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Study Objectives The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM) Conditions: Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection Intervention / Treatment: BIOLOGICAL: Comparator: V505 formulation 1, DRUG: Comparator: V505 formulation 2, DRUG: Comparator: V505 formulation 2, BIOLOGICAL: Comparator: V505 formulation 3, BIOLOGICAL: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant, BIOLOGICAL: Comparator: Placebo (unspecified) Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Female between 16 to 26 years old * Has never had Pap testing or have only had normal Pap test results * Lifetime history of 0 to 4 sexual partners Exclusion Criteria: * History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser * History of severe allergic reaction that required medical attention * Are pregnant * Received a marketed HPV vaccine * Currently enrolled in a clinical trial * Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)

Study Objectives An open-label, single center study with 99mTc-ADAPT6 SPECT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-ADAPT6 SPECT and standard histopathology from relevant tumor and lymph node biopsies. Conditions: Breast Cancer, Female Intervention / Treatment: DRUG: ADAPT6-SPECT Location: Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subject is > 18 years of age * Diagnosis of primary breast cancer with lymph node metastases * Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative * Hematological, liver and renal function test results within the following limits: * White blood cell count: > 2.0 x 109/L * Hemoglobin: > 80 g/L * Platelets: > 50.0 x 109/L * ALT, ALP, AST: =< 5.0 times Upper Limit of Normal * Bilirubin =< 2.0 times Upper Limit of Normal * Serum creatinine: Within Normal Limits * A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination * Subject is capable to undergo the diagnostic investigations to be performed in the study 8. Informed consent Exclusion Criteria: * Any system therapy (chemo-/targeted therapy) * Second, non-breast malignancy * Active current autoimmune disease or history of autoimmune disease * Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C * Administration of other investigational medicinal product within 30 days of screening * Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Study Objectives The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors Conditions: Cancer Intervention / Treatment: DRUG: E7080 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Subjects with histologically and/or cytologically diagnosis of solid tumor * Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available * Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia) * Subjects who completed previous anti-tumor therapy before at least 4 weeks * Subjects who are >= 20 years * Subjects with 0 to 1 of Performance Status * Subjects agree to be hospitalized for DLT observation * Subjects with adequate organ functions * Males and females of childbearing potential must agree to use appropriate contraception from the agreement to 30 days after study drug administration. * Agree to participate in this study in writing based on voluntary will Exclusion Criteria * Subjects with brain metastasis accompanying clinical symptoms or requiring treatment * Subjects with the severe complication or disease history * Subjects unable to take oral medication. * Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study. * Scheduled for surgery during the projected course of the study. * Positive for human immunodeficiency virus (HIV antibody) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test. * Subjects who in the view of the investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addict * Pregnant or nursing subjects * Subjects who are participating in another clinical trial.

Study Objectives The primary objective of this study is to evaluate the safety, tolerability, and efficacy of temozolomide in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) participants who are not candidates for standard induction therapy and exhibit low MGMT expression. Conditions: Leukemia, Acute Myeloid, Myelodysplastic Syndrome Intervention / Treatment: DRUG: temozolomide Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Confirmed diagnosis of acute myeloid leukemia (AML), any subtype except acute promyelocytic leukemia (APL), by the World Health Organization (WHO) criteria, or high risk MDS with blasts between 10 and 20% in the bone marrow. * No prior AML chemotherapy except hydroxyurea. * Leukemic blast count <30x10^9/L at the start of therapy. Prior cytoreduction with hydroxyurea (maximum 14 days) is permitted. * Participant is not a candidate for aggressive induction based on at least one of the following: adverse-risk cytogenetics (complete or partial deletion of 5 or 7, complex [>3] cytogenetic abnormalities, inv3, 11q23 abnormalities); secondary AML (antecedent hematologic disorder or therapy-related AML); comorbid medical illnesses precluding standard induction therapy; participant's refusal of standard induction therapy. * Confirmed low MGMT expression (MGMT: beta-actin <=0.2), as evaluated by Western blot, or weak MGMT expression defined as > 0.2 and <=2.5 if promoter is methylated, upon Sponsor approval. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Use of medically approved contraception in fertile males and females. * Negative urine or serum pregnancy test for women of childbearing potential (72 hours prior to Baseline). Exclusion Criteria: * Serum bilirubin >2 times the upper limit of normal (ULN), or serum aspartate aminotransferase/ alanine aminotransferase >5 times ULN. * Serum creatinine >200 umol/L. * History of other malignancies within 1 year prior to study entry, with the exception of localized nonmelanomatous skin cancer or cervical cancer in situ. * Presence of active uncontrolled infection. * Known human immunodeficiency virus (HIV) infection. * Any medical condition that may interfere with protocol evaluation or oral medication intake. * Prior chemotherapy other than hydroxyurea.

