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Study Objectives Primary Objective: To determine the efficacy (as assessed by progression-free survival \[PFS\]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine therapy. Secondary Objectives: * To determine the efficacy of vandetanib when compared to placebo in this participant population as assessed by efficacy variables including duration of response (DOR), objective response rate (ORR), change in tumour size (TS) and overall survival (OS). * To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and potentially investigate any influence of participant demography and pathophysiology on vandetanib PK. * To demonstrate an improvement in time to worsening of pain (TWP) in participants treated with vandetanib when compared to placebo in this participant population. * To evaluate the safety and tolerability of vandetanib treatment in this participant population. Conditions: Differentiated Thyroid Cancer Intervention / Treatment: DRUG: Vandetanib (SAR390530), DRUG: Placebo Location: Japan, Italy, Brazil, Spain, Denmark, United States, China, Czechia, Russian Federation, Sweden, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Provision of informed consent to participate in the study as well as provision of informed consent to provide a sample of a previously obtained archival tumour biopsy. * Female or male aged 18 years and older with previously confirmed histological diagnosis of locally advanced or metastatic differentiated (excluding minimally invasive follicular) thyroid cancer not amenable to surgical resection, external beam radiotherapy or local therapy. * Measurable disease defined as at least one lesion, not irradiated within 12 weeks of the date of randomisation, that can be accurately measured at baseline. * Participants must have experienced progression within 14 months and be RAI-refractory/resistant or unsuitable for RAI. * Thyroid-stimulating hormone (TSH) suppression below 0.5 mU/L is required. * World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2. * Negative pregnancy test (urine or serum) for female participants of childbearing potential. Exclusion Criteria: * Inadequate organ function as defined by: (1) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 x upper limit of normal (ULN), or greater than 5.0 x ULN if judged by the Investigator to be related to liver metastases. (2) Serum bilirubin greater than 1.5 x ULN. This criterion does not apply to participants with known Gilbert's Disease. (3) Creatinine clearance <50 mL/min (calculated by Cockcroft-Gault formula). * Risk of prolonged interval between Q and T (QT) on an electrocardiogram (ECG) corrected for heart rate (QTc) as defined by: (1) Current therapy with any medication known to be associated with Torsades de pointes or potent inducers of cytochrome CYP3A4. (2) History of QT prolongation. (3) Congenital long QT syndrome. (4) QT interval corrected for heart rate by the Bazett's method (QTcB) correction unmeasurable or greater than 480 ms on screening ECG. * Previous therapy with approved or investigational tyrosine kinase or anti- vascular endothelial growth factor (VEGF) receptor inhibitors or targeted therapies (e.g. multi-targeted kinase inhibitors such as sorafenib, AMG-706, sunitinib, pazopanib, lenvatinib). * RAI therapy within 12 weeks prior to first dose of study drug, and radiation therapy other than RAI, including external beam, if not completed prior to randomization.

Study Objectives The purpose of this study is to evaluate progression-free survival in participants with gastric or gastroesophageal junction cancer who have had disease progression following first-line therapy who undergo treatment with ramucirumab. Conditions: Gastric Cancer Intervention / Treatment: DRUG: Ramucirumab Location: Japan 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 gastric carcinoma, including gastric adenocarcinoma or Gastroesophageal Junction (GEJ) adenocarcinoma * Metastatic disease or locally recurrent, unresectable disease * Measurable disease and/or evaluable disease * Experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy * Life expectancy of at least 3 months * Resolution to Grade less than or equal to 1 by the National Cancer Institute Common Terminology Criteria for Adverse , Version 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy * Eastern Cooperative Oncology Group performance status score of 0-1 * Has adequate organ function * Must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods), if sexually active * Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment Exclusion Criteria: * Documented and/or symptomatic brain or leptomeningeal metastases * Bone metastases * Experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment * Experienced any arterial thromboembolic event within 6 months prior to enrollment * Ongoing or active significant infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thromboembolic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator * Ongoing or active psychiatric illness or social situation that would limit compliance with study requirements * Blood pressure in abnormal range despite standard medical management * Has a serious or nonhealing wound, ulcer, or bone fracture * Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer * Received any investigational therapy within 30 days prior to enrollment * Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment * Received prior therapy with an agent that directly inhibits vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor 2 (VEGFR-2) activity (including bevacizumab), or any anti-angiogenic agent * Receiving chronic therapy with nonsteroidal anti-inflammatory drugs or receiving other antiplatelet agents. Aspirin use at doses up to 325 milligrams per day is permitted * Has elective or planned major surgery to be performed during the course of the clinical study * Has a known allergy to any of the treatment components * Pregnant or breastfeeding * Have positive test results for human immunodeficiency virus, hepatitis B, or hepatitis C antibodies * Known alcohol or drug dependency * Previous or concurrent malignancy except for basal or squamous cell skin cancer (nonmelanoma) and/or pre-invasive carcinoma of the cervix, mucosal gastrointestinal or uterine carcinoma, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to enrollment * Currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Study Objectives The objective of this study will be to investigate the safety and tolerability of AZD6244 given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following the combination regimen dose escalation phase (Part A) of the study additional patients may be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population. Conditions: Neoplasms,, Metastatic Cancer,, Non-Small Cell Lung Cancer, Advanced Solid Malignancies Intervention / Treatment: DRUG: AZD6244 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients diagnosed with lung cancer who have not responded to prior therapy or have become worse. * Patients who have overall good general conditions. * Patients who have at least one lesion that can be accurately assessed by imaging. * Patients who have appropriate renal conditions confirmed by test results for taking part in the study. * Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status. Exclusion Criteria: * Patients with brain metastases or spinal cord compression. * Patients with significant abnormal ECG findings. * Patients with evidence of severe or uncontrolled systemic disease. * The main organ functional test values for bone marrow, kidney, and liver, etc., do not meet the standards. * Patients with known hypersensitivity to docetaxel or products containing polysorbate 80. Only for monotherapy cohort eligibility criteria Patients with advanced solid malignancies refractory to standard treatment or for which no standard therapy exists irrespective of the stage and previous treatment. Patients with histologically or cytologically confirmed advanced solid malignancies.

Study Objectives This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women. Conditions: Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection Intervention / Treatment: BIOLOGICAL: V503 Location: Finland, Germany, Italy, Spain, Belgium, Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * good physical health Exclusion Criteria: * history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results * history of HPV-related condition * history of known prior vaccination with an HPV vaccine * pregnant * user of recreational or illicit drugs * history of severe allergic reaction, including known allergy to any vaccine component * immunocompromised * history of certain medications or is currently taking or has taken certain medications (details will be discussed at the time of consent) * has thrombocytopenia or other coagulation disorder * concurrently enrolled in a clinical study of investigational agent

Study Objectives The primary objectives of this study is to assess the safety and tolerability of intravenously (i.v.) administered 186 Rhenium-isotope (186Re)-labelled bivatuzumab and to investigate the biodistribution and pharmacokinetics of 186 Re-labelled bivatuzumab in patients with non-small cell lung cancer (NSCLC) Conditions: Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: hMAb BIWA 4 Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histological or cytological confirmation of Non small cell lung cancer (NSCLC) stage I, II or IIIa according to the staging system of the American Joint Committee on Cancer (AJCC) * Patients destined for resection of the tumour * Patients over 18 years of age * Patients younger than 80 years of age * Patients who had given 'written informed consent' * Patients with a life expectancy of at least 3 months * Patients with a good performance status: Karnofsky > 60 Exclusion Criteria: * Life-threatening infection, allergic diathesis, organ failure (bilirubin > 30µmol/l and/or creatinine > 150 µmol/l) or evidence of a recent myocardial infarction on Electrocardiogram (ECG) or unstable angina pectoris * Pre-menopausal women (last menstruation <= 1 year prior to study start) * Not surgically sterile (hysterectomy, tubal ligation) and * Not practicing acceptable means of birth control, (or not planned to be continued throughout the study). Acceptable methods of birth control include oral, implantable or injectable contraceptives * Women with a positive serum pregnancy test at baseline * White blood cell count < 3000/mm³, granulocyte count < 1500/mm³ or platelet count < 100000/mm³. Details of prior chemotherapy and radiotherapy had to be known. * Hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy

Study Objectives The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Lenalidomide, DRUG: Dexamethasone, DRUG: Dexamethasone, DRUG: Dexamethasone, BIOLOGICAL: Elotuzumab (BMS-901608; HuLuc63) 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: * Subjects with Multiple Myeloma (MM) and renal function fitting one of three categories: 1. Severe renal impairment: estimated creatinine clearance (CrCl) <30 ml/min, but not requiring dialysis 2. End-stage renal disease: requiring hemodialysis 3. Normal renal function: estimated CrCl >=90 ml/min * Documented evidence of symptomatic MM, either newly diagnosed or relapsed/refractory * Prior Lenalidomide exposure is permitted only if the subject did not discontinue Lenalidomide due to a Grade >=3 related Adverse Event (AE) Exclusion Criteria: * Monoclonal Gammopathy of Undetermined Significance (MGUS), Waldenstrom's macroglobulinemia, or smoldering myeloma * Active plasma cell leukemia * All adverse events of any prior chemotherapy, surgery, or radiotherapy not resolved * POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * Acute renal failure

Study Objectives This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients with advanced, non-small cell lung cancer. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DRUG: Imatinib mesylate, DRUG: Paclitaxel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age >= 70 years * Histologic or cytologic diagnosis of non-small cell lung cancer * At least one site of measurable disease, as defined by the modified RECIST criteria (See section 7.6) * Stage IIIB with pleural effusion or Stage IV disease. Includes patients who received surgery alone for early stage disease, now in relapse with advanced disease. Staging is according to the American Joint Committee on Cancer classification scheme, 6th edition.48 * Adequate hepatic, renal and marrow function * Liver function tests: total bilirubin < 1.25 x upper limit of normal (ULN), AST and ALT < 2.5 x ULN, Creatinine < 1.5 x ULN * Baseline absolute neutrophil count > 1500/μL * Baseline platelet count > 100,000/μL * ECOG Performance Status 0, 1 or 2 at the time of informed consent. (See Appendix 1) * Written, voluntary consent * Patients with reproductive potential must use an acceptable contraceptive method. Such methods include: 1) Male hormonal contraception; 2) Partner without reproductive potential, including post-menopausal status or history of tubal ligation; 3) Partner with intrauterine device (IUD) or contraceptive vaginal ring; 4) Partner takes oral contraceptive pill, wears contraceptive patch, or has contraceptive implant; 5) Routine use of barrier method, such as condoms or diaphragm, during sexual intercourse. Exclusion Criteria: Uncontrolled brain metastasis. Patients with known brain metastasis must have completed treatment with surgery, radiation or both. In addition, they must be off corticosteroids. * Symptomatic neuropathy (Grade 2 or higher) * Prior chemotherapy for advanced non-small cell lung cancer. (Prior adjuvant, neoadjuvant, or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence.) * Patient is < 5 years free of another primary malignancy, except: a) if the other malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other primary malignancy is not considered clinically significant and is requiring no active intervention * Prior radiation therapy to > 25% of bone marrow * Grade III/IV congestive heart failure, as defined by NYHA criteria, or myocardial infarction within 6 months. * Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study. * Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis or cirrhosis. * Major surgery two weeks prior to study treatment * Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent * Any condition requiring continuous administration of systemic corticosteroids. * The patient is on therapeutic anti-coagulation with warfarin.

Study Objectives Pancreatic cancer represents the most lethal of the common malignancies with a 5-year survival rate of less than 5%. For patients who are eligible for potentially curative resection, despite mortality and morbidity rates after surgery have improved, the recurrence rate is up to 85% within 2 years. Data from clinical trials indicate that adjuvant chemotherapy enhances 5-year survival to \~25% for patients who have undergone surgery to remove their tumor; and gemcitabine is the standard regimen of chemotherapy. Metformin is the first-line treatment for type 2 diabetes mellitus. Literatures reported that metformin might inhibit tumor growth by blocking some enzymes needed for cell growth. Some retrospective studies have revealed that diabetic patients taking metformin were less likely to develop pancreatic cancer. Additionally, pancreatic cancer patients treated with metformin showed a better survival than those without metformin. In this study, the researchers intend to investigate the activity and safety of the combination of gemcitabine and metformin in treating patients with pancreatic cancer that have removed by surgery. Conditions: Stage IA Pancreatic Adenocarcinoma, Stage IB Pancreatic Adenocarcinoma, Stage IIA Pancreatic Adenocarcinoma, Stage IIB Pancreatic Adenocarcinoma Intervention / Treatment: DRUG: Gemcitabine, DRUG: Metformin, DRUG: placebo Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Signed informed content obtained prior to treatment * Age >= 18 years and <= 80 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patients must have histologically confirmed pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant) after curative resection (R0). The pathological staging does not exceed the stage IIB. * No tumor lesions are seen by abdominal and thoracic CT scan 4~8 weeks after surgery, and no serious adverse events are occurred during this period * The expected survival after surgery >= 6 months * White blood cell (WBC) >= 3 × 10^9/L; Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelets (PLT) >= 100 × 10^9/L; Hemoglobin (Hgb) >= 9 g/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) <= 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) <= ULN; Creatinine (CRE) <= 1.5 × ULN * Prothrombin time (PT) and international normalized ratio (INR) <= 1.5 × ULN * Patients with diabetes (diagnosed after surgery) are eligible for this trial; all diabetic patients who are enrolled on this study should discuss the need to change their diabetes management regimen with their primary care physician or endocrinologist prior to enrollment * Diabetic patients who are on metformin are eligible as long as they have been on metformin for less than 6 months (estimated 6 months or less duration of metformin therapy from start of metformin to enrollment on study) Exclusion Criteria: * Active second primary malignancy or history of second primary malignancy within the last 3 years * Patients who have received any form of anti-tumor therapy before surgery, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy * Use of any other investigational agents * Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, internal hemorrhage, pancreatic leakage, bile leakage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * History of allergic reactions attributed to compounds of similar chemical or biological composition to metformin or gemcitabine * Current use of metformin for more than 6 months prior to enrollment on study * Metabolic acidosis, acute or chronic, including ketoacidosis * Pregnant or nursing women * Human immunodeficiency virus (HIV)-positive patients * Patients who are unwilling or unable to comply with study procedures

Study Objectives Metastatic pheochromocytoma / paraganglioma (MPP) are rare while the prognosis was poor. Temozolomide (TMZ) is a novel oral alkylation chemotherapeutic agent. TMZ has been recommended in National Comprehensive Cancer Network (NCCN) Guidelines Version 1.2019 for treating MPP patients.However, studies investigating TMZ efficacy in MPP patients are extremely limited. The largest study involved only 15 patients till date. The safety and efficacy of TMZ treatment in MPP patients need to be verified in larger studies. Conditions: Pheochromocytoma, Metastatic, Paraganglioma, Malignant, Pheochromocytoma Malignant Intervention / Treatment: DRUG: Temozolomide capsule Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Patients with metastatic pheochromocytomas and paragangliomas. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Estimated life expectancy longer than 6 months. Having normal organ function as defined by hemoglobin levels >=10 g/dL, absolute neutrophil count >= 1.5 x 109/L, platelet count >= 80 x 109/L, total bilirubin <=1.5 institutional upper limit, aspartate aminotransferase <=5 institutional upper limit, alanine aminotransferase <=5 institutional upper limit, and serum creatinine <3.0 mg/dL. Exclusion Criteria: Didn't meet eligibility for organ function. Pregnancy or breastfeeding. Uncontrolled congestive heart failure and severe infection.

Study Objectives Phase II single arm, open label, nonrandomized study. The aim of our study is to assess the Progression Free Survival (PFS) in suboptimally cytoreduced epithelial ovarian/ primary peritoneal/ fallopian tube cancer patients treated with the novel combination of carboplatin every 21 days (triweekly) /weekly paclitaxel IV with pembrolizumab IV followed by maintenance pembrolizumab IV. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Pembrolizumab, DRUG: Carboplatin, DRUG: Paclitaxel 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: * Have advance stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer * Be willing and able to provide written informed consent/assent for the trial. * Be 18 years of age or older on day of signing informed consent. * Suboptimal cytoreductive surgery defined as any residual disease noted per operative report and/or have measurable/macroscopic disease (defined as target and/or non-target lesions) based on RECIST 1.1. * Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor. * Have a performance status of 0, 1 or 2 on the ECOG Performance Scale. * Demonstrate adequate organ function * All screening labs should be performed within 28 days of treatment initiation. * Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. * Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Exclusion Criteria: * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. * Has a known history of active TB (Bacillus Tuberculosis) * Hypersensitivity to pembrolizumab or any of its excipients. * Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent. * Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Has a known additional malignancy within the last 3 years, or that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Has an active infection requiring systemic therapy. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study. The investigator should consult the Study Chair. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive 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 received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). * Patients with borderline ovarian tumors, recurrent epithelial ovarian/ primary peritoneal cancer/fallopian tube cancer or non-epithelial ovarian cancer are not eligible. * Has received a live vaccine within 30 days of planned start of study therapy.

Study Objectives The purpose of this study is to obtain an estimate of the biochemical response rate as determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma. CA125 response is defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days after initial evaluation (baseline is defined as the higher value of 2 pre-treatment CA125 assessments). Conditions: Ovarian Epithelial Carcinoma Intervention / Treatment: DRUG: PD0332991 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma. * 2. Baseline paraffin embedded tissue from the patient's primary diagnosis is requested before study enrolment and should be forwarded to the designated central laboratory where central assessment of Rb and p16 expression will be performed by using immunohistochemistry. In patients with measurable disease a tissue biopsy may be obtained by core biopsy and submitted to the designated central laboratory. * GCIG-defined CA125 progression and absence of disease upon imaging or small-volume asymptomatic disease upon imaging and who have progressed following one, two or three lines of chemotherapy for recurrent disease. * If patients have small-volume disease the current study will be restricted to patients with minimal ascites not causing abdominal distention/mesenteric thickening or not requiring paracentesis, or lesions <=4 cm by spiral computed tomography [CT] or magnetic resonance imaging [MRI] at baseline. * Two pretreatment CA125 values (documented on two occasions taken at least one week apart) must be at least twice the upper limit of normal, or twice the nadir value if pretreatment CA125 values never normalized. * Patients with platinum-sensitive or platinum-resistant disease defined by recurrence or progression of disease > 6 months or <= than 6 months after completion of frontline platinum based chemotherapy. * ECOG performance status <= 1 and patients are to be >=21 years of age. * Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE v.3.0 Grade <= 1 and to baseline laboratory values as defined in the inclusion criterion immediately below. * Adequate organ and bone marrow function as evidenced by: * hemoglobin >= 9.0 g/dL * absolute neutrophil count >= 1.5 x 109/L * platelet count >= 100 x 109/L * Renal function, as follows: * Serum creatinine <= 1.5 x the ULN or calculated creatinine clearance >= 40 mL/min * AST and ALT <= 2.5 x ULN * total bilirubin <= 1.5 x ULN unless increase is due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin, * Adequate coagulation parameters (within 21 days prior to registration), International Normalized Ratio (INR) <=1.5; Activated ProThrombin Time (APTT) <= 1.5 x ULN. * Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. * Informed consent must be obtained in writing for all patients prior to performing study/screening procedures and prior to registration into the study. Exclusion Criteria Patients presenting with any of the following will not be included in the study: * More than 4 prior chemotherapy regimens in the treatment of ovarian cancer. * Anticipation of immediate need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the trial. * Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri or breast. * Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks of trial enrolment. * Any of the following within 6 months prior to trial registration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event. PD0332991 in Recurrent Ovarian Cancer * History of brain metastases, spinal cord compression, or carcinomatous meningitis. * Patient of child-bearing potential is evidently pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding. A woman with child bearing potential is defined as not surgically sterile or being post-menopausal for less than 6 months. * Patient of child-bearing potential is not willing to use adequate contraceptive precautions. Adequate effective method of contraception are those which result in low failure rates, less than 1% per year, such as non-hormonal IUD, condoms, sexual abstinence or vasectomised partner. * Known active infection, or on antiretroviral therapy for HIV disease or positive test for chronic hepatitis B or C infection. * Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the trial. * Refusal or inability to give informed consent to participate in the trial. * Corrected QT (QTc) interval >470 msec. * If radiotherapy is required in a given patient, that patient should be withdrawn from the study. * Current use or anticipated need for: Food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine. * Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial.

Study Objectives This phase I/II trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy and chemotherapy. Drugs used in chemotherapy, such as ixabepilone, mitoxantrone hydrochloride, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells Conditions: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer Intervention / Treatment: DRUG: mitoxantrone hydrochloride, DRUG: ixabepilone, DRUG: prednisone Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Progressive metastatic disease (i.e., positive bone scan or measurable disease) despite castrate levels of testosterone (either from orchiectomy or luteinizing hormone-releasing hormone [LHRH] agonist therapy) * Progressive disease after discontinuing hormonal therapy * Progressive disease is based on any of the following*: * Transaxial imaging * Rise in prostate-specific antigen (PSA) * Radionuclide bone scan (must show new metastatic lesions) * Nonmeasurable or measurable disease * For measurable disease, progression is defined by RECIST criteria * Positive bone scan and elevated PSA required for nonmeasurable disease * PSA evidence of progressive prostate cancer during or after first-line chemotherapy consists of a PSA level >= 2 ng/mL that has risen on >= 2 successive occasions >= 1 week apart * Received >= 3 prior courses of paclitaxel- or docetaxel-based therapy, with disease progression documented during therapy or after cessation of therapy * No more than 1 prior chemotherapy regimen * Re-treatment with the same taxane-based regimen allowed * Changes in prior chemotherapy regimen (addition of other agents) for disease progression are considered 2 chemotherapy regimens, and are not allowed * PSA >= 2 ng/mL * Testosterone < 50 ng/dL * Patients must continue primary androgen deprivation with LHRH analogue if they have not undergone orchiectomy * No known active brain metastases * ECOG performance status 0-2 * Life expectancy >= 12 weeks * Creatinine <= 1.5 times upper limit of normal (ULN) OR creatinine clearance > 40 mL/min * ALT and AST < 2.5 times ULN * Granulocyte count >= 2,000/mm³ * Platelet count >= 100,000/mm³ * Bilirubin < 1.5 times ULN * Ejection fraction normal by MUGA scan or echocardiogram * No significant cardiovascular disease, including any of the following: * Congestive heart failure (New York Heart Association class III-IV heart disease) * Active angina pectoris * Myocardial infarction within the past 6 months * No serious infections or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by study therapy * No psychiatric illness or social situation that would preclude study compliance * No pre-existing motor or sensory peripheral neuropathy > grade 1 * No known prior severe hypersensitivity reactions to agents containing Cremophor® EL * No "currently active" second malignancy other than nonmelanoma skin cancer * Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered to be at < 30% risk of relapse * Fertile patients must use effective contraception prior to, during, and for 3 months after completion of study treatment * See Disease Characteristics * No prior mitoxantrone hydrochloride, ixabepilone, or other epothilones * At least 4 weeks since prior hormonal therapy (i.e., any dose of megestrol, finasteride, or any herbal product known to decrease PSA levels [e.g., saw palmetto or PC-SPES]) other than LHRH agonist or a stable dose of corticosteroids from a prior chemotherapy regimen * More than 4 weeks since other prior systemic therapies for prostate cancer * At least 4 weeks since prior radiation therapy * More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) * No concurrent moderate to strong CYP3A4 inhibitors * No concurrent prophylactic colony-stimulating factors * No concurrent radiotherapy

Study Objectives RATIONALE: Nerve-sparing radical prostatectomy with nerve grafting followed by standard therapies for erectile dysfunction may be effective in helping patients with prostate cancer improve sexual satisfaction and quality of life. It is not yet known whether erectile dysfunction therapy and nerve-sparing prostatectomy are more effective with or without nerve grafting. PURPOSE: This randomized phase II trial is studying nerve grafting and standard therapy to see how well they work compared to standard therapy alone in treating erectile dysfunction in patients undergoing nerve-sparing radical prostatectomy for localized prostate cancer. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Alprostadil (E1), DRUG: Papaverine, DRUG: Phentolamine mesylate, DRUG: Sildenafil citrate, PROCEDURE: conventional surgery Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient must be a candidate for a unilateral nerve sparing radical retropubic prostatectomy. a) Gleason score 7 or less in the cores on the side to be spared * Patient must have no discernable preoperative erectile dysfunction, defined as the ability to have successful penetration on at least 75% of attempts. * Patient must be <= 65 years of age at the time of study enrollment. * Patient must have no peripheral neuropathy precluding procurement of a sural nerve graft * Patient must have no significant psychiatric illness or demonstrable vasculogenic source of impotence. * No prior history of pelvic irradiation or androgen deprivation therapy (LHRH agonists or anti-androgens) Exclusion Criteria:

Study Objectives The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between diagnosis and radical cystectomy (RC). Conditions: Urinary Bladder Cancer Intervention / Treatment: DRUG: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 Location: United States, Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Histological proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-III). Subjects with evidence of metastatic nodal disease to the obuturator or presacral lymph nodes only may be included (N1 M0). Subjects with any degree of fixation of the pelvic sidewall are not eligible. * In Arm 1, subjects must have residual visible tumor following TURBT. In Arm 2, subjects must be fully resected (i.e., no visible tumor or as little tumor as possible) after restaging TURBT 2-6 weeks prior to Study Day 0. * Adequate bone marrow, liver, and renal function, as assessed by the following requirements conducted within 21 days prior to dosing: 1. Hemoglobin >= 9.0 g/dL 2. Absolute neutrophil count (ANC) >= 1,500/mm3 3. Platelet count >= 100,000/mm3 4. Total bilirubin <= 1.5xULN (upper limit of normal) 5. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) <= 2.5xULN 6. Glomerular Filtration Rate (GFR) >= 30% (>= 30 ml/min/1.73 m2) * Subjects must be willing to undergo a cystoscopy on study for investigational product removal. * Eligible for and willing to undergo RC per the attending urologist. * Subjects must be deemed ineligible for cisplatin-based combination chemotherapy by the attending medical oncologist. * Subjects medically eligible for neoadjuvant cisplatin-based combination chemotherapy who refuse this therapeutic option and understand the risks and benefits of doing so. * Prior radiation therapy is allowed provided that no radiation therapy was administered to the urinary bladder. * Written informed consent and Health Insurance Portability and Accountability Act of 1966 (HIPAA) authorization for release of personal health information. * Age > 18 years at the time of consent. Exclusion Criteria: * Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome. * Prior systemic chemotherapy for transitional cell carcinoma of the bladder. Any other prior systemic chemotherapy for a non-urothelial carcinoma must have been completed > 5 years prior to initiation of study. * Previous exposure to gemcitabine instillations. * Currently receiving other intravesical chemotherapy. * Concurrent clinically significant infections as determined by the treating investigator. * Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use or removal of TAR-200. * Documented history of vesicoureteral reflux or the presence of an indwelling ureteral stent or nephrostomy tube at the time of screening. * Pelvic radiotherapy administered within less than 6 months prior to enrollment. Subjects who received radiotherapy >= 6 months prior to enrollment must demonstrate no cystoscopic evidence or symptoms of radiation cystitis. * Bladder Post-Void Residual Volume (PVR) of > 250-mL. * Active, uncontrolled urogenital bacterial, viral or fungal infections, including urinary tract infection that in the opinion of the investigator, contraindicates participation. Skin/nail fungal infections are not exclusionary. Subjects with active shingles (varicella zoster infection) will be excluded from the study. * History or presence of any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, gynecological, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder that, in the opinion of the investigator, contraindicates participation. * History of diagnosis of neurogenic bladder. * Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors, within 2 weeks of Study Day 0, exclusive of steroid doses <= 5 mg daily. * Difficulty providing blood samples. * Unwilling or unable to provide informed consent or comply with the requirements of this protocol, including the presence of any condition (physical, mental or social) that is likely to affect the subject's return for scheduled visits and follow-up. * Other unspecified reasons that, in the opinion of the investigator or TARIS, make the subject unsuitable for enrollment.

