypothesis is that the suggested biomarkers will allow the selection of the patients who will benefit the most from the biweekly cetuximab treatment. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: FOLFIRI (m), DRUG: FOLFOX-6 (m), DRUG: Cetuximab Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SCREENING Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female, age >= 18 years * Able to sign an informed consent form * Advanced and/or metastatic colorectal cancer * Colorectal cancer with KRAS wild type genotype * At least one unidimensionally measurable lesion according to RECIST criteria (1.1 revised) (to be assessed <= 28 days prior to the study treatment) * All patients with the following features will be included: 1. Progression free survival > 6 months after adjuvant treatment +/- radiotherapy 2. "De novo" diagnosis of the disease * Performance ECOG status of 0-2 * Life expectancy >= 3 months * Adequate bone marrow function: neutrophils >=1,5 x 10^9/L; platelets >= 100 x 10^9/L; hemoglobin >=9 g/dL. * Adequate liver, renal and hematological function as follows: 1. Adequate liver function: SGOT and SGPT 2.5 x ULN (5 x ULN in case of hepatic metastasis). Total bilirubin < 1,5 x ULN. Alkaline phosphatase 2,5 x LSN (5 x ULN if hepatic metastasis or 10 x ULN if bone metastasis) 2. Creatinine clearance or creatinine clearance during 24 hours >= 50 mL/min 3. Magnesium >= LLN, calcium >= LLN Exclusion Criteria: * PS > 2 or elderly patients with fragility criteria * Previous surgery for metastasis * Previous systemic treatment for the metastatic colorectal cancer * Previous treatment with antibodies anti-EGFR or treatment with small-molecule EGFR tyrosine kinase inhibitors or EGFR signal transduction inhibitors. Subjects who suspend their first dose due to a reaction to the infusion can participate * Central nervous system metastasis (except: treated subjects with asymptomatic CNS metastasis who have not received steroids within the 30 days prior to inclusion) * Prior malignant tumor in the last 5 years, except: basal cell carcinoma of the skin or pre-invasive cervical cancer * Unresolved toxicities from a prior systemic treatment which do not qualify the patient for inclusion * Presence of peripheral neuropathy (degree > 1 in the ctc version 3.0) and serious nonhealing wound, ulcer, or bone fracture * Hormonal treatment, immunotherapy or experimental or approved antibodies/proteins <= 30 days before the inclusion * Uncontrolled serious cardiovascular disease or: congestive cardiac failure NYHA lll or lV, unstable angina pectoris, myocardial infarction precedents in the past 12 months, significant arrhythmias * Interstitial pneumonitis or pulmonary fibrosis precedents, or interstitial pneumonitis or pulmonary fibrosis signs on the thoracic CT-scan * Treatment for systemic infection within the 14 days prior to treatment * Acute/subacute intestinal occlusion and/or active inflammatory bowel disease or any other bowel disease producing chronic diarrhea * Precedent of Gilbert's syndrome or dihydropyrimidine dehydrogenase deficiency * Precedent of any disease which can increase the risks associated to the participation in the study or interfere in the study results * Known positive test for the following infections: HIV, Hepatitis C + abnormal liver enzymes values, active chronic Hepatitis B (except Hepatitis C seropositive with normal liver enzymes) * All concurrent diseases which can increase the toxicity risk * The individual presents a disorder of any kind which jeopardizes their ability to give their written consent form and/or fulfill the study procedures * Any investigational agent within 30 days before enrolment * Pregnant or breastfeeding woman, or planning to get pregnant within the 6 months after treatment * Surgery (excluding the diagnostic biopsy or placing of a central venous catheter) * Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the study and 6 months after de last administration for women, and 1 month for men * Unability to fulfill the study requirements by the patients * Psychological, family, sociological or geographical conditions that may interfere with the fulfillment of the study protocol and the follow-up calendar

Study Objectives The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: YM155, DRUG: Docetaxel Location: Germany, Czech Republic, United Kingdom, United States, Belgium, Ireland, Russian Federation, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically- or cytologically-proven adenocarcinoma of the breast that is HER2 negative. Subjects with hormone receptor positive or negative status are eligible. Additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and HER2 negative) are eligible * No prior chemotherapy regimen for metastatic breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status <= 1 at the Baseline Visit * The subject's life expectancy is estimated to be > 12 weeks at the Baseline Visit * The subject must be non-pregnant and non-lactating. All sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period Exclusion Criteria: * Hypersensitivity to docetaxel or polysorbate 80 * Neuropathy >= Grade 2 at the Baseline Visit * Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination * The subject has known Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen or hepatitis C antibody

Study Objectives This is a pilot study to assess the safety and measure image-based absorbed dose of 177Lu-P17-087/177Lu-P17-088 in patients with metastatic castration-resistant prostate cancer (mCRPC) who will undergo radioliagnd therapy using 177Lu-P17-087/177Lu-P17-088. All patients underwent whole-body 68Ga-PSMA PET/CT for selection and accepted intravenous injection with single dose 1.1 GBq (30 mCi) of 177Lu-P17-087/177Lu-P17-088 within one week, then monitored at 1.5 hours, 4 hours, 24 hours, 48 hours, 72 hours, 120 hours and 168 hours after 177Lu-P17-087/177Lu-P17-088 administration with serial whole body planar and SPECT/CT imaging. Conditions: Metastatic Castration-resistant Prostate Cancer Intervention / Treatment: DRUG: 1.1 GBq (30 mCi) of 177Lu-P17-087, DRUG: 1.1 GBq (30 mCi) of 177Lu-P17-088 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy; * Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-P17-087/177Lu-P17-088. Exclusion Criteria: * Patients were excluded if they had [18F]FDG positive tumors without corresponding PSMA uptake. Patients were also not eligible if they accepted other radionuclide therapies within 6 months or had clinically significant impaired bone marrow, liver, or kidney function with a hemoglobin level of less than 9.0 g/dL, a white blood cell count of less than 2.5×109/L, a platelet count of less than 100×109/L and a serum creatinine > 100 μmol/L.

Study Objectives The purpose of this study is to evaluate the safety, and tolerability of HLA-A\*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine Conditions: Pancreatic Cancer Intervention / Treatment: BIOLOGICAL: VEGFR1-1084, VEGFR2-169, DRUG: Gemcitabine Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: DISEASE CHARACTERISTICS * Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer * Measurable disease by CT scan PATIENTS CHARACTERISTICS * ECOG performance status 0-2 * Life expectancy > 3 months * Laboratory values as follows: * 2,000/mm3 < WBC < 15000/mm3 * Platelet count >= 750,000/mm³ * Total Bilirubin <= 1.5 x * Aspartate transaminase < 150 IU/L * Alanine transaminase < 150 IU/L * Creatinine <= 3.0 mg/dl * HLA-A*2402 * Able and willing to give valid written informed consent Exclusion Criteria: * Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) * Breast-feeder * Active or uncontrolled infection * Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks * Serious or uncured wound * Active or uncontrolled other malignancy * Steroids or immunosuppressing agent dependent status * Interstitial pneumonia * Ileus * Decision of unsuitableness by principal investigator or physician-in-charge

Study Objectives Primary Objectives: 1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in adult patients receiving autologous or allogeneic transplantation for lymphoid malignancies or myeloma. 2. To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this regimen. 3. To determine the disease-free and overall survival of patients receiving this preparative regimen. 4. To determine the treatment-related morbidity and mortality of this combination of drugs. Conditions: Multiple Myeloma, Lymphoma Intervention / Treatment: DRUG: Busulfan, DRUG: Melphalan 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 with lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or recurrent), or multiple myeloma (beyond first complete remission or unresponsive to therapy. Complete remission for multiple myeloma defined by absence of detectable paraprotein in serum and/or urine by immunoelectrophoresis or immunofixation, and < 5% plasma cells in the bone marrow), not qualifying for treatment protocols of higher priority. * Age 18 to 65 years of age. * Adequate renal function as defined by estimated serum creatinine clearance > 50 ml/min and serum creatinine < 1.8 mg/dL. * Adequate hepatic function, as defined by serum glutamic pyruvic transaminase (SGPT) < 3 * upper limit of normal; serum bilirubin and alkaline phosphatase < 2 * upper limit of normal, or considered not clinically significant. * Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and Capacity of the Lung for Carbon Monoxide (DLCO)> 50%. Exceptions may be allowed for patients with pulmonary involvement after discussing with principal investigator (PI). * Adequate cardiac function with left ventricular ejection fraction >= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease. * Zubrod performance score < 2. * Patients receiving an allogeneic transplant must have an HLA matched, or one A, B, or DR mismatched related donor. Unrelated donor must be matched at A, B, and DR (defined as A, B serologic matched and DRB1 molecular matched). Donor must be willing to donate peripheral blood or bone marrow progenitor cells. * Patient and donor should be willing to participate in the study by providing written consent. * Female patient must not be pregnant and have negative pregnancy. Exclusion Criteria: * Patients with unresolved grade >= 3 non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI. * Patients with active Central Nervous System (CNS) disease. * Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy. * Uncontrolled infection, including Human immunodeficiency virus (HIV) or Human T-lymphotropic virus Type I (HTLV-1) infection. * Patients who have had a previous autologous or allogeneic stem cell transplant during the past year.

Study Objectives This is a prospective Belgian, multi-center, open-label, single-arm phase II study of weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer to evaluate tumor response in the breast and the axilla. Conditions: Breast Cancer Intervention / Treatment: DRUG: Paclitaxel, DRUG: Carboplatinum, DRUG: Epirubicin, DRUG: Cyclophosphamide Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Stage II-III operable triple negative (ER and PR < 10%; Her2 IHC 0-1 or FISH <2.0) breast cancer in women age > 18. For patients aged >= 65 years the G8 geriatric screening test should be > 14 (on a total of 17). * Baseline mammography, US. MR of the breast on clinical indication. * FNA of suspicious axillary lymph node is indicated * Pre-treatment SN biopsy is indicated in clinical N0 * Measurable loco-regional disease * Adequate bone marrow function, defined as * Absolute neutrophil count(ANC) >1500*109/L * Platelet count >100.000*109/L * Adequate liver function defined as * Serum(total) bilirubin <1.5*upper limit of normal(ULN), unless the patient has documented Gilbert's Syndrome * AST and/or ALT <2.5*ULN * Alkaline phosphatase <2.5*ULN * Normal cardiac function measured by ultrasound with a left ventricular function > 55% * Creatinine clearance > 40 ml/min according to local laboratory standard (MDRD, CDK-epi, Cockroft-Gault, or other established formula to calculate renal function) Exclusion Criteria: * T4d breast tumor * Bilateral breast cancer * Other invasive cancer in the past except for a localized squamous cell cancer or basal cell of the skin or an in situ squamous cell cancer of the cervix. * Pregnant or lactating patients