Study Objectives This study is an open, multicenter, prospective phase I dose escalation clinical trial followed by an expansion cohort. The aim of this study is to asses the Recommended Phase 2 Dose (R2PD) and the safety profile, among other efficacy, in FGFR1/2/3 positive, hormone receptor-positive breast cancer (HRPBC) patients with metastatic disease after progression to the combination of an aromatase inhibitor plus palbociclib, abemaciclib or ribociclib, according RECIST 1.1 criteria. Conditions: Breast Cancer Metastatic, Hormone Receptor Positive Malignant Neoplasm of Breast Intervention / Treatment: DRUG: Combination, Rogaratinib + palbociclib + fulvestrant Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Women >=18 years-old. * Diagnostic of metastatic or locally advanced non-resectable breast cancer. * Ability to understand and signing of the PIS/ICF for FGFR testing. FGFR testing will be performed centrally at CNIO (RNAscope and FISH). * Ability to understand and signing the written PIS/ICF for study treatment eligibility. * Availability of fresh tumor biopsy specimen for FGFR1/3 mRNA expression and FISH testing. * Hormone-receptor positivity defined by at least 5% positivity of ER and/or PR (no central laboratory testing is required). * Positivity of FGFR1/2/3 by RNA-scope and/or FISH. * Patients must have undergone a previous hormonal treatment line for metastatic disease, with anastrozole, letrozole or exemestane, plus a cell cycle inhibitor (palbociclib, ribociclib or abemaciclib). * Recovery of toxicities from previous regimens to equal or below tolerable grade II. * HER2-negativity (Herceptest 0+, 1+ or 2+ with negative FISH/CISH/SISH). * ECOG performance status of 0/1. * Life expectancy of >24 weeks. * Adequate bone marrow, liver and renal function as assessed by laboratory requirements: 1. Absolute neutrophil count (ANC) >= 1,500/mm3 2. Hemoglobin >= 10 g/dL (without transfusion or erythropoietin . 3. Platelet count >= 100,000/mm3 4. Total bilirubin <= 1.5 × the upper limit of normal (ULN). 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 × ULN 6. Alkaline phosphatase <= 2.5 times ULN 7. Lipase and amylase <= 2 × ULN. 8. Serum albumin >= 2.5 g/dl. 9. Glomerular filtration rate (GFR) >= 60 mL/min/1.73 m2 * INR <= 1.5 × ULN and PTT or activated PTT (aPTT) <= 1.5 × ULN. * Negative serum pregnancy test in women of childbearing potential. * Women of reproductive potential must agree to use highly effective contraception when sexually active. * Evaluable disease according to RECIST 1.1 criteria. Exclusion Criteria: * Involvement in the planning and/or conduct the study. * Previous enrollment in the present study. * Previous or concurrent cancer except: 1. Cervical carcinoma in situ. 2. Treated basal-cell carcinoma or squamous cell skin cancer. 3. Any other cancer curatively treated > 3 years before the first study drug administration. * Receipt the last dose of anticancer therapy at least 21 days prior to the first dose of study drug. * Acute toxic effects of previous anticancer chemotherapy or immunotherapy have to be normalized completely * Anti-cancer therapy is defined as any agent or combination of agents with clinically proven anti-tumor activity * Previous treatment with anti-FGFR directed therapies. * Irradiation of single bony lesions with risk of fracture. Zoledronic acid or denosumab started prior to trial registration is allowed. * Symptomatic metastatic brain or meningeal tumors. * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: 1. Congestive heart failure, unstable angina (symptoms of angina at rest) or 2. New-onset angina 3. Myocardial infarction (MI). 4. Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. 5. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, must be on a stable medical regimen. * Known human immunodeficiency virus (HIV) infection. * Active hepatitis B virus or hepatitis C infection requiring treatment. 1. Patients with past HBV infection or resolved HBV infection are eligible if HBV DNA is negative. 2. Patients positive for hepatitis C virus are eligible only if polymerase chain reaction is negative for HCV RNA. * Any condition that in the opinion of the investigator would interfere with evaluation of study treatment or interpretation of patient safety or study results, or inability to comply with the study and follow-up procedures. * Previous or concomitant participation in another clinical study with investigational medicinal products. * Active tuberculosis. * Clinically active infections. * Treatment with therapeutic oral or i.v. antibiotics. * Patients receiving prophylactic antibiotics are eligible. * Seizure disorder requiring medication. * History of organ allograft. * Evidence or history of bleeding diathesis or coagulopathy. * Any hemorrhage / bleeding event CTCAE v.5.0 >= Grade 3. * Serious, non-healing wound, ulcer or bone fracture. * Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. * Any malabsorption condition. * Current diagnosis of any retinal disorders including retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion. * Peripheral