Study Objectives This study will examine the extent to which lower doses of a broccoli-derived beverage enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose shown to be effective previously. Conditions: Environmental Carcinogenesis Intervention / Treatment: DRUG: Broccoli Sprout-derived Beverage, DRUG: Placebos Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * in good general health with no history of chronic illness * normal liver function tests * normal renal function tests Exclusion Criteria: * personal history of cancer except for non-melanoma skin cancer * use of prescribed medicines * for women, a positive pregnancy test

Study Objectives This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally twice per week, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy dose not exist. Conditions: Advanced Solid Tumors Intervention / Treatment: DRUG: Gimatecan Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria * Patients with histological or cytological confirmed advanced solid tumors, which progressed despite standard therapy or for whom no standard therapy exists * Life expectancy of at least 3 months * No dysfunction of bone marrow * No major impairment of renal and hepatic function Exclusion criteria * Gastrointestinal dysfunction, such as gastrectomy or malabsorption syndrome, that could alter absorption of the study drug * Receipt of any investigational compound within the 28 days prior to the first dose of study drug, or failure to recover from the side effects of such prior therapy * Receipt of other antineoplastic therapy including chemotherapy, hormone therapy, immunotherapy, radiation therapy within the 28 days * Patients known to be HIV, or hepatitis B or C viruses positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection * Patients with a history of allergies to the camptothecin family of drugs Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives This observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months. Conditions: Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: Afatinib Location: Germany Study Design and Phases Study Type: OBSERVATIONAL

Inclusion criteria: * EGFR- tyrosine kinase inhibitor (TKI) naive patients with histologically confirmed locally advanced or metastatic NSCLC with activating EGFR-mutations * Age >= 18 years * No diagnostic or therapeutic measures beyond routine clinical practice are required * Patients for whom the treating physician has decided to initiate treatment with GIOTRIF * Written informed consent prior inclusion Exclusion criteria: * Contraindication for Afatinib according to the Summary of Product characteristics * Participation in another clinical study until 30 days after end of treatment * Prior systemic chemotherapy (Neo-/adjuvant therapy is permitted) * Previous treatment with an EGFR-tyrosine kinase inhibitor * Patients not willing or not able to fill in quality of life questionnaires * Patients with missing or impaired legal capacity * Pregnancy

Study Objectives To assess the efficacy and safety of salvage tratment with Gemcitabine and S-1 Combination in metastatic colorectal cancer Conditions: Advanced Colorectal Cancer Intervention / Treatment: DRUG: Gemcitabine/S-1 Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * non resectable colorectal adenocarcinoma. * disease progression during or within 6months after treatment with irinotecan and oxaliplatin contaning regimens. * estimated life expectancy of more than 3 months. * ECOG status 2 or lower Exclusion Criteria: * other tumor type than adenoarcinoma. * presence or history of CNS metastasis. * evidence of gastrointestinal bleeding.

Study Objectives The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of the phase I portion of this trial is to find out the highest dose of cetuximab that can be taken together with erlotinib. This study will also give an idea of how well cetuximab shrinks lung cancer when given with erlotinib. The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib or gefitinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of this phase is to determine if cetuximab given with erlotinib causes lung cancers to shrink in size. Conditions: Lung Adenocarcinoma Intervention / Treatment: DRUG: erlotinib with cetuximab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Pathologic evidence of lung adenocarcinoma confirmed at MSKCC * Measurable (RECIST) indicator lesions not previously irradiated * Radiographic progression by RECIST during treatment with erlotinib * Received treatment with erlotinib throughout the one month prior to enrollment * Received treatment with erlotinib for >3 months * At least one of the following: * Previously received treatment with erlotinib, gefitinib, or an investigational EGFR TK inhibitor (patients may have received other treatments subsequently including radiation or chemotherapy) and had a radiographic partial or complete response to treatment as defined by RECIST criteria * A documented mutation in EGFR exons 19 or 21. * Karnofsky performance status >= or = to 70% * Total bilirubin: within normal institutional limits. AST/(SGOT)/ALT(SGPT)< or = to 2.5 X institutional upper limit of normal (ULN) * Signed informed consent * Effective contraception * * Age > 18 years old *Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control. All WOCBP MUST have a negative pregnancy test within two weeks prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study. In addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation. The Investigator must immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study. Exclusion Criteria: * CNS lesions which are symptomatic and/or requiring escalating doses of corticosteroids. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Prior cetuximab or panitumumab. Prior severe infusion reaction to a monoclonal antibody. * Current grade 2 or greater skin toxicity on erlotinib therapy * Radiotherapy <= or = to 14 days prior to enrollment * Any investigational agent or therapy <= or = to 30 days before enrollment * Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (except erlotinib) <= or = to 30 days before enrollment * Women who are pregnant or lactating. * Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection * Major surgery within 28 days or minor surgery within 14 days of study enrollment * Men or women of child-bearing potential (women who are post-menopausal < 52 weeks, not surgically sterilized, or not abstinent) not consenting to use adequate contraception (per institutional standard of care) during the course of the study and after the last investigational product(s) administration (24 weeks for women, 4 weeks for men)

Study Objectives This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212. Conditions: Melanoma Intervention / Treatment: DRUG: GSK1120212, DRUG: Chemotherapy Location: Canada, United States, Greece, Austria, Czechia, France, Poland, Italy, Ukraine, United Kingdom, Russian Federation, Belgium, Sweden, Norway, Germany, New Zealand, Switzerland, Australia, Argentina Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * >=18 years of age * Stage III unresectable (Stage IIIc) or metastatic (Stage IV) cutaneous melanoma which is also determined to be BRAF V600E/K mutation-positive by the central laboratory * Received no prior treatment or up to one prior regimen of chemotherapy for advanced or metastatic melanoma. Prior treatment with immunotherapy (with the exception of prior ipilimumab, which is only allowed if given in the adjuvant setting), cytokine therapy, biological or vaccine regimen is permitted. Prior use of sorafenib is allowed * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) * Women of childbearing potential and men with reproductive potential must agree to use effective contraception during the study. Additionally women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Adequate screening organ function Exclusion Criteria: * Any prior use of BRAF inhibitors or MEK inhibitors. * Subjects who have received dacarbazine or paclitaxel prior to randomization will not be eligible to receive the same chemotherapy as study medication (i.e. a subject who received prior dacarbazine cannot receive dacarbazine on this trial and would thus receive paclitaxel if randomized to the control arm) * History of another malignancy. Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled. Consult GSK Medical Monitor if unsure whether second malignancies meet requirements specified above * Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection which will be allowed) * Brain metastases with the following exceptions that are ALL confirmed by the GSK Medical Monitor: All known lesions must be previously treated with surgery or stereotactic radiosurgery, and Brain lesion(s), if still present, must be confirmed stable (i.e. no increase in lesion size) for >=90 days prior to randomization (must be documented with two consecutive MRI or CT scans using contrast), and asymptomatic with no corticosteroids requirement for >= 30 days prior to randomization, and no enzyme-inducing anticonvulsants for >= 30 days prior to randomization * History or evidence of cardiovascular risk including any of the following: * QTcB >= 480 msec. * History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for >30 days prior to randomization are eligible * History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization. * History or evidence of current >= Class II congestive heart failure as defined by New York Heart Association * History of interstitial lung disease or pneumonitis * History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR): * History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes). * Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as: * Evidence of new optic disc cupping. * Intraocular pressure > 21 mm Hg as measured by tonography

Study Objectives This study was designed to explore the changes brought about by gelatin encapsulated extract of American Ginseng Root (LEAG) in breast cancer tumors and surrounding normal breast epithelial cells. Various tumor biomarkers, as well as inflammatory mediators, will be examined in tissue following LEAG treatment. Conditions: Breast Cancer Intervention / Treatment: DRUG: American Ginseng root 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 cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 1.0 cm greatest diameter on imaging * Surgical patients undergoing lumpectomy, subtotal or total mastectomy * 18 years of age or greater * female * available tissue blocks from diagnostic biopsy * negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal * must be willing to forego surgery for minimum of 5 days * ability and willingness to sign written consent * if hypertensive, on stable dose of medication at least 30 days * if diabetic, well controlled (HbA1C < 8.5 within past 60 days or documented FPG < 140 mg/dl for 3 consecutive days * ECOG status < 2 or Karnofsky of 60% or greater Exclusion Criteria: * previous or current malignancy, excluding non-melanomic skin cancer * evidence of distant metastatic disease * history of chemotherapy, biologic or radiotherapy with 6 months of biopsy * usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug * history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG * history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications * active bleeding or a pathological condition that carries a high risk of bleeding * any swallowing dysfunction * uncontrolled intercurrent illness * poorly controlled diabetes (control indicated with HbA1c < 8.5 within past 60 days or documented fasting blood glucose < 140 mg/dl for three consecutive days) * known diabetics who have experienced episodes of symptomatic hypoglycemia in the last 6 months are also considered poorly controlled and will be excluded from study participation. * uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHG) * pregnant or breast feeding women Women must be willing to use birth control throughout study duration. * current investigational medications or treatment with an investigational agent within 6 weeks prior to biopsy * current coumadin therapy or who have been treated with coumadin within the 2 weeks prior to biopsy * current monoamine oxidase inhibitors treatment

Study Objectives The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred. Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months. The number of patients required in this multicentric and prospective study is 150 (13 participating centers). This is a phase II, controlled, randomized, non comparative and open-label multicentric study. Conditions: Lymphoma, Myeloma Intervention / Treatment: DRUG: Injection of Pegfilgrastim, DRUG: Injection of Filgrastim Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Male or female patients aged >= 18 years * Patients with histologically confirmed lymphoma or myeloma * Treatment with high-dose chemotherapy before inclusion * Intensification with high dose Melphalan for patients with myeloma * Whatever the conditioning regimen, except TBI for patients with 1st relapse of Hodgkin's lymphoma or with MNHL NB: Patients having received two intensification courses are eligible if there has been more than 100 days between courses. * Autologous PSC transplantation at the time of inclusion * Reinjection of >= 2.106 CD34/kg * Patients hospitalized in the investigator center throughout the procedure until recovery from aplasia (PNN > 0.5 G/L) * Mandatory affiliation with a health insurance system * Patients able to understand, read and write French * Signed, written informed consent Exclusion Criteria: * TBI during conditioning * Severe intolerance to the growth factor under study, or hypersensitivity to one of their components * Immunosuppressive syndrome * Pregnant or lactating women * Difficult follow-up * Documented history of cognitive or psychiatric disorders * Participation or consideration of participation in another biomedical study during the follow-up period of the present trial.

Study Objectives The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081. Conditions: Neoplasms Intervention / Treatment: DRUG: JNJ-63898081 Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Histology: Part 1: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed. mCRPC is defined by prostate Cancer Working Group (PCWG )3 criteria. Part 2: mCRPC as defined above or pathologically confirmed metastatic renal cell carcinoma (RCC) as defined by world health organization (WHO) 2016 Classifications * Measurable or evaluable disease: Part 1: Either measurable or evaluable disease for prostate cancer. Part 2: At least one measurable lesion as per RECIST v1.1. * Evidence of disease progression on prior therapy that requires a new line of treatment * Participants with accessible lesions enrolled in selected pharmacokinetic (PK)/pharmacodynamics (PD) cohorts and in Part 2 must agree to undergo the mandatory fresh tumor biopsies, unless collection of the biopsy presents a safety risk Exclusion Criteria: * Less than 2 weeks between prior anticancer treatment (including radiotherapy) discontinuation and the first dose of study drug, and toxicities have not returned to Grade less than or equal to (<=) 1 or baseline * Prior treatment with prostate-specific membrane antigen (PSMA)-targeted therapy except for PSMA-targeted vaccine is permitted * Solid organ or bone marrow transplantation * Seizure or known condition that may predispose to seizure or intracranial masses * Other active malignancy requiring systemic treatment <=12 months prior to enrollment

Study Objectives This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag. Conditions: Myelodysplastic Syndrome Intervention / Treatment: DRUG: eltrombopag olamine, OTHER: Placebo Location: Germany, Korea, Republic of, Italy, Brazil, United Kingdom, Denmark, United States, Puerto Rico, Taiwan, Hong Kong, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Adult subjects (18 years of age or older) with advanced MDS, sAML/MDS, or de novo AML with >=10% and <=50% blasts in bone marrow. Peripheral blood blast change over time should not be suggestive of highly proliferative disease (as judged by the investigator). * Subjects must be dependent on regular platelet transfusions or have a platelet count taken within the 4 weeks prior to randomization that is <30 Gi/L. * Subjects must be relapsed, refractory or ineligible to receive standard treatment options of azacitidine and decitabine and must be relapsed, refractory or ineligible to receive intensive chemotherapy or autologous/allogeneic stem cell transplantation. A subject may be considered relapsed/refractory to a standard treatment if it is discontinued due to lack of efficacy. For subjects ineligible for standard treatments, it is permissible to start one of these standard treatments while on study medication if the Investigator considers that the subject becomes eligible during the course of the study. * Prior therapy with demethylating agents (azacitidine or decitabine), lenalidomide or IL-11(oprelvekin) must have been completed at least 4 weeks before Day 1; antithymocyte/antilymphocyte globulin, intensive chemotherapy, or autologous/allogeneic stem cell transplantation must have been completed at least 2 months before Day 1. If a subject must discontinue a course of therapy due to lack of efficacy, the washout periods listed above do not apply (and the patient may be screened and randomized immediately if other eligibility criteria are met). * Subjects must have platelet count and platelet transfusion data available over a period of 4 weeks prior to randomization. * Subjects with advanced MDS, sAML/MDS, or de novo AML must have stable disease indicated by a doubling time of peripheral blast counts >7 days during screening. * During the 4 weeks prior to randomization, subjects must have a baseline bone marrow examination including the following: * cytomorphology to confirm bone marrow blasts between 10-50%, * cytogenetics (provide only most prevalent abnormal clone), The results of the above tests are required prior to subject randomization. * Supportive/palliative therapies such as cytokines (except for IL-11; oprelvekin), valproic acid, all-trans retinoic acid or mild chemotherapy are allowed if part of the local SOC, provided those therapies have been at a stable dose for 4 weeks. If the subject chooses to discontinue these therapies prior to study entry, they must be completed 4 weeks prior to enrollment into this study, unless the therapy is discontinued due to lack of efficacy. Erythropoiesis-stimulating agents (ESAs) in anemic subjects or granulocyte colony-stimulating factor (G-CSF) in subjects with severe neutropenia and recurrent infections are allowed during the study as per accepted standards. Subjects who enter the study on ESAs or G-CSF should continue at the same dose schedule until the optimal dose of study medication has been established. * ECOG Status 0-3. * Subject is able to understand and comply with protocol requirements and instructions. * Subject has signed and dated informed consent. * Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) must be within 80 to 120% of the normal range at baseline. * Adequate baseline organ function defined by the criteria below: * total bilirubin (except for Gilbert's Syndrome) <= 1.5xULN * ALT and AST <= 3xULN * creatinine <= 2xULN * albumin must not be below the lower limit of normal (LLN) by more than 20%. * Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal >1 year), or of childbearing potential and use 1 of the following highly effective methods of contraception (i.e., Pearl Index <1.0%) from 2 weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: * Complete abstinence from intercourse; * Intrauterine device (IUD); * Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); * Male partner is sterile prior to entry into the study and is the only partner of the female; * Systemic contraceptives (combined or progesterone only). Exclusion Criteria: * Subjects with a diagnosis of acute promyelocytic leukemia. * History of treatment for cancer (other than MDS, sAML/MDS, or de novo AML) with systemic chemotherapy and/or radiotherapy within the last 2 years. * History of treatment with romiplostim or other TPO-R agonists. * Pre-existing cardiovascular disease (including congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc >450 msec (QTc >480 msec for subjects with Bundle Branch Block). * Bone marrow fibrosis that leads to an inability to aspirate marrow for assessment. * Spleen size >14 cm (length as per ultrasound examination). * Leukocytosis >=25,000/uL prior to Day 1 of study medication. * Female subjects who are nursing or pregnant (positive serum or urine Beta-human chorionic gonadotropin [B-hCG] pregnancy test) at screening or pre-dose on Day 1. * Current alcohol or drug abuse. * Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication. * Active and uncontrolled infections. * Subjects infected with Hepatitis B, C or Human Immunodeficiency Virus (HIV). * Subjects with liver cirrhosis.

Study Objectives PD-1 antibody has been approved as second line therapy for driven mutation negative non-small cell lung cancer, but overall response rate is only between 15-20%. Basic study found NK cell can enhance anti-tumor ability of PD-L1 antibody. This study evaluates the efficacy and safety of NK cell combined with PD-1 antibody for advanced driven mutation negative non-small cell lung cancer (NSCLC) as second-line therapy. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: COMBINATION_PRODUCT: NK cell and PD-1 antibody Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * (1) Age >= 18 years old. * (2) Locally advanced (IIIB/IIIC phase) or metastatic NSCLC (squamous or non-squamous) confirmed by histological examination. * (3) Disease progression occurred after platinum-based chemotherapy in the previous line, and measurable lesions existed according to RECIST v1.1. * (4) Patients must be able to provide fresh or archived tumor tissue and pathology reports. Non-squamous NSCLC must be able to provide a report that is confirmed to be wild-type EGFR by tissue-based assays. * (5) Eastern Cooperative Oncology Group(ECOG) performance status(PS) <= 1. * (6) The vital organs are fully functional, and the following results are obtained for each laboratory indicator (accepting the results of the examinations made within <= 28 days before randomization): * Cardiac ultrasound indicates a cardiac ejection fraction >= 50%; blood oxygen saturation >= 90%; * Absolute neutral cell count (ANC) >= 1.5 x 109/L, platelet count >= 100 x 109/L, hemoglobin >= 90g/dL; * Creatinine (Cr) <= 2.5 times normal range; * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 times normal range, total bilirubin (TBIL) <= 1.5 times normal range. * (7) No contraindications for apheresis and cell separation. * (8) Male or female with fertility needs to agree to take effective contraceptive measures during the study period and at least 120 days after the end of medication. * (9) A written informed consent can be provided and the research requirements are understood and followed. Exclusion Criteria: * (1) Previously received immunological checkpoint inhibitors targeting PD-1, PD-L1 or C ytotoxic T - L ymphocyte A ntigen 4(CTLA-4) and other immunotherapies (including but not limited to interferon or IL-2, chimeric antigen receptor T Cells, vaccines, etc.). * (2) NSCLC with EGFR gene mutation or ALK gene translocation. * (3) The toxicity caused by previous anticancer treatment has not recovered to baseline level or returned to stability (except for hair loss, rash, pigmentation or specific laboratory abnormalities). * (4) A history of severe allergic reactions to other monoclonal antibodies. * (5) History of interstitial pneumonia, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, and pulmonary fibrosis. * (6) Clinically severe pericardial effusion. * (7) Pleural effusion or ascites that is clinically uncontrolled and requires thoracentesis or abdominal puncture drainage within 2 weeks prior to randomization. * (8) Active pia mater disease or unstable brain metastasis. * (9) Major surgery, open biopsy or severe traumatic injury was performed <= 28 days prior to randomization, or major surgical procedures were expected during the study. * (10) Other malignant tumors other than NSCLC (except for surgically resected non-melanoma skin cancer, fully treated cervical carcinoma in situ, cured local prostate cancer, fully treated low-grade bladder cancer, Curatively treated breast ductal carcinoma in situ, or a malignant tumor diagnosed 2 years ago, but there is currently no evidence of disease in the absence of treatment <= 2 years prior to randomization). * (11) Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral treatment, including HIV, hepatitis B virus(HBV), hepatitis C virus(HCV) infection. * (12) Active autoimmune disease or a history of autoimmune disease but may recur. * (13) Subjects who require systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization. * (14) Those who have undergone organ transplantation or hematopoietic stem cell transplantation. * (15) Any live vaccine against infectious diseases (eg, influenza, chickenpox, etc.) was used within 28 days prior to randomization. * (16) Meet any of the following cardiovascular disease criteria: * Evidence of acute or positive myocardial ischemia * There are currently symptomatic pulmonary embolisms * Acute myocardial infarction occurred within <=6 months before randomization. * Has reached the New York Heart Association grading standard (see Appendix 5) 3 or 4 before randomization <= 6 months Grade of heart failure. * A >=2 grade ventricular arrhythmia occurred within <=6 months before randomization. * A cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within <=6 months before randomization. * (17) Pregnant and lactating women. * (18) If the patient is unable to follow the study procedures, limitations, and requirements, the investigator believes that the patient is not allowed to participate in the study.