Study Objectives This study was a single-arm, open-label, phase II study of PD-1 monoclonal antibody combined with anlotinib in the treatment of advanced non-small cell lung cancer (NSCLC) with EGFR uncommon mutations. Twenty-one patients of NSCLC harboring rare EGFR mutations after previous treatments, including a platinum-based regimen and a targeted treatment (regardless of EGFR Ex20ins), were enrolled. Patients received sintilimab (anti-PD-1) combined with anlotinib (multi-target anti-angiogenesis). The primary endpoint was the objective response rate (ORR) based on RECIST 1.1. Secondary goals included progression-free survival (PFS), overall survival (OS), disease control rate (DCR) based on RECIST 1.1; safety Sex and tolerance. Exploratory objectives include the use of tumor tissue and plasma specimens to detect biomarkers predicting the efficacy of sidilimumab: including but not limited to tumor mutation burden (TMB), PD-L1 expression, etc.; exploring potential predictions in peripheral blood. Biomarkers for anti-group efficacy, including but not limited to TCR. Conditions: Lung Cancer Intervention / Treatment: DRUG: sintilimab and anlotinib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Sign written informed consent before any trial-related processes are implemented; * Age >= 18 years old and <= 75 years old; * Life expectancy exceeds 3 months; * The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if it is confirmed to have progressed; * Patients with treated metastatic or recurrent (stage IV) NSCLC confirmed by histology or cytology according to the International Association for the Study of Lung Cancer and the American Association for the Classification of Cancer Classification, 8th edition; * The Eastern Cancer Cooperative Group (ECOG) has a fitness status score of 0 or 1; * Patients with genetic testing (allowing PCR and NGS detection methods) confirmed uncommon mutations (EGFR G719X, L861Q, S768I, and 20ins et al.), patients can accept two or more types of EGFR rare co-mutation. Populations with the primary EGFR T790M mutation can also be included in the study. * Patients who have experienced disease progression after at least two treatment regimens for advanced/metastatic disease must include a platinum-containing systemic chemotherapy and an EGFR-TKI treatment. Patients with EGFR 20ins who have experienced disease progression only after platinum-containing systemic chemotherapy. * Hematological function is sufficient, defined as absolute neutrophil count >=1.5×109 /L, platelet count >=100 ×109 /L, hemoglobin >=90g/L (no history of blood transfusion within 7 days); * Hepatic function is adequate, defined as all patients with total bilirubin levels <= 1.5 times normal upper limit (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <= 2.5 times ULN, or for patients with liver metastases , AST and ALT levels <= 5 times ULN; * adequate renal function, defined as creatinine clearance >= 45 ml/min (Cockcroft-Gault formula); * Coagulation function is adequate, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulant therapy, as long as the INR or PT is within the range of anticoagulant drugs can; * Female subjects of childbearing age should be negative for urine or serum pregnancy test within 3 days prior to receiving the first study drug. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required; * If there is a risk of conception, male and female patients need to use high-efficiency contraception (ie, an annual failure rate of less than 1%) and continue until at least 180 days after stopping the trial treatment; Note: If abstinence is normal for the subject Lifestyle and preferred methods of contraception can be used as a method of contraception. Exclusion Criteria: * Histology is NSCLC, if there are small cell carcinoma, neuroendocrine carcinoma, sarcoma components, it can not be included; * Patients with known EGFR-sensitive mutations (19-Del and L858R); * Cavity lung squamous cell carcinoma, or non-small cell lung cancer patients with hemoptysis (>50 mL/day); * Patients whose tumor has invaded an important blood vessel or who is judged by the investigator to have major bleeding during the follow-up study; * Patients with any signs or history of bleeding physique; * Currently participating in interventional clinical research treatment, or receiving other research drugs or research equipment within 4 weeks prior to the first dose; * Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or against another stimulus or synergistic inhibition of T cell receptors (eg CTLA-4, OX-40, CD137) drug; * Received a proprietary Chinese medicine or immunomodulatory drug (thymosin, interferon, interleukin, etc.) with anti-cancer indications within 2 weeks before the first dose, or received major surgery within 3 weeks before the first dose; * Received a physical organ or blood system transplant; * There is clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not need drainage or stop drainage and have no significant increase in 3 days of effusion can be enrolled); * The tumor compresses important organs (such as the esophagus) around it and is accompanied by related symptoms, oppression of the superior vena cava or invasion of the mediastinal vessels, heart, etc.; * Class III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias; * Any arterial thrombosis, embolism or ischemia occurred within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack. A history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to enrollment (implanted IV port or catheter-derived thrombosis, or superficial vein thrombosis is not considered a "serious" thrombosis embolism); * It is known that there is an allergic reaction to the active ingredient of sindril mAb and or any excipients; * Active autoimmune diseases requiring systemic treatment (eg, using disease-modifying drugs, corticosteroids or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (such as thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments; * Patients who require long-term systemic use of corticosteroids. Patients with intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroids due to COPD or asthma may be enrolled. * has not fully recovered from toxicity and/or complications caused by any intervention prior to initiation of treatment (ie, <=1 or baseline, excluding fatigue or alopecia); * diagnosis within 5 years prior to initial dosing For other malignancies, it does not include radical cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ. If more than 5 years before the drug is diagnosed as other malignant tumors or lung cancer, pathological or cytological diagnosis of recurrent metastatic lesions is required; * symptomatic central nervous system metastasis. For patients with asymptomatic brain metastases or brain metastases with stable symptoms after treatment, as long as all the following criteria are met, participate in this study: measurable lesions outside the central nervous system; no midbrain, pons, cerebellum, meninges, Medulla or spinal cord metastasis; maintain clinical stability for at least 2 weeks; stop hormone therapy 14 days before the first study drug; * One year before the first dose, a history of non-infectious pneumonia requiring corticosteroid treatment or the presence of non-infectious pneumonia; * active infections requiring treatment or systemic anti-infectives used within one week prior to first administration; * There are known cases of mental illness or substance abuse that may have an impact on compliance with the test requirements; * A history of human immunodeficiency virus (HIV) infection (ie, HIV 1/2 antibody positive), known syphilis infection (positive syphilis antibody), and active tuberculosis are known. * Untreated active hepatitis B; Note: Hepatitis B subjects meeting the following criteria are also eligible for inclusion: The HBV viral load must be <1000 copies/ml (200 IU/ml) or below the lower limit of detection before the first dose. Subjects should receive anti-HBV treatment during the entire study chemotherapy drug treatment to avoid viral reactivation. For subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation is closely monitored; * Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection); * Vaccination with live vaccine within 30 days prior to first dose; Note: Injectable inactivated virus vaccine for seasonal influenza is permitted; however, live attenuated influenza vaccine for intranasal administration is not permitted; * There are medical history, disease, treatment, or laboratory abnormalities that may interfere with the test results, hinder the subject's full participation in the study, or the investigator believes that participating in the study is not in the best interest of the subject. * Local or systemic diseases caused by non-malignant tumors, or secondary reactions to cancer, and may lead to higher medical risks and/or uncertainty in survival assessment.

Study Objectives Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in previously treated adult patients with locally advanced or metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, NSCLC, urothelial carcinoma or other solid tumors. This is a 2 Part study whereby the safety and tolerability of increasing dose levels of intravenous (IV) or subcutaneous (SC) PF-06801591 was assessed in Part 1. Part 2 expansion is designed to further evaluate the safety and efficacy of SC PF-06801591 in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose. Conditions: Part 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA Intervention / Treatment: DRUG: PF-06801591, DRUG: PF-06801591 Location: Bulgaria, Malaysia, Korea, Republic of, Ukraine, United States, Russian Federation, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Masking: NONE

Inclusion Criteria (Part 2 Only): * Histological or cytological diagnosis of locally advanced or metastatic NSCLC or urothelial carcinoma who have progressed on or were intolerant to standard of care systemic therapy, or for whom standard of care systemic therapy was refused (refusal must be documented) or unavailable. * No prior treatment with anti-PD-1 or anti-PD-L1 therapy. * NSCLC patients whose tumor is not known to have ALK or EGFR mutations must have progressed on or after no more than 1 prior line of platinum-containing systemic therapy or were intolerant or refused standard of care systemic therapy. * NSCLC patients whose tumor is known to have ALK or EGFR mutation must have received prior systemic therapies that only include 1 or more lines of ALK or EGFR targeting drugs and chemotherapy limited to 1 line of a platinum-based regimen and they must have progressed on or after both types of therapies. * Urothelial carcinoma patients must have received up to 2 lines of prior systemic therapy and progressed on or after, experienced disease recurrence within 12 months of neoadjuvant or adjuvant treatment, were intolerant to, ineligible or refused platinum-containing systemic therapy. If urothelial cancer patients are treatment naïve and eligible for platinum-containing systemic therapy but are refusing platinum chemotherapy, they must also be documented to have previous PD-L1 high status. * Provide archived tumor tissue sample taken within the past 2 years or provide a fresh tumor biopsy sample. * At least one measurable lesion as defined by RECIST version 1.1. * Adequate renal, liver, thyroid and bone marrow function. * Performance status 0 or 1. * Patient is capable of receiving study treatment for at least 8 weeks. Exclusion Criteria (Part 2 Only) * Active brain or leptomeningeal metastases. * Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy or prior allogeneic bone marrow or hematopoietic stem cell transplant. * Patients with a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Patients with a history of interstitial lung disease, non-infectious pneumonitis, or active pulmonary tuberculosis. Those with active lung infections requiring treatment are also excluded. * History of Grade >=3 immune mediated AE (including AST/ALT elevations that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy. * Active hepatitis B or C, HIV/AIDS. * Other potentially metastatic malignancy within past 5 years.

Study Objectives This ia a single-arm, not-randomized, open-label phase II study. The purpose of this study is to evaluate the safety and efficacy of KN046 (PD-L1 /CTLA-4 Bispecific antibody) combined with Lenvatinib(TKI) for the treatment of advanced hepatocellular carcinoma. Conditions: HCC Intervention / Treatment: BIOLOGICAL: KN046, DRUG: Lenvatinib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology； * Barcelona Clinic Liver Cancer (BCLC) Stage B or C； * Age >=18 years or <=75 years for both genders； * ECOG performance status: 0-1； * Child Pugh score<=7； * LVEF>=50% or above LLN of the research institution； * Enough organ function； * Has at least one measurable lesion based on RECIST 1.1； * Life expectancy >=3 months； * Patients must be able to understand and willing to sign a written informed consent document； Exclusion Criteria: * Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma etc; * Tumor thrombus invasion at the main portal vein (Vp4), inferior vena cava or heart involvement; * Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.); * Subjects who have received liver local treatment (transcatheter chemoembolization, transcatheter embolization, hepatic artery perfusion, radiotherapy, radioembolization or ablation) within 4 weeks before administration; * Subjects who need corticosteroids or immunosuppressive agents for systemic therapy; * Any previous or current active autoimmune disease or history of autoimmune disease; * History of hepatic encephalopathy or liver transplantation; * History of interstitial lung disease or non-infectious pneumonia; * History of allergic reactions to related drugs; * Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy; * With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable; * Subjects with clinically significant gastrointestinal bleeding or thrombosis or embolic events within 6 months; * Untreated hepatitis infection: HBV DNA>2000IU/ml or10000 copies/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive; * Evidence of active pulmonary tuberculosis (TB); * Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); * Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage;

Study Objectives Three month treatment of acute VTE with Fragmin in pediatric cancer patients Conditions: Venous Thromboembolism Intervention / Treatment: DRUG: dalteparin Location: Norway, Spain, United States, Slovenia, Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Exclusion Criteria: *