sensory neuropathy of CTCAE v.5.0 Grade 2 or higher. * Current evidence of endocrine alteration of calcium phosphate homeostasis. * Concomitant therapies that are known to increase serum phosphate levels. * Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study. * Breast-feeding. * Use of strong inhibitors of CYP3A4 and strong inducers of CYP3A4. * Autologous bone marrow transplant or stem cell rescue. * Major surgery, open biopsy or significant traumatic injury. * Renal failure requiring peritoneal dialysis or hemodialysis. * Systolic/diastolic blood pressure <= 100/60 mmHg and concurrent heart rate >= 100/min. * Inability to swallow oral tablets. * Close affiliation with the investigational site; e.g. a close relative of the investigator or a dependent person. * Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism.

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

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

Study Objectives The purpose of this study is to compare and determine the efficacy of combined N-acetyl cysteine and clomiphene citrate(CC)with combined metformin and CC in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone. Conditions: Polycystic Ovary Syndrome Intervention / Treatment: DRUG: combined N-acetyl cysteine -CC, DRUG: combined metformin-CC Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * CC resistant PCOS Exclusion Criteria: * Congenital adrenal hyperplasia * Cushing syndrome * Androgen secreting tumors

Study Objectives Co-administration of propofol and remifentanil is considered to be an ideal total intravenous anesthesia technique, which is widely used in induction and maintenance of general anesthesia. Remifentanil and propofol can be mixed in polypropylene syringes for one hour with a remaining concentration of 91% in small concentrations of remifentanil. However, delivery of remifentanil-propofol mixture by target-controlled infusion(TCI) for general anesthesia in surgical procedure has not been described. Breast cancer surgery ( including modified radical mastectomy and breast-conserving surgery) is a less time-consuming procedure for patients with breast cancer with one-hour duration in our hospital. This pilot study was to examine the merit of remifentanil-propofol mixture as a GA regimen for breast cancer surgery. Conditions: Anesthetics, Remifentanil, Propofol Intervention / Treatment: COMBINATION_PRODUCT: Remifentanil-propofol mixture Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * ASA II or III * age more than 18 years * scheduled for breast cancer surgery under general anesthesia. Exclusion Criteria: * previously allergic to propofol or remifentanil * combining other surgical procedure leading to extended operative time

Study Objectives The goal of this clinical research study is to learn if the study drug AZD2014 can shrink growing or symptomatic meningiomas. Conditions: Neurofibromatosis 2, Meningioma Intervention / Treatment: DRUG: AZD2014 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have a confirmed diagnosis of neurofibromatosis 2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the NF2 gene. * Participants must have progressive or symptomatic meningioma. NOTE 1: Histologic confirmation of meningioma is not required in the setting of compatible radiographic appearance, NOTE2: progression is defined as an increase in target meningioma volume >= 20% OR >= 3 mm during the past 2 years. -- Subjects must have a target meningioma that is not amenable to surgery due to patient preference or high risk for surgical complications * Participants must be willing and able to undergo regular MRI scans of the brain * Patients must have measurable disease, defined as at least one meningioma >= 1.0 ml that can be accurately measured by contrast-enhanced cranial MRI scan, performed within 28 days of study registration. * Prior surgical resection and radiation therapy for the progressive meningioma are not required for study enrollment. * Patients must have received less than 3 prior chemotherapy regimens for progressive meningioma. * Patients receiving dexamethasone must be able to be treated with alternative corticosteroids such as prednisone, prednisolone, or methylprednisolone in the opinion of the treating physician. * Patients must have available an archival paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides. * Age >= 18 years at the time of study enrollment. * ECOG performance status <=2 (Karnofsky >=60%) with no deterioration over the previous 2 weeks * Life expectancy of greater than 3 months * Within 14 days of study registration, participants must have normal organ and marrow function as defined below: * leukocytes >=3,000/mcL * absolute neutrophil count >=1,500/mcL * hemoglobin >=90 g/L * platelets >=100,000/mcL * total bilirubin <=1.5 x institutional upper limit of normal * AST(SGOT)/ALT(SGPT) <=2.5 × institutional upper limit of normal * Serum creatinine <=1.5 x institutional upper limit of normal concurrent with creatinine clearance >=50 mL/min (measured or calculated