Study Objectives The primary objective of the study is to determine a recommended phase II dose (RP2D). The secondary objective of the study are: 1. To evaluate preliminary incidence and duration of clinical benefits as determined by improvements of pain, PSA decline and bone scan changes. 2. To evaluate the toxicity profile of the escalating doses of Docetaxel in combination with Samarium 153 in patients with advanced, hormone refractory prostate cancer metastatic to the bone. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Docetaxel, DRUG: Docetaxel, DRUG: Docetaxel, DRUG: Docetaxel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients age >18 with HRPC including patients who failed conventional systemic treatments. Conventional eligibility criteria for HRPC are applicable, pain is not a requisite. * Histologically proven adenocarcinoma of the prostate (metastatic) that is unresponsive to hormone therapy. * Evidence of progressive disease following appropriate hormonal deprivation. Disease progression is defined by a confirmed PSA rise at least 1 week apart and/or evidence of disease progression on bone scan, CT scan or physical examination. * Evidence of progressing disease despite antiandrogen withdrawal (i.e., must have PSA rise noted >four weeks following cessation of flutamide therapy, nilandron therapy. For those patients treated with bicalutamide (Casodex), patients must have a rising PSA noted >six weeks after cessation of therapy. * For patients treated by medical means of gonadal ablation (GnRH analogues), or estrogens, evidence of appropriate testosterone suppression should be obtained prior to study entry (testosterone <50 ng/L). Continuation of gonadal androgen suppression should be carried out with GnRH analogues only. Antiandrogens or other steroidal compounds (except for dexamethasone used in this study) should be discontinued as noted in section 4.1.3 prior to study entry. Patients receiving low dose (<10 mg of prednisone/day) continuous corticosteroids >6 months, who present with objective evidence of disease progression may continue on the steroids (prednisone 10 mg) and are considered eligible. Prior orchiectomy is allowed and at least 4 weeks must have elapsed since completion of surgery. Patients may not be receiving Megace. * Patients must have metastatic disease documented within 28 days prior to study entry. X-rays, scans, and physical exam of all measurable and non- measurable disease must be completed within 28 days prior to study entry. * No concomitant chemotherapeutic, biological response modifiers or radiation therapy. At least 28 days must have lapsed since the last treatment with chemotherapy or biological response modifiers. * Patients may have received prior taxane treatment and is considered by the treating physician as a candidate for further treatment with this class of compounds. * ECOG performance status of 0-2 and life expectancy >3 months * WBC >=3500/ mm3, ANC >=1500/ mm3,and platelet count >=100,000/ mm3 and hemoglobin >=8.0 g/dl. * BUN <30 and serum creatinine <2.0 mg/dl. * Total Bilirubin <ULN, AST < 1.5 x ULN and ALT < 1.5 x ULN. * Recovered from major infections and/or surgical procedure and, in the opinion of the investigator, not have significant active concurrent medical illness. * No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated and controlled stage I or II transitional cell carcinoma of the bladder or any other cancer from which the patient has been disease-free for 5 years. * Peripheral neuropathy must be <grade 1 * Ability to understand and sign an IRB approved informed consent. * Patient must agree to use effective contraception from the day of initiation of treatment and for one year after completion of chemotherapy. Exclusion Criteria: * Patients with a history of brain metastases. * Uncontrolled medical problems (neurological, cardiovascular, or other illness considered by the primary investigator as unwarranted high risk for investigational drug treatment. * Non adenocarcinoma cell type. * Known hypersensitivity to steroids, docetaxel, polysorbate 80 or Samarium153. * Patients who received > whole pelvic radiation for therapeutic or palliative reasons are excluded from study. * Peripheral neuropathy >= grade 1

Study Objectives Primary objective: 1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer. Secondary objectives: 1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors. 2. To investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors. This study is a randomized double-blind placebo controlled trial of time release melatonin for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning and/or difficulty falling asleep. Conditions: Cancer Malignancies Intervention / Treatment: DRUG: melatonin, DRUG: placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * A St. Jude Life participant who was previously treated at St. Jude Children's Research Hospital * 10 or more years from diagnosis * 18 years of age or older * Able to speak and understand the English language * Participant has a full scale intelligence quotient (FSIQ) score >79. * Cohort 1 participant: * Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning <=10th percentile. * Is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes < once a week during the past month. * Cohort 2 participant: * Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning <=10th percentile. * Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes >= once a week during the past month. * Cohort 3 participant: * Is absent of neurocognitive impairment defined as performance >10th percentile on all six measures of attention, memory, and executive functioning. * Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes >= once a week during the past month. * Female participant of childbearing age must not be pregnant or lactating * Female research participant of childbearing age and male research participant of child fathering potential agrees to use safe contraceptive methods Exclusion Criteria: * Known allergy to melatonin or any ingredients of the study product or placebo * Participant currently is taking melatonin * Known sleep apnea or medically treated sleep disorder (e.g. restless leg syndrome) * Known diabetes mellitus - insulin treated * Participant has uncontrolled seizure disorder in past 12 months * Reported current illicit drug or alcohol abuse or dependence * Reported current major psychiatric illness (i.e. schizophrenia, bipolar disorder) * Current treatment with: (1) benzodiazepines or other central nervous system depressants, (2) fluvoxamine, (3) anticoagulants (e.g. coumadin), (4) immunosuppressant or corticosteroids, OR (5) nifedipine (Procardia XL(R)) * Employed in a position that requires night work (i.e. 10pm to 6am) * Females who are pregnant or lactating/nursing * History of neurologic event (i.e. traumatic brain injury) unrelated to cancer or its treatment * Sensory impairment (vision, hearing) that prohibits completion of neurocognitive examination

Study Objectives The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread. Conditions: Broad Solid Tumor Intervention / Treatment: DRUG: BMS-986207, BIOLOGICAL: Nivolumab, BIOLOGICAL: Ipilimumab Location: Chile, Canada, Japan, Romania, United States, Australia, Singapore, Argentina Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive >= 1% for a participant to be eligible for enrollment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization Exclusion Criteria: * Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll * Other active malignancy requiring concurrent intervention * Uncontrolled or significant cardiovascular disease * Active, known, or suspected autoimmune disease * NSCLC without prior treatment in the advanced or metastatic setting (Part 2C) Other protocol-defined inclusion/exclusion criteria apply

Study Objectives In Western industrialized countries, endometrial cancer is the most common malignancy of the female reproductive tract. The general therapy options are surgery, radiotherapy, chemotherapy and endocrine therapy. This trial will investigate the efficacy and safety of letrozole in the treatment of advanced or recurrent hormone receptor-positive endometrial cancer . Conditions: Endometrial Cancer Intervention / Treatment: DRUG: Letrozole Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed informed consent * Age > 18 years * Presence of histologically proven adenocarcinoma or adenosquamous carcinoma of the endometrium * Presence of advanced or recurrent endometrial cancer, FIGO stage I-IV, incurable with surgery and/or radiation therapy * Documented ER and/or PgR positive endometrial cancer. Hormone receptor positivity is defined according to routine practice at each participating laboratory. * Patient must be postmenopausal defined as * Age >=55 years. * Age <55 but no spontaneous menses for at least 1 year. * Age <55 and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (luteinizing hormone and follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (<5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved. * Bilateral oophorectomy * Radiation menopause * Presence of measurable disease (by clinical/radiological examination - according to RECIST criteria : minimum indicator lesion size : 20 mm (unless spiral CT scan in which case > 10 mm) * ECOG performance status of 0, 1 or 2 * Adequate bone marrow function (WBC >= 3.5 x 1'000'000'000/L and platelets >= 100.0 x 1'000'000'000/L) and hemoglobin > 10.0 g/dl * Adequate renal function (creatinine < 120 µmol/L) and hepatic function (bilirubin < 25 µmol/L, AST (SGOT < 60 U/L) * Minimum life expectancy of at least 6 months * Patients who are accessible for treatment and follow-up Exclusion Criteria: * Presence of non-measurable disease only * Other concomitant anti-cancer treatment (except external radiation treatment [XRT] for symptomatic metastatic lesions if other assessable untreated lesions are present) * Prior treatment with aromatase inhibitors or anti-estrogens (up to one previous progestational hormone therapy regimen for recurrent disease is permitted) * Clear cell or papillary serous histology, uterine sarcomas, mixed Mullerian tumors (MMT) and/or adenosarcomas * Other concurrent malignant disease with the exception of cone-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin's disease or non-Hodgkin lymphoma (NHL), provided 5 years have elapsed from completion of therapy, and there has been no recurrence * Known central nervous system (CNS) metastases, bilateral diffuse lymphangiosis carcinoma of the lung (>50 % of lung involvement, or dyspnea at rest requiring supplemental oxygen therapy), evidence of metastases estimated as more than a third of the liver as defined by sonogram and/or CT scan * Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's Syndrome, Addison's disease (treated or untreated) * Unstable angina and uncontrolled cardiac disease * Treatment with other investigational drugs (drugs not marketed for any indication) within the past 30 days and/or the concomitant use of investigational drugs * A history of non-compliance to medical regimens and patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study * Inability to swallow pills Additional protocol-defined inclusion/exclusion criteria may apply.

Study Objectives Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat. Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is eventually required In order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCCA, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with vismodegib as standard of care. Patients with tumors that do not respond to treatment with Vismodegib, and those who have a good response but poor tolerance of Vismodegib, will be offered surgical excision of the tumor. Patients with a good response and good tolerance of Vismodegib may continue the treatment as long as clinically indicated. Conditions: Carcinoma, Basal Cell Intervention / Treatment: DRUG: Vismodegib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Adult patients over 18 years of age with locally advanced or recurrent orbital or periorbital basal cell carcinoma (BCCA), or a medial canthal BCCA that threatens the lacrimal drainage system. * Clinical assessment score obtained at baseline. * Medical Oncology screening performed at baseline. * Adequate BCCA size and location. * Adequate hematopoietic capacity, hepatic and renal function. * Male patients must agree to use condoms during treatment and for 3 months after last dose. * Male patients must agree to not donate sperm during treatment and for 3 months after last dose. * Participant must agree not to donate blood during the study and for 7 months after last dose. * Informed consent signed. * If the patient consents to enroll, then blood will be drawn and stored for biomarker analysis. Exclusion Criteria: * Inability or unwillingness to swallow capsules. * Inability or unwillingness to comply with study procedures. * Pregnant, lactating, or breast feeding women. * Women of childbearing potential. * Uncontrolled medical illness. * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. * Age under 18 years.

Study Objectives This is a dose escalation study of CS-1008 (humanized anti-DR5 antibody) to determine the recommended Phase 2 dose and the maximum tolerated dose. Drug will be administered for six weeks and possibly up to 12 weeks depending on response. Conditions: Malignancies, Lymphoma Intervention / Treatment: DRUG: CS-1008 (humanized anti-DR5 antibody) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically diagnosed metastatic solid tumors or lymphomas (with no leukemic component) which are refractory to, not curable with, or not eligible for standard treatment(s). * Eighteen years of age or older * Eastern Cooperative Oncology Group (ECOG) performance status equal to or less than 2 * Resolution of any toxic effects (except alopecia) of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 grade of equal to or less than 1 * Men and women of childbearing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months thereafter. * All female patients of childbearing potential must have a negative pregnancy test (serum or urine) within 3 days prior to treatment * Patients must be fully informed about their illness and the investigational nature of the study protocol Exclusion Criteria: * Anticipation of the need for a major surgical procedure or radiation therapy during the study * Treatment with chemotherapy, hormonal therapy, radiotherapy, major surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery) of study enrollment * Cumulative radiation therapy to greater than 25% of the total bone marrow * Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolytic event; clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease [COPD] or asthma) * Patients with a clinically active brain metastasis (i.e., not treated or still requiring therapy with steroids or radiotherapy [RT]; or with progression 4 weeks after the completion of RT) or an uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis * Clinically significant active infection which requires antibiotic therapy, or HIV-positive patients receiving antiretroviral therapy. * Chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction

Study Objectives This study will examine the safety of clofarabine, TLI and ATG as a reduced conditioning regimen prior to allogeneic transplantation. The impact of the conditioning regimen on the presence of the circulating regulatory as compared to activated T cell populations will be assessed.The recovery of DC populations post-transplant will be examined, along with the effect of the regimen on disease free and overall survival. Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphocytic Leukemia, Relapsed/Refractory Chronic Lymphocytic Leukemia, Relapsed/Refractory Non Hodgkin's Lymphoma, Hodgkins Disease, Relapsed Refractory Multiple Myeloma Intervention / Treatment: DRUG: Antithymocyte Globulin, DRUG: Clofarabine, DRUG: Clofarabine, DRUG: Clofarabine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with a)acute myeloid leukemia exclusive of patients in first complete remission with good risk cytogenetics (translocation 8,21,translocation 15, 17 or inversion 16); B)myelodysplastic syndrome; c)acute lymphocytic leukemia exclusive of patients in first remission without negative prognostic markers; d) relapsed or refractory nonHodgkin's lymphoma or Hodgkin's disease; e)relapsed or refractory multiple myeloma or f)relapsed or refractory chronic lymphocytic leukemia. * Patients who are considered appropriate for reduced intensity transplantation must present with at least one of the following: A. Age over 50 B. History of a prior hematopoietic stem cell transplant C. Patient with compromised organ function or comorbid conditioning such that a standard ablative transplant would be considered high risk. D. Patient with low grade Lymphoma or CLL for which reduced intensity transplant would be the optimal therapy compared to an ablative regimen * Patients will have a related or unrelated donor matched at 5/6 or 6/6 HLA loci. * Patients must be greater than or equal to 18 years old, and younger than or equal to 75 years old to participate in the study. * Patients must have ECOG performance status of 0-2 * Pulmonary function tests demonstrate DLCO (adjusted for Hgb)>50% predicted * Cardiac ejection fraction >40% * Laboratories: * Bilirubin less than or equal to 1.5mg/dL x ULN * AST/ALT/Alkaline Phosphatase less than or equal to 2.5x ULN * Serum creatinine less than or equal to 1.0mg/dL; if serum creatinine > 1.0MG/dL, then the estimated glomerular filtration rate (GFR) must be >60mL/min/1.73m^2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GRF (ml/min/1.73m^2)=186x (serum creatinine)^1.154x(age in years)^-0.203x(0.742 if patient is female) x (1.212 if patient is black) * Patients with serologic evidence of hepatitis B or C exposure will undergo liver biopsy to assess for presence of active hepatitis or fibrosis and quantification of risk of proceeding with transplant. * All patients must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent. All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines. * Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. * Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment Exclusion Criteria: * Patients who are HIV+ will be excluded. * Patients must not have serious intercurrent illness such as uncontrolled systemic infection or significant organ compromise which significantly increases the risk of undergoing allogeneic transplantation. * Pregnant and lactating women will be excluded.

Study Objectives This phase II trial is studying how well tandutinib works in treating patients who have undergone surgery for metastatic kidney cancer. Tandutinib may stop the growth of kidney cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving tandutinib after surgery may kill any tumor cells that remain after surgery. Conditions: Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer Intervention / Treatment: DRUG: tandutinib, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed RCC of clear cell histology; subjects must have a component of conventional clear cell RCC with or without sarcomatoid features * Patients must have evidence of metastatic disease and must have had a cytoreductive nephrectomy at least 28 days prior to first day of treatment * Archival tissue from nephrectomy must be available for correlative studies * Patients must have measurable disease, defined by RECIST criteria * Patients must have received at least one prior FDA approved therapy for metastatic renal cell carcinoma with either Sutent, or Nexavar, and may have received up to three prior systemic therapies for metastatic disease; prior cytokine therapy is also permitted * Prior systemic therapy with other antiangiogenic agents such as Thalidomide, Bevacizumab, or AG013736 is permitted * Patients must have a life expectancy of >= 3 months * Patients must have an ECOG performance status of 0-1 (Karnofsky >= 70%) * Patients must be at least 4 weeks from radiation therapy and recovered from all related toxicity * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/mcL * Hemoglobin >= 8.5 g/dl * Total Bilirubin =< 1.5 X institutional upper limit of normal * AST (SGOT)/ALT (SGPT) =< 3.5 X institutional upper limit of normal * Alkaline phosphatase =< 2.5 ULN (=< 10 x ULN in presence of bone metastasis) * Serum calcium of =< 12 mg/dl * Creatinine =< 1.5 X institutional upper limit of normal * INR =< 1.5, except for subjects receiving warfarin therapy; for subjects who are receiving warfarin for prophylaxis or treatment of thrombosis, INR values should be carefully monitored while patients are on study * Electrocardiogram (12-lead) with cQTC < 500 msec using the Bazett's formula * Absence of significant effusions and/or ascites * No major surgery requiring general anesthesia within the past 28 days * Patients may not have had brain metastasis * Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of MLN518 will be determined following review of their case by the Principal Investigator; because MLN518 is a substrate of the P-glycoprotein (P-gp) drug efflux pump, co- administration of agents that inhibit or induce this mechanism may alter exposure to MLN518 * The effects of MLN518 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because receptor tyrosine kinase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; sexually active patients must continue to use contraception for three months after completion of study therapy * All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines; a copy of the informed consent document signed by the patient must be given to the patient Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients may not be receiving any other investigational agents * Patients may not be co-medicated with an agent that causes QTc prolongation * Patients with a mean QTc > 500 msec using the Bazett's formula taken from the screening electrocardiogram or history of familial long QT syndrome are ineligible * Left ventricular ejection fraction (LVEF) < 40% * Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Ongoing vomiting, or nausea >= grade 2 (NCI CTCAE v3.0) * Patients with 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, or active peptic ulcer disease) that impairs their ability to swallow pills or absorb oral medications are excluded * Known or suspected primary muscular or neuromuscular disease (e.g., muscular dystrophy, myasthenia gravis) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN518 such as Tarceva™, Iressa® and Cardura® XL * Patients with any CNS metastases or uncontrolled seizure disorder * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements * Any malignancy other than a renal cell carcinoma, with the following exceptions: * Basal or squamous cell carcinomas of the skin * Carcinoma in-situ of the uterine cervix * Any malignancy treated with curative intent and in complete remission for > 3 years * Patients with organ allografts * Patients with non-clear cell carcinoma i.e., papillary, collecting duct, or chromophobe * Pregnant women are excluded from this study because MLN518 is a receptor tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MLN518, breastfeeding should be discontinued if the mother is treated with MLN518 * HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MLN518; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated * Inability to comply with study and/or follow-up procedures

Study Objectives Patients with untreated clinical stage II breast cancer are eligible. An excisional biopsy of the primary tumor is acceptable, but without definitive local therapy or prior chemotherapy. Histologic confirmation of invasive carcinoma is required. Patients are prospectively randomized to receive five 21-day cycles of dose-intense (5-fluorouracil, adriamycin, leucovorin, cytoxan, granuloctye-colony stimulating factor \[FLAC/G-CSF\]) chemotherapy either before (preoperative) or after (postoperative) local therapy. Chemotherapy is given as an outpatient. For patients receiving preoperative chemotherapy, local therapy (modified radical mastectomy, or breast segmentectomy/axillary dissection/breast radiotherapy according to patient preference) is performed 3-4 weeks after last chemotherapy. For patients receiving postoperative chemotherapy, chemotherapy will begin 2-3 weeks after local therapy. Immediate reconstruction for mastectomy is acceptable. Upon completion of local therapy and chemotherapy in either treatment group, all estrogen receptor positive patients receive tamoxifen for 5 years. Follow-up consists of history and physical examination each 3 months for first 3 years, each six months for years 4 and 5, and yearly thereafter. Mammogram, bone scan, chest x-ray and blood work are performed yearly. Conditions: Breast Neoplasm, Neoplasm Metastasis Intervention / Treatment: DRUG: preoperative dose intense chemotherapy (FLAC/G-CSF) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT

INCLUSION CRITERIA Women of any age with clinical stage II breast cancer who met the following criteria: Patients with stage II breast cancer will include primary tumor less than or equal to 5 cm in size with axillary lymph nodes which are clinically ([N0 or N1] [T1N1, T2N0, T2N1]). Patients will be staged according to the 1986 AJCC TMM classification. Patients with bilateral breast cancer will be eligible provided at least one tumor is invasive and classified as stage I or II, and neither breast is stage III. Histologic sections of the breast tumor must be classified as an invasive primary breast neoplasm of epithelial origin. Patients must be geographically accessible for follow-up and willing to return for the follow-up at the NCI. Patients must be mentally competent to understand and give informed consent for the protocol. Estrogen receptor (ER) status can include ER positive, negative, or unknown. Patients with prior cancers may be eligible as long as they have received curative therapy and have had no evidence of recurrence for greater than or equal to 10 years. EXCLUSION CRITERIA Patients will be excluded from this protocol for the following reasons: Advanced local disease or distant metastases (stage III or IV). Previous therapy to the breast other than excisional biopsy. Pregnancy. Unwillingness to use birth control during chemotherapy. Chronic disease such as heart, lung, liver, kidney, blood or metabolic disorders which may render the patient a poor risk for surgery or chemotherapy. Specifically, liver function - SGOT, SGPT, alkaline phosphatase and total bilirubin should be less than 1.5 x the upper limits of normal. Renal function - creatinine should be less than 1.7 and/or creatinine clearance should be greater than 45 ml/min. If there is any history of cardiac disease, patients must have a normal ejection fraction on MUGA scan and no angina.

Study Objectives Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact. Conditions: Breast Cancer Intervention / Treatment: DRUG: Gemcitabine, DRUG: Epirubicin, DRUG: Docetaxel Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: To be included in this study, you must meet the following criteria: * Adenocarcinoma of the breast confirmed by biopsy * Female Patients >18 years of age * Normal cardiac function * Ability to perform activities of daily living with minimal assistance * Chemotherapy naïve or have received prior chemotherapy > 5 years ago * Adequate bone marrow, liver and kidney function * Be informed of the investigational nature of this study * Sign an informed consent form * Sentinel lymph node and/or axillary dissection prior to enrollment Exclusion Criteria: You cannot participate in this study if any of the following apply to you: * Life expectancy of < than 6 months * History of significant heart disease * Prior chemotherapy or hormonal therapy * Concurrent Trastuzumab therapy * History of significant psychiatric disorders * History of active uncontrolled infection Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Objectives Adult patients with gastric carcinoma which has progressed after initial treatment with a fluoropyrimidines-containing regimen will be treated with paclitaxel plus RAD001 or plus placebo. The hypothesis is that patients with RAD001 have significantly prolonged overall survival compared to patients who are treated with paclitaxel alone. Conditions: Advanced Gastric Cancer, Esophagogastric Junction Cancer Intervention / Treatment: DRUG: Paclitaxel, DRUG: RAD001 Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Male or female patients >= 18 years old * Histologically or cytologically confirmed and documented gastric adenocarcinoma. Adenocarcinomata of the gastro-esophageal junction will be allowed, if they have advanced disease (inoperable, recurrent or metastatic disease). * Documented progressive disease during/after one, two or three prior treatments containing 5FU and/or its precursors or derivatives in the palliative setting * At least one measurable or evaluable lesion by RECIST as determined by Computed Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) * ECOG performance status of 0, 1 or 2 * The following laboratory parameters: * Absolute neutrophil count >= 1.5 x 109/L * Platelets >= 100 x 109/L * Hemoglobin (Hgb) >= 9 g/dL * Serum creatinine <= 2 x Upper Limit of Normal (ULN) * Adequate liver function: * Total serum calcium (corrected for serum albumin) or ionized calcium >= LLN * Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of study treatments and must be willing to use adequate methods of contraception during the study and for 3 months after last study drug administration. * Written informed consent Exclusion Criteria: * Current treatment with any anti cancer therapy or treatment with anti cancer therapy <= 2 weeks prior to study treatment start unless rapidly progressing disease is measured * Known hypersensitivity to RAD001 (everolimus) or to its excipients, or to other rapamycins (e.g. sirolimus, temsirolimus) * Known prior history of hypersensitivity to paclitaxel. * Paclitaxel refractory disease, which is defined as a disease progression under or within 12 weeks of last taxan treatment * Chronic treatment with steroids (except for oral, topical or local injection) or another immunosuppressive agent * Major surgery <= 2 weeks prior to starting study treatment or patients who have not recovered from such therapy * Lack of resolution of all acute toxic effects (excluding alopecia) of prior chemotherapy, prior radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade <= 1. Note: Neuropathy due to prior chemotherapy is allowed. * Unstable CNS disease * Requiring increasing doses of steroids to maintain stable neurological status * Deteriorating / changing neurological status * Known history of HIV seropositivity (HIV testing is not mandatory) or Hepatitis B or C. * Active, bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin, as long as the INR is <= 2.0) * Any other severe and/or uncontrolled medical conditions

Study Objectives This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate and the rate of resection, At the same time, the study before and after the anti angiogenesis therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular endothelial growth factor(VEGF) expression level, to understanding the correlation between the clinical efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these markers. In order to find the reference basis for the prediction of the effect of curative effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer before and after treatment with CT perfusion imaging are studied. Conditions: Non Small Cell Lung Cancer Intervention / Treatment: DRUG: Endostatin, DRUG: Vinorelbine, DRUG: Cisplatin Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * The pathology proved to be non small cell lung cancer (must be histologically). * At present, the patients with ⅢA stage (N2) were evaluated by the assistant examination; * The patients were evaluated by imaging, laboratory examination and other examination; * Without chemotherapy or anti angiogenic therapy; * There can be measured lesions * Informed consent. Exclusion Criteria: * Pregnant, lactating women, or patients with fertility but did not take contraceptive measures. * Severe infection. * Severe heart disease.Neuropsychiatric disorders, which is not easy to control. * Severe diabetes. * There is obvious bleeding tendency. * The 5 years history of other tumors

Study Objectives The overall goal is to provide an innovative approach to restage patients with biochemical recurrence of prostate cancer by using hybrid PET/MR with innovative radiotracers (68Ga-PSMA and 68Ga-RM2) Conditions: Prostate Cancer Intervention / Treatment: DRUG: 68Ga-PSMA, DRUG: 68Ga-RM2 Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histological proven diagnosis of prostate cancer. * Patients treated with radical therapy (RP o EBRT, with or without further adjuvant therapies), who present rising serum PSA values >= 0.2 ng/mL. * Age >= 18 years-old. * Willing to provide a signed informed consent. Exclusion Criteria: * Age < 18 years-old. * Previous and/or concomitant androgen deprivation therapy will be excluded. * Any additional medical condition that may significantly interfere with study compliance. * Contraindications to MR study (i.e. Pacemaker