Study Objectives Cannabis sativa is one of the most ancient psychotropic drugs known to humanity. Although most Western countries have outlawed the use of cannabis according to the UN Convention of Psychotropic Substances, an increasing number of states in the USA, Canada and several European countries allow the medicinal use of cannabis subject to a doctor's recommendation. In oncology, the beneficial effects of treatment with the plant or treatment with medicine produced from its components are related to symptoms of the disease: pain, nausea and vomiting, loss of appetite and weight loss. There is only partial clinical evidence of the efficacy of cannabis for these indications. In Israel, according to Ministry of Health regulations, permission to use medicinal cannabis for oncology patients can be given for two indications: to relieve disease-related symptoms in advanced disease or during chemotherapy treatment to reduce side effects. The indications are very wide and allow a great deal of freedom for the physician's decisions, but also cause high demands for cannabis from patients. The cannabis plant and the synthetic drugs based on the plant are considered to be medically safe. Most of the adverse effects are related to the fact that the plant and the drugs are psychoactive. Among the effects named were dizziness, euphoria, difficulty concentrating, disturbances in thinking, memory loss, and loss of coordination. Recently, we published the results of a prospective, observational study evaluating the medical necessity for medicinal cannabis treatment in cancer patients on supportive or palliative care. No significant side effects, except for memory lessening in patients with prolonged cannabis use (p=0.002), were noted. Chemotherapy-related cognitive impairment (CRCI) is a phenomenon of cognitive decline that patients may experience during or after chemotherapy. Memory loss and lack of concentration and attention are the most frequent symptoms encountered. Evidence suggests that CRCI is of significant concern to patients and has become a major quality-of-life issue for survivors, with estimates of its frequency ranging from 14-85% of patients. The influence of cannabis use on cognitive functions of oncology patients has never been tested. Theoretically, the combination of chemotherapy and cannabis can cause severe reduction in cognitive functions in additive or synergistic ways. However, this hypothesis, too, has never been tested, although the number of patients using cannabis during chemotherapy treatments in Israel and in other Western countries is growing. Goals of current research: The main goal of the study is to evaluate prospectively the level of reduction in cognitive function of cancer patients who are on active oncology treatments and use cannabis, comparing to a group of patients without cannabis treatment. The second goal is to identify high-risk groups for cognitive impairment due to cannabis use. Patients and Methods: The study will be comprised of a cannabis user group that will include patients who will come for guidance sessions before being issued with a cannabis license and a control group of patients on active oncology treatments, meeting the same inclusion and exclusion criteria (except for cannabis use), and willing to complete the same pack of questionnaires and cognitive tests at the same three time points. All patients will sign an informed consent form. The study includes questionnaires on quality of life (EORTC-Q30), anxiety, depression (HADS) and fatigue (BFI), and cognitive tests (MoCA, DSST, Digital Finger Tapping) administered by the nurses who give guidance on cannabis according to the patient's language (Hebrew, Russian or Arabic). The nurses will have a short guidance course on "how to do cognitive tests" and a monthly meeting with a neuropsychologist to test the quality of the cognitive tests. The questionnaires and cognitive tests will be done on the day of entering the study (T0) and after 3 (T3) and 6 months (T6). The patients will be asked not to use cannabis in the 12 hours before the interviews after 3 and 6 months. Sample size: The sample size was built to show a difference of 1.1 points in the MoCA test (half the SD for the normal population) between two groups after three months of cannabis use. The number of patients needed with a power of 80%, β≤0.05 and SD=3.1 (the SD for mild cognitive impairment in the MoCA test) is calculated at 42 patients in each group (total 84 patients). Due to an expected drop-out of 20%, the number of patients to be included in the study is 101. Conditions: 1- Cancer Patients During Chemotherapy Treatment, 2- Use of Cannabis Comparing to Control Without Cannabis Use Intervention / Treatment: DRUG: cannabis Location: Israel Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age >18 years * Histological or cytological documentation of malignancy * Chemotherapy treatment * Life expectancy of at least 6 months * Able to sign informed consent. Exclusion Criteria: * Brain tumors or CNS metastasis * Past cannabis use, * Known cognitive diseases such as Alzheimer's disease or other dementias

Study Objectives Chemotharapy plus targeted therapy regimen, as an adjuvant therapy, can effectively reduce the rate of both intrahepatic and extrahepatic recurrence in initially unresectable CRLM patients. Those with KRAS/NRAS/BRAF mutated tumors or cycle of conversion therapy ≤ 4 can benefit more from chemotharapy plus targeted therapyrather than from chemotharapy alone, with a tolerable toxicity profile. Conditions: Colorectal Cancer Metastatic Intervention / Treatment: DRUG: Targeted agent Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age >= 18 and <= 75 years; * Histologically confirmed CRC; * Initially unresectable synchronous liver metastases (LMs); * Accepted conversion therapy and successfully converted into resectable status; * Underwent R0 intestinal and hepatic resection; * Accepted adjuvant therapy. Exclusion Criteria: * R1/R2 resection; * Extrahepatic metastases; * Accepted postoperative monotherapy; * Lack of follow-up data.

Study Objectives Workplace exposure to secondhand cigarette smoke or environmental tobacco smoke (ETS)is widespread, effecting between 19 and 49% of the U.S. workforce. The first part of this study is designed to test whether exposure to ETS in the workplace effects a person's risk of developing chronic diseases such as cardiovascular disease and cancer. The second part of this study is designed to test whether antioxidant supplementation in this group of ETS exposed individuals can reduce their risk of developing chronic disease. The study will look at 375 non-smokers who either work on a casino floor or as bartenders or cocktail servers. Initial baseline data will be collected (questionnaires and blood samples taken) and the subjects will be randomized into one of three groups, placebo, low antioxidant supplementation and high antioxidant supplementation. They will be followed over a two-year period, coming in for follow-up testing every six months. Statistical analysis will be conducted to see whether this group of ETS exposed individuals has a greater risk of developing chronic disease and whether the use of antioxidant supplements can moderate any risks. Conditions: Cardiovascular Disease, Cancer Intervention / Treatment: DRUG: Antioxidants Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: FACTORIAL Masking: DOUBLE

Inclusion Criteria: Non-smoker Work in a casino - on the casino floor or work as a bartender or cocktail server for at least 1 year Do not take antioxidant supplements Healthy - not diagnosed with any major chronic diseases. Exclusion Criteria: Blood pressure SBP>200,<85 DBP>100, <40 Pulse >120, <45 Cholesterol >400 Triglycerides >700 Blood Cotinine >10 ng/ml BMI >35

Study Objectives The purpose of this study is to test the safety and effectiveness of two investigational drugs (drugs that are not currently approved by the FDA) given in combination with radiation therapy or ablation. Conditions: Metastatic Colorectal Cancer Intervention / Treatment: DRUG: durvalumab, DRUG: tremelimumab, RADIATION: Radiotherapy (RT), PROCEDURE: ablation Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Be willing and able to provide written informed consent for the trial. * Histologically- or cytologically- confirmed CRC. * Metastatic CRC. * Subjects have received at least two standard chemotherapy regimens for which they would be considered eligible (at least one containing a 5-fluoropyrimidine), or systemic chemotherapy is not indicated in the setting of low volume metastatic disease. * At least one tumor for which palliative RT is considered appropriate standard therapy (cohort 1); or, at least one tumor for which palliative ablation is considered appropriate standard therapy (cohort 2). * At least one index lesion that will not undergo RT or ablation, and which is measurable based on RECIST 1.1. * Be >= 18 years of age on day of signing informed consent. * Consent for tumor biopsies (for patients enrolled in stage 1 only) and blood draws for research purposes (for all patients). * Consent for use of available archived tissue and tumor obtained during a standard procedure, for research purposes. * Have a performance status of 0 or 1 on the ECOG Performance Scale. * Female subjects must either be of non-reproductive potential (i.e., post-menopausal by history: >=60 years old and no menses for >= 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment. * Demonstrate adequate organ function as defined all screening labs should be performed within 4 weeks prior to treatment initiation. * Hemoglobin >= 8.0 g/dL * Absolute neutrophil count (ANC) >=1,500 /mcL * Platelets >=100,000 / mcL * Serum creatinine <=1.5 X upper limit of normal (ULN) OR * Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) OR * Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance. * Serum total bilirubin <= 1.5 X ULN OR Direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN * AST (SGOT) and ALT (SGPT) <= 2.5 X ULN OR <= 5 X ULN for subjects with liver metastases. aCreatinine clearance should be calculated per institutional standard. Exclusion Criteria: * Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment. * Chemotherapy, monoclonal antibody, targeted small molecule therapy, within 4 weeks prior to dose #1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent (excluding alopecia or toxicity not anticipated to interfere with planned treatment on study). * Known or suspected MSI-H CRC. * Any prior Grade >=3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1, including anti-PD-1, anti-PD-L1, anti-CD137, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, except for endocrinopathies and asymptomatic amylase/lipase. * If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention per clinical discretion of the investigator prior to starting therapy. * Concurrent active malignancy that requires systemic treatment. * Known CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable without evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. The use of topical steroids is permitted. * Active autoimmune disease requiring systemic immune suppressive treatment within the past 2 years. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. * Has active, non-infectious pneumonitis. * Active or prior documented inflammatory bowel disease. * History of allogeneic organ transplant. * Has an active infection requiring systemic therapy. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Has known active and untreated Hepatitis B (e.g., HBsAg reactive) or active Hepatitis C (e.g., HCV RNA [qualitative] is detected). * Has received a live vaccine within 30 days prior to the first dose of trial treatment. * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab with the exceptions of premedication and intranasal, topical and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10mg/day of prednisone, or an equivalent corticosteroid. * Hypersensitivity to durvalumab or tremelimumab, or any excipients on the formulation. * Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results. * Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period. * QT interval corrected for heart rate (QTc) >= 470ms calculated from 1 electrocardiogram (ECG) using Fridericia's Correction. * History of primary immunodeficiency. * Known history of previous clinical diagnosis of tuberculosis. * Subjects with uncontrolled seizures.

Study Objectives This protocol is a multicentric interventional phase II study from the French CML Intergroup (FILMC). The core of the protocol is to explore the efficacy and safety of an optimization strategy consisting in the modulation of the dasatinib daily dose according to the results of repeated plasmatic levels of dasatinib. The objective of this strategy is to improve the overall results of the treatment of early CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase mutations. The study will be conducted in selected FILMC and Canadian centers. The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb. The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing authorization is granted in that indication. Conditions: Chronic Myelogenous Leukemia, BCR/ABL Positive Intervention / Treatment: DRUG: Dasatinib Location: France, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Male or female patient >= 18 years * ECOG Performance Status score 0-2 * Philadelphia chromosome positive newly diagnosed (<= 3 months) CP-CML * patients not previously treated except with hydroxyurea or imatinib (less than 4 weeks for imatinib) * Signed written inform consent * Adequate hepatic function defined as: total bilirubin <= 2.0 times the institutional ULN; ALT and AST <= 2.5 times the institutional upper limit of normal (ULN). * Adequate renal function defined as serum creatinine <= 3 times the institutional ULN. * Women of childbearing potential (WOCBP) must be using an adequate method of contraception. Exclusion Criteria: * Patients with BCR-ABL positive, Philadelphia negative CML * Patient previously treated with a tyrosine kinase inhibitor (TKI) except with imatinib during less than 4 weeks. * Pregnancy * Active malignancy * Uncontrolled or significant cardiovascular disease * Patients with QTc > 450 ms * Significant bleeding disorder unrelated to CML * Concurrent severe diseases which exclude the administration of therapy