by Cockcroft and Gault equation), confirmation of creatinine clearance is only required when creatinine is >1.5xULN * Urine protein <=1+ on urine dipstick (if 2+ seen on first test, re-test at least 24 hours later) * PT/INR/PTT (aPTT) <1.5x institutional upper limit of normal * The effects of AZD2014 on the developing human fetus are unknown. For this reason and because mTOR kinase inhibiting agents are known to be teratogenic, female patients must be willing to use 2 forms of highly effective contraception (per institution standards) from the time of screening until 4 weeks after discontinuing study, must not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child bearing potential or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening: (1) post-menopausal women, defined as either women aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments, or, (2) women under 50 years old who have been amenorrhoeic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in the postmenopausal range for the institution. Alternatively, women must have documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. * Male patients should either be surgically sterile or willing to use an effective barrier method of contraception during the study and for 16 weeks following the last dose of study treatment if sexually active with a female of childbearing potential. If not done previously, storage of sperm prior to receiving AZD2014 will be advised to male patients with a desire to have children. * Ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures, sampling, and analyses. * Ability to swallow and retain oral medication Exclusion Criteria: * Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment (not including palliative radiotherapy at focal sites). Prior use of an investigational monoclonal antibody therapy within 3 months, or prior use of nitrosoureas or mitomycin C within 6 weeks. Patients must have recovered from acute toxicity due to radiotherapy. * With the exception of alopecia, any unresolved toxicities from prior anti-tumor treatments (excluding corticosteroids) should be no greater than CTCAE (Version 4.0) Grade 1 at the time of study entry. * Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery (excluding tumor biopsies) within 14 days of first dose of study treatment * Participation in another clinical study with an investigational product during the last 21 days. * History of hypersensitivity to active or inactive excipients of AZD2014 or drugs with a similar chemical structure or class to AZD2014. * Exposure to potent or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix B) * Exposure to sensitive or narrow therapeutic range substrates of the drug metabolizing enzymes CYP2C8, CYP2C9, CYP2C19, CYP2D6 or the drug transporters Pgp (MDR1), BCRP, OATP1B1, OATP1B3, OCT1 and OCT2 within the appropriate wash-out period (a minimum of 5 x reported elimination half-life) before the first dose of study treatment (see Appendix B) * Any haemopoietic growth factors (e.g., filgrastim [granulocyte colony-stimulating factor; G-CSF], sargramostim [granulocyte-macrophage colony-stimulating factor; GM-CSF]) within 14 days prior to receiving study treatment.. * Pre-treatment with other mTOR inhibitors may be allowed and should be discussed for each protocol and tumor type separately * Current refractory nausea and vomiting, malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction. * Previous meningioma progression during treatment with other mTORC1/2 inhibitors (but not mTORC1 inhibitors such as everolimus or other rapalogues) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, severe hepatic impairment, interstitial lung disease (bilateral, diffuse, parenchymal lung disease), uncontrolled chronic renal diseases (glomerulonephritis, nephrotic syndrome, Fanconi Syndrome or renal tubular acidosis), current unstable or uncompensated respiratory or cardiac conditions, uncontrolled hypertension, active bleeding diatheses, active hepatitis B or C infection, known active human immunodeficiency virus (HIV) infection, or psychiatric illness/social situations that would limit compliance with study requirements. Screening for chronic conditions is not required. * History of other malignancies, except: Malignancy treated with curative intent and with no known active disease present for >=5 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician, (2) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, (3) adequately treated carcinoma in situ without evidence of disease, or (4) Gleason 6 prostate cancer under observation. * Patients who have experienced any of the following procedures or conditions currently or in the preceding 12 months: * coronary artery bypass graft * angioplasty * vascular stent * myocardial infarction * angina pectoris * congestive heart failure New York Heart Association Grade >=2 ( ventricular arrhythmias requiring continuous therapy) * supraventricular arrhythmias including atrial fibrillation, which are uncontrolled * haemorrhagic or thrombotic stroke, including transient