Study Objectives This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in this study. Conditions: Classical Hodgkin Lymphoma Intervention / Treatment: DRUG: Bendamustine, DRUG: Prednisone, DRUG: Vinblastine, DRUG: Doxorubicin Location: Belgium, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient with a first diagnosis of classical Hodgkin lymphoma according to the World Health Organization (WHO) criteria excluding nodular lymphocyte predominant subtype * Age of >= 61 years * No previous treatment for Hodgkin lymphoma * Ann Arbor stages: * II with mediastinum/thorax >=0.33 or extranodal localization and with B symptoms * Or III * Or IV * Baseline 18-FluoroDeoxyGlucose (FDG) PET scan (PET0) performed before any treatment with at least one hypermetabolic lesion * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Adequate cardio-pulmonary function with Left Ventricular Ejection Fraction (LVEF) >= 50% * Adequate renal function with creatinine clearance >= 40 mL/mn (MDRD formula) * For patients aged 70 years old and more, a Mini Nutritional Assessment (MNA) >= 17 * A minimum life expectancy of 3 months * Negative Human Immunodeficiency Virus, Hepatitis B (HB) Virus (anti-HB c negativity) and Hepatitis C Virus serologies tests <= 30 days before inclusion (except after vaccination) * Having previously signed a written informed consent * The patient must be covered by a social security system, if applicable * Men patient must agree to use an adequate method of contraception during the study treatment and until 6 months after the end of the study treatment. Exclusion Criteria: * Any other type of lymphoma including nodular lymphocyte predominant subtype * Any history of treated Hodgkin lymphoma * Contra-indication to any drug contained in the chemotherapy regimens * Any serious active disease (according to the investigator's decision) * Poor hepatic function (total bilirubin level > 30 μmol/L or transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma * Poor bone marrow reserve as defined by leukocytes < 2 G/L or platelets < 100 G/L, unless related to bone marrow infiltration * Any history of cancer during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if they fulfil all the followings: 1. their disease was T1-T2a, N0, M0, with a Gleason score <= 7, and a prostate specific antigen (PSA) <= 10 ng/mL prior to initial therapy, 2. they had definitive curative therapy (i.e. prostatectomy or radiotherapy) >= 2 years before Day 1 of Cycle 1, 3. at a minimum 2 years following therapy, they had no clinical evidence of prostate cancer and their PSA was undetectable if they underwent prostatectomy or < 1 ng/mL if they did not undergo prostatectomy * Severe metabolic disease interfering with normal application of protocol treatment as uncontrolled diabetes mellitus leading to impossibility to perform PET scan * Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study * Adult under tutelage

Study Objectives GSK1120212 is a reversible and highly selective allosteric inhibitor of MEK1 and MEK2 activation and kinase activity currently being developed for the treatment of malignant melanoma. This is a Phase I, open-label, non-randomized, single-dose study designed to characterize the absorption, distribution, metabolism, and elimination (ADME) of a single oral dose of MEK inhibitor \[14C\]GSK1120212 as a solution in male subjects with solid tumor malignancies. A sufficient number of subjects will be enrolled to complete approximately four evaluable subjects. Following completion of the study, subjects may elect to continue dosing with GSK1120212 in the rollover study, MEK114375. Conditions: Cancer Intervention / Treatment: DRUG: GSK1120212 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male 18 years old or older. * Written informed consent provided * Body weight greater than or equal to 45 kg and a BMI greater than or equal to 19 kg/m2 and less than or equal to 35 kg/m2 (inclusive). * Able to swallow and retain oral medication. * Histologically or cytologically confirmed diagnosis of a solid tumor. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Agree to use one of the contraception methods listed in the protocol from the time of the first dose of study medication until sixteen weeks after the last dose of study medication. * A history of regular bowel movements (approximately once per day). * Adequate baseline organ function as listed in the protocol. Exclusion Criteria: * Currently receiving cancer therapy as specified in the protocol. * Serious and/or unstable pre-existing medical psychiatric disorder, or other conditions. * Any major surgery within the last four weeks. * Unresolved toxicity equal to or greater than Grade 2 from previous anti-cancer therapy except alopecia. * An occupation within the past 12 months which requires monitoring for radiation exposure, nuclear medicine procedures or excessive x-rays. * Radiation exposure from the previous three year period over 10 mSv if exposed to ionizing radiation above background as a result of work with radiation as category A (classified) workers or as a result of research studies. * History of interstitial lung disease or pneumonitis. * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to dimethyl sulfoxide (DMSO). * Current use of a prohibited medications described in the protocol. * Use of anticoagulants such as warfarin is permitted. * History RVO or CSR. * Predisposing factors to RVO or CSR. * Visible retinal pathology that is considered a risk factor for RVO or CSR such as: - Evidence of new optic disc cupping - Intraocular pressure greater than 21 mm Hg as measured by tonography. 11.1. Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. (Previously treated and have had stable CNS disease for greater than 3 months, asymptomatic and off corticosteroids, or on stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted). *2. Receiving enzyme inducing anti-epileptic drugs (EIAEDs). 12. History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 6 months. 13. QTcB greater than or equal to 480 msec. 14. History or evidence of current clinically significant uncontrolled arrhythmias. * History or evidence of current greater than or equal to Class II congestive heart failure. * Active gastrointestinal disease or other condition (e.g., gastrectomy, bariatric surgery, small bowel or large bowel resection, or cholecystectomy). * A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus, or Hepatitis C Virus. * Alcohol or drug abuse within six months prior to screening. 19. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs or excipients. * Participated in a clinical trial and has received an investigational product within 30 days or five half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) before the 1st dose. * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. * Mentally or legally incapacitated.

Study Objectives The purpose of this post marketing study is to determine the plasma concentration of bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug enters and leaves the blood and tissues over time) properties in the Taiwanese population. It will also provide expanded access (expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a participant with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options) to bortezomib for the same group of participants with multiple myeloma (cancer of the types of cells normally found in bone marrow). Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Bortezomib Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Participants previously diagnosed with multiple myeloma based on standard criteria * Participant has received at least 2 previous lines of therapy for multiple myeloma and, in the Investigator's opinion, currently requires therapy because of relapsed (the return of a medical problem) or progressive disease * Female participants either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control from Screening through the Final Visit * If male, the participant agrees to use an acceptable barrier method for contraception from Screening through the Final Visit * Participant has a Karnofsky performance status classifies participants as to their functional impairment and is used to compare effectiveness of different therapies and to assess the prognosis [outlook, probable outcomes] in individual participants) greater than 60 Exclusion Criteria: * If the participant received bortezomib in a previous trial, the Participants' best response to bortezomib must be progressive disease * If the participant received bortezomib in a previous trial, the participant must have experienced 1 or more serious adverse events * Participants who have received nitrosoureas within 6 weeks or any other chemotherapy (treatment of disease, usually cancer, by chemical agents) within 3 weeks before enrollment * Participants who have received corticosteroids (greater than 10 milligram per day prednisone or equivalent) within 3 weeks before enrollment * Human Immunodeficiency Virus (HIV - a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person)-positive or hepatitis-B surface antigen-positive participants or participants with known active hepatitis-C infection

Study Objectives Single dose versus double dose tamsulosin in Management of Moderate and severe lower urinary tract symptoms due to benign prostatic hyperplasia Conditions: Prostatic Neoplasms, Prostate Disease, Prostate Obstruction, Prostate Hypertrophy Intervention / Treatment: DRUG: Single dose tamsulosin 0.4mg, DRUG: Double dose tamsulosin 0.4mg Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * age more than 50 years * moderate to severe lower urinary tract symptoms Exclusion Criteria: * prostatic cancer * urethral stricture * prostate surgery * Neurogenic bladder

Study Objectives This is an open-label, multi-center, dose-escalation Phase I study to evaluate safety, pharmacokinetics and activity of CH5132799 administered orally as a single agent in patients with advanced solid tumors. Conditions: Solid Tumors Intervention / Treatment: DRUG: CH5132799 Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Provision of signed written informed consent. * Histologically or cytologically confirmed diagnosis of advanced solid tumor. * Age >= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. * Life expectancy of >= 12 weeks. * Disease measurability: Patients must have a measurable - as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1 - and/or evaluable disease. * Paraffin-embedded archival tumor tissue available. Fresh biopsies will be required if no paraffin embedded tumor tissues available. * Adequate bone marrow function. * Adequate cardiac function: Patient should have Left Ventricular Ejection Fraction (LVEF) of >= 50% as determined by echocardiography (ECHO) or Multi Gated Acquisition (MUGA) scans. * Adequate liver function. * Adequate renal function. * Adequate adrenal function assessed by baseline cortisol of > 200 nmol/L * Ability to comply with protocol requirements. * Female patients must be postmenopausal (12 months of amenorrhea), surgically sterile or they must agree to use a physical method of contraception. Male patients who have been sterilized must agree to use a barrier method of contraception. Male subjects must also commit to use a barrier method of contraception until at least 3 months after the end of study treatment. * Female patients of child-bearing potential must have a negative serum pregnancy test within the seven days prior to the first study drug administration. Exclusion Criteria: * History of allergic reactions attributed to components of the formulated product. * Inability to swallow oral medications or impaired gastrointestinal absorption due to active inflammatory bowel disease. * Known Central Nervous System (CNS) metastases or leptomeningeal metastases will be eligible only if it could be radiologically demonstrated that there is no CNS disease progression during the 3 months prior to the study * Known active or uncontrolled pulmonary dysfunction. * Uncontrolled hypertension * Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy for bone pain), or immunotherapy within 28 days of first receipt of study drug (within 6 weeks for nitrosoureas and mitomycin C). Hormone therapy within 14 days of first receipt of study drug, with exception of prostate cancer if indicated. * Prior toxicities from chemotherapy or radiotherapy which have not regressed to Grade <= 1 severity - National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0). * Type 1 or 2 diabetes mellitus requiring regular medication and/or a fasting plasma glucose (FPG) >= 120 mg/dL (or 6.6 mmol/dL) at screening. * Increased QTc interval (QTc > 450 ms for male; > 460 ms for female). * History of heart failure, refractory hypokalemia to adequate supplementation, family history of long QT syndrome or other risk factors for "Torsades de Pointes", and/or the use of concomitant medications that prolong the QT/QTc interval. * Prior corticosteroid therapy within 14 days of first receipt of study drug. * Treatment with any investigational agent within 28 days of first receipt of study drug. * Acute or chronic infection. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, contraindicates the use of an investigational drug, or will impose excessive risk to the patient. * Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection. * History of clinically significant bowel disease including abdominal fistula, gastro-intestinal perforation, and diverticulitis. * Major surgery within 28 days of first receipt of study drug. * Pregnant or lactating women * Altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.

Study Objectives The purpose of this study is to assess the current smoking status and smoking cessation attempts among smokers or recent smoking quitters during the perioperative period, to describe postoperative pulmonary complications (PPCs) and other postoperative complications (PCs) following a lung surgery, and to describe the smoking cessation methods and services patients received from their health care professionals (HCPs) and participant's satisfaction among participants with lung cancer, chronic obstructive pulmonary disorder (COPD), a pulmonary lesion (example, nodule, or ground glass opacity) or other pulmonary conditions who are admitted to the thoracic surgical unit of the participating hospitals in China. Conditions: Lung Neoplasms, Pulmonary Disease, Chronic Obstructive Intervention / Treatment: OTHER: No intervention Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Participants who have been scheduled for an elective lung surgery by the treating physician's judgement, due to the following conditions: known lung cancer, COPD, a pulmonary lesion (example. nodule, ground glass opacity) or other pulmonary conditions * Smokers who are or were smoking on average no fewer than 5 cigarettes per day for equal or more than 3 years within 3 months prior to the scheduled surgery, or recent smoking quitters with a history of smoking on average no fewer than 5 cigarettes per day for equal or more than 3 years, who quit smoking between 3 months and 5 years prior to the scheduled surgery * Being willing to participate the study and sign the participant informed consent form (ICF) Exclusion Criteria: * Participants who have emergency lung surgery due to accident or injury * Participants are not likely to be able to complete the 6-month follow-up after the lung surgery

Study Objectives This phase I trial studies the safety and best dose of anti-LAG-3 (anti-LAG-3 monoclonal antibody BMS-986016) or urelumab alone and in combination with nivolumab in treating patients with glioblastoma that has returned (recurrent). Anti-LAG-3 monoclonal antibody BMS-986016, urelumab, and nivolumab are antibodies (a type of protein) that may stimulate the cells in the immune system to attack tumor cells. It is not yet known whether anti-LAG-3 monoclonal antibody BMS-986016 or urelumab alone or in combination with nivolumab may kill more tumor cells. (The Anti-CD137 antibody (BMS-663513 - urelumab) treatment arm closed by BMS on 10/16/18 due to closure of BMS Urelumab development program. Subjects currently on treatment may continue.) Conditions: Glioblastoma, Gliosarcoma, Recurrent Brain Neoplasm Intervention / Treatment: BIOLOGICAL: Anti-LAG-3 Monoclonal Antibody BMS 986016, BIOLOGICAL: Anti-PD-1, OTHER: Pharmacological Study, OTHER: Laboratory Biomarker Analysis, BIOLOGICAL: Anti-CD137 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: * Patients must have histologically proven glioblastoma or gliosarcoma which is progressive or recurrent following radiation therapy and temozolomide * Tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation status must be available; results of routinely used methods for MGMT methylation testing (e.g. mutagenically separated polymerase chain reaction [MSPCR] or quantitative polymerase chain reaction [PCR]) are acceptable * Patients must have measurable contrast-enhancing disease (defined as at least 1 cm x 1 cm) by magnetic resonance imaging (MRI) imaging within 21 days of starting treatment (patients may have gross total resection, but should have measurable disease post-operatively); patients must be able to undergo MRI of the brain with gadolinium; patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to this baseline MRI * Patients must be in first recurrence of glioblastoma following radiation therapy and temozolomide * Patients must have recovered from severe toxicity of prior therapy; an interval of at least 12 weeks must have elapsed since the completion of radiation therapy or placement of Gliadel wafers, and at least 6 weeks must have elapsed from the last dose of temozolomide (TMZ); no prior therapies are allowed other than radiation, temozolomide, and Gliadel wafers (placed during the first surgery at diagnosis of GBM) * Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others) * Absolute lymphocyte count >= 1000/ul * Absolute neutrophil count >= 1,500/ul * Platelets >= 100,000/ul * Hemoglobin >= 9 g/dl * Total bilirubin =< institutional upper limit of normal * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal * Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 ml/min/1.73m^2 for patients with creatinine levels above institutional normal * Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal * Patients must be able to provide written informed consent * Women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to treatment start; women of childbearing potential must agree to use two methods of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and through 23 weeks after the last dose of study drug; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 31 weeks after the last dose of study drug * Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five years Exclusion Criteria: * Patients receiving any other investigational agents are ineligible * Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to anti-LAG-3, anti-CD137, and anti-PD1 are ineligible; the investigator brochures can be referenced for more information * Patients with active or recent history of known or suspected autoimmune disease are ineligible; subjects with type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, and skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment, are permitted to enroll * Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study entry are ineligible * Patients must not be receiving greater than 1 mg dexamethasone/day (or an equivalent amount of an alternative corticosteroid) for at least 1 week prior to treatment start * Patients must have no evidence of mass effect and no midline shift * Patients must have no evidence of significant hematologic, renal, or hepatic dysfunction; patients with underlying hepatocellular disease should be given careful risk/benefit consideration prior to enrollment; patients with a history of any chronic hepatitis as evidenced by the following are ineligible: * Positive test for hepatitis B surface antigen (HBsAg) * Positive test for qualitative hepatitis C viral load (by PCR) (Note: subjects with positive hepatitis C antibody and negative quantitative hepatitis C by PCR are eligible; history of resolved hepatitis A virus infection is not an exclusion criterion) * History of alcoholic or non-alcoholic steatohepatitis (NASH), auto-immune hepatitis, or previous grade 3-4 drug-related hepatitis, or any form of chronic liver disease * Patients must be hepatitis C virus (HCV) negative (by quantitative PCR [qPCR]) and hepatitis B virus core antibody (HBcAb) negative (no prior hepatitis B infection) * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with these agents * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Study Objectives This is an open-label, multi-dose, Phase I, dose escalation study to define the safety profile and preliminary anti-tumor activity of SGN-40 in patients with refractory or recurrent non-Hodgkin B-cell lymphomas. Conditions: Non-Hodgkin Lymphoma Intervention / Treatment: DRUG: SGN-40 (anti-huCD40 mAb) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have a histological diagnosis of B cell non-Hodgkin's lymphoma, including diffuse large B-cell, mantle cell, follicular, small lymphocytic, and marginal zone lymphoma by the World Health Organization criteria. * Patients must have an archived paraffin or fresh tumor specimen available for immunohistologic evaluation of CD40, CD20, & CD79a. * Patients must have relapsed lymphoma and must have failed frontline chemotherapy. * Patients who have not received autologous stem cell transplant must have refused or be ineligible for it. * Patients must have completed radiotherapy, chemotherapy, and/or treatment with investigational anti-cancer agents 4 weeks prior to registration. Patients must have completed any monoclonal antibody treatment, including rituximab, 6 months prior to registration. * Patients must have completed autologous bone marrow transplant 4 months prior to registration. * Patient must have at least one site of measurable disease defined by unidimensional lesion >= 2 cm by conventional CT scan. * Patients must have an ECOG performance status <= 2 and a life expectancy > 3 months. * Patients must have the following required baseline laboratory data: * Platelet count >= 75,000/mm3, * Hemoglobin >= 9.0 g/dL, * Absolute neutrophil count >= 1,250/mm3, * ALT/AST <= 2.5 times ULN, * Total bilirubin <= 1.5 times ULN, * Creatinine < 1.5 mg/dL, * Females of childbearing potential must have a negative serum β-hCG pregnancy test result within 3 days prior to the first dose of SGN-40 and must agree to use an effective contraceptive method during the course of the study and for 6 months following the last dose of study drug. * If a deep venous thrombosis or other vascular even has required medical or surgical intervention in the past year, patients must either be on stable dose of anticoagulant therapy for at least 3 weeks or have completed anticoagulant therapy at least 3 months prior to registration with radiographic confirmation that thrombosis is resolved. * Patients must be at least 18 years of age. * Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution. Exclusion Criteria: * Patients with history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma. * Patients with a documented history within 6 months of registration of a cerebral vascular event, myocardial infarction, deep venous thrombosis or other vascular event that has required medical or surgical intervention. Patients must have completed anticoagulant therapy at least 3 months prior to registration. Prophylactic anticoagulant therapy for indwelling catheters is acceptable. * Patients who have received an allogeneic stem cell transplant. * Patients who have had major surgery within 4 weeks prior to registration. * Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation. * Patients with a history of another primary malignancy that has not been in remission for at least 5 years (non-melanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear are exempt from the five year limit). * Patients with any active systemic viral, bacterial, or fungal infection within four weeks prior to registration. * Patients with known positivity for HIV, hepatitis B or hepatitis C infection. * Patients with a history of significant chronic or recurrent infections requiring treatment. * Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment. * Patients on systemic steroids who have not been on a stable daily dose (not exceeding 10 mg prednisone or equivalent) during 4 weeks prior to the first dose of SGN 40. * Patients who are pregnant or breastfeeding. * Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment. * Patients with dementia or altered mental status that would preclude the understanding and/or rendering of informed consent.

Study Objectives Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors Conditions: Bladder Cancer Intervention / Treatment: DRUG: Tamoxifen Citrate 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: Males and females age >= 21 years. Histologic evidence of urothelial carcinoma of the bladder. Low/Intermediate-risk papillary urothelial carcinoma of the bladder, at initial occurrence or recurrent with >6 months interval free of disease. Patients with multifocal tumors must have resectable lesions. Patients may be treatment-naïve or have failed 1 previous regimen of intravesical therapy. At least one endoscopically measurable tumor 6 - 10mm in diameter. Adequate hepatic and renal function. Patient or authorized proxy needs to have signed the informed consent form. * Exclusion Criteria: Patients with sessile appearing tumors, which may be invasive or high-grade. Diagnosis of urothelial carcinoma involving the prostatic urethra or upper urinary tract. Plans for pelvic radiation while participating in the study. Concurrent use of warfarin, heparin, or chronic use of NSAIDs, including aspirin (other than cardioprotective doses of 80mg daily) within 30 days prior to registration or during the trial. Concurrent use of selective serotonin reuptake inhibitors or aromatase inhibitors. Chronic or acute renal or hepatic disorder or any other condition, medical or psychological that, in the opinion of the investigator, could jeopardize the subject's safe participation. Any other investigational drug within 30 days prior to registration and during the study. Women Exclusion Pregnant or lactating women. Personal history of endometrial cancer or any abnormal uterine bleeding. Previous or concurrent treatment with SERM and/or hormonal replacement therapy within 3 months of the study. *

Study Objectives This trial's aim is to evaluate the efficacy and toxicity of sorafenib in relapsed advanced Non-Small Cell Lung Cancer (NSCLC) after failure of epidermal growth factor receptors-tyrosine kinase inhibitor (EGFR-TKI) treatment and to explore the correlation between clinical outcomes and biochemical modulation of signal transduction pathways. Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: sorafenib (Nexavar) Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological or cytological documented stage IIIB (not amenable for radical regional therapy) or stage IV NSCLC. The pathological diagnosis must be adenocarcinoma with or without bronchioalveolar carcinoma. Sputum cytology alone is excluded. * Recurrent or progressive disease after prior one EGFR-TKI treatment. The patient must have stopped the EGFR-TKI treatment for at least two weeks. The response to EGFR-TKI should be partial response or complete response or stable disease (the duration of stable disease should be more than 3 months). Patients who had never received chemotherapy or received one regimen chemotherapy before EGFR-TKI are eligible. * Prior surgery, including palliative surgery, is permitted if performed 4 weeks before the start of study treatment and the patient is fully recovered. * Prior localized radiotherapy 4 weeks before the start of study is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented. Patient has recovered from CTCAE grade 3/4 toxicity of radiotherapy. Palliative radiotherapy within 4 weeks of start of study is also permitted. * Age > 18 years. * ECOG Performance Status of 0, 1,or 2. Life expectancy of at least 3 months. Measurable disease, according to the RECIST, the presence of at least one uni-dimensional measurable lesion with longest diameter > 20 mm by conventional techniques or > 10 mm by spiral CT scan. * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * Hemoglobin > 9.0 g/dl * Platelet count > 75x109/L * Total bilirubin <= 1.5 x upper limit of normal * ALT and AST < 2.5 x upper limit of normal without liver metastasis, ALT and AST < 5 x upper limit of normal with liver metastasis. * International normalized ratio (INR) <= 1.5 x the upper limit of normal and prothrombin time (PT) <= 1.5 x the upper limit of normal. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists. * Serum creatinine < 1.5 x upper limit of normal. Exclusion Criteria: * Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial. * Mixed small cell and non-small cell lung cancer histology. Other pathological types of NSCLC than adenocarcinoma and bronchioloalveolar cell carcinoma. * Failure of EGFR-TKI is due to toxicity. * Prior with exposure to biotherapy, immunotherapy within 4 weeks of study entry. * Prior exposure to sorafenib or other agents targeting the Ras/MARK pathway or VEGFR. * Any unresolved toxicity more than CTCAE grade 2 from previous anti-cancer therapy. * Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0(Conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTC > 0.45-0.47 second); however, patients with grade 2 atrial fibrillation may be included. * Significant cardiovascular event: congestive heart failure > NYHA class 2; unstable angina, active CAD (myocardial infarction more than 6 months prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. * Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication (sorafenib) or that might affect the interpretation of the results or render the subject at high risk from treatment. * Central nervous system (CNS) tumor or metastatic tumor. * Clinically significant gastrointestinal bleeding within 30 days of study entry.