Study Objectives This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Recurrent Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx Intervention / Treatment: DRUG: Akt inhibitor MK2206 Location: United States, Singapore, China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed non-keratinizing nasopharyngeal carcinoma that has recurred at locoregional and/or distant sites, and is not amenable to potentially curative radiotherapy or surgery * Measurable disease according to the RECIST criteria * Progressed =< 24 months of receiving one or two prior line(s) of chemotherapy for recurrent disease, of which at least one line must contain platinum drugs such as cisplatin, carboplatin or oxaliplatin * ECOG performance status 0, 1, or 2 * Hemoglobin >= 9 g/dL * ANC >= 1,500/μL * Platelet count >= 100,000/μL * Total bilirubin =< 2.5 times upper limit of normal (ULN) * ALT =< 2.5 times ULN (=< 5 times ULN for patients with liver metastases) * Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 * Ability to understand and the willingness to sign a written informed consent document * Willingness to donate blood for mandatory correlative research studies * Negative (serum) pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Exclusion Criteria: * Any of the following * Chemotherapy =< 4 weeks prior to registration * Radiotherapy =< 4 weeks prior to registration * Nitrosoureas or Mitomycin C =< 4 weeks prior to registration * Those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * NOTE: Prior palliative radiotherapy to bone metastases is allowed =< 4 weeks prior to registration * Prior investigational agents =< 4 weeks prior to registration * Symptomatic brain metastases; NOTE: primary nasopharyngeal cancers that directly invade the skull base and extend into the infratemporal fossa(e) are not regarded as brain metastases and are not excluded * History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or other agents used in the study * Prior potent and moderate inhibitors and inducers of CYP3A4 =< 2 weeks prior to registration: * Drugs that are forbidden, potent inducers of CYP3A4: phenytoin, phenobarbitone, carbamazepine, barbiturate, rifampicin, St John's Wort. * Drugs that significantly affect metabolizing activity by way of enzyme inhibition of CYP3A4: ketoconazole, itraconazole, fluconazole, indinavir, ritonavir, erythromycin, cimetidine, clarithromycin * Unwillingness to go off other inducers and inhibitors of CYP3A4 during the first 2 cycles of MK-2206; NOTE: avoiding these drugs is critical during the first 2 cycles of MK-2206when blood samples are being taken for the correlative study unless there is an urgent medical need and alternatives are not available * Poorly controlled diabetes mellitus or insulin controlled diabetes; NOTE: As a general guide, patients with a fasting glucose level > 150 mg/dL (HbA1c <8%, > 8.3 mmol/L), or a random glucose level of >180mg/dL (> 10 mmol/L) is considered to have inadequately controlled diabetes and are not eligible for this study; however, such patients can become eligible in the future if their fasting glucose levels improve with medical treatment * QTc prolongation (defined as a QTc interval > 450 msec for males and >470 msec for females) or other significant ECG abnormalities; NOTE: patients with clinically significant cardiac conduction abnormalities should be excluded, these include left bundle branch block (LBBB), 2nd or 3rd degree AV block, bifascicular block, sick sinus syndrome, Wolff-Parkinson-white syndrome, sinus bradycardia (< 50bpm); however, patients with asymptomatic right bundle branch block (RBBB) or 1st degree AV block, in the absence of known cardiac disease (e.g. coronary, valvular) are not excluded * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection, * Symptomatic congestive heart failure, * Unstable angina pectoris, * Uncontrolled symptomatic cardiac arrhythmia, * Psychiatric illness/social situations that would limit compliance with study requirements * Diagnosed to have any of the following condition(s), and/or have undergone any one of the following procedure(s) =< 3 months prior to registration: * Symptomatic thrombotic or hemorrhagic cerebral vascular accident * Coronary bypass graft * Angioplasty * Myocardial infarction * Patients having continuing >= grade 2 adverse events (excluding alopecia) due to agents (chemotherapy or radiotherapy) administered > 4 weeks prior to registration based on Common Terminology Criteria for Adverse Events (CTCAE version 4.0) =< grade 1 * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * NOTE: because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MK-2206, breastfeeding should be discontinued if the mother is treated with MK-2206; women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation * HIV-positive patients on combination antiretroviral therapy; NOTE: HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MK-2206; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy * Recent major surgery =< 4 weeks prior to registration (excluding the placement of vascular access), or minor surgery =< 2 weeks prior to registration * Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption) that impairs patients ability to swallow MK-2206 tablets

Study Objectives This clinical study was planned in order to assess the superiority of INNOCELL Corp. "Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Temozolomide to glioblastoma patients when compared with the control group who did not receive administration of the drug. Conditions: Glioblastoma Intervention / Treatment: DRUG: Activated T lymphocyte(Immuncell-LC) 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: * Patients who, prior to the study, received explanation of the purpose and content of study and of characteristics of the test drug from the test administrator and have consented to the study by providing signature of self, guardian, or legal representative. * Patients who are between 18 and 70 years of age * Patients whose cause of cancer has been found to be glioblastoma via pathological testing * patients who have received surgery for glioblastoma (Complete or partial extirpation or biopsy) 2 weeks prior to the study * Patients whose survival is expected to be longer than 3 months * Patients whose KPS is greater than 60 * Patients who satisfy the following conditions of the blood test, kidney function test, and liver function test * Hemoglobin is bigger than 10 gm% * Platelet Count is bigger than 100,000/µL * Absolute granulocyte count is bigger than 1,500/µL * BUN or Creatinine 1.5 x upper normal limit * Bilirubin level is smaller than 2.0 mg/dL * SGOT, SGPT, alkaline phosphatase is smaller than 1.5 x upper normal limit Exclusion Criteria: * Patients who have been determined to have serious Cardio - Pulmonary function disability by the clinical study staff * Patients who are immune deficient or have a history of auto immune diseases (Ex. Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.) * Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of skin cancer, local prostate cancer, and cervical cancer. * Patients with history of severe allergies * Patients with serious mental illness * Patients who are pregnant or nursing * Patients who have participated in other clinical tests in the recent 4 weeks prior to the study

Study Objectives Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by uncontrolled proliferation of the myeloid line of white blood cells and impaired production of normal blood cells. If untreated, patients die of infection or bleeding usually in a matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the cells that are thought to drive AML but that are not effectively killed by standard treatment. The aims of the study are to determine a biologically active dose of CSL360 and generate understanding of a rational schedule of administration for future studies. Conditions: Acute Myeloid Leukemia (AML) Intervention / Treatment: DRUG: CSL360 Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Clinical diagnosis of acute myeloid leukemia * Recent bone marrow biopsy * Prior treatment or medically unfit for standard therapy Exclusion Criteria: * Peripheral blood blast count > 30 x 109/L, or rapidly progressive AML * Previous solid organ transplant * Active GvHD or immunosuppression * Concurrent treatment with other anti-cancer therapy * Active infections

Study Objectives This trial was to evaluate the efficacy of intratumoral PTS injection in alleviating airway obstruction and dyspnea by improving the percentage of lumen patency of patients with central air way NSCLC tumor severe obstruction. Conditions: Nsclc Intervention / Treatment: DRUG: Para-Toluenesulfonamide Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female inpatients, aged 18 to 83 years old. * Patients with central air way non-small cell lung cancer (NSCLC) severe obstruction; definition of severe airway obstruction: >=1/2 trachea is obstructed by tumor; and/or block >=2/3 of primary bronchi, right and middle bronchi. And the longest diameter of the lesion > 0.5 cm. * Pathologically confirmed lung cancer. * Patients with tracheal tumor lesions suitable for local intratumoral injection via fibro-bronchoscopy. * At least one measurable lesion that could be evaluated by imaging examination (bronchoscopy, CT, MRI or X-ray etc.) according to the Response Evaluation Criteria in Solid Tumors. * Blood platelet count >= 100,000/mm3. * Subjects who were able to understand and comply with the trial protocol and give written consent. Exclusion Criteria: * Brain metastases. * History of cardiovascular diseases, including congestive heart failure > New York Heart Association (NYHA) Grade II. Patients with unstable angina pectoris (angina pectoris symptoms at rest), recent angina pectoris (occurred in the recent 3 months) or with myocardial infarction in recent 6 months must be excluded. * Severe infections or dysbolism. * Poor hepatic functional reserve or severe hepatocirrhosis, with abnormal blood coagulation indicators. * Poor general conditions or cachexia. * The target lesion had been treated with radiotherapy within 6 months. * Pregnant or breast-feeding woman. * Known hypersensitivity to PTS or related compounds. * Lung cancer lesions not suitable for local treatment. * Any other reason deemed reasonable by the investigator.

Study Objectives The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors) mutations or ERBB2 amplifications (Cohort A), and EGFR (Epidermal Growth Factor Receptor) amplification positive tumours (Cohort B), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis. The antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the trial. A key secondary endpoint will also be defined, the objective response rate (ORR). Conditions: Urologic Neoplasms Intervention / Treatment: DRUG: Afatinib Location: Italy, France, Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Recurrent or metastatic urothelial cancer * Patients must have failed prior platinum based treatment (adjuvant or 1st line) * Archival tissue sample available for biomarker testing at pre-screening and tissue banking. * Patients should complete a pre-screening biomarker analysis and should fulfill the following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should show EGFR (Epidermal Growth Factor Receptor) amplification. * Further inclusion criteria apply Exclusion criteria: * Prior use of EGFR, ERBB2 or ERBB3 targeted treatment * Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first * Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis * Further exclusion criteria apply

Study Objectives TQB3616 capsule is a small molecule oral drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., which inhibits cyclin-dependent kinases 4 and 6 (CDK4/6). Its main mechanism of action is to inhibit the proliferation of tumor cells by reducing the phosphorylation level of retinoblastoma protein (Rb) in cancer cells and blocking the progression of cells from G1 phase to S phase. This study is a randomized, open-label, single-center, two-period, two-crossover phase I clinical trial to assess the effect of food on the pharmacokinetics of TQB3616 capsules in healthy adult subjects, to evaluate the effect of food on the pharmacokinetics of TQB3616 capsules after oral administration in healthy adult Chinese subjects and to observe the safety of TQB3616 capsules after single oral administration in healthy subjects.Each subject will be randomly assigned to one of two groups (group A and B). A total of 16 subjects were enrolled, all taking TQB3616 capsules 180mg, including 8 subjects in group A and 8 subjects in group B. The study included screening period, randomization, first cycle, washout period and second cycle. The first cycle and second cycle each contained 3 return visits. 18 pharmacokinetic samples were collected every cycle for pharmacokinetic index analysis. Vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, adverse events, drug combination and non-drug therapy information were collected during the study to ensure the safety of the subjects. Conditions: Recurrent/Metastatic Breast Cancer Intervention / Treatment: DRUG: TQB3616 Capsule Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * 1 Sign the informed consent form before the trial and fully understand the content, process and possible adverse reactions of the trial; * 2 Be able to complete the study according to the requirements of the study protocol; * 3 Subjects aged 18 to 65 years (including 18 and 65 years); * 4 Body mass index (BMI) >= 18 and <= 28 kg/m2, and male body weight >= 50 kg Female body weight >= 45 kg; * 5 Health condition: no mental disorders, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities; * 6 Subjets had no plans to become pregnant and voluntarily took effective contraceptive measures from 2 weeks before dosing to at least 6 months after the last dose of study drug. Exclusion Criteria: * 1 Patients with a history of neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hemolymphatic, hepatic or renal insufficiency, endocrine, musculoskeletal system disease or other diseases, which may affect drug metabolism or safety as judged by the investigator; * 2 Allergic constitution or previous history of two or more kinds of food or drug allergy; * 3 Hyperactive/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism; * 4 Patients with multiple factors affecting oral drugs (such as inability to swallow, gastrointestinal diseases); * 5 Taking any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 1 month before taking the study drug; * 6 Administration of CYP3A4 inhibitors or inducers within 1 month before screening or before study drug; * 7 Taking special diet (including grapefruit, etc.) or strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 14 days before screening; * 8 Abnormal and clinically significant laboratory findings during the screening period; * 9 Blood donation or significant blood loss (> 450 mL) within 3 months prior to administration of study drug; * 10 Participated in any drug clinical trial within 3 months before taking the study drug; * 11 Smoking more than 5 cigarettes per day within 3 months before the trial; * 12 Positive breath alcohol test or history of alcoholism (14 units of alcohol per week: 1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine); * 13 Drug screening positive or drug use 3 months before the trial; * 14 Inability to tolerate venipuncture for blood sampling or poor vascular status; * 15 Subjets cannot complete the trial due to personal reasons; * 16 Other conditions considered inappropriate by the investigator.