ischaemic attacks or any other central nervous system bleeding * History of drug abuse or alcohol abuse, as judged by the Investigator * Abnormal echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) at baseline (left ventricular ejection fraction [LVEF] <55%. Appropriate correction to be used if a MUGA is performed. * Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis * Mean resting corrected QT interval (QTc), calculated using Fridericia's formula, > 470 msec obtained from 3 electrocardiograms (ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes within 12 months of the patient entering in the study * Patients with Diabetes Type I or uncontrolled Type II (HbA1c >8% assessed locally) as judged by the Investigator or Abnormal fasting glucose value defined as >126 mg/dL (>7 mmol/L). * Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation or risk of arrhythmic events (such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age). * Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug. * Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements. Note: patients who are likely to require surgery or radiation for NF2-related tumors during the first year of treatment in the investigator's opinion should not be enrolled on this clinical trial. * Pregnant women are excluded from this study because AZD2014 is an mTORC1/2 inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD2014, breastfeeding should be discontinued if the mother is treated with AZD2014. * HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2014. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca, CRO staff, and/or staff at the CPU)

Study Objectives This phase II trial is studying how well etanercept works in treating young patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Etanercept may be effective in treating patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Conditions: Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes, Disseminated Neuroblastoma, Juvenile Myelomonocytic Leukemia, Previously Treated Childhood Rhabdomyosarcoma, Previously Treated Myelodysplastic Syndromes, Pulmonary Complications, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Neuroblastoma, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Recurrent/Refractory Childhood Hodgkin Lymphoma, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes Intervention / Treatment: BIOLOGICAL: etanercept, DRUG: methylprednisolone Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of acute, noninfectious idiopathic pulmonary dysfunction (IPS) as defined by the following: * Evidence of diffuse lung injury occurring within the first several months after hematopoietic stem cell transplantation for which an infectious etiology is not identified. To meet the criteria for IPS there must be: * Evidence of widespread alveolar injury * Diffuse multi-lobar infiltrates on chest x-ray or CT scan * Evidence for abnormal respiratory physiology based upon 1 of the following: * Room air oxygen saturation < 93% * Supplemental oxygen required to maintain an oxygen saturation >= 93% * Absence of active lower respiratory tract infection, defined as Bronchoalveolar lavage (BAL)-negative for infection based on one of the following: * Gram stain, fungal stain, acid-fast bacilli stain * Bacterial culture (a quantitative culture >= 10^4 colony-forming units/mL is considered positive) * Fungal culture * Mycobacterial culture * Viral culture (respiratory syncytial virus [RSV], parainfluenza, adenovirus, influenza A and B, and cytomegalovirus [CMV]) * If direct fluorescent antibody (DFA) screening is performed on BAL, it must be negative for all viruses listed above * Pneumocystis carinii pneumonia by polymerase chain reaction (PCR), DFA stain, or cytology * Evidence of bilateral pulmonary infiltrates (on chest radiograph) * Patients may have diffuse alveolar hemorrhage (DAH) or peri-engraftment respiratory distress syndrome (PERDS) * Presence of "mixed oral flora," "rare Candida species," or the presence of a Penicillium species reported on BAL fluid analysis allowed * A radiographic finding of pulmonary edema does not exclude the diagnosis of IPS, provided the other criteria have been met and provided the treating physician concludes by clinical (or echocardiographic) criteria that the pulmonary edema is not secondary to cardiac dysfunction or iatrogenic fluid overload * Patients must require supplemental oxygen * Must have undergone an allogeneic bone marrow, cord blood, or peripheral blood stem cell transplantation within the past 120 days * There are no restrictions based upon underlying disease, donor source, the degree of HLA match, the intensity of the pre-transplant conditioning regimen, or the use of a prior donor leukocyte infusion * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No documented invasive fungal or systemic viral infection within the past 14 days * Patients with asymptomatic viruria allowed * No signs of CMV reactivation (by CMV, PCR, antigenemia, or shell vial culture) within the past 14 days * No sepsis syndrome or