Study Objectives The purpose of this phase II clinical study is to test the good and bad effects of T-VEC (talimogene laherparepvec) with or without hypofractionated radiotherapy on people with melanoma, Merkel cell carcinoma, or other solid tumors with skin metastasis. Conditions: Melanoma, Merkel Cell Carcinoma, Other Solid Tumors Intervention / Treatment: DRUG: TALIMOGENE LAHERPAREPVEC (TVEC), RADIATION: Hypofractionated Radiotherapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Man or woman >= 18 years old * Life expectancy > 4 months * Histopathologically confirmed melanoma, Merkel cell carcinoma or other solid tumor malignancy * Cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis not suitable for surgical resection * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis that is amenable to injection and irradiation and > 10 mm in longest dimension ° Cutaneous metastasis in a region of previous radiation therapy is amenable to radiation therapy as part of this protocol if at least 6 months has elapsed since prior radiotherapy and the dose of radiotherapy previously administered did not exceed an equivalent dose of 60 Gy in 2 Gy equivalent fractions at the skin surface (using linear-quadratic modeling with alpha/beta=11.5) * Metastasis that is > 10 mm in longest dimensionor exhibits radiotracer uptake consistent with metastasis on PET/CT * Adequate coagulation function (platelet count >50 k/mcL, international normalized ratio of < 1.5) * Resolution or stabilization of clinically significant adverse events from prior therapy * Able to provide valid written informed consent Exclusion Criteria: * Active herpetic skin lesions or prior complications of HSV-1 infection (such as herpetic keratitis, herpetic encephalitis) * Receipt of a therapeutic anticoagulant * Receipt of live vaccine within 28 days of planned first dose of TVEC * Receipt of another cancer therapy (targeted therapy, chemotherapy, investigational therapy, immunotherapy, radiotherapy or surgery) which is yielding an overall response (by response criteria in this study) ° Patients with stable or progressing disease (as determined by at least 2 consecutive assessments at 6-week interval) can continue to receive the same therapy during treatment as part of this protocol * History of symptomatic autoimmune disease (such as lupus, scleroderma, Crohn's disease, ulcerative colitis) requiring systemic treatment (for example corticosteroids or immunosuppressants); replacement therapy (for example, thyroxine, insulin) is not considered a systemic treatment * History of high grade (CTCAE >= Grade 3) immune mediated adverse event from prior cancer immunotherapy * History of CTCAE >= Grade 2 immune mediated endocrinopathy from prior cancer immunotherapy * Intermittent or chronic use of oral or intravenous antiherpetic drug (such as acyclovir) * Active or chronic hepatitis B or C infection ° Previously infected, with evidence of immunity and no evidence of active hepatitis is not an exclusion criterion * Known human immunodeficiency virus (HIV) infection * Known leukemia or lymphoma * Common variable immunodeficiency * Patients requiring chronic high dose immunosuppressants including steroids (prednisone daily equivalent of >= 10 mg) * Known severe congenital or acquired cellular or humoral immunodeficient or immunocompromised patients * High likelihood of protocol non-compliance (in opinion of investigator) * Woman of childbearing potential unwilling to use effective contraception during protocol treatment and for 3 months after last dose of Talimogene Laherparepvec * Woman of childbearing potential that is pregnant or breast-feeding, or planning to become pregnant or breast-feed during protocol treatment and for 3 months after last dose of Talimogene Laherparepvec

Study Objectives The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Sagopilone (ZK 219477) + prednisone Location: United States, Argentina Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Must have evidence of confirmed metastatic prostate cancer * Serum testosterone must be less than 50 ng/mL * Disease must be progressing despite anti-androgen therapy * PSA level must be elevated * Additional criteria determined at screening visit Exclusion Criteria: * Any previous cytotoxic chemotherapy for prostate cancer * Use of any investigational drug in the last 4 weeks * Symptomatic brain tumors requiring radiation to the brain * Active infection * Additional criteria determined at screening visit

Study Objectives This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of obinutuzumab + Atezo + Pola in participants with relapsed or refractory (RR) FL and rituximab + Atezo + Pola in participants with RR DLBCL. The study will include an initial dose-escalation phase designed to determine the recommended Phase 2 dose (RP2D) for Pola in this treatment combination, followed by an expansion phase in which Pola will be given at the RP2D. All participants will receive induction treatment with obinutuzumab + Atezo + Pola for 6 cycles. RR FL participants achieving a complete response (CR), partial response (PR), or stable disease (SD) at the end of induction (EOI) will receive maintenance treatment with obinutuzumab. Conditions: Lymphoma Intervention / Treatment: DRUG: Atezolizumab [TECENTRIQ], DRUG: Obinutuzumab, DRUG: Polatuzumab Vedotin, DRUG: Rituximab Location: Poland, United States, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * For obinutuzumab + Atezo + Pola treatment group: relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-Cluster of Differentiation (CD)20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator * For rituximab + Atezo + Pola treatment group: relapsed or refractory DLBCL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody, in participants who are not eligible for second line combination (immuno-) chemotherapy and autologous stem-cell transplantation or who have failed second line combination (immuno-) chemotherapy or experienced disease progression following autologous stem-cell transplantation * Histologically documented CD20-positive lymphoma and fluorodeoxyglucose (FDG)-avid lymphoma (that is PET-positive lymphoma) with at least one bi-dimensionally measurable lesion * Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL or DLBCL * For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or to use contraceptive methods that result in a failure rate of less than (<) 1% per year during the treatment period for greater than or equal to (>=) 5 months after last dose of Atezo, >= 12 months after last dose of rituximab, >= 12 months after last dose of Pola, and >= 18 months after last dose of obinutuzumab * For men: agreement to remain abstinent or to use contraceptive measures that result in a failure rate of <1% per year during the treatment period and for at least 3 months after last dose of obinutuzumab, rituximab, and Atezo and for 5 months after last dose of Pola, and agreement to refrain from donating sperm during this same period Exclusion Criteria: * Grade 3b follicular lymphoma * History of transformation of indolent disease to DLBCL * Known CD20-negative status at relapse or progression; CNS lymphoma or leptomeningeal infiltration * Prior allogeneic stem cell transplantation (SCT), completion of autologous SCT within 100 days prior to Day 1 of Cycle 1 (D1C1) * Prior anti-cancer therapy including: Fludarabine or alemtuzumab within 12 months prior to D1C1; radioimmunoconjugate within 12 weeks prior to D1C1; monoclonal antibody or antibody drug conjugate (ADC) within 5 half-lives or 4 weeks prior to D1C1 ; radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to D1C1; anti-programmed death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4), anti-CD137/41-BB agonist, or anti-CD40 agonist antibodies * Treatment with systemic immunosuppressive medications, including but not limited to prednisone, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to D1C1 * History of solid organ transplantation and of severe allergic or anaphylactic reaction to humanized, chimeric, or murine monoclonal antibodies * Active infection; positive for hepatitis B surface agent (HbsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening; known history of HIV positive status, progressive multifocal leukoencephalopathy (PML), autoimmune disease * Vaccination with a live virus vaccine or live attenuated vaccine within 28 days prior to D1C1 * Pre-existing Grade greater than (>) 1 neuropathy * Major surgical procedure other than for diagnosis within 28 days prior to D1C1 * Inadequate hematologic function, renal function, and liver function * Pregnant or lactating women * Life expectancy < 3 months

Study Objectives To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: TAS-102, DRUG: Placebo Location: Thailand, Korea, Republic of, China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Has provided written informed consent * Has adenocarcinoma of the colon or rectum * Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Is able to take medication orally * Has adequate organ function (bone marrow, kidney and liver) * Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Study Objectives This phase 1/2 trial the studies side effects and best dose of crizotinib and to see how well it works in treating young patients with solid tumors or anaplastic large cell lymphoma that has returned after a period of improvement or does not respond to treatment. Crizotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. (Phase 1 completed 2/15/13) Conditions: Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Malignant Solid Neoplasm, Recurrent Neuroblastoma, Refractory Anaplastic Large Cell Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Neuroblastoma Intervention / Treatment: DRUG: Crizotinib, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, OTHER: Questionnaire Administration Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Patients receiving the formulated capsules must have a body surface area (BSA) >= 0.63 m^2 at the time of study enrollment * Patients must have had histologic verification of malignancy at original diagnosis or relapse * * Phase 1 (Part A1) - COMPLETE: Patients with relapsed or refractory solid tumors or anaplastic large cell lymphoma (excluding patients with primary or metastatic central nervous system [CNS] tumors or patients with primary cutaneous ALCL) * * Phase 1 (Part A2) - COMPLETE: Patients with confirmed ALK fusion proteins, ALK mutations, ALK amplification (defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm) or MET proto-oncogene, receptor tyrosine kinase (MET) mutation or amplification; testing to confirm the presence of ALK fusion proteins, ALK mutations, ALK amplification or evidence of MET mutation or amplification for eligibility purposes must be performed as a Clinical Laboratory Improvement Act (CLIA)-certified assay; ALK immunohistochemistry can be used as a surrogate for fluorescent in situ hybridization (FISH) for patients with inflammatory myofibroblastic tumors (IMT) or ALCL * ** Note: Evidence for MET mutation or amplification is defined as: * Positive for c-Met amplification by FISH; or * Positive for known c-Met kinase domain activating mutations including V1110L, H1112L, H1112Y, H1124D, M1149T, T1191I, V1206L, L1213V, V1238I, M1268T, P1009S, T1010I, R988C, V941L, but excluding Y1248C, Y1248H, Y1248D, and Y1253D; or * Chromosomal translocations that lead to altered transcriptional regulation of c-Met and/or hepatocyte growth factor (HGF) including metastatic alveolar soft part sarcoma, clear cell sarcoma, rhabdomyosarcoma, or translocation associated renal cell carcinoma) * * Phase 1 (Part A3) - COMPLETE: Patients with relapsed or refractory neuroblastoma, with or without bone marrow involvement, who are not eligible for Part A1 or A2 or cannot enroll on Part A1 because of stratum suspension or lack of available slots (these patients will be enrolled at one dose level below the dose level at which patients on Part A1 are actively enrolling) * * Phase 2 (Part B): Patients with ALK+ relapsed or refractory neuroblastoma * * Phase 2 (Part C): Patients with ALK+ relapsed or refractory ALCL (excluding patients with primary cutaneous ALCL) * * Phase 2 (Part A2): Patients with diagnoses other than neuroblastoma or ALCL with confirmed ALK fusion proteins, ALK mutations, ALK amplification (defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm) or MET mutation or amplification; testing to confirm the presence of ALK fusion proteins, ALK mutations, ALK amplification or evidence of MET mutation or amplification for eligibility purposes must be performed as a CLIA-certified assay; ALK immunohistochemistry can be used as a surrogate for FISH for patients with IMT * Disease status: * Phase 1 (Part A): Patients must have either measurable and/or evaluable disease * Phase 2 (Part B): Patients with neuroblastoma must have proven ALK+ disease with either measurable and/or evaluable disease as indicated below: * Measurable tumor on magnetic resonance imaging (MRI), computed tomography (CT) scan or X-ray obtained within 2 weeks prior to study enrollment * Evaluable tumor by meta-iodobenzyl guanidine I 123 (MIBG) scan and/or bone marrow involvement with tumor cells seen on routine morphology * Phase 2 (Part C): Patients must have proven ALK+ disease with either measurable or evaluable disease * Performance level: Karnofsky >= 50 for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age); Note: patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score * Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy: * Myelosuppressive chemotherapy: * Solid tumors: Patients with solid tumors must not have received chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea) * Lymphoma: Patients with lymphoma who relapse during standard maintenance therapy are eligible at time of relapse; for patients with ALCL who relapse while they are receiving cytotoxic therapy, at least 14 days must have elapsed since the completion of cytotoxic therapy; Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of Crizotinib * At least 7 days since the completion of therapy with a growth factor * At least 7 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair * At least 7 days or 3 half-lives, whichever is longer, must have elapsed since prior treatment with a monoclonal antibody * >= 2 weeks (wks) for local palliative radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of MIBG; >= 6 months must have elapsed if prior total body irradiation (TBI), craniospinal XRT or >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial bone marrow (BM) radiation * Bone marrow/stem cell transplant or infusion without TBI: * Part A1 or Part C: No evidence of active graft vs host disease and >= 3 months must have elapsed since stem cell transplant or infusion * Part A2, Part A3, or Part B: No evidence of active graft vs host disease and >= 6 weeks must have elapsed since stem cell transplant or infusion * At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines * Patients must not have received prior therapy with Crizotinib * Patients on Part A1 or Part C of the study: * For patients with solid tumors or ALCL without bone marrow involvement: * Peripheral absolute neutrophil count (ANC) >= 1,000/mm^3 * Platelet count >= 75,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment) * Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) * Patients with known bone marrow metastatic disease: * Peripheral absolute neutrophil count (ANC) >= 750/mm^3 * Platelet count >= 25,000/mm^3 (may receive platelet transfusions) * Hemoglobin >= 8.0 g/dL (may receive RBC transfusions) * Not known to be refractory to RBC or platelet transfusions Transfusions are permitted to meet both the platelet and hemoglobin criteria; Note: patients with known bone marrow metastatic disease are not evaluable for hematological toxicity for the purposes of dose escalation * Patients eligible for Part A2, Part A3, or Part B of the study must meet the hematologic criteria below for enrollment: * Peripheral absolute neutrophil count (ANC) >= 750/mm^3 * Platelet count >= 25,000/mm^3 (may receive platelet transfusions) * Hemoglobin >= 8.0 g/dL (may receive RBC transfusions) * Not known to be refractory to red cell or platelet transfusions Transfusions are permitted to meet both the platelet and hemoglobin criteria * Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows: * 1 to < 2 years: 0.6 mg/dL * 2 to < 6 years: 0.8 mg/dL * 6 to < 10 years: 1 mg/dL * 10 to < 13 years: 1.2 mg/dL * 13 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female) * >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female) * Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L * Serum albumin >= 2 g/dL * Corrected QT interval (QTc) =< 480 msec * All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines * Patients taking the capsule formulation must be able to swallow capsules; feeding tube administration is allowed for patients receiving the oral solution (OS) Exclusion Criteria: * Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the prior 7 days are not eligible * Patients who are currently receiving another investigational drug are not eligible * Patients who are currently receiving other anti-cancer agents, with the exception of hydroxyurea for patients with ALCL, are not eligible * As Crizotinib is an inhibitor of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices including pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; the topical use of these medications (if applicable) is allowed * Patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to, ketoconazole, itraconazole, miconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed * Patients chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, tipranavir, ritonavir, and St. John's wort are not eligible; the topical use of these medications (if applicable) is allowed * Patients with known interstitial fibrosis or interstitial lung disease are not eligible * Patients with a known history of myocardial infarction or cerebrovascular accident are not eligible * Patients with central nervous system (CNS) tumors or known CNS metastases are not eligible; patients with a history of CNS metastases that have been surgically resected are eligible only if the baseline evaluation shows no evidence of current CNS metastases; patients with any evidence of CNS metastases on baseline evaluation are not eligible, regardless of whether the lesions have been previously treated and/or appear stable * Patients who have an uncontrolled infection are not eligible * Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

Study Objectives BACKGROUND: Previous studies of short-term surgical outcomes after preoperative exposure to anti-TNF therapy in ulcerative colitis (UC) patients who have undergone IPAA have been conflicting. We sought to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the colorectum, which may be a potential factor in adverse anastomosis complications following IPAA surgery. METHODS: Individuals who received infliximab as maintenance therapy and who received their last dose within 180 days of the first stage of IPAA were selected. The control group comprised UC patients who were not exposed to anti-TNF therapy, matched by age, sex, BMI, disease duration, albumin levels, and post-operative leak outcome. Hematoxylin and eosin- (H\&E) and trichrome-stained slides from the most distal, well-oriented, full-thickness section of colorectum from each patient's total colectomy specimen were evaluated. Blinded assessment of the degree of fibrosis in the lamina propria, the submucosa, the submucosa immediately adjacent to the muscularis propria, and the subserosa was performed by a single observer using a semi-quantitative pictorial scale. Conditions: Ulcerative Colitis, Anti TNF Therapy, Ileal Pouch Anal Anastomosis (IPAA) Intervention / Treatment: DRUG: Anti-TNF Drug Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed . Exclusion Criteria: * Patients with CD * Patients without adequate clinical records documenting the 30-day postoperative clinical outcomes .

Study Objectives Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors Conditions: Breast Cancer, Ovarian Cancer, Gynecological Cancer, Head and Neck Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Non-squamous Cell Lung Cancer Intervention / Treatment: DRUG: PM01183 + paclitaxel +/- bevacizumab Location: United States, Spain, Switzerland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Voluntarily signed and dated written informed consent * Age between 18 and 75 years old (both inclusive) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <= 1 * Life expectancy >= 3 months. * Patients with a histologically/cytologically confirmed diagnosis of advanced and/or unresectable disease of any of the following tumors: 1. Breast cancer 2. Epithelial ovarian cancer or gynecological cancer 3. Head and neck squamous cell carcinoma 4. Non-small cell lung cancer 5. Small cell lung cancer 6. Platinum-refractory germ-cell tumors. 7. Adenocarcinoma or carcinoma of unknown primary site * Adequate bone marrow, renal, hepatic, and metabolic function * Recovery to grade <= 1 or to baseline from any Adverse Event (AE) derived from previous treatment (excluding alopecia of any grade). * Pre-menopausal women must have a negative pregnancy test before study entry and agree to use a medically acceptable method of contraception throughout the treatment period and for at least six weeks after treatment discontinuation Exclusion Criteria: * Prior treatment with PM01183 or weekly paclitaxel or nanoalbumin-paclitaxel * Patients who have previously discontinued paclitaxel-based regimes due to drug related toxicity. * Known hypersensitivity to bevacizumab or any component of its formulation * Patients who have previously discontinued bevacizumab-containing regimes due to drug-related toxicity. * More than three prior lines of chemotherapy * Less than three months since last taxane-containing therapy. * Wash-out period: 1. Less than three weeks since the last chemotherapy-containing regimen 2. Less than three weeks since the last radiotherapy dose 3. Less than four weeks since last monoclonal antibody-containing therapy * Concomitant diseases/conditions: Unstable angina, myocardial infarction, valvular heart disease, encephalopathy, ischemic attacks, hemorrhagic or ischemic cerebrovascular accident (CVA) or ongoing pulmonary embolism within last year, arrhythmia, hepatopathy, uncontrolled infection, hemoptysis or oxygen requiring dyspnea, known HIV infection, bleeding risk, muscular problems, peripheral neuropathy, Symptomatic or progressive brain metastases or leptomeningeal disease. * Men or pre-menopausal women who are not using an effective method of contraception as previously described; actively breast feeding women. * Patients who have pelvic irradiation with doses >= 45 Grays (Gy). * History of previous bone marrow and/or stem cell transplantation. * Confirmed bone marrow involvement

Study Objectives This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body. Conditions: Metastatic Prostate Cancer Intervention / Treatment: DRUG: 18F-DCFBC Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological confirmation of prostate cancer * Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, [18F]Sodium Fluoride PET, and/or [18F]FDG PET * Rising PSA on two observations taken at least 1 week apart * Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration * Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease * Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging * Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits * Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures Exclusion Criteria: * Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration * Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest) * Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression. * Serum creatinine > 3 times the upper limit of normal * Total bilirubin > 3 times the upper limit of normal * Liver Transaminases > 5times the upper limit of normal * Unable to lie flat during or tolerate PET/CT * Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Study Objectives This is a Phase I Study of veliparib (ABT-888) in combination with Gemcitabine and Intensity Modulated Radiation Therapy in Patients with Locally Advanced, Unresectable Pancreatic Cancer. Primary Objectives: * Determine the maximum tolerable dose of veliparib in combination with gemcitabine and intensity modulated radiation therapy in patients with locally advanced pancreatic cancer. * Determine the safety and toxicity of the combination of veliparib with gemcitabine and radiation therapy in patients with locally advanced pancreatic cancer Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Veliparib, DRUG: Gemcitabine, RADIATION: Intensity modulated radiation therapy 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 histopathological or cytological diagnosis of adenocarcinoma of the pancreas, as well as those with high clinical suspicion of adenocarcinoma, which is deemed locally advanced unresectable or borderline resectable as determined by a pancreatic cancer surgeon and/or following evaluation by a GI oncology tumor board. * Age >= 18 years Exclusion Criteria: * Patients who have had prior anti-cancer treatment for their disease * Patients who are currently receiving any other investigational agents * Metastatic disease * History of allergic reactions attributed to compounds of similar chemical or biologic composition to PARP [Poly (ADP-ribosome) polymerase] inhibitors or gemcitabine * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study Objectives A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients. Conditions: Gastric Cancer Intervention / Treatment: DRUG: S-1, DRUG: Capecitabine Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Pathologically proven gastric or gastroesophageal junction adenocarcinoma * Metastatic or recurrent unresectable disease * Measurable lesions (according to Response Evaluation Criteria in Solid Tumors [RECIST]) * Age: 65-85 years old * Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 * Adequate bone marrow function: absolute neutrophile counts(ANC) >= 1,500/ul, platelet count >= 100,000/ul, hemoglobin >= 9 g/dl) * Adequate renal function (serum creatinine<= 1.5) * Adequate liver function (serum bilirubin <= 2 x upper limits of normal [UNL], aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 3 x UNL) * No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to study treatment is allowed with the exception of capecitabine or S-1) Written informed consent was signed by the patient Exclusion Criteria: * Previous palliative chemotherapy * Known allergy to study drugs * CNS metastasis * Significant medical comorbidities * Active ongoing infection which antibiotic treatment is needed. * Previous ( within 5 years) history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ.

Study Objectives The goal of this study is to evaluate the efficacy and safety of a combination of the anti-CD20 monoclonal antibody Rituximab, Dexamethasone, daily high dose Cytarabine twice, and Carboplatin; delivered in an outpatient setting. Conditions: Relapsed Non Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma Intervention / Treatment: DRUG: Rituximab, DRUG: Carboplatin, DRUG: Cytarabine Injection, DRUG: Dexamethasone, DRUG: Filgrastim 0.3 MG/ML Location: Mexico Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of recurrent or refractory B-cell non-Hodgkin lymphoma * Performance status: Eastern Cooperative Oncology Group 0-2 * At least three weeks from last chemotherapy * Toxicities by Common Terminology Criteria Version 4.0 <= 1 * Glomerular filtration rate >50 ml/min * Women of childbearing potential must use effective methods of contraception Exclusion Criteria: * Post-transplant relapse of lymphoma * Central nervous system involvement of lymphoma * Serious infections * Known allergies to one or more of the experimental drugs * Diabetes with glucose >200 mg/dl * Pregnant or lactating females * Known HIV or B Hepatitis positivity * Known allergies to filgrastim

Study Objectives The purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients. Conditions: Condylomata Acuminata Intervention / Treatment: DRUG: Polyphenon E Ointment 10%, Polyphenon E Ointment 15% Location: Mexico, Chile, Peru, Romania, United States, Colombia, Argentina Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Age >= 18 years at the time of enrollment * Clinical diagnosis of external genital warts (located genital, inguinal, perineal or perianal) * At least 2, but no more than 30 external genital warts * A total wart area between 12 and 600mm² * Negative pregnancy test and willingness to use effective contraception (for women of child-bearing potential) * For partners of male patients who are of child-bearing potential: use of effective contraception during the treatment period * Written informed consent * Ability to comply with the requirements of the study Exclusion Criteria: * Participation in an investigational trail within 30 days prior to enrollment * Previous participation in a trial investigating Polyphenon E in the treatment of external genital warts * Treatment of external genital warts within 30 days prior to enrollment and for the whole study duration * Systemic intake of virostatics within 30 days prior to enrollment and for the whole study duration * Systemic intake of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment and for the whole study duration * Current infection with Herpes genitalis or history of Herpes genitalis infection within the last 3 month * Any current and/or recurrent pathologically relevant genital infections other than genital warts * Current known acute or chronic infection with HBV or HCV * Known HIV infection * Any current uncontrolled infection * Organ allograft * For female patients: pregnancy or lactation * Known allergies against any of the ingredients of the treatments * Any chronic or acute skin condition susceptible of interfering with the evaluation of the drug effect * Any chronic condition susceptible, in the opinion of the investigator, of interfering with the conduct of the study * Internal (vaginal or rectal) warts requiring treatment

Study Objectives The study will be conducted in patients with solid tumors for whom single-agent docetaxel, in the dose of 75 mg/m2, is a suitable treatment option. Each patient, meeting all the inclusion criteria and none of the exclusion criteria, will receive test or reference product in a cross over manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 22 (Period II) Conditions: Docetaxel, Solid Tumours, Bioequivalence Intervention / Treatment: DRUG: BH009 (Docetaxel injection), DRUG: Docetaxel injection Location: India Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: OTHER Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: Patients meeting all of the following criteria will be considered for enrollment in the study. * Patients of either gender, >=18 years of age. * Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures. * Histologically or cytologically confirmed advanced solid tumors who are scheduled to receive treatment with single-agent docetaxel, in the dose of 75 mg/m2 or those whose are already receiving single-agent docetaxel (taxotere® or an approved generic drug of taxotere®), in the dose of 75 mg/m2 and are scheduled to two more cycles, in the same dose, as per the actual treatment plan. Note: Metastatic castration-resistant prostate cancer will not be considered for the study as the patients are required to receive prednisone along with docetaxel and the regime of dexamethasone (CYP 3A4 inducer is different from that in other indications) * ECOG performance status 0 or 1 and Life expectancy >=3 months (as per the Investigator's discretion). * Adequate Hematopoietic, Renal and Liver function defined as the following: Bone marrow function :ANC >=1500/mm3, Platelet count >=100,000/mm3, Haemoglobin > 9.0 g/dl Hepatic function:ALT/AST <= 1.5 × ULN, Alkaline phosphatase <= 2.5 × ULN ,Total Bilirubin <= ULN Renal function:Serum creatinine <=1.5 x ULN * Prothrombin time, international normalized ratio or activated partial thromboplastin time <1.5 × ULN; Use of full dose anticoagulants is permitted. These laboratories should be maintained within the therapeutic range and closely monitored by the Investigator. * Recovery, to Grade 0-1 (as per CTCAE 5.04 criteria), from adverse events related to prior anticancer therapy except alopecia and endocrinopathies controlled with hormone replacement therapy. * Prior chemotherapy (except ongoing taxotere or an approved generic of taxotere, in which last dose must have been received at least 21 days prior to cycle 1 of the study), immunotherapy and radiation therapy must be completed at least 30 days prior to randomization (42 days for mitomycin C or nitrosoureas). Completion of palliative radiotherapy to a single disease site must be completed at least 14 days prior to randomization. * In case of female patient, the serum pregnancy test at screening visit and urine pregnancy test at baseline must be negative. * Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 1 month prior to study drug administration, during study and up to 6 month after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. * In case of male patients: either partner or patient must use an effective method of avoiding pregnancy for at least 1 month prior to study drug administration, during study and up to 3 month after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. Exclusion Criteria: Patients will be excluded from the study, if they meet any of the following criteria: * Hypersensitivity or idiosyncratic reaction to docetaxel, its excipients, and/or related substances including polysorbate 80, paclitaxel, alcohol, dexamethasone and Antiemetic (Granisetron or Ondansetron). * Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; uncontrolled arrhythmia within 6 months of study entry. * Average corrected QT (QTc) interval by Frederica's formula (QTcF) on triplicate ECGs at screening > 470 msec (females) or > 450 msec (males); or on concomitant medications that would prolong the QT interval; or have family history of long QT syndrome. * Patients with an active infection (e.g. tuberculosis, sepsis and opportunistic infections). * Patients with severe pleural effusion (volume involving > 40% of the hemithorax on CT scan chest) or gross ascites (>800ml of ascitic fluid)3,4. * Peripheral neuropathy >=grade 2 (as per CTCAE 5.04 criteria). * A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies. * Patients with HIV infection. * Patients with known brain metastasis or those showing neurologic symptoms due to brain metastasis. * Recent or clinically significant history of drug or alcohol abuse. * Patients require concomitant treatment with potent Cytochrome P450 3A4 inhibitors, inducers or substrates. * Use of any Cytochrome P450 3A4 inducers, inhibitors, or substrates that may alter docetaxel metabolism (e.g. dronedarone, epirubicin, sorafenib, CNS depressants) within 14 days before randomization. * Major surgery within 4 weeks prior to study entry; minor surgery within 2 weeks prior to study entry. * Patients found positive on urine scan for drugs of abuse and/or breath test for alcohol consumption at screening or baseline. Note: Benzodiazepines and /or opioids given in therapeutic doses under the observation of physician for management of insomnia / anxiety / pain, etc., will be allowed, provided that there is no drug-drug interaction with the study drug and an approval from the Veeda medical monitor is taken. * The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days (or 5 half-lives, whichever is longer) prior to the first dose of investigational medicinal product for the current study. * Pregnant or Breast feeding female. * Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study. * Abnormal baseline laboratory / physical findings considered to be clinical significant by the investigator. * Patients with any significant history of non-compliance or inability to reliably grant informed consent.