Study Objectives The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC). Conditions: Prostate Cancer Intervention / Treatment: DRUG: CTT1403, DRUG: CTT1057, DRUG: 68Ga-PSMA-11 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: * Patients must have histologically confirmed prostate adenocarcinoma that is metastatic and castration resistant (mCRPC). * At least 3 metastatic foci avid for PSMA-specific PET agent (CTT1057) uptake on Screening PSMA PET. * Has received docetaxol, ineligible for docetaxol, or refused docetaxol for the treatment of prostate cancer. * Has progression by the PCWG3 criteria during or after treatment with either abiraterone or enzalutamide * Male Age >= 18 years. * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2). * Demonstrate adequate organ function Exclusion Criteria: * Has received previous treatment with radium-223 or another radiopharmaceutical within 3 months prior to first dose of CTT1403. * Has received prior systemic anti-cancer therapy (excluding radiopharmaceutical) within 14 days, or 5 half-lives, whichever is shorter, prior to first dose of CTT1403. * Has received external-beam radiation within 14 days prior to first dose of CTT1403. * Has received cabazitaxel for the treatment of mCRPC. * Has received previous treatment with a therapeutic targeting PSMA. * Has an additional active malignancy requiring therapy that may confound the assessment of the study endpoints. * Has clinically significant cardiovascular disease * Has a history of untreated brain metastases * Has evidence of diffuse bone marrow involvement by prostate cancer in the judgment of study investigator. * Clinically significant urinary obstruction or moderate/severe hydronephrosis on baseline imaging. * Has a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before CTT1403 administration. * Has known positive status for chronic hepatitis B or hepatitis C * Known or suspected myelodysplastic syndrome. * Has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.

Study Objectives The purpose of this study is to test the effect of the combination of sunitinib and bortezomib. We will see what effects it has on your cancer and find the highest dose of each agent that can be given without causing severe side effects. Conditions: Solid Tumors Intervention / Treatment: DRUG: Sunitinib and Bortezomib 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: Each patient must meet all of the following inclusion criteria to be enrolled in the study: * Refractory advanced solid tumor that has failed standard therapy. * ECOG PS <= 2 * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. * Male subject agrees to use an acceptable method for contraception for the duration of the study. * Cardiac ejection fraction is more than 45% Exclusion Criteria: * Patient has a platelet count of <100 x 109/L within 14 days before enrollment. * Patient has an absolute neutrophil count of ANC <1.0 x 109/L within 14 days before enrollment. * Patient has a calculated or measured creatinine clearance of <30 mL/minute within 14 days before enrollment. * AST, ALT, total bilirubin > twice the upper limits of normal. * Received radiation to more than 30% of marrow volume * Patient has greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment. * Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. * Patient has hypersensitivity to sunitinib, bortezomib, boron or mannitol. * Uncontrolled hypertension * History of venous thromboembolic events. * Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. * Patient has received other investigational drugs with 14 days before enrollment * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Hemorrhagic tendency of the tumor

Study Objectives The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: Cediranib, DRUG: Bevacizumab, DRUG: 5-fluorouracil ( in FOLFOX), DRUG: Leucovorin (in FOLFOX), DRUG: Oxaliplatin (in FOLFOX) Location: Hungary, Canada, Turkey, Egypt, United States, Taiwan, Austria, Philippines, France, Poland, Vietnam, Israel, India, Thailand, Italy, Ukraine, United Kingdom, South Africa, Russian Federation, Finland, Spain, Belgium, Latvia, Germany, Czech Republic, Malta, Australia, Slovakia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Clinical Diagnosis of colon or rectal cancer * No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received >12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received >6 months prior to study entry. Exclusion Criteria: * Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib. * Poorly controlled hypertension

Study Objectives This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second line therapy in patients with stage IV, metastatic breast cancer Conditions: Breast Cancer Intervention / Treatment: DRUG: Trastuzumab, DRUG: Oxaliplatin 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: * Females >= 18 years of age * Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH +) and evidence of metastatic disease. Tumor may be of any estrogen and progesterone receptor type * Measurable disease by RECIST and an ECOG <= 2 * Patients with known evidence of brain metastases are eligible if they are asymptomatic and have completed all therapy (surgery, radiotherapy, and/or steroids) * Baseline LVEF value within the institutional normal range * Any number of prior hormonal therapy treatments in the adjuvant setting or for metastatic disease. A subject must have progressed on hormonal therapy and all hormonal therapy (including birth control pills) must be discontinued at study entry. * Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen for metastatic disease is allowed. * Patients may have received one prior trastuzumab/chemotherapy containing regimen or prior single agent trastuzumab. * Prior radiation therapy in the adjuvant setting or for metastatic disease, provided it was not to the only site of evaluable disease. * All prior chemotherapy, trastuzumab and radiation therapy should be completed > 2 weeks before enrollment. * Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate were started within < 2 months prior to enrollment, the bone lesions will not be evaluated for response and the patient must have another site of metastatic disease that is either measurable or evaluable for response. * Patients must have recovered from toxicities due to prior therapy. * Lab values in accordance with the protocol * Patients must be nonpregnant and nonlactating. Patients of childbearing potential must implement an effective method of contraception during the study (birth control pills are not allowed). Exclusion Criteria: * Bone only disease are ineligible * Patients who received more than 1 prior chemotherapy regimen for metastatic disease are ineligible. * Patients with a history of other cancers except curatively-treated carcinoma of the cervix in situ or non-melanomatous skin cancer. * Active serious infection or other underlying medical condition that would impair their ability to receive protocol treatment. * Uncontrolled nervous system metastases * Dementia or significantly altered mental status that would interfere with proper consenting. * Receiving other investigational therapy.

Study Objectives Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years. Conditions: Breast Cancer Intervention / Treatment: DRUG: Zoledronic acid, DRUG: Letrozole Location: Korea, Republic of, Italy, Netherlands, Spain, Belgium, Saudi Arabia, Argentina, South Africa, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Stage I-IIIa breast cancer * Postmenopausal * Recent surgery for breast cancer Exclusion Criteria: * Metastatic disease * Invasive bilateral disease * Clinical or radiological evidence of existing fracture in spine or hip Other protocol-defined inclusion / exclusion criteria may apply.

Study Objectives The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available. Conditions: Advanced Solid Tumors, Recurrent Solid Tumors Intervention / Treatment: DRUG: ONO-4538 Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The treatment phase has been completed in the ONO-4538-13 study Exclusion Criteria: * The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study. * It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.

Study Objectives A randomized controlled trial (RCT), 60 HNC patients who underwent radiotherapy (RT) with or without chemotherapy represented the sample of the study. They were assigned randomly into two equal groups, control group (CG) and study group (SG). Routine methods of nursing were given during radiotherapy including health education, skin self-care, and skin protective agent for both groups CG and SG. The patients in study group treated with photon therapy (3x/week) for 6 weeks with a total of 18 sessions. The severity of skin reactions was assessed by the criteria of the Radiation Therapy Oncology Group (RTOG) and dermoscopy for both groups were recorded. Conditions: Head and Neck Cancers - Nasopharyngeal Intervention / Treatment: DEVICE: photon therapy face mask Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * All patients were free from any skin diseases, All patients enrolled to this study signed their informed consent,All the patients who had Nasopharyngeal tumor receiving radiotherapy who participated in this study, diagnosed by an oncologist and confirmed by MRI, C.T and laboratory investigations). Exclusion Criteria: * patients with communication disorders, patients who were unwilling to take part in this treatment, patients with tumor recurrence, patients with tumor stage 3 or more and patients with skin diseases

Study Objectives To determine the effect of increasing serum 25(OH)D from prevailing levels with vitamin D3 supplementation, while maintaining adequate calcium intake, on incidence of all-type cancer in a population sample of healthy postmenopausal women. Conditions: Cancer Intervention / Treatment: DIETARY_SUPPLEMENT: Vitamin D3, DIETARY_SUPPLEMENT: Calcium carbonate Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Age: >= 55 years * Last menstrual period (LMP): >= 4 years * Good general health * Willingness to participate in this 4 year long study * Able to give informed consent * Able to live independently and travel to the Fremont Area Medical Center (FAMC) for study visits Exclusion Criteria: * History of cancer except * Superficial basal or squamous cell carcinoma of the skin * Other malignancies treated curatively more than 10 years ago * History of renal calculi or chronic kidney disease * History of sarcoidosis * History of tuberculosis * Participation in the previous Creighton cancer prevention study * Mini-Mental Status Exam (MMSE) score of <= 23. Use the MMSE if there are any concerns about the person's cognitive abilities or ability to give fully informed consent to the study. Concerns may be related to a person's lack of orientation to person, place, or time; language difficulties (inability to structure simple, complete sentences); or short term memory. The Hartford Institute for Geriatric Nursing recommends that a score of 23 or lower indicates cognitive impairment. (Accessed at www.harforddign.org). See appendix.

Study Objectives This study will investigate the drug-drug interactions (DDIs) between rucaparib and oral rosuvastatin (Arm A), and between rucaparib and oral ethinylestradiol and levonorgestrel (Arm B), with rucaparib as a perpetrator. Conditions: Neoplasms Intervention / Treatment: DRUG: Rucaparib, DRUG: Rosuvastatin, DRUG: Oral Contraceptives Location: Hungary, Slovakia, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria (All patients): * Willing to sign the ICF and to comply with the study restrictions * Body mass index (BMI) 18.0 to 35.0 kg/m2 * Histologically or cytologically confirmed advanced solid tumor * Patients who, in the opinion of the Investigator, could potentially benefit from treatment with rucaparib * ECOG performance status less than or equal to 1 * Adequate organ function Inclusion Criteria (Arm A): * Male or female patients >= 18 years of age Inclusion Criteria (Arm B): * Female patients >= 18 years of age Exclusion Criteria (All patients): * Specific cancer treatments within 14 days prior to Day 1 * Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, acute coronary syndrome, cardiac angioplasty, stenting, or poorly controlled hypertension within the last 3 months prior to screening * Pre-existing duodenal stent, recent or existing bowel obstruction * Untreated or symptomatic central nervous system (CNS) metastases. Patients with treated asymptomatic CNS metastases are eligible * Known HIV or AIDS-related illness, acute or history of chronic hepatitis B or C * Female patients who are pregnant or breastfeeding * Participation in another investigational drug trial within 30 days prior to Day 1 or exposure to more than 3 new investigational agents within 12 months prior to Day 1 * Presence of active infection requiring antibiotics * Active second malignancy * History of drug abuse (including alcohol) Exclusion Criteria (Arm A): * Current use of rosuvastatin or any other statin * History of hypersensitivity to rosuvastatin * Current, or history of, clinically significant myopathy Exclusion Criteria (Arm B): * Current use of any 1 of the contraceptive drugs or previous contraceptive implants or depot injections, which may still be clinically effective * History of hypersensitivity to ethinylestradiol or levonorgestrel

Study Objectives Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. The primary objective of this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. The secondary "hypothesis generating" objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain). Conditions: Breast Neoplasms, Prostatic Neoplasms, Multiple Myeloma, Osteolysis Intervention / Treatment: DRUG: Clodronate (Bonefos, BAY94-8393) Location: Czech Republic Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Diagnosis of breast cancer, prostate cancer, multiple myeloma and other skeletal events causing tumors * Bone metastases * Therapy with clodronate (1600 mg per day, 800 mg tablets) according to SmPC (Summary of Product Characteristics) Bonefos. * By agreeing to usage of patients diaries and goodwill with accounting of tablets Exclusion Criteria: * According to SmPC (Summary of Product Characteristics) Bonefos.