hypotension that requires inotropic support (except dopamine < 5mcg/kg/minute) * No documented bacteremia within the past 48 hours * Persistent fever allowed * No evidence of cardiac failure by clinical or echocardiographic findings * No known hypersensitivity to etanercept * No known history of tuberculosis (Tb) or prior Tb exposure * No prior chronic hepatitis B or hepatitis C infection * Concurrent treatment for acute or chronic GVHD allowed * More than 14 days since prior etanercept * More than 7 days since prior investigational drug trials (phase I, II, or III) for the treatment of acute graft-versus-host disease (GVHD) * Not on mechanical ventilation for > 48 continuous hours prior to study entry * Must not be receiving > 2 mg/kg/day of methylprednisolone or corticosteroid equivalent within 24 hours of study entry * Concurrent continuous veno-venous hemofiltration or hemodialysis allowed

Study Objectives The purpose of this study is to test the safety of RAD-001 and Sunitinib given in combination for renal cell cancer. We also want to find out what effects (good and bad) the combination of RAD-001 and Sunitinib have on you and your tumor. RAD001 is a pill that works by shutting down some of the pathways in the cell that make tumors grow. Sunitinib is a pill that works by shutting off the signal in the cancer cells that tell the cells to grow blood vessels. Without this signal, the blood vessels to the tumors shrink down. Conditions: Renal Cell Carcinoma, Kidney Cancer Intervention / Treatment: DRUG: RAD001, Sunitinib 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: * Any histologically confirmed renal cell carcinoma with metastases. Patients with unresected primary tumors may be enrolled as long as evidence of metastatic disease is also present. * No prior sunitinib or m-TOR inhibitor. The washout period must be at least 4 weeks for any prior therapy. * Male or female, 18 years of age or older. * ECOG performance status 0 or 1. * Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to NCI CTCAE grade less than or equal to 1. * Adequate organ function as defined by the following criteria: * Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) less than or equal to 2.5 x upper limit of normal (ULN) or less than 5 x ULN in the presence of liver metastases. * Total serum bilirubin less than or equal to 1.5 mg/dL * Total leukocyte count greater to or equal to 3000 cells/ul * Absolute neutrophil count (ANC) greater than or equal to 1500/µL * Platelets greater than or equal to 100,000/µL * Hemoglobin greater than or equal to 9.0 g/dL * Serum calcium less than or equal to 12.0 mg/dL * Serum creatinine less than or equal to 2.0 x ULN * PT less than or equal to 1.5 ULN * Negative serum or urine pregnancy test in women of child-bearing age * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment. * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: * Major surgery, open biopsy, traumatic injury, radiation or systemic therapy within 4 weeks of starting the study treatment. Anticipation of major surgical procedure during the study. Prior palliative radiotherapy to metastatic lesion(s)is permitted, provided there is at least one measurable lesion that has not been irradiated. * More than 3 prior systemic therapies for metastatic RCC. * Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0. * No other approved or investigational anticancer treatment will be permitted during the study period, including chemotherapy, biological response modifiers, hormone therapy, or immunotherapy, with the exception of palliative radiation therapy. No other investigational drug may be used during treatment on this protocol, and concurrent participation in another clinical trial is not allowed. * NCI CTCAE grade 3 hemorrhage within the past 1 month. * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0. * Chronic treatment with systemic steroids or other immunosuppressive agent * Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of Sunitinib or RAD001 (e.g. malabsorptive disorder, ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or small bowel resection) * Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin) * Current spinal cord compression, or carcinomatous meningitis. * Any of the following within the 12 months prior to study drug administration: * severe/unstable angina, * MI, * CABG, * symptomatic congestive heart failure, * cerebrovascular accident or transient ischemic attack or peripheral vascular disease. * Ongoing cardiac dysrhythmias of NCI CTCAE grade greater or equal to 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males and >470 msec for females. * Blood pressure > 150/100mmHg * Evidence of bleeding diathesis or coagulopathy * Serious, non-healing wound, ulcer or bone fracture * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. * Current treatment on another therapeutic clinical trial. * Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. * Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study. * Receipt of any investigational agent within 4 weeks prior to study entry.