Study Objectives Lung cancer is the leading malignancy worldwide and in Bangladesh. Most of the lung cancer is of Non-small Cell Lung Cancer (NSCLC) type. For locally advanced NSCLC, combined modality treatment is required. Concurrent chemo-radiotherapy and sequential chemo-radiotherapy are the two recommended options. Sequential chemo-radiotherapy is mainly practiced in Bangladesh due to its less toxicity profile. There is no head to head comparative study done which focuses on the sequential chemotherapy regimens used in locally advanced NSCLC. Hypothesis: Null Hypothesis (H0): Sequential chemotherapy with cisplatin and vinblastine followed by radiotherapy and paclitaxel and carboplatin followed by the same radiotherapy in locally advanced NSCLC, there is no difference in loco-regional tumor control. Alternative Hypothesis (HA): Sequential chemotherapy with cisplatin and vinblastine followed by radiotherapy and paclitaxel and carboplatin followed by the same radiotherapy in locally advanced NSCLC, cisplatin and vinblastine is more responsive and effective in loco-regional tumor control than paclitaxel and carboplatin. Conditions: Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: Paclitaxel, DRUG: Carboplatin, DRUG: Cisplatin, DRUG: Vinblastine Sulfate, RADIATION: three dimensional conformal radiotherapy Location: Bangladesh Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * * Patients with locally advanced (stage III a, b) non-small cell lung cancer. * Patients who are inoperable. Patients Eastern Co-operative Group (ECOG) performance score up to grade 2. Exclusion Criteria: * * Age below 18 years. * Patients with history of prior chemotherapy or radiotherapy to lung region. * Serious concomitant medical illness including severe heart disease, uncontrolled diabetes mellitus or hypertension. * Life expectancy < 6 months. * Patient with uncontrolled infection * Pregnant or lactating woman. * Psychiatric illness.

Study Objectives The goal of this clinical research study is find the highest safe dose of cisplatin that can be given with liposomal doxorubicin in the treatment of advanced cancer involving the liver. PRIMARY Objectives: To determine the toxicity and safety of a monthly cytotoxic regimen combining intraarterial hepatic (HAI) cisplatin with systemic intravenous liposomal doxorubicin in patients with cancer metastatic to the liver. SECONDARY Objectives: To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial cisplatin in combination with systemic liposomal doxorubicin. Conditions: Advanced Cancer Intervention / Treatment: DRUG: Cisplatin, DRUG: Liposomal Doxorubicin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with Histologically confirmed diagnosis of malignancy and liver involvement as dominant site of metastasis (over 50% of all tumor burden). * Pediatric patients eligible at the discretion of the primary investigator. * Performance Status Equivalent or Grater than 60% in the Karnofsky's Performance scale (Requires occasional assistance but is able to care for own needs). * Adequate Renal Function (Serum CRE <= 1.5 mg/dL) or calculated Creatinine Clearance >= 50 ml/min (Cockcroft Formula). * Adequate Hepatic Function (Total Bilirubin <= 1.5 mg/dL or ALT <= 5 times upper normal reference value). * Adequate Bone Marrow Function (Absolute neutrophil count (ANC) >= 1.5 cells/uL; number of platelets (PLT) >= 100,000 cells/uL). * At least three weeks from previous cytotoxic chemotherapy before day 1 of HAI infusion. After targeted or biologic therapy there should be 5 half-lives or three weeks, whichever is shorter. * All Females in Childbearing Age MUST have a negative urine or serum Human chorionic gonadotropin or human chorionic gonadotrophin (hCG) test unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity). * Ability to fully read, comprehend, and sign informed consent forms. In pediatric patients, the informed consent forms will be signed by a parent or legal guardian. * Patients with germ cell tumors and lymphoma MUST have had documented progression of disease prior to enrollment. Exclusion Criteria: * Clinical or radiographic evidence of Ascites. * Pregnant females. * Hypersensitivity to platinum compounds or anthracyclines. * Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements. * Jaundice. (Bilirubin > 1.5 mg/dL). * Bleeding Diathesis.(Prothrombin time > 20 secs or International Normalized Ratio (INR) > 2.0). * Portal vein thrombosis. * Grade 2 Peripheral Neuropathy (CTC V3.0: Sensory alteration interfering with function but not interfering with ADL) * Medical History or Clinical Evidence of Congestive Heart Failure.

Study Objectives This is a Phase I, open label, dose-escalation study of MetMAb administered by intravenous (IV) infusion in patients with advanced solid malignancies that are refractory to or for which there is no standard of care. The study consists of a dose-escalation stage, an expansion stage testing MetMAb at the recommended Phase II dose (RP2D), and a dose-escalation stage testing the combination of MetMAb, at two different doses with bevacizumab at a recommended dose. Conditions: Solid Cancers Intervention / Treatment: DRUG: bevacizumab, DRUG: MetMAb, DRUG: MetMAb Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologic documentation of incurable, locally advanced, or metastatic solid malignancy that has failed to respond to at least one prior regimen or for which there is no standard therapy * Disease that is measurable or evaluable by Response Evaluation Criteria In Solid Tumors (RECIST) * Life expectancy >=12 weeks Exclusion Criteria: * Less than 4 weeks since the last anti-tumor therapy * Patients receiving erythropoietin products * Active infection requiring antibiotics * Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs * Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy * Clinically important history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis * Known human immunodeficiency virus infection * Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases

Study Objectives This phase II trial is studying how well CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. Conditions: Gastrointestinal Stromal Tumor, Recurrent Adult Soft Tissue Sarcoma, Stage I Adult Soft Tissue Sarcoma, Stage II Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma Intervention / Treatment: DRUG: temsirolimus, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologic confirmed soft tissue sarcoma * Measurable disease; for patients having only lesions measuring at least 1 cm to less than 2 cm, must use spiral CT imaging for both pre- and post-treatment tumor assessments * Absolute neutrophil count (ANC) >= 1,500/μL * Platelets (PLTS) >= 100,000/μL * Hgb >= 10.0 g/dL * Direct bilirubin =< 1.5 x ULN (upper limit normal) * AST(SGOT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present * ALT(SGPT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present * Creatinine =< 1.5 x ULN, or if greater, creatinine clearance >= 50 mL/min/1.73 m^2 * Baseline glucose levels * Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L) * Fasting triglycerides =< 400 mg/dL (4.56 mmol/L) * ECOG Performance Status (PS) 0, 1 or 2 * Life expectancy >= 12 weeks * Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent Exclusion Criteria: * Any of the following as this regimen may be harmful to a developing fetus or nursing child: * Pregnant women * Breast-feeding women * Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception ( diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) * Any of the following: * Nitrosoureas or mitomycin =< 6 weeks prior to study entry * Other chemotherapy =< 4 weeks prior to study entry * Radiotherapy =< 4 weeks prior to study entry * Concurrent use of any other investigation agent * Adverse events due to agents administered =< 4 weeks prior to study entry * History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779 * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, diabetes, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Known HIV-positive patients receiving combination anti-retroviral therapy * Prior chemotherapy for metastatic disease * Exceptions: * Patients with GIST who fail Gleevec are eligible * Patients who have had adjuvant/neoadjuvant chemotherapy are also eligible * Known brain metastases * Exception: Patients with treated brain metastatic disease with stable symptoms after treatment for >= 1 month

Study Objectives The aim of this study is the safety and efficacy of Trastuzumab plus natural killer(NK) immunotherapy to recurrent breast cancer. Conditions: Recurrent Breast Cancer Intervention / Treatment: DRUG: Trastuzumab, BIOLOGICAL: NK immunotherapy Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence * Body tumor 1-6, the maximum tumor length < 5 cm * KPS >= 70, lifespan > 6 months * Platelet count >= 80×109/L，white blood cell count >= 3×109/L, neutrophil count >= 2×109/L, hemoglobin >= 80 g/L Exclusion Criteria: * Patients with cardiac pacemaker * Patients with brain metastasis * Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Study Objectives Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard administration dose and schedule. This application is a non-labeled indication for cabazitaxel and will inform future drug development in gastroesophageal malignancies, where docetaxel remains an approved first line agent, but is not routinely used due to excessive toxicity and marginal efficacy. At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel in refractory gastric cancer, with preferential activity in one or more gastric cancer subtypes Conditions: Gastric Adenocarcinoma, Gastroesophageal Adenocarcinoma, Distal Esophageal Adenocarcinoma Intervention / Treatment: DRUG: Cabazitaxel 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: * Subject must have histologically or cytologically confirmed gastric, or gastroesophageal adenocarcinoma, or distal esophageal adenocarcinoma. * Subject must have unresectable or metastatic gastroesophageal adenocarcinoma. * Subject must have evaluable disease as per RECIST criteria. * Subject must have had at least one prior cytotoxic chemotherapy regimen for unresectable or metastatic disease. Prior taxane therapy is allowed. * Age >=18 years old. * ECOG performance status status >= 2 * Subject must have normal organ and marrow function as defined below: * WBC >= 3,000/uL * Total Bilirubin <= 1.5 x upper limits of normal * AST (SGOT) <= 2.5 x upper limits of normal * ALT (SGPT) <= 2.5 x upper limits of normal * Hgb > 7.5 g/dl (without transfusion within 7 days) * ANC > 1000 /ml * Plt > 75 K/ml (without transfusion) * Creatinine* < 2.0 g/dl *or a calculated creatinine clearance > 45/cc (using Cockroft-Gault formula) * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 10. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Subject with previously untreated unresectable or metastatic gastroesophageal adenocarcinoma. * Subject with more than 2 prior cytotoxic therapies (not including treatment administered for locally curable disease) for unresectable or metastatic gastroesophageal adenocarcinoma. * Subject with CNS metastases with active neurologic dysfunction. These patients are excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse event. * Significant medical co-morbidity that would preclude safe administration of cytotoxic therapy, including but not limited to: a.Cardiac disease i. Unstable angina ii. Myocardial infarction < 3 months prior to study initiation b. Ongoing serious infection i. Bacteremia or sepsis requiring intravenous antibiotics ii. HIV with AIDS defining illness c.Inadequate oral nutritional intake i. Requirement for daily intravenous fluids or total parenteral nutrition. d. Psychiatric illness/social situations that would limit compliance with study requirement * Subject who has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from prior treatment related toxicity with persistent symptoms >= grade 2 due to agents administered more than 4 weeks earlier. * Subject may not receive another investigational agent. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cabazitaxel, or to drugs formulated with polysorbate 80. * Pregnant (positive pregnancy test) and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.

Study Objectives NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields within the human body using surface electrodes (transducer arrays). Intermediate frequency electric fields (TTFields) stunt the growth of tumor cells. The purpose of this study is to determine the efficacy of the combination of Bevacizumab and NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients with recurrent glioblastoma (GBM) as measured by 6-month progression free survival. Conditions: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor Intervention / Treatment: BIOLOGICAL: Bevacizumab, DEVICE: NovoTTF-l00A, OTHER: Quality of Life Assessment 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 histologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy. * Patients with up to two prior recurrences are allowed. * Karnofsky performance status >=70. * Patients must have the following laboratory values: * Absolute neutrophil count (ANC) >=1.5 x 10^9/L * Platelets >= 100 x 10^9/L * Hemoglobin (Hgb) > 9 g/dL * Serum total bilirubin: <= 1.5 x ULN * ALT and AST <= 3.0 x ULN * Serum creatinine <= 1.5 x ULN * Blood coagulation parameters: INR <= 1.5 * Minimum interval since completion of radiation treatment is 12 weeks * Minimum interval since last drug therapy: * 3 weeks since last non-cytotoxic therapy * 3 weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen * 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen. * Patients must have signed an approved informed consent and authorization permitting release of personal health information. * Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. The effects of bevacizumab on developing fetus or nursing infant are not known. Female patients of child-bearing potential must have a negative pregnancy test. * Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease-free for >= three years. * Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment and/or for at least 5 days before starting treatment. Exclusion Criteria: * Patients who have had previous treatment with bevacizumab, and or NovoTTF 100A system. * Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury <= 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device <=1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury * Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following: * History or presence of serious uncontrolled ventricular arrhythmias * Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE) * Uncontrolled hypertension (defined by a systolic blood pressure (SBP) >= 160 mm Hg or diastolic blood pressure (DBP) >= 100 mm Hg while on anti-hypertensive medications) * Patients with cirrhosis, or active viral or nonviral hepatitis. * Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias. * Infra-tentorial tumor * Evidence of increased intracranial pressure (clinically significant papilledema, vomiting and nausea or reduced level of consciousness) * Known sensitivity to conductive hydrogels * Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) * Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol * Pregnant or breast-feeding women * Patients unwilling or unable to comply with the protocol * Patients with leptomeningeal disease

Study Objectives High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients with acute myeloid leukemia. However, most patients receiving this therapy are required to be admitted to the hospital during their treatment course. The purpose of this study is to compare the safety and cost of high-dose cytarabine treatment given in an in-patient setting versus an out-patient setting. Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: Cytosine Arabinoside Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Inclusion Criteria for Outpatient Administration of HiDAC * Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia). * Documented complete remission (CR) following induction chemotherapy as defined as (18): * Bone marrow with <5% blasts; absence of blasts with Auer rods * Absolute neutrophil count >1000/mcL * Platelets >100,000/mcL * Independence of red cell transfusions * Absence of extramedullary disease * Age >= 55 years. * Relapsed AML patients are eligible as long as they meet other inclusion and exclusion criteria. * Good performance status of (ECOG 0-2), see appendix 15.3. * Adequate renal and hepatic function (Cr <= 1.2, alkaline phosphatase <3.0 x upper limit of normal, total bilirubin <1.5 x upper limit of normal unless there is a history of Gilbert's disease). Inclusion Criteria for Quality of Life Comparison Group * All patients decline to participate as an out-patient or who are not eligible for participation in the out-patient portion of the study will be approached to participate in the QOL comparison. * Age >= 18 years Exclusion Criteria: Exclusion Criteria for All Patients * Active, uncontrolled viral, bacterial, or fungal infection. * Documented CNS leukemia. * If unable to do a reliable cerebellar examination for monitoring of neurotoxicity. * History of prior autologous or allogeneic bone marrow/stem cell transplant. * New York Heart Association class III/IV congestive heart failure, see appendix 15.4, or active ischemic heart disease. * Pregnant or lactating women (women and men of childbearing age should use effective contraception). * Concomitant active malignancy requiring treatment with cytotoxic chemotherapy or radiation therapy. (Ongoing hormonal therapy for the treatment of malignancy would not exclude patients from this trial.) * Time period of greater than 10 weeks between initiation of induction chemotherapy and day 1 of the first cycle of consolidation chemotherapy. * Patients seropositive for infection with Human Immunodeficiency Virus (HIV) are excluded due to potential for serious infectious complications associated with T-cell suppressive therapy in these patients.

Study Objectives BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in laboratory experiments and information from those research studies suggests that this drug may help to slow the growth of renal cancer cells. In this research study, the investigators are testing the safety to BKM-120 at different dose levels. The investigators will also be studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of kidney cancer. Conditions: Renal Cell Carcinoma Intervention / Treatment: DRUG: BKM-120 Bevacizumab 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: * Metastatic RCC with clear cell component or papillary RCC * Life expectancy > 12 weeks * Must have failed at least 1 prior anti-VEGF systemic therapy for metastatic RCC Exclusion Criteria: * Prior treatment with a P13K inhibitor or bevacizumab * Untreated brain metastases * Acute or chronic liver or pancreatic disease * Major mood disorder * Concurrent severe and/or uncontrolled medical condition * Diabetes mellitus * GI disease * Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant * Pregnant or breastfeeding * HIV positive * History of another malignancy within 3 years except cured basal cell carcinoma of the skin or excised in situ carcinoma of the cervix * Uncontrolled hypertension

Study Objectives This study evaluates the clinical safety and tolerability, and the immunological effects of local intradermal injection of tremelimumab in patients with clinical stage I/II melanoma patients undergoing a sentinel node biopsy (SNB). Patients will be treated by local intradermal injections around the excision site of the primary tumor with escalating doses of 2, 5, 10 or 20 mg tremelimumab. Conditions: Cutaneous Melanoma Intervention / Treatment: DRUG: Tremelimumab Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age >= 18 years * Clinical stage I/II melanoma patients, planned to undergo a sentinel lymph node biopsy (SNB) * ECOG performance status 0 or 1 * White blood count (WBC) >= 3 x10^9/L * Platelet count >= 100 x10^9/L * Hemoglobin >= 6.5 mmol/L * Serum creatinine <= 2.5 x ULN * Total serum bilirubin, AST, ALT and LDH <= 2x ULN Exclusion Criteria: * Non-oncology vaccine therapy used for prevention of infectious diseases (up-to) 4 weeks prior and/r 8 weeks after any dose of tremelimumab * Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist * Uncontrolled infectious disease including negative testing for HIV, HBV, HCV * Autoimmune disease

Study Objectives Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA Conditions: Rectal Neoplasms Intervention / Treatment: DRUG: Chemotherapy, radiation therapy & surgery Location: Saudi Arabia Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with localized rectal CA

Study Objectives Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated with metabolic syndrom, diabetes and and increased risk og cardiovascular disease. The study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS. 70 women will be included in af RCT. Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease. Conditions: Polycystic Ovary Syndrome, Cardiovascular Disease Intervention / Treatment: DRUG: Liraglutide for 26 weeks, DRUG: placebo Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * PCOS * >18 years * premenopausal * BMI >25 og 25 and thereunder + insulin resistent Exclusion Criteria (including): * actualt or intended pregnancy * inadeqvat contraception * hormonal contraception within 6 weeks * metfoomin, GLP-1-analog or DPP IV inhibitor within 3 months * medications affectiv hemostatic mechanisme * diabetes or other severe comorbidity * familar MEN * ...

Study Objectives The purpose of this study is to use Sorafenib plus Docetaxel to evaluate pharmacodynamics (PD) in Patients with prostate cancer. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Sorafenib (Nexavar), DRUG: Docetaxel Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with metastatic hormone refractory prostate cancer

Study Objectives This pilot clinical trial studies the side effects of cytarabine and daunorubicin hydrochloride and to see how well they work in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine and daunorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading, and may be safer for the heart. Conditions: Acute Myeloid Leukemia Intervention / Treatment: PROCEDURE: Bone Marrow Aspiration and Biopsy, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, OTHER: Laboratory Biomarker Analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have morphologically confirmed newly diagnosed acute myelogenous leukemia (AML) with blood or bone marrow disease; patients with only extramedullary disease in the absence of bone marrow or blood involvement are eligible; note: this protocol uses World Health Organization (WHO) diagnostic criteria for AML; patients with acute promyelocytic leukemia (APL, French-American-British Classification [FAB], M3) or blastic transformation of chronic myelogenous leukemia (CML) are not eligible * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 * Patients with ECHO EF >= 45% within 28 days prior to registration * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Exclusion Criteria: * Patients who have received prior induction chemotherapy for AML or myelodysplastic syndrome (MDS); temporary prior measures such as apheresis or hydroxyurea are allowed; patients who have received a limited and short-term exposure of ATRA (all trans retinoic acid) while AML-M3 (acute promyelocytic leukemia) was being ruled out, and which has been discontinued, will be eligible * Patients receiving any other investigational agents * Patients with prolonged corrected QT (QTc) interval (> 500 msec) determined by electrocardiogram (EKG) within 28 days prior to registration * Patients not suitable for cardiac MRI; contraindications include: * Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices * Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal * Allergy to gadolinium or other severe drug allergies * Claustrophobia * Congestive heart failure (New York Heart Association [NYHA] class III or IV) * Significant valvular disease, or significant pulmonary disease requiring supplemental oxygen therapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to daunorubicin or cytarabine * Patients with documented central nervous system (CNS) involvement * Patients who are known to be human immunodeficiency virus (HIV) positive (+) may be eligible providing they meet all of the following additional criteria within 28 days prior to registration: * CD4 cells >= 500/mm^3 * Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on combination antiretroviral therapy (cART) or < 25,000 copies HIV mRNA if not on cART * No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria are not eligible for this study * Patients with other uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study; breastfeeding should be discontinued prior to beginning treatment

Study Objectives The purpose of this study is to to determine the recommended dose level of JNJ-30979754 (decitabine) as well as to assess the safety and effectiveness in patients with Myelodysplastic Syndrome (MDS). Conditions: Myelodysplastic Syndrome Intervention / Treatment: DRUG: JNJ-30979754 15 mg/m2, DRUG: JNJ-30979754 20 mg/m2 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Myelodysplastic syndrome (de novo or secondary) fitting any of the recognized French-American-British classifications: refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia with white blood cells less than 13,000 /mm3 * International Prognostic Scoring System (IPSS) greater than or equal to 0.5 (Intermediate-1, Intermediate-2 or high risk) by bone marrow assessment and bone marrow cytogenetics within 28 days before study registration * >= 20 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Normal renal and hepatic function Exclusion Criteria: * Acute Myeloid Leukemia (AML) with bone marrow blasts greater than or equal to 30% * Participants with a history of high-dose cytarabine (Ara-C) therapy (greater than 1,000 mg/m2/day) * Participants administered adrenal cortex hormones or anabolic hormones within 7 days of study initiation * Participants who have received a colony stimulating factor (CSF) formulation within 7 days of study initiation * Active double cancer * Uncontrolled cardiac disease or cognitive heart failure * Uncontrolled restrictive or obstructive pulmonary disease * Uncontrolled diabetes mellitus * Active viral or bacterial infection * Known positive serology for Human immunodeficiency virus

Study Objectives Document treatment patterns and evaluate LUCRIN / LUCRIN-TRIDEPOT® (Leuprolide) and alternative therapeutic approaches to the treatment of advanced prostate cancer during normal clinical practice and in accordance with the terms of the Belgian marketing authorization and reimbursement conditions. Conditions: Prostatic Neoplasm Intervention / Treatment: DRUG: leuprolide (Lucrin/Lucrin-Tri-depot) Location: Belgium, Luxembourg Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients with advanced prostate cancer who have been prescribed Lucrin/ Lucrin-Tri-depot or any other treatment with local reimbursement guidelines; Patients willing to consent to data being collected and provided to Abbott Laboratories. Exclusion Criteria: * Contraindications according to the Summary of Product Characteristics (SPC).