Study Objectives The goal of this clinical research study is to learn how dasatinib affects biomarker levels in patients with malignant pleural mesothelioma that may be able to be removed by surgery. The safety and effectiveness of this drug will also be studied. This research study is financially supported by the United States Department of Defense. Conditions: Malignant Pleural Mesothelioma Intervention / Treatment: DRUG: Dasatinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with potentially resectable malignant pleural mesothelioma, IMIG stage I-III * Subject, age >= 18 years * Any patient who is able to tolerate general anesthesia for the extended surgical staging and the definitive surgical resection. * No prior chemotherapy for mesothelioma within the last 3 years * No prior radiation to the area of primary disease. Radiation to chest wall port sites is acceptable. * No prior targeted biologic therapy (i.e. EGFR inhibitors, VEGF inhibitors) within the last 3 years * Adequate Organ Function: a) Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN), b) Hepatic enzymes (AST, ALT ) <= 2.5 times the institutional ULN, c) Serum Na, K+, Mg2+, Phosphate and Ca2+>= Lower Limit of Normal (LLN), d) Serum Creatinine < 1.5 time the institutional ULN, e) Hemoglobin, Neutrophil count, Platelets, PT, PTT all Grade 0-1 * Ability to take oral medication (dasatinib must be swallowed whole) * Women of childbearing potential (WOCBP) must have: A negative serum or urine pregnancy test (sensitivity <= 25IU HCG/L) within 72 hours prior to the start of study drug administration * Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped * Signed written informed consent including HIPAA according to institutional guidelines Exclusion Criteria: * Malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 3 years. * Prior therapies to be excluded: any prior chemotherapy or targeted biologic therapy for mesothelioma used within the last 3 years * Concurrent medical condition which may increase the risk of toxicity, including: a) Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease) b) Any disease which requires persistent anticoagulation therapy (and the patient may not be taken off the anti-coagulation safely) with coumadin, factor Xa inhibitors, or heparin (low-molecular weight, standard) * Cardiac Symptoms, consider the following: a) Uncontrolled angina, congestive heart failure or MI within (6 months), b) Diagnosed congenital long QT syndrome: 1. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes), 2. Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec), 3. Subjects with hypokalemia or hypomagnesemia if it cannot be corrected * History of significant bleeding disorder unrelated to cancer, including: a) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease), b) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies), c) Ongoing or recent (<= 3 months) significant gastrointestinal bleeding * Concomitant Medications, consider the following prohibitions: a) Drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib): A) quinidine, procainamide, disopyramide, B) amiodarone, sotalol, ibutilide, dofetilide, C) erythromycin, clarithromycin, D) chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide E) cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine. F) moxifloxacin, levofloxacin * The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended.The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy.a)Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy,b)Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia,c)Patient may not be receiving any prohibited CYP3A4 inhibitors,d)Patient may not be receiving any alternative herbal remedies during the dasatinib treatment period * Women: a) are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or, b) have a positive pregnancy test at baseline, or c) are pregnant or breastfeeding, d) Sexually active women of childbearing potential (WOCBP) must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized., * -continued from exclusion #8-: e) Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy., f) All WOCBP MUST have a negative pregnancy test prior to first receiving dasatinib. If the pregnancy test is positive, the patient must not receive dasatinib and must not be enrolled in the study. * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

Study Objectives The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in subjects with advanced ovarian cancer. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Genexol-PM 220mg/㎡, Carboplatin 5AUC, DRUG: Genexol-PM 260mg/㎡, Carboplatin 5AUC, DRUG: Genexol-PM 300mg/㎡, Carboplatin 5AUC Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Women >= 18 years old. * Signed informed consent before inclusion. * Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV) * Subjects who have measurable disease by RECIST after debulking surgery. * ECOG performance status of 0, 1, or 2. * Estimated life expectancy of more than 6 months * Subjects who have the clinically acceptable function of blood, kidney and liver at screening visit * Hb >= 10g/dl * ANC >= 1.5×10^9/L * Platelet Count >= 100×10^9/L * Serum total bilirubin <= 1.5×ULN * Serum AST and ALT <= 2.5×ULN * Serum ALP <= 2.5×ULN * Serum creatinine <= 1.5×ULN Exclusion Criteria: * Subjects who have received chemotherapy for ovarian cancer other than debulking surgery. * Subjects who have a history of radiotherapy to pelvis or abdominal cavity * Subjects who receive immunotherapy or hormonal therapy for ovarian cancer * Subjects who have other malignancies within the past 5 years * Subjects who have had a major surgery other than debulking surgery within 2 weeks prior to the screening/baseline visit * Subjects who have a history of metastasis or currently have a metastasis to the central nervous system(CNS) * Subjects who have a preexisting sensory or motor neuropathy of grade >= 1 based on NCI CTCAE V3.0 * Subjects who have serious medical condition * Uncontrolled or severe cardiovascular disease(Ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure) * Uncontrollable infection * Previous allergic reactions in connection with paclitaxel and carboplatin * Subjects who participate another clinical trial within the last 4 weeks before inclusion

Study Objectives The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab. Conditions: Colon Cancer, Rectal Cancer Intervention / Treatment: BIOLOGICAL: Ramucirumab, BIOLOGICAL: Icrucumab, DRUG: mFOLFOX-6 Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI [capecitabine + irinotecan], with or without bevacizumab) * Age >= 18 years * Life expectancy of >= 6 months * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry * Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication * Provided signed informed consent Exclusion Criteria: * Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered > 12 months prior to randomization) * Has documented and/or symptomatic brain or leptomeningeal metastases * Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders * On chronic non-topical corticosteroid treatment. A participant discontinuing such treatment > 3 months prior to randomization is eligible * Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy * Has a concurrent active malignancy. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years * If female, is pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG] test) or lactating * Has received a prior autologous or allogeneic organ or tissue transplantation * Has undergone major surgery within 28 days prior to randomization * Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization * Has an elective or planned major surgery to be performed during the course of the trial * Has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization

Study Objectives This is an open label, multi-center, Phase 1/2 study of BBI608 administered in combination with immunotherapy in adult patients with advanced cancers. The goal of the study is to determine the RP2D of BBI608 in combination with each of the immunotherapeutic agents. Conditions: Cancer Intervention / Treatment: DRUG: BBI608, DRUG: Ipilimumab, DRUG: Nivolumab, DRUG: Pembrolizumab 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: * Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements * A histologically or cytologically confirmed cancer that is metastatic, unresectable, or recurrent and for which treatment with ipilimumab, or nivolumab, or pembrolizumab is a reasonable therapeutic option in the opinion of the investigator. * >= 18 years of age * Measurable disease as defined by Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last dose * Females of childbearing potential must have a negative serum pregnancy test * Aspartate transaminase (AST) < 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) <= 2.5 × upper limit of normal (ULN). * Hemoglobin (Hgb) >= 9 g/dl * Total bilirubin <= 1.5 × ULN. Patients with liver lesions who do not have hepatocellular carcinoma and who have a total bilirubin < 2.0 x ULN may be eligible if agreed upon by the investigator and medical monitor for the sponsor. * Creatinine <= 1.5 × ULN or, for patients with creatinine levels above institutional upper limit of normal, creatinine clearance must be > 60 mL/min/1.73 m^2. * Absolute neutrophil count >= 1.5 x 10^9/L * Platelets >= 100 x 10^9/L; patients with hepatocellular carcinoma may enroll provided they have a platelet count >= 75 x 10^9/L. * Life expectancy >= 3 months Exclusion criteria: * Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose of BBI608. Patients may begin BBI608 on a date determined by the investigator and medical monitor for the sponsor after a minimum of 7 days since last receiving anti-cancer treatment, provided that all treatment-related adverse events (AEs) have resolved or have been deemed irreversible * Had a surgical procedure requiring general anesthesia or inpatient hospitalization for recovery less than 4 weeks prior to beginning protocol therapy. * Any known, untreated, brain metastases. Treated subjects must be stable 4 weeks after completion of treatment for brain metastases and image documented stability is required. Patients must have no clinical symptoms from brain metastases and have not required systemic corticosteroids >10 mg/day prednisone or equivalent for at least 2 weeks prior to first dose of study drug. * Pregnant or breastfeeding * Unable or unwilling to swallow BBI608 capsules daily * Significant gastrointestinal disorder(s) (e.g., active Crohn's disease or ulcerative colitis, or a history of extensive gastric resection and/or small intestinal resection) such that absorption of oral medications is impaired. * Has an active autoimmune disease requiring immunosuppression with the exception of subjects with isolated vitiligo, resolved childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and euthyroid patients with a history of Grave's disease. * Has interstitial lung disease or active, non-infectious pneumonitis * Has a transplanted organ or has undergone allogeneic bone marrow transplant * Has received a live vaccine within 30 days prior to first dose. * Known hypersensitivity to a component of protocol therapy * Uncontrolled concurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or on mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements * Subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; c) localized prostate cancer not requiring systemic therapy; and c) other primary tumors with no known active disease present that, in the opinion of the investigator and medical monitor for the sponsor, will not affect patient outcome in the setting of the current diagnosis. * Abnormal ECGs that are clinically significant such as QT prolongation (QTc > 480 msec), clinically significant cardiac enlargement or hypertrophy, new bundle branch block or existing left bundle branch block, or signs of new, active ischemia.