Study Objectives Although the overall incidence of gastric cancer has steadily declined in many Western countries during the last few decades, it is still one of the most common tumors in China. It is now well recognised that combination chemotherapy regimens improve patient outcomes, but there is no accepted global standard regimen for advanced gastric cancer. The ToGA study was the first randomized, prospective, multicenter, phase III trial to show the efficacy and safety of Trastuzumab in HER2- positive GC. Trastuzumab reduced the risk of death by 26% (HR 0.74; 95% CI 0∙60, 0∙91; p=0∙0046) when combined with a reference chemotherapy (Capecitabine plus Cisplatin) and prolonged the median survival by nearly 3 months (from 11.1 to 13.8 months) in patients with HER2-positive(FISH+ or IHC3+) advanced GC. Oxaliplatin has been shown to be as effective as cisplatin, and exhibits a favorable toxicity profile with a substantially lower rate of nephrotoxicity, ototoxicity, and myelosuppression. In the current study, the efficacy and safety of Trastuzumab in combination with Oxaliplatin/capecitabine chemotherapy will be evaluated in Chinese patients with HER2 positive advanced or recurrent gastric cancer. Conditions: Gastric Cancer Intervention / Treatment: DRUG: Trastuzumab+Capecitabine+Oxaliplatin Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy. * Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0), assessed using imaging techniques (CT or MRI). * HER2 positive tumour (primary tumour or metastasis) as assessed by the central laboratory. (Both IHC and Dual SISH will be performed on all patients in the central laboratory.) * ECOG Performance status 0, 1 or 2. * Life expectancy of at least 3 months. * Male or female. Age >= 18 years. * Signed informed consent. Exclusion Criteria: * Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; the total dose of cisplatin should be less than 300mg/m2, adjuvant/neoadjuvant therapy with oxaplatin is not allowed). * No prior use of EGFR-targeting drugs,such as Trastuzumab,lapatinib or other TKIs. * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe). * Patients with active (significant or uncontrolled) gastrointestinal bleeding. * Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity >= grade 2 NCI-CTCAE 4.0. * Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. * Neutrophil count < 1.5 × 109/L, or hemoglobin < 90 g/L,or platelet count < 100 × 109/L. * Serum bilirubin > 1.5 × upper limit of normal (ULN); or, AST or ALT > 2.5 × ULN(or > 5 × ULN in patients with liver metastases); or, alkaline phosphatase > 2.5 × ULN (or > 5 × ULN in patients with liver metastases, or > 10 × ULN in patients with bone but no liver metastases); or, albumin < 25 g/L. * Creatinine clearance < 60 mL/min. * History of documented congestive heart failure; angina pectoris requiring medication;evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias. * Baseline LVEF < 50% (measured by echocardiography or MUGA). * Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy. * Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed). * Clinically significant hearing abnormality. * Known dihydropyrimidine dehydrogenase (DPD) deficiency. * History or clinical evidence of brain metastases. * Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes. * Positive serum pregnancy test in women of childbearing potential. * Subjects with reproductive potential not willing to use an effective method of contraception. * Received any investigational drug treatment within 4 weeks of start of study treatment. * Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastastic site peripherally and patient recovered from any acute toxicity;prior adjuvant radiotherapy is allowed if complete at least 6 months ). * Major surgery within 4 weeks of start of study treatment, without complete recovery. * Patients with known active infection with HIV, HBV, or HCV. * Known hypersensitivity to any of the study drugs.

Study Objectives The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic reovirus in combination with paclitaxel and carboplatin is effective and safe in the treatment of squamous cell carinoma of the lung. Conditions: Metastatic or Recurrent Squamous Cell Carcinoma of the Lung Intervention / Treatment: BIOLOGICAL: REOLYSIN, DRUG: Paclitaxel, DRUG: Carboplatin 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 histologically or cytologically confirmed metastatic stage IIIB (pleural effusion; IVA on revised IASLC staging) or stage IV, or recurrent squamous cell carcinoma of the lung. * have measurable disease. * be chemotherapy naïve for their metastatic or recurrent SCCLC, with some exceptions. * have NO continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures. * have an ECOG Performance Score of <= 2. * have a life expectancy of at least 3 months. * absolute neutrophil count (ANC) >= 1