Study Objectives A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be developed. The investigators propose to investigate the effect of RANKL inhibition with denosumab on breast tissue markers in high-risk premenopausal women with dense breasts. Study findings could provide robust evidence to move forward with a clinical trial targeting RANKL inhibition in premenopausal breast cancer prevention. Conditions: Breast Cancer Prevention, Mammographic Density Intervention / Treatment: PROCEDURE: Ultrasound-guided core needle biopsy, DRUG: Denosumab, PROCEDURE: Blood draw, DRUG: Calcium, DRUG: Vitamin D Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Female. * Premenopausal. * At least 35 years of age. * Dense breasts on routine mammogram. * Willing to take calcium (1,200mg) and vitamin D (800 IU) daily. * At increased risk for breast cancer using any of the following: * Positive family history of breast cancer * Breast cancer risk prediction models * Able and willing to return for repeat biopsy. * Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: * Current use of tamoxifen, aromatase inhibitors, or bisphosphonates. * Concurrently participating in another cancer chemoprevention trial (unless no longer receiving the intervention). * Pregnant or lactating. * Recent tooth extraction or dental procedure. * Unhealed and/or planned dental/oral surgery. * History of osteonecrosis/osteomyelitis of the jaw. * History of osteoporosis or severe osteopenia. * Unable/unwilling to return for repeat biopsy.

Study Objectives Chemo-N0 (1993-1998) is the first prospective randomized multicenter trial in N0 BC designed to prospectively evaluate the clinical utility of a biomarker. It used uPA/PAI 1 as stratification criteria and randomized high-risk patients to chemotherapy versus observation; low-risk patients remained without any systemic therapy. The trial was designed to answer two principle questions: 1. Can the reported prognostic impact of uPA and PAI 1 be validated in a prospective multicenter therapy trial? Does low uPA/PAI 1 identify those low-risk N0 patients who are candidates for being spared necessity and burden of adjuvant chemotherapy? 2. Do uPA/PAI 1 high-risk patients benefit from adjuvant CMF chemotherapy? Conditions: Breast Cancer Intervention / Treatment: DRUG: CMF Chemotherapy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * N0 breast cancer patients tumor size >= 1 and <= 5 cm in diameter undergoing standard loco-regional treatment Exclusion Criteria: * M1 status

Study Objectives The purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen. Conditions: Breast Cancer Intervention / Treatment: DRUG: Tamoxifen, DRUG: Anastrozole Location: Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy. * At least 6 lymph nodes examined. * Good or intermediate tumour differentiation. * <6 weeks before start of adjuvant therapy. * Oestrogen or Progesterone positive Exclusion Criteria: * Premenopausal. * Preoperative hormonal/antihormonal/radiation/cytoxic chemo. Second malignant tumour/status post second malignant tumour. * In-situ/T4 carcinoma. * Age >80 years. * World Health Organisation performance index >3. * Serious accompanying diseases

Study Objectives The purpose of this study is to evaluate how tumors in patients with Waldenstrom's macroglobulinemia respond to treatment with bortezomib (Velcade) and to see what effects (good and bad) it has on the cancer. Conditions: Waldenstrom's Macroglobulinemia, Lymphoplasmacytic Lymphoma Intervention / Treatment: DRUG: Bortezomib (Velcade) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Clinicopathological diagnosis of Waldenstrom's macroglobulinemia who have failed one first line therapy * Measurable disease, defined as presence of immunoglobulin M (Ig M) paraprotein with a minimum IgM level of >2 times ULN * Karnofsky performance status of >60 * Life expectancy of > 3 months * Baseline platelet count >50,000,000,000/L and ANC of 750,000,000/L * AST and ALT < 3 x ULN * Total bilirubin < 2 x ULN * Calculated or measured creatinine clearance > 30mL/minute * Serum sodium > 130 mmol/L Exclusion Criteria: * Greater than or equal to Grade 2 peripheral neuropathy * Hypersensitivity to bortezomib, boron or mannitol * Prior therapy with Velcade * Pregnant or lactating women

Study Objectives A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External Genital Warts and Perianal Warts Conditions: Genital Warts, Perianal Warts Intervention / Treatment: DRUG: NVN1000 8% Gel, DRUG: NVN1000 16%, DRUG: Vehicle, DRUG: NVN1000 24% Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * At least 2 but not more than 20 genital/perianal warts with a maximum total wart surface area no more than 1% body surface area * If a woman of child-bearing potential, have a negative pregnancy test and use effective contraception * If currently receiving wart treatment, be willing to stop all treatment for 28 days prior to randomization and during the study Exclusion Criteria: * Immunocompromised patients including those with HIV, receiving radiation, or drugs that suppress the immune system * Pregnant, planning to become pregnant, or nursing * History of cancer (including cervical cancer) within 5 years, with exception of non-melanoma skin cancer in non-genital skin * Recent history of other genital skin infections * Active HSV and frequent HSV recurrences unless receiving suppression therapy * Have hemoglobin < 10 G/dl or methemoglobin > 3% * Known allergy to any component of the gel including excipients * Previously participated in any study with NVN1000 or SB204

Study Objectives This randomized phase II trial studies how well vandetanib works in preventing head and neck cancer in patients with precancerous head and neck lesions. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vandetanib may keep cancer from forming in patients with premalignant lesions Conditions: Lip and Oral Cavity Squamous Cell Carcinoma, Oral Cavity Verrucous Carcinoma, Precancerous Condition Intervention / Treatment: DRUG: vandetanib, OTHER: placebo, OTHER: immunohistochemistry staining method, OTHER: laboratory biomarker analysis, PROCEDURE: biopsy, OTHER: pharmacological study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Histological/cytological confirmation of oral cavity dysplasia and one of three additional criteria: * Prior history of OSCC * Loss of heterozygosity (LOH) at 3p or 9p * Expression by immunohistochemistry (IHC) of budding uninhibited by benzimidazoles 3 (BUB3)/sex determining region Y (SOX4) * Provision of informed consent * Females of child bearing age must have a negative serum pregnancy test within 7 days of first dose of study drug * Patients must not have been taking steroids or are on a stable dose of steroids for at least 14 days before enrollment * Patients must have a Karnofsky Performance Score of 70% or above Exclusion Criteria: * History of malignancy within the last 5 years other than squamous cell carcinoma of the head and neck (SCCHN) and superficial non-melanoma skin cancer; patients with a history of SCCHN must be free of active carcinoma * Currently receiving treatment for any malignancy * Serum bilirubin > 1.5x the upper limit of reference range (ULRR) * Creatinine clearance =< 30 mL/minute (calculated by Cockcroft-Gault formula) * Potassium, < 4.0 mmol/L despite supplementation; or above the Common Terminology Criteria for Adverse Events (CTCAE) grade 1 upper limit * Magnesium below the normal range despite supplementation, or above the CTCAE grade 1 upper limit * Serum calcium above the CTCAE grade 1 upper limit; in cases where the serum calcium is below the normal range, 2 options would be available: 1) the calcium adjusted for albumin is to be obtained and substituted for the measured serum value; exclusion is to then be based on the adjusted for albumin values falling below the normal limit; 2) Determine the ionized calcium levels; if these ionized calcium levels are out of normal range despite supplementation, then the patient must be excluded * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULRR * Alkaline phosphatase (ALP) > 2.5 x ULRR * Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol * Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome [SVC], New York Heart Association [NYHA] classification of heart disease > 2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia * History of arrhythmia (multifocal premature ventricular contractions (PVCs), bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation), which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia; atrial fibrillation, controlled on medication is not excluded * QTc prolongation with other medications that required discontinuation of that medication * Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age * Presence of left bundle branch block (LBBB) * QTc with Bazett's correction that is unmeasurable or >=450 msec on screening electrocardiogram (ECG); (Note: If a subject has a QTc interval >= 450 msec on screening ECG, the screen ECG may be repeated twice [at least 24 hours apart]; the average QTc from the three screening ECGs must be < 450 msec in order for the subject to be eligible for the study) * Any concurrent medication with a known risk of inducing Torsades de Pointes, that in the investigator's opinion cannot be discontinued * Concomitant medications that are potent inducers (rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital and St. John's Wort) of Cytochrome P450 3A4 (CYP3A4) function * Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm mercury (Hg) or diastolic blood pressure greater than 100 mm Hg) * Currently active diarrhea that may affect the ability of the patient to absorb the ZD6474 or tolerate diarrhea * Women who are currently pregnant or breast-feeding * Receipt of any investigational agents within 30 days prior to commencing study treatment * Previous enrollment or randomization of treatment in the present study * Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy * Involvement in the planning and conduct of the study (applies to both Astra Zeneca staff and staff at the study site)

Study Objectives This protocol is a randomized, open-label, national, multicenter trial studying maintenance treatment with lenalidomide and dexamethasone versus lenalidomide, dexamethasone and MLN9708 after autologous hematopoietic stem cell transplantation in patients with newly-diagnosed symptomatic multiple myeloma. A total of 316 patients, from the study GEM2012MENOS65, will be enrolled in the study. The pre-treatment period includes the screening visit in which participants provide informed consent in writing in order to take part in the study. The patient is then assessed to determine his/her eligibility. The selection process will begin 21 days before the first dose of medication is administered (days -21 to 0). All procedures during the pre-treatment period will be carried out after completion of the two cycles of post-transplant consolidation with VRD which coincide with the end-of-study visit of clinical trial GEM2012MENOS65. During the treatment period, eligible patients will be included in the study and receive maintenance treatment with lenalidomide/dexamethasone versus lenalidomide/dexamethasone/MLN9708. Each cycle will last 28 days. Treatment arm A will consist of oral administration of 15 mg/day of oral lenalidomide on days 1-21, and 20 mg/day of dexamethasone administered orally on days 1-4 and 9-12 for a period of two years. Arm B of the maintenance treatment will be the same as arm A, with the addition of MLN9708 during the two year maintenance period, at a dose of 4 mg/day on days 1, 8 and 15 of the cycle. At two years, patients with negative MRD will finish maintenance treatment. Patients with positive MRD will continue treatment with lenalidomide/dexamethasone until they have completed five years of maintenance treatment. In this case, 20 mg/day of dexamethasone will only be administered on days 1-4 of the cycle. The dose of lenalidomide will not be adjusted. (unless necessary to treat adverse events) Once this phase of active treatment is complete, patients will begin the long-term follow-up phase, during which they will be visited every three months to evaluate progression and survival. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: MLN9708, DRUG: Lenalidomide, DRUG: Dexamethasone Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * The patient must, in the opinion of the investigator, be capable of complying with all requirements of the trial. * Have signed the informed consent form * Be between 18 and 67 years of age * Have an ECOG Performance Status <= 2 (or 3 if the ECOG is due to myeloma, e.g. pathological fracture) * Multiple myeloma patient who was included in the GEM2012MENOS65 trial, and who is found to have, at a minimum, minimal response after consolidation * Life expectancy > 3 months * The patient must have the following laboratory values in the 21 days prior to initiation of treatment (day 1, cycle 1): 1. Platelet count >= 100 x 109/L and absolute neutrophil count of >= 1.0 x 109/L. - Platelet transfusions to help patients meet eligibility criteria are not allowed. 2. Corrected serum calcium < 14 mg/dL. 3. Aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 x the upper limit of normal (ULN) 4. Total bilirubin within normal range 5. Calculated creatinine clearance > 30 mL/min * Female patients who: 1. Are postmenopausal for at least 1 year before the screening visit, OR 2. Are surgically sterile, OR 3. If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND 4. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR 5. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) * Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: 1. Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR 2. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR 30 Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) Exclusion Criteria: * Patients not included in clinical trial GEM2012MENOS65 * Patients included in GEM2012MENOS65 who are not found to have a least minimal response after consolidation * Patients included in GEM2012MENOS65 who were discontinued prematurely due to toxicity or disease progression * Female patients who are lactating or have a positive serum pregnancy test during the screening period. * Central nervous system involvement * Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment. * Systemic treatment, within 14 days before the first dose of MLN9708, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort. * Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. * Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing. * Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. * Peripheral neuropathy >= grade 2 in the 21 days prior to inclusion. * Known hypersensitivity to lenalidomide or to MLN9708, their analogues, or excipients in the various formulations of any agent. * Patients who have had a myocardial infarction in the six months prior to inclusion in the clinical trial, or who are class III or IV according to the New York Heart Association (NYHA), heart failure unstable angina, uncontrolled ventricular arrhythmias or acute ischemia detected by electrocardiogram, or conduction disorders. * Patients who are currently participating in another clinical trial or receiving any other investigational product. * Seropositive for HVB, HVC or HIV.

Study Objectives The purpose of this study was to determine the activity of two doses of robatumumab (SCH 717454, MK-7454) in participants with relapsed or recurrent colorectal cancer. The primary study hypothesis was that decreases in Positron Emission Tomography (PET)-assessed tumor glucose metabolism (i.e., fluorodeoxyglucose \[FDG\] standardized uptake value \[SUV\]) following administration of 10 mg/kg robatumumab will exceed those following administration of 0.3 mg/kg robatumumab in participants with relapsed or recurrent colorectal cancer who had progressed after first-line chemotherapy. Investigator choices of standard chemotherapy: irinotecan as a single agent +/- cetuximab OR capecitabine as a single agent, OR FOLFOX (leucovorin calcium \[folinic acid\]\[FOL\] + fluorouracil \[F\] + oxaliplatin \[OX\]) OR CAPEO(capecitabine \[CAPE\] or Xeloda® \[XEL\] + oxaliplatin \[OX\]) OR FOLFIRI (leucovorin calcium \[folinic acid\]\[FOL\] + fluorouracil \[F\] + irinotecan \[IRI\]) +/- cetuximab OR cetuximab as a single agent. Conditions: Colorectal Cancer Intervention / Treatment: BIOLOGICAL: Robatumumab, DRUG: Irinotecan, BIOLOGICAL: Cetuximab, DRUG: Capecitabine, DRUG: FOLFOX, DRUG: CAPEOX/XELOX, DRUG: FOLFIRI Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * >= 18 years years of age, of any race, and gender; * Diagnosis of histologically confirmed relapsed or recurrent colorectal carcinoma that has progressed on at least first-line therapy; * Must have a computed tomography (CT) or magnetic resonance imaging (MRI) scan performed at some point during their immediate prior treatment or observation in order to determine tumor growth rate; * Must have measurable disease on a CT or MRI study, performed during Screening; * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2 and a minimum life expectancy of >=4 months; * Must have adequate organ function within 3 weeks prior to treatment assignment Exclusion Criteria: * History of another malignancy; * Known treated or untreated leptomeningeal metastasis, or a metastatic central nervous system lesion; * Surgery within 3 weeks; * Radiation therapy within 6 weeks; * A history of uncontrolled diabetes mellitus, defined as a hemoglobin A1C of >7.5% in a participant with known diabetes mellitus; * A recent myocardial infarction (within the past year); or a participant who at the time of Screening presents with unstable or uncontrolled angina, New York Heart Association Class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram abnormality; * An active infection; * Has clinically significant hepatitis at Screening, or is hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV) seropositive.

Study Objectives This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease. Conditions: Squamous Cell Carcinoma of the Head and Neck Intervention / Treatment: BIOLOGICAL: MEDI4736, BIOLOGICAL: Tremelimumab, BIOLOGICAL: MEDI4736+Tremelimumab, BIOLOGICAL: Cetuximab, DRUG: 5-fluorouracil (5FU), DRUG: Cisplatin, DRUG: Carboplatin Location: Canada, United States, Greece, Taiwan, Austria, Philippines, France, Poland, Vietnam, India, Thailand, Italy, Ukraine, United Kingdom, Russian Federation, Spain, Brazil, Belgium, Germany, Japan, Korea, Republic of, Romania, Slovakia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age >=18 years at the time of screening * Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx). * A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy. * No prior systemic chemotherapy for recurrent or metastatic disease * World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment * No prior exposure to immune-mediated therapy, Exclusion Criteria: * Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland) * Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting * Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis

Study Objectives Multi-centre one year trial for patients who have rising PSA while on Casodex 50mg daily dose. Casodex dosage escalated to 150 mg tablet daily. Treatment will be continued until patient demonstrates clinical benefit at one year, PSA progression, toxicity, or withdrawal. Treatment will be continued after one year if patient demonstrates continued clinical benefit. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Escalating dose of Casodex from 50mg daily to 150 mg daily Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Provision of written informed consent. * Men, over 18 years of age, with histologically-confirmed prostate cancer * Treatment with Zoladex (goserelin acetate) for greater than 3 months prior to Day 1 * Serum testosterone level < 50 ng/ml * Current treatment with bicalutamide 50 mg daily.** * Two consecutive rises in PSA above a nadir value, with the absolute value of the latest PSA > 2.0 ng/ml. * Highest PSA level no greater than or equal to 30 ng/ml. * Life expectancy of greater than 1 year - Exclusion Criteria: * Patients may not have received prolonged anti-androgen therapy other than with bicalutamide. Patients who have received short term (2 months or less) non-steroidal anti-androgen therapy with an agent other than bicalutamide to block flare are not excluded.* * PSA level greater than 30 ng/ml. * In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease which would make it undesirable for the patient to participate in the trial. * Subjects who have received prior chemotherapy. * Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder. * Absolute neutrophil count less than 1.5 x 109/L or platelets less than 100 x 109/L. * Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR). * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR. * Serum creatinine greater than 1.5 times -

Study Objectives The purpose of this study is to evaluate the safety and tolerance of entinostat administered orally as a single agent in a weekly dosing schedule. Additionally, this study will characterize the pharmacokinetics parameters in Chinese postmenopausal women with advanced breast cancer. And to define the profile of adverse events, including laboratory parameters in these subjects Conditions: Breast Cancer Intervention / Treatment: DRUG: Entinostat, DRUG: Exemestane Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: For inclusion in the study patients should fulfil the following criteria: * Provision of informed consent prior to any study specific procedures. * Postmenopausal women aged <= 65years. * Estrogen receptor (ER) and / or progesterone receptor (PR) positive breast cancer confirmed by pathology. * Once received a non-steroidal aromatase inhibitor (letrozole / anastrozole) treatment, the disease recurrence or progression of breast cancer currently. * Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. And recently (past 2 months), weight loss is no more than 10% of average weight. * Patients must have a life expectancy >3 months. * Patients must have adequate organ and bone marrow function as defined by the following laboratory results. 1. .absolute neutrophil count ( ANC )>= 1,500 /mm3 2. . Platelets>=100,000 /mm3 3. . White blood cell count(WBC） >= 3,000 /mm3 4. . Hemoglobin >= 9 g/dL. 5. . Creatinine <= 1.5 times the upper limit of normal (ULN) for the institution or Creatinine clearance >= 60 ml/min/1.73m2 6. . Total bilirubin <= 1.5 times the upper limit of normal for the institution(ULN) 7. .Aspartate transaminases (AST/SGOT) or alanine transaminase (ALT/SGPT) <= 2.5 times the upper limit. * Patients must be able to take drugs and don't spit out, no malabsorption problem. * Able to comply with study procedures and follow-up examinations. Exclusion Criteria: * Patients have known central nervous system metastasis except patients who have terminated steroid treatment for brain metastasis or spinal cord compression with remain disease stable for at least 1 month. * Previous treatment with entinostat or any other histone deacetylase inhibitor (Valproic acid, Chidamide etc). * Known allergy to any ingredients of entinostat and other drugs in the same class. * Women who are pregnant or breast-feeding (premenopausal). For women of childbearing potential, agreement to use a medically approved contraception measures (such as the intrauterine device (IUD), birth control pills or condoms) and to continue its use for the duration of study treatment and for 3 months after the last dose of study treatment. * Had received chemotherapy/radiotherapy or other anticancer therapy during the study or within 4 weeks of start of study treatment. Patients must completely recovered from all adverse events due to previous agents administered before 4 weeks (except alopecia). * Major surgery within 28 days of start of study treatment. * Patients have serious or uncontrolled systemic disease (such as severe liver dysfunction, severe renal dysfunction, poorly controlled diabetes, poorly controlled acute infections). Unstable or decompensated respiratory or cardiovascular disease, or peripheral vascular disease (including diabetic vascular disease), or organ transplantation. * Received potent CYP1A2 or CYP3A4 inducer and/or inhibitor (including but not limited following drug: ketoconazole, rifampicin, atazanavir, Clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice, rifabutin, phenytoin, Carbamazepine and phenobarbital). * Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [cervical intraepithelial neoplasia （CIN）/cervical carcinoma in situ] or melanoma in-situ). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years. * Active bleeding or new thrombotic diseases using of anticoagulant drugs, patients with bleeding tendency. * Meet with any of the following criteria about cardiac parameters: * the corrected QT interval (QTc) >470 msec under resting conditions. * myocardial infarction or arterial thrombosis events within 6 months, or experiencing severe or unstable angina, or New York Heart Association (NYHA) Class III or IV disease. * Resting ECG imply any clinically significant abnormal on rhythm, conduction and morphology, for example, left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec. * Any factors (such as, heart failure, hypokalemia, inherited long QT syndrome, acquired long QT syndrome or family history of unexplained sudden death in immediate family members under 40 years old) or known combined drug (such as, sotalol, cisapride, clozapine, amiodarone and erythromycin, etc.) to increase risk of prolongation of QTc interval or arrhythmic event. * History of or known human immunodeficiency virus (HIV) infection * Known drug or long-term alcoholics. * Patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study. * Involvement in the planning and conduct of the study. * Possible of lower inclusion criteria according to the researchers (such as weak, etc), or the other is not suitable for this study.