Study Objectives This phase II trial studies how well pembrolizumab and lenvatinib work in treating patients with differentiated thyroid cancer that has spread to other places in the body or has come back and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Conditions: Columnar Cell Variant Thyroid Gland Papillary Carcinoma, Follicular Variant Thyroid Gland Papillary Carcinoma, Metastatic Thyroid Gland Follicular Carcinoma, Metastatic Thyroid Gland Papillary Carcinoma, Poorly Differentiated Thyroid Gland Carcinoma, Recurrent Differentiated Thyroid Gland Carcinoma, Recurrent Thyroid Gland Follicular Carcinoma, Recurrent Thyroid Gland Papillary Carcinoma, Stage III Differentiated Thyroid Gland Carcinoma AJCC v7, Stage III Thyroid Gland Follicular Carcinoma AJCC v7, Stage III Thyroid Gland Papillary Carcinoma AJCC v7, Stage IV Thyroid Gland Follicular Carcinoma AJCC v7, Stage IV Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVC Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7, Tall Cell Variant Thyroid Gland Papillary Carcinoma, Thyroid Gland Hurthle Cell Carcinoma, Unresectable Differentiated Thyroid Gland Carcinoma, Unresectable Thyroid Gland Carcinoma Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, DRUG: Lenvatinib, DRUG: Lenvatinib Mesylate, BIOLOGICAL: Pembrolizumab 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: * Locally recurrent and unresectable and/or distant metastatic differentiated thyroid cancer (DTC), histologically or cytologically confirmed; the diagnosis of DTC includes the following subtypes: papillary thyroid cancer (PTC) (including but not limited to variants such as follicular variant, tall cell, columnar cell, Hurthle cell variant of papillary carcinoma, and poorly differentiated), follicular thyroid cancer (FTC), including insular variant, Hurthle cell carcinoma and poorly differentiated thyroid cancer * Measurable disease meeting the following criteria: * At least 1 lesion of >= 1.0 cm in the longest diameter for a non-lymph node or >= 1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI); if there is only one target lesion and it is a non-lymph node, it should have a longest diameter of >= 1.5 cm * Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion * For cohort 1 only: evidence of disease progression =< 14 months prior to registration according to RECIST 1.1, as confirmed by the site study principal investigator (PI) * For cohort 2 only: progressive disease (PD) on lenvatinib per RECIST 1.1 =< 60 days prior to registration, as confirmed by the site study PI; patients need to have documented imaging and measurement of RECIST target lesions within 30 days of starting pembrolizumab * Radioiodine (RAI)-resistant disease as defined by one or more of the following criteria: * One or more measurable lesions that do not demonstrate RAI uptake * One or more measurable lesions progressive by RECIST 1.1 =< 14 months of prior RAI therapy * One or more measurable lesions present after cumulative RAI dose of >= 600 mCi * One or more measurable lesions that are fludeoxyglucose F-18 (FDG)-avid (> 5 standardized uptake value [SUV]), if positron emission tomography (PET)/CT scan performed; these lesions may also be RAI-avid * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Absolute neutrophil count (ANC) >= 1,500 /mcL (obtained =< 30 days prior to registration) * Platelets >= 100,000 / mcL (obtained =< 30 days prior to registration) * Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin dependency (=< 7 days prior to registration) (obtained =< 30 days prior to registration) * Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (obtained =< 30 days prior to registration) * Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (obtained =< 30 days prior to registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases (obtained =< 30 days prior to registration) * Albumin >= 2.5 mg/dL (obtained =< 30 days prior to registration) * International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (obtained =< 30 days prior to registration) * Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (obtained =< 30 days prior to registration) * Adequately controlled blood pressure with or without antihypertensive medications defined as blood pressure (BP) < 150/90 mmHg at screening * Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only * Ability to complete patient medication and blood pressure diaries by themselves or with assistance * Willing and able to provide informed written consent * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Note: during the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up * Willing to provide tissue and blood samples for correlative research purposes Exclusion Criteria: * Cohort 1 only: prior treatment with previous VEGFR active multikinase inhibitor * Cohort 2 only: discontinued lenvatinib due to toxicity * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment * Female subjects of childbearing potential: unwilling or unable to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; NOTE: subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year * Male subjects: unwilling or unable to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive (HIV 1/2 antibodies) and currently receiving antiretroviral therapy * Currently participating and receiving study therapy (except lenvatinib for patients in cohort 2) or has participated in a study of an investigational agent and received study therapy within 4 weeks prior to registration * Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy =< 7 days prior to the first dose of trial treatment * Known history of active TB (Bacillus tuberculosis) * Hypersensitivity to pembrolizumab or any of its excipients * Prior anti-cancer monoclonal antibody (mAb) =< 4 weeks prior to registration or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered >= 4 weeks prior to registration * Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 (except lenvatinib for patients in cohort 2) or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent * NOTE: * Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study * If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to registration, as deemed by treating investigator or site PI * Known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis; NOTE: subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for >= 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); NOTE: replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment * Known history of, or any evidence of active, non-infectious pneumonitis that required steroids * Active infection requiring systemic therapy * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent * Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) * Received a live vaccine =< 30 days of planned start of study therapy; NOTE: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed * Proteinuria > 1+ on dipstick urinalysis; patients with > 1+ proteinuria on dipstick urinalysis will undergo 24-hour urine collection for quantitative assessment; NOTE: patients with > 1 g/24 hours will be ineligible * Clinically significant gastrointestinal malabsorption syndrome * New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months; ejection fraction (EF) by multi-gated acquisition (MUGA) or echo should not be less than the institutional lower limit of normal * Corrected QT (QTc) prolongation > 480 msec, as calculated by either the Bazett or Fridericia formula, as per institutional standard * Active hemoptysis (bright red blood > 1 teaspoon on more than one occasion) =< 3 weeks prior to registration * Cohort 2 only: more than one prior treatment with VEGFR active multikinase inhibitor prior to original start of lenvatinib

Study Objectives Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general anaesthesia through binding to its receptors in the brainstem. However, it has not been proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the relationship between fentanyl doses and cough suppression during emergence from sevoflurane anaesthesia. Conditions: Thyroid Neoplasm Intervention / Treatment: DRUG: fentanyl citrate, DRUG: saline Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm. * ASA I-II. * 20-59 years old. * female only. Exclusion Criteria: * signs of difficult intubation. * risks for perioperative pulmonary aspiration. * history of chronic respiratory disease. * recent upper respiratory track infection. * previous and recent smoking history

Study Objectives This study is a pilot study to evaluate high-dose conformal radiation therapy (HDCRT) administered in combination with pembrolizumab in patients with solid tumors. Conditions: Solid Tumor Intervention / Treatment: RADIATION: High-Dose Conformal Radiation Therapy, DRUG: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects must have a histologically or cytologically proven advanced solid tumor malignancy for which palliative radiation is recommended. In solid tumors where pembrolizumab has been approved for use, patients may receive pembrolizumab as indicated, in the context of this protocol. In solid tumors where pembrolizumab has not been approved for use, the following criteria apply: * Patients must be resistant to at least 1 prior conventional chemotherapy regimen or other standard of care regimen, * Patient must have no remaining conventional treatment options proven to provide long-term disease control, and * Patient has declined other conventional treatment options * Palliative radiation therapy may be recommended for primary tumor and/or any metastatic site that is accessible to biopsy. * At least one site of disease that is accessible to radiation and multiple biopsies. Subjects may have disease that is encompassed within the radiation field or may have known disease both inside and outside of the radiation field. * Must be able to provide tissue from 2-3 separate biopsy procedures that will be completed throughout the course of the study. * A performance status of 0, 1 or 2 on the ECOG Performance Scale. * Subjects must demonstrate adequate organ function. * A life expectancy >= 6 months. Exclusion Criteria: * Requires urgent treatment with cytotoxic chemotherapy or other therapy is indicated. * A diagnosis of immunodeficiency. * A known history of active TB (Bacillus Tuberculosis). * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with untreated brain metastases and patients who have had brain metastases re-treated with radiation will be excluded. Patients whom have either midline shift, or any signs of herniation (even if disease has been treated with GK) will be excluded. Subjects with previously treated brain metastases may participate provided they are 1) stable (without clinical evidence of progression) 2) are out at least 10 days from CNS radiation and 3) and are not using steroids as part of treatment for their brain lesions for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Active autoimmune disease that has required systemic treatment in the past 2 years. * A history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * An infection requiring systemic therapy. * Pregnancy. * HIV positivity. * Evidence of active Hepatitis B virus or Hepatitis C virus. * Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, uncontrolled arrhythmias, or severe valvular heart disease, or a myocardial infarction within 6 months prior to the first dose of study treatment. * Active bleeding disorders or evidence of chronic or acute disseminated intravascular coagulation (DIC). * Class III or IV heart disease (New York Heart Association classification).

Study Objectives The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated with the combination of these drugs; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make your tumor smaller or disappear, and for how long. Conditions: Carcinoma, Transitional Cell Intervention / Treatment: DRUG: Pemetrexed, DRUG: Gemcitabine, DRUG: Platinol 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: * Biopsy-proven metastatic bladder cancer * No prior chemotherapy for metastatic disease except before or after surgery, which was completed 6 months before enrollment * Prior radiation allowed, if it is not the only site of measurable disease and if completed 3 weeks before enrollment * 18 years of age and older Exclusion Criteria: * Pure adeno- or squamous urothelial cancer * Brain metastases that causes symptoms * Have not received treatment within the last 30 days with a drug that has not received regulatory approval for any indication * Inability to take dexamethasone, folic acid or vitamin B12, according to the protocol * Clinically relevant fluid collection in the lungs or abdomen that cannot be controlled

Study Objectives This Phase I study is designed to evaluate the systemic exposure and safety of KX2-391 Ointment in adult subjects when applied to an area of skin containing at least 5 clinically typical, visible, and discrete Actinic Keratosis lesions on the face or balding scalp. Conditions: Actinic Keratoses Intervention / Treatment: DRUG: KX2-391 Ointment 1% 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: * Males and females >=18 years old. * Able to comprehend and are willing to sign an informed consent form (ICF). * At least 5 clinically typical, visible, and discrete AKs on 25 cm2 of the face or balding scalp. * Subjects who, in the judgment of the Investigator, are in good general health based on: 1. Medical history 2. Physical examination (PE) findings 3. ECG, clinical chemistry, hematology, and urinalysis results. * In the case of a female of childbearing potential, TKL will initiate two forms of birth control at Screening and that at least one had to be in place for 30 days prior (oral/implant/injectable/transdermal contraceptives, intrauterine device (IUD), condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes; * Females of childbearing potential, must agree to continue to use two methods of birth control for 30 days following the last dose of study treatment; * In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS); * In the case of sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment; * In the case of a female of non-childbearing potential, has had a hysterectomy or is postmenopausal (at least 2 years with no menses prior to enrollment); * All subjects must agree not to donate sperm or eggs or attempt conception from Screening through 90 days following their last dose of study treatment; * Willing to avoid direct sun or ultraviolet (UV) light exposure to the face or scalp. Exclusion Criteria: * Clinically atypical and/or rapidly changing AK lesions on the treatment area, e.g., hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on two previous occasions) and/or cutaneous horn. * Location of the treatment area: 1. Within 5 cm of an incompletely healed wound 2. Within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) * Been previously treated with KX2-391 ointment. * Has QTcF >450 ms for males and 470 ms for females or other relevant pathological changes in the ECG, in the opinion of the Investigation, at Screening. * Anticipated need for in-patient hospitalization or in-patient surgery during the study. * Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within 2 cm of the treatment area, within 8 weeks prior to the Screening visit. * Use of the following therapies and/or medications within 2 weeks prior to the Screening visit: 1. Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within 2 cm of the selected treatment area 2. Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within 2 cm of the selected treatment area 3. Topical salves (non-medicated/non-irritant lotion and cream are acceptable) or topical steroids within 2 cm of the selected treatment area; artificial tanners within 5 cm of the selected treatment area. * Use of the following therapies and/or medications within 4 weeks prior to the Screening visit: 1. Treatment with immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/interferon inducers 2. Treatment with systemic medications that suppress the immune system (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab) 3. Therapy/treatment with UVA or UVB. * Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit. * A history of sensitivity and/or allergy to any of the ingredients in the study medication. * A skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the subject to unacceptable risk by study participation. * Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would exposure the subject to unacceptable risk by study participation. * Females who are pregnant or nursing. * Participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives or the investigational product, whichever is longer, before dosing.