Study Objectives This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), following surgery and chemotherapy (neo-adjuvant or adjuvant). Conditions: Breast Cancer Intervention / Treatment: DRUG: Trastuzumab Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast * HER2-positive disease * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Hormonal therapy will be allowed as per institutional guidelines * Prior use of anti-HER2 therapy will be allowed * Left ventricular ejection fraction (LVEF) greater than or equal to (>=) 50 percent (%) * No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant) * Use of concurrent radiotherapy will be permitted * Completion of surgery and chemotherapy (if applicable) Exclusion Criteria: * History of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for the last 5 years * Participants with severe dyspnea at rest or requiring supplementary oxygen therapy * Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness * Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension * Pregnant or lactating women * Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment * Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment * Known hypersensitivity to trastuzumab, murine proteins, to any excipients of Herceptin, including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma * Inadequate hepatic or renal function

Study Objectives This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of CNCT19 in adult patients with relapsed or refractory diffuse Non-Hodgkin lymphoma. Conditions: Diffuse Non-Hodgkin Lymphoma Intervention / Treatment: BIOLOGICAL: single dose of CNCT19 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Informed consent is signed by the subject. * Age 18 to 75. * Relapsed or refractory NHL with CD19-positive after at least two systemic lines of therapy a. Diffuse large B cell lymphoma (DLBCL) non-specific (NOS), T-cell / Histiocyte Rich large B-cell lymphoma, elderly EBV-positive diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), chronic inflammation-associated DLBCL, follicular lymphoma (FL) transformed large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and / or BCL6 rearrangement and High-grade B-cell lymphoma-unspecified; b. Chemotherapy-refractory disease, defined as one of more of the following: * No response to last line of therapy; i. Progressive disease (PD) as best response to most recent therapy regimen; ii. Stable disease (SD) as best response to at least 4 courses of first-line treatment / at least 2 courses of end-line treatment (2 lines and above) with duration no longer than 6 month from last dose of therapy OR; * Refractory post-autologous stem cell transplant (ASCT); i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed individuals); ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy; Any BM relapse after autologous stem cell transplantation (ASCT); c. Individuals must have received two systemic lines of therapy * anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative; * an anthracycline containing chemotherapy regimen; * FL-transformed DLBCL must have received pre-chemotherapy for FL and become resistant after conversion to DLBCL. * At least one measurable lesion, defined as at least 1 lymph node >1.5 cm in the longest diameter, per revised IWG Response Criteria. * Any previous systemic immune checkpoint therapy (such as anti-PD1 / PD-L1 monoclonal antibody, etc.), at least 3 half-lives away from the Cell Product Preparation; other systemic treatments should be stoped at least 2 weeks or 5 half-lives before Cell Product Preparation (shorter Whichever comes first). * Eastern cooperative oncology group (ECOG) performance status of 0 to 1. * Sufficient bone marrow reserves defined as: 1. Absolute neutrophil (ANC) > 1,000 / mm3; 2. Lymphocyte absolute value (ALC) >= 100 / mm3; 3. Platelet (PLT) >= 50,000 / mm3. * Adequate organ function defined as: 1. aspartate aminotransferase (AST) <= 3 upper limit of normal (ULN); 2. Serum alanine aminotransferase (ALT) <= 3 upper limit of normal (ULN); 3. Total bilirubin <= 2 ULN, except in individuals with Gilbert's syndrome; Note: Patients with Gilbert's syndrome that bilirubin <= 3 ULN and direct bilirubin <= 1.5 ULN will be eligible; 4. A serum creatinine<= 1.5 ULN or Creatine removal rate >= 60mL/min (Cockcroft and Gault); 5. Must have a minimum level of pulmonary reserve as <= Grade 1 dyspnea and oxygen saturation > 91% on room air; 6. International normalized ratio (INR) <= 1.5 ULN and activated partial thromboplastin time (APTT) <= 1.5 ULN; * Non-hematological toxic reactions (excluding diseases related) caused by previous treatment were restored to <= 1 level before screening (excluding <= 2 level of neurotoxicity caused by hair loss and chemotherapy drugs). * Women of childbearing age have a negative blood / urine pregnancy test within 7 days before the CNCT19 infusion. Women of child-bearing potential and all male participants must use highly effective methods of contraception throughout the study and for a period of at least six months after the CNCT19 infusion. Exclusion criteria: * Active CNS involvement by malignancy. * Patients who received chemotherapy within 2 weeks before CNCT19 infusion. The following situations are excluded: 1. Lymphodepleting Chemotherapy prescribed by the protocol; 2. CNS prophylaxis treatment must be stopped > 1 week prior to CNCT19 infusion. * Has had treatment with any prior anti-CD19 therapy. * Plans to receive autologous stem cell transplantation (ASCT) within 6 weeks before the CNCT19 infusion. * Patients who have previously received Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT). * Patients with systemic vasculitis (such as Wegener granulomatosis, nodular polyarteritis, systemic lupus erythematosus) and active or uncontrolled autoimmune disease (such as autoimmune hemolytic anemia, etc.). * Patients who are positive for any of HBsAg, HCV-Ab, TP-Ab. * Patients who have previously received surgery within 4 weeks before the screening that was unsuitable for enrollment by the investigator's assessment. * Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease. Patients with Prior malignancy that has been cured for >= 2 years are excluded. * a. Left Ventricular Ejection Fraction (LVEF) <=45%; b. III/IV congestive heart failure (NYHA); c. Severe arrhythmia (except for Atrial fibrillation, Paroxysmal supraventricular tachycardia); d. QTc>=450ms (male)or QTc>=470ms (female)(QTcB=QT/RR1/2); e. Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery < 6 months prior to CNCT19 infusion; f. Clinically significant valvular disease; g. Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy. * Clinically significant pleural effusion. * Patients with a history of epilepsy, cerebrovascular ischemia / hemorrhage, cerebellar disease or other active central nervous system diseases. * Lymphoma affects the atrium or ventricle. * Clinical emergencies (such as intestinal obstruction or vascular compression) that requires urgent treatment due to obstruction or compression of lymphoma tumors during screening. * History of deep vein thrombosis or pulmonary embolism within 6 months of screening. * Known history of hypersensitivity to ingredients used in the drug. * Has had treat with live vaccine within 6 weeks prior to screening. * Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.). * Life expectancy < 12 weeks. * Patient in other interventional clinical studies within 3 months before the CNCT19 infusion, who have received active drug therapy, or who intend to participate in another clinical trial or receive anti-tumor therapy outside the protocol during the entire study. * Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.

Study Objectives The standard treatment for early-stage breast cancer is breast-conserving surgery followed by adjuvant radiation therapy to the whole breast. This approach leads to low recurrence rates with a good cosmesis and provides an effective alternative to mastectomy. However, in most women receiving radiotherapy radiation dermatitis occur to some degree. Radiation dermatitis generally manifests within a few weeks after the start of radiation therapy. Its onset varies depending on the radiation dose intensity and the normal tissue sensitivity of individuals. As the cumulative dose of radiation increases the transient erythema occurring during the first weeks of radiotherapy may evolve into the more persistent erythema and to dry or even moist desquamation that reflects the damage to the basal cell layer and the sweat and sebaceous glands. There is currently no evidence that prophylactic treatments, beyond keeping the irradiated area clean and dry, are effective in reducing the incidence or severity of radiation dermatitis (Bolderston et al. 2006). However, together with other enzymes of the peroxidase pathway, SOD scavenges the superoxide, hydroxyl, and other oxygenated free radicals (Klug et al. 1972; Tainer at al. 1983). In physiological conditions, the production of free radicals (Monte \& Sacerdote 1994) and the action of antiradicals' enzymes is balanced. Following tissue injuries, either pathological or caused by agents such as radiation therapy, an excess production of free radicals is observed (Petkau 1986; Lorette \& Machet 2001). Furthermore, basal SOD is increased in breast cancer patients before radiation therapy as compared to controls (Seth et al. 2003), and decreases after radiotherapy (Ray at al. 2000). Hence, liposomal rhSOD applied during radiotherapy could be used to prevent the effects of free radicals and thus might protect the patient's skin from radiation-induced skin reactions. TREATMENT PLAN All patients receive APN201 and placebo at the same time. The irradiated region is divided vertically into two symmetric areas (left and right). One area is treated with APN201, the other area is treated with placebo in a double-blind fashion. Study treatment (APN201 and placebo) starts on the day of initiation of radiation therapy and continues until the end of radiation therapy to the whole breast (25 or 28 daily fractions to a total dose of 50.0 Gy or 50.4 Gy, respectively) (see schedule of assessments, section 5.1). Study treatment is stopped if radiation dermatitis of ≥ grade 2 occurs in one or both treated areas for ≥ 3 days AND a difference in the severity of radiation dermatitis of ≥ 1 grade is seen between the two treated areas. From that point in time the patient only receives the treatment that appeared to be beneficial and this treatment is applied to the whole irradiated region until completion of the 25th, respectively 28th, fraction. Treatment stops earlier in case of progressive disease or unacceptable toxicity or intolerability. Conditions: Radiation Induced Dermatitis Intervention / Treatment: DRUG: APN201, DRUG: Placebo Location: Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Women >= 18 years of age, with breast cancer, treated by breast conserving surgery and scheduled to receive adjuvant radiotherapy to the breast alone * Bra cup size <=D * Karnofsky performance status of >= 80% * Women of childbearing potential must have a negative pregnancy test before study entry and must agree to use a medically acceptable method of birth control throughout the study period * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * Bilateral breast cancer * Inflammatory breast cancer * Lymphangiosis carcinomatosa * Medically significant dermatologic conditions affecting the irradiated area * Planned use of other agents with the aim of preventing and/or treating radiation dermatitis * Concomitant medications which might exacerbate radiation dermatitis * History of previous radiation therapy of the breast * Pregnancy or breastfeeding * Having received any other investigational agent within 4 weeks before enrolment * Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements

Study Objectives 100 patients with Breakthrough pain will be allocated to receive either oral prioxicam (OP) (n=50) or sublingual fentanyl (SLF) (n=50) . Patients will be divided randomly into two equal groups: oral prioxicam (OP) Group and sublingual fentanyl citrate (SLF) Group, comprising of 50 patients each. Pain intensity level on a 0-10 visual analog scale (VAS), patients will be instructed about the use of a 10-cm visual analog scale (VAS) (0 = no pain to 10 = worst possible pain). frequency of Breakthrough pain throughout the day, onset of relief (0-5, 6-10, 11-15, or over 16 min), time required for dose titration, patient satisfaction and adverse effects were assessed at 3, 7, 15, and 30 days after starting the treatment. Conditions: Neoplasm Metastases Intervention / Treatment: DRUG: oral perixicam Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: Eligible participants were all: * adults aged 18 or over * suffering from Background pain cancer pain * whose cancer pain was treated with strong opioids and * who had breakthrough pain which met the criteria described by Portenoy. Exclusion Criteria: Exclusion criteria were: * less than18 years old, * non-controlled basal pain, * hospitalized patients, or cognitive disturbances, * patients with contraindication to NSAIDS such as: * gastric ulcer, * impaired renal function, * cerebrovascular accident, * coronary artery bypass graft, * uncontrolled hypertension, * patients with coagulation anomalies such as hepatic disease or * patients a previous history of allergy to NSAID.

Study Objectives This phase II trial is studying how well fluorine F 18 sodium fluoride positron emission tomography (PET) works in evaluating response to dasatinib in patients with prostate cancer and bone metastases. Diagnostic procedures, such as fluorine F 18 sodium fluoride PET, may help doctors predict a patient's response to treatment and help plan the best treatment. Conditions: Hormone-Resistant Prostate Cancer, Metastatic Malignant Neoplasm in the Bone, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer Intervention / Treatment: RADIATION: Fluorine F 18 Sodium Fluoride Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Must be able to provide a written informed consent * Men >= 18 years with metastatic castration-resistant prostate cancer enrolling onto the Febbo clinical trial with dasatinib therapy (must meet all inclusion criteria for dasatinib treatment study and comply with requirements of that specific clinical trial) * Histologic confirmation of original prostate cancer diagnosis * Presence of at least one convincing bone metastasis as defined by bone scintigraphy, computed tomography (CT) scan (magnetic resonance imaging [MRI] if indicated), or plain X-ray * Must currently have castrate testosterone levels (< 50 ng/dL) from orchiectomy or maintenance on a luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist Exclusion Criteria: * On the nilutamide-only arm (Arm A of the clinical therapeutic trial) * Note: However, if a patient crosses-over from nilutamide at the time of progression to add dasatinib therapy, he may be eligible for 18F-fluoride PET imaging protocol if he meets all inclusion criteria for this trial * Any condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent * A serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and imaging studies * Expected lifespan of 12 weeks or less * Extremely poor intravenous access, prohibiting the placement of a peripheral IV line for injection of radiotracer * Initiation of bisphosphonate therapy less than 4 weeks from the first PET scan * Radiation treatment to bone less than 4 weeks from first PET scan * Radiopharmaceutical treatment to bone less than 4 weeks from first PET scan * Treatment with granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte CSF (G-CSF) within 4 weeks prior to first PET scan * Inability to lie still for the imaging * Weight > 300 lbs. (due to equipment specifications)

Study Objectives Study to compare 2 different chemical forms of GSK1363089. Conditions: Solid Tumours Intervention / Treatment: DRUG: GSK1363089 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of solid tumor malignancy. * 18 years old with ECOG of 0-1. * female subject who is not pregnant * Male subjects must agree to use contraception methods * Able to swallow and retain oral medication. * The subject will refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study. * QTcB or QTcF < 470 msec. * Bilirubin = 1.5mg/dl, AST, ALT, ALP <2X ULN in absence of malignant disease in the liver or <5X ULN in case of liver involvement by the tumor. * Serum Creatinine <1.5mg/dL Exclusion Inclusion: * The subject has received anticancer treatment. * The subject has participated in a clinical trial and has received an investigational product within 21 days. * The subject has known brain metastases. * The subject has uncontrolled intercurrent illness. * History of sensitivity to any of the study medications, or components. * The subject is known to be positive for the human immunodeficiency virus (HIV). * Subjects who have had partial or complete gastrectomy. * Pregnant females as determined by positive ß-hCG test at screening or prior to dosing. * Lactating females. * Unwillingness or inability to follow the procedures outlined in the protocol.

Study Objectives This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 weeks. Conditions: Stage III Ovarian Cancer, Stage IV Ovarian Cancer Intervention / Treatment: BIOLOGICAL: Vigil™ Vaccine, DRUG: Bevacizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed papillary serous or endometrioid ovarian cancer. * Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group B) or patients with vaccine prepared for CLPTL 105 but not otherwise qualifying. * Recurrent cisplatinum resistant/refractory disease (defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels greater than 100 u/mL at two consecutive measurements with no intervening therapy. * Successful manufacturing of 4 vials of Vigil™ vaccine. * Recovered from all clinically relevant toxicities related to prior therapies. * ECOG PS 0-2 prior to Vigil™ vaccine administration. * Normal organ and marrow function as defined below: 1. Absolute granulocyte count >=1,500/mm3 2. Absolute lymphocyte count >= 200/mm3 3. Platelets >=100,000/mm3 4. Total bilirubin <=1.5 x ULN 5. AST(SGOT)/ALT(SGPT)/alkaline phosphatase <=2.5 x ULN 6. Creatinine <1.5 mg/dL 7. INR < 1.5 * Baseline blood pressure must be under 140/90 * Urine protein-to-creatinine ratio < 1.0 mg/dL. * Patients must be off all "statin" drugs for >= 2 weeks prior to initiation of therapy. * Ability to understand and the willingness to sign a written informed protocol specific consent. Exclusion Criteria: * Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to vaccination. Steroid therapy within 1 week prior to vaccination. * Major surgery within 6 weeks or minor surgery within 2 weeks of receiving bevacizumab. * Patient must not have received any other investigational agents within 4 weeks prior to study entry. * Patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation. * Patients with history of brain metastases. * Patients with compromised pulmonary disease. * Short term (<30 days) concurrent systemic steroids <= 0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded. * Prior splenectomy. * Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for >= 2 years. * Kaposi's Sarcoma. * Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major blood vessels. * History of Stroke/Transient Ischemic Attack * Use of bleeding diathesis * Use of anti-coagulants * Patients with clinically significant cardiovascular disease including any of the following: 1. Significant cardiac conduction abnormalities (e.g., PR interval > 0.24 sec or second or third degree AV block. 2. Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg. 3. Myocardial infarction, cardiac arrhythmia, or unstable angina within the past 6 months. 4. New York Heart Association grade II or greater congestive heart failure. 5. Serious cardiac arrhythmia requiring medication. 6. Grade II or greater peripheral vascular disease except episodes of ischemia < 24 hours induration that are managed non-surgically and without permanent deficit 7. History of cerebrovascular accident within the past 6 months. 8. No significant traumatic injury within the past 28 days. * Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements. * Patients with known HIV. * Patients with chronic Hepatitis B and C infection. * Patients with uncontrolled autoimmune diseases.

Study Objectives This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test. Conditions: Non-small Cell Lung Cancer(NSCLC) Intervention / Treatment: DRUG: BP102, paclitaxel, carboplatin, DRUG: Avastin®, paclitaxel, carboplatin Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Aged from 18 to 75 (including 18 and 75), male or female; * Patients with locally advanced and unresectable NSCLC that has been histologically or cytologically proven, metastatic, or recurrent NSCLC. * No previous systematic antitumor therapy for current stage diseases. If previous adjuvant therapy has been received, it is necessary to ensure that the interval between the end of adjuvant therapy and the first administration of this study is more than 6 months, and that all adjuvant treating-related toxic reactions have recovered. * Patients must be able to document the EGFR mutation and ALK fusion gene status, and ALK must be negative. Patients who have not previously been tested for EGFR and ALK genes should be tested during screening; * There must be at least one measurable lesion as a target (according to RECIST V1.1); * ECOG: 0~1; * Life expectancy >=24 weeks; * Major organs' function well. Exclusion Criteria: * Patients with non-small cell lung cancer of other pathological tissue types; * Tumor histology or cytology confirmed positive ALK fusion gene; * Patients with imaging evidence of tumor invasion of large blood vessels; * Patients with uncontrolled pleural effusion and pericardial effusion that require repeated drainage; * Patients with abdominal effusion; * During the screening period, chest CT showed tumor cavity formation, or CT scan was highly suspected of idiopathic pulmonary fibrosis, mechanized pneumonia, drug-associated pneumonia, idiopathic pneumonia or active pneumonia; * Patients with hypertension whose blood pressure has not been satisfactorily controlled by antihypertensive drugs, and patients with previous hypertensive crisis or hypertensive encephalopathy; * Have heart disease or clinical symptoms that are not well controlled; * Patients with unhealed wounds, active gastric ulcers or fractures; * Patients diagnosed with esophagotracheal fistula; * People with known hereditary bleeding tendency or coagulation disorder; * Patients with known central nervous system metastases.

Study Objectives The primary objective was to evaluate efficacy of a single dose of Liproca Depot in patients with localized prostate cancer. Primary efficacy variable was the proportion of patients showing PSA nadir. 24 Caucasian men, with a mean age at inclusion of 68.4 years, with localized prostate cancer were injected once with a ready made paste including 600 mg 2-hydroxyflutamide (Liproca Depot) into the site of the prostate where the tumour was localized. The patient was monitored for prostate-specific antigen (PSA) for maximum 6 months or to progression within this time period. The primary endpoint showed interesting results with high success rate (83%), i.e. proportion of patients (Responders) that reached plasma PSA nadir. Conditions: Prostate Cancer Intervention / Treatment: DRUG: 2-hydroxyflutamide (2-HOF) [Liproca Depot], DRUG: 2-Hydroxyflutamide Location: Finland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age >= 45years * Histologically confirmed localized prostate cancer (T1-T2), predominantly in one side of the peripheral zone, verified by biopsy. * PSA value < 20 ng/ml within 6 weeks before enrolment. * Gleason score <= 3+4 at diagnostic biopsy * Adequate renal function: Creatinine < 1.5 times upper limit of normal. * Adequate hepatic function: ASAT, ALAT and ALP < 1.5 times upper limit of normal. * Negative dipstick for bacturia. * Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit. Exclusion Criteria: * Previous or ongoing hormone therapy for prostate cancer. * Ongoing or previous therapy (within3 month) of finasteride or dutasteride. * Ongoing or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT). * Symptoms or signs of acute prostatitis. * Symptoms or signs of ulceric proctitis * Severe micturation symptoms (I-PSS >17) * Concomitant systemic treatment with corticosteroids, or immunomodulating agents. * Known immunosuppressive disease (e.g. HIV, insulin dependent diabetes). * Simultaneous participation in any other study involving not market authorized drugs or having participated in a study within the last 12 months prior to start of study treatment.

Study Objectives Postmenopausal women, stratified by a peroxisome proliferator-activated receptor gamma-2 (PPARG) polymorphism, were given the following treatments in a random order with a 5w wash-out period: a 400mg ibuprofen tablet or a placebo tablet; both treatments were followed after 30min by a single acute dose of 0.4g alcohol per kg bw. Serum estrogen levels were measured before and at three timepoints after alcohol intake. It is hypothesized that the acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is modulated by ibuprofen and by PPARG genotype. Conditions: Breast Cancer Intervention / Treatment: DRUG: Ibuprofen Tab 400 MG, DRUG: Placebo tab Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: BASIC_SCIENCE Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: QUADRUPLE

Inclusion Criteria: * postmenopausal (last menses at least 1 year earlier); * having a weekly alcohol use of less than 14 drinks * having a BMI of 18-35; Exclusion Criteria: * a history of alcohol abuse * alcohol abstaining * history of hysterectomy before last menses with preservation of both ovaries (unless a medical confirmation for the postmenopausal status exists or the participant is >= 60 years); * major health problems, such as ulcers, heart diseases, diabetes or cancer * previous or current use of HRT * taking prescription medications that could interfere with the study (i.e. daily use of NSAIDs and/or medication that interact with PPARγ e.g. cholesterol lowering medicine); * being allergic to alcohol and/or Ibuprofen * smoking

Study Objectives The purpose of this research is to compare reactions and antibody responses following receipt of different doses of the experimental influenza vaccine or standard influenza vaccine. Conditions: Influenza Intervention / Treatment: BIOLOGICAL: Trivalent inactivated influenza vaccine, BIOLOGICAL: Trivalent Baculovirus-expressed Influenza HA vaccine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Patients with non-Hodgkin's B-cell lymphoma (NHL) including follicular, large cell and Mantle cell lymphoma will be included. * Patients in complete clinical remission and determined to have no evidence of active disease (NED). * Ambulatory, medically stable persons; community dwelling; able to give informed consent and available for all study visits; able to understand and comply with planned study procedures; ECOG performance status less than or equal to 2. * Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs are controlled with medical therapy. * Patients with a non-metastatic secondary solid tumor or malignancies not currently (< 3 months) being treated will be included. * Patients greater than or equal to 18 years of age who have given informed consent and signed the IRB approved informed consent. Exclusion Criteria: * Patients with Hodgkin's disease, and T-cell lymphoma. * Patients undergoing antineoplastic therapy. * Patients who have received chemotherapy within the past 3 months. * Individuals who were given rituximab (ibritumomab tiuxetan) in < 6 months. * Patients receiving systemic corticosteroids and/or high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent). * Splenectomized individuals will not be included. * Known allergy to eggs or other components of vaccine (e.g., thimerosal). * Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: acute febrile illness, known chronic liver disease; significant renal disease; oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV dyspnea; unstable or progressive neurologic disorder; insulin-dependent diabetes mellitus). * Concomitant use of investigational vaccines and/or other medications within 4 weeks prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products prior to study completion. * Previous exposure to parenteral immunoglobulins or other blood product within 6 months prior to enrollment into the study. * Subject is enrolled in a conflicting clinical trial. * Use of experimental vaccines or medications within one month of study entry. * Any acute or chronic condition which in the opinion of the investigator would render vaccination unsafe or interfere with the evaluation of response. * Patients with a known history or risk factors (IV drug abuse or casual sex within the past year) of Hepatitis B, Hepatitis C, or Human Immunodeficeincy Virus.

Study Objectives Title: Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer. Protocol code: IRST157.01 Phase: II Study Design: monocentric, prospective, open-label not randomized trial. Description of Study Treatment: radio-chemotherapy schedule * GEMOX: Gemcitabine (GEM) 1000 mg/m2, day 1, and Oxaliplatin (OX) 100 mg/m2, day 2, every 2 weeks for 4 cycles. * Hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days, one session per day excluding Saturday and Sunday) administered 15 days after the 4th chemotherapy cycle. * Further 4 cycles of GEMOX, starting 7-15 days after the end of the radiotherapy. Objectives: Step A: primary objective = to evaluate the safety of radiotherapy treatment. Secondary objective = the control of IM (internal margin) intra-fraction. Step B: primary objective = to evaluate the proportion of the resectable patients after radio-chemotherapy. Secondary objectives = overall Response Rate (ORR); safety profile of combinated treatment;overall survival (OS); local progression free survival (LPFS) and progression free survival (PFS). Statistical Considerations: Step A: Assuming that the probability to observe a toxicity involving the radiotherapy treatment discontinuation with the new treatment is less than 20%, 11 patients are to be evaluated for toxicity. If no toxicity involving the radiotherapy treatment discontinuation will be observed in 11 patients, the treatment can be considered safe with a probability \> 90%. If 1 toxicity involving the radiotherapy treatment discontinuation will be observed, 7 more patients needs to be recruited. If no further toxicity involving the radiotherapy treatment discontinuation occurs, the treatment could be considered safe with a probability ≥ 90%. If 2 or more toxicity involving the radiotherapy treatment discontinuation on 11 patients or 2 or more toxicity involving the radiotherapy treatment discontinuation on 18 patients will be observed, the study will be stopped because not safe and another kind of radiotherapy schedule must be designed. Step B: If the radiotherapy treatment will be considered no toxic, the study will continue in Step B : the goal of this phase II study is to increase the proportion of resectable patients of at least 15% with the new radio-chemotherapeutic treatment. By using the single-stage design (Gehan EA, J Chron Dis 1961) a total of 40 patients is required to be recruited in 2 years, and a further one-year period of follow-up is requested. If at least 7 patients out of 40 enrolled will be resectable, the hypothesis that the proportion of resectable patients will be less or equal to P1 (P1=the proportion of resectable patients with the new radio-chemotherapeutic treatment) will be refused and the treatment could be considered active. Conditions: Unresectable Pancreatic Cancer, Nonmetastatic Pancreatic Cancer, Locally Advanced Pancreatic Cancer Intervention / Treatment: DRUG: Gemcitabine, DRUG: Oxaliplatin, RADIATION: Hypofractionated RT Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer are candidates for the trial. * Stage III disease (AJCC TNM 6th edition, 2002). Inoperable disease, by radiological and surgical evaluation; * Age >18 years and <=75 years. * Life expectancy of greater than 12 weeks. * ECOG performance status 0-2 (see Appendix A). * Presence of at least of one measurable lesion in agreement to RECIST criteria * Patients must have normal organ and marrow function as defined below: * Leukocytes >3,000/uL * Absolute neutrophil count >1,500/uL * Platelets >100,000/uL * Total bilirubin < 1.5 X ULN * AST (SGOT)/ALT (SGPT) <2.5 X ULN * Creatinine < 1.5 X ULN * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have had any chemotherapy or radiotherapy prior to entering the study; * Stage IV disease; * Participation in another clinical trial with any investigational agents within 30 days prior to study screening. * Previous malignancy except cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors, or other malignancies curatively treated >5 years before study entry. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and oxaliplatin or other agents used in the study. * Active brain or leptomeningeal disease * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.