Study Objectives Standard treatment for locally advanced cancer of the rectum is preoperative chemoradiotherapy with 5-Fluorouracil (5-FU) plus 4 cycles of postoperative chemotherapy with 5-FU. According to our previous study (CAO/ARO/AIO-94, published in the New England Journal of Medicine 2004; 351:1731-40) this treatment results in only 6% of local failures, yet, still 36% of all patients develop distant metastasis. Therefore, our new study (CAO/ARO/AIO-04) incorporates new drugs, i.e. 5-FU + oxaliplatin, in an effort to improve the control of distant metastases. It is our hypothesis that the rate of disease free survival will improve by 5 to 8% after 3 years of follow-up. Conditions: Rectal Neoplasms Intervention / Treatment: DRUG: 5-FU and oxaliplatin, DRUG: 5-FU Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Minimum age: 18 years * Histologically proven, advanced primary carcinoma of the rectum (tumor ? 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease * No prior therapy except a diverting stoma * ECOG PS less than or equal 2 * Adequate bone marrow function: Leukocytes > 3,5 x 10^9/L Absolute neutrophil count > 1,5 x 10^9/L Platelet count > 100 x 10^9/L Hemoglobin > 10 g/dl * Adequate hepatic function: Total bilirubin < 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT < 3 x ULN 7. Serum creatinine < 1,5 mg/dl, creatinine-clearance > 50 ml/min * Written informed consent before randomization Exclusion Criteria: * Pregnant or breast feeding women * Fertile patients without adequate contraception during therapy * Past or ongoing drug abuse or alcoholic excess * Prior chemotherapy * Prior radiotherapy to the pelvis * Prior (within 4 weeks) or concurrent treatment with any other investigational agent * Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:* Central nervous system disorders or psychiatric disability including dementia or epileptic disease; * active uncontrolled intercurrent infections or sepsis * Peripheral neuropathy > 2 (NCI CTC AE grading) * Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator * Chronic diarrhea (> NCI CTC AE-Grad 1) * Known allergy to substances containing platinum compounds * Concurrent use of the antiviral agent sorivudine or chemically related analogues * Known deficiency of dehydropyrimidindehydrogenase (DPD)

Study Objectives The purpose of this study is to determine the clinical benefits of using a rapidly cycling, non-cross reactive regimen of FDA-approved prostate cancer therapeutic agents in the management of castration resistant prostate cancer. The hypothesis is that the identification of optimal combinations and sequencing of therapies can help prevent or delay the development of therapeutic drug resistance, and can be safely tolerated. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Abiraterone acetate, DRUG: Prednisone, DRUG: Radium-223 dichloride, DRUG: cabazitaxel, DRUG: Carboplatin, DRUG: Enzalutamide 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 or cytologically confirmed adenocarcinoma of the prostate * Metastatic castrate resistant prostate cancer, defined by progressive disease based on either rising PSA, new bone metastases, or progression of measurable disease on standard imaging, according to PCWG2 guidelines, despite androgen deprivation therapy * Ongoing androgen deprivation therapy with a GnRH analogue, GnRH antagonist, or bilateral orchiectomy * ECOG performance status 0-1 * Serum testosterone level < 50 ng/dL * Absolute neutrophil count > 1,500/μL, platelet count > 100,000/μL, and hemoglobin > 9 g/dL * Creatinine < 2 mg/dL * Total bilirubin < 1 times the upper limit of normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <= 1.5 times the upper limit of normal Exclusion Criteria: * History of uncontrolled seizure disorder * Clinically significant cardiovascular disease including: 1. Myocardial infarction or uncontrolled angina within 6 months 2. Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past 3. Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit * Have used or plan to use from 30 days prior to enrollment through the end of the study medication known to lower the seizure threshold or prolong the QT interval * Major surgery within 4 weeks of enrollment * Radiation therapy within 4 weeks of enrollment * Prior use of abiraterone acetate, enzalutamide, docetaxel, cabazitaxel, carboplatin, or radium-223 for the treatment of castration-resistant disease * Prior docetaxel use in the hormone-sensitive disease setting is allowed, but must be completed >= 4 weeks prior to enrollment * Prior sipuleucel-T use is allowed, but must be completed >= 4 weeks prior to enrollment * Concurrent use of zoledronic acid or denosumab is allowed on study

Study Objectives This multicenter, open-label, dose-escalating study will assess the safety, tolerability, and pharmacokinetics of DMOT4039A in participants with unresectable pancreatic or platinum-resistant ovarian cancer. Cohorts of participants will receive multiple ascending intravenous doses of DMOT4039A. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: DMOT4039A Location: United States, Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Histologically documented, incurable, locally advanced or metastatic disease for which no standard therapy exists, consisting of one of the following: Unresectable pancreatic ductal adenocarcinoma or platinum-resistant ovarian cancer * Measureable disease, defined as at least one bi-dimensionally measurable non-lymph node lesion greater than or equal to (>=) 1 centimeter (cm) in long-axis diameter on spiral computed tomography (CT) scan or at least one bi-dimensionally measurable lymph node measuring >= 1.5 cm in short-axis diameter on spiral CT scan * Adequate hematological, renal and liver function Exclusion Criteria: * Treatment with anti-tumor therapy, including chemotherapy, biologic, experimental or hormonal therapy, within 4 weeks prior to Day 1 * Known active infection * Current Grade >= 2 toxicity (except for alopecia, anorexia and fatigue) from prior therapy or Grade >= 2 neuropathy * Untreated or active cerebral nervous system metastases * Pregnant or breastfeeding women

Study Objectives This study investigates the safety/toxicity and potential anti-tumor activity of sequential administration of nivolumab and escalating doses of the mTOR inhibitor ABI-009 in advanced Ewing's sarcoma, PEComa, epithelioid sarcoma, desmoid tumor, chordoma, non-small cell lung cancer, small cell lung cancer, urethelial carcinoma, melanoma, renal cell carcinoma, squamous cell carcinoma of head and neck, hepatocellular carcinoma, classical Hodgkin's lymphoma, MSI-H/dMMR metastatic colorectal cancer, and tumors with genetic mutations sensitive to mTOR inhibitors Conditions: Ewing Sarcoma, PEComa, Epithelioid Sarcoma, Desmoid Tumor, Chordoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Melanoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Hepatocellular Carcinoma, Classical Hodgkin Lymphoma, Colorectal Cancer, MTOR Activating Mutation Intervention / Treatment: DRUG: Nab-Rapamycin, BIOLOGICAL: Nivolumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: A patient will be eligible for inclusion in this study only if all of the following criteria are met: * Patients must have a histologically confirmed diagnosis of Ewing's sarcoma, PEComa, epithelioid sarcoma, desmoid tumor, chordoma, non-small cell lung cancer, small cell lung cancer, urethelial carcinoma, melanoma, renal cell carcinoma, squamous cell carcinoma of head and neck, hepatocellular carcinoma, classical Hodgkin's lymphoma, MSI-H/dMMR metastatic colorectal cancer, and tumors with genetic mutations sensitive to mTOR inhibitors, that is either metastatic or locally advanced and for which surgery is not a recommended option. * Patients must have one or more measurable target lesions by CT scan or MRI. Measurable disease by RECIST v1.1. * Patients must not have been previously treated with a PD-1 inhibitor in combination with an mTOR inhibitor. * Prior treatment (investigational or other), chemotherapy, radiotherapy, surgery, or other therapeutic agents (except immunotherapy and mTOR inhibitors) is allowed, if completed after 5 half-lives or >=28 days prior to enrollment, whichever is shorter. * Eligible patients, >= 12 years, with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Patients must have the following blood chemistry levels at screening (obtained <=14 days prior to enrollment (local laboratory): 1. total bilirubin <=1.5 x upper limit of normal (ULN) mg/dl 2. AST <=2.5 x ULN (<=5 x ULN if attributable to liver metastases) 3. serum creatinine <=1.5 x ULN * Adequate biological parameters as demonstrated by the following blood counts at screening (obtained <=14 days prior to enrollment, local laboratory): 1. Absolute neutrophil count (ANC) >=1.5 × 109/L; 2. Platelet count >=100,000/mm3 (100 × 109/L); 3. Hemoglobin >=9 g/dL. * Serum triglyceride <300 mg/dL; serum cholesterol < 350 mg/dL. * Male or non-pregnant and non-breast feeding female: Females of child-bearing potential must agree to use effective contraception without interruption from 28 days xprior to starting IP and while on study medication and have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. A second form of birth control is required even if she has had a tubal ligation. Male patients must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study. A second form of birth control is required even if he has undergone a successful vasectomy. * Life expectancy of >3 months, as determined by the investigator. * Ability to understand and sign informed consent. * Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Exclusion Criteria: A patient will not be eligible for inclusion in this study if any of the following criteria apply: * Concurrent or prior immunotherapy with a PD-1 inhibitor in combination with an mTOr inhibitor. * Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A patient with controlled and asymptomatic CNS metastases may participate in this study. As such, the patient must have completed any prior treatment for CNS metastases >=28 days (including radiotherapy and/or surgery) prior to start of treatment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases. * Active gastrointestinal bleeding. * Pre-existing thyroid abnormality is allowed provided thyroid function can be controlled with medication. * Uncontrolled serious medical or psychiatric illness. Patients with a "currently active" second malignancy other than non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pT2 with Gleason Score <= 6 and postoperative PSA <0.5 ng/mL), or other adequately treated carcinoma-in-situ are ineligible. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >=1 year). * Liver-directed therapy within 2 months of enrollment. Prior treatment with radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial embolization (with or without chemotherapy) or cyrotherapy/ablation) is allowed if these therapies did not affect the areas of measurable disease being used for this protocol. * Recent infection requiring systemic anti-infective treatment that was completed <=14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection). * Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy. * Unstable coronary artery disease or myocardial infarction during preceding 6 months. * Receiving any concomitant antitumor therapy. * Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension. * Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to receiving the first dose of ABI-009. * Known Human Immunodeficiency Virus (HIV). * Active Hepatitis B or Hepatitis C. * Non-oncology vaccine therapy used for prevention of infectious disease within 4 weeks of trial enrollment * Autoimmune disease including rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis and motor neuropathy considered to be of autoimmune origin (e.g. Guillain-Barre Syndrome) * Systemic immunosuppression, including HIV positive status with or without AIDS * Skin rash (psoriasis, eczema) affecting > 25% body surface area * Inflammatory bowel disease (Crohn's or ulcerative colitis) * Ongoing or uncontrolled diarrhea within 4 weeks of trial enrollment * Recent history of acute diverticulitis, intraabdominal abscess or gastrointestinal obstruction within 6 months of trial enrollment, which are known risk factors for bowel perforation * Current, active or previous history of heavy alcohol abuse * Pituitary endocrinopathy * Adrenal insufficiency or excess

Study Objectives Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions. Conditions: Hepatocellular Carcinoma Intervention / Treatment: DRUG: Sorafenib (Nexavar, BAY43-9006) Location: Italy Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made * Patients must have signed the informed consent form * Patients must have a life expectancy of at least 8 weeks Inclusion criteria must follow the approved local product information. Exclusion Criteria: * Prior treatment with sorafenib * Concomitant participation in other clinical studies Exclusion criteria must follow the approved local product information.

Study Objectives This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer. Conditions: Pancreatic Neoplasms Intervention / Treatment: DRUG: nab-Paclitaxel, DRUG: Gemcitabine, DRUG: Chemoradiation, DRUG: Capecitabine, PROCEDURE: Surgery Location: Canada, Italy, Spain, United States, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients * No prior anticancer therapy for pancreatic cancer *>= 18 years of age with a performance status of 0 or 1 *Adequate complete blood counts, hepatic function, and renal function * Signed informed Consent Exclusion Criteria: * Active bacterial, viral, or fungal infection * Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive * Subjects with sensory neuropathy, ascites, or plastic biliary stent. * Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders) * Women who are pregnant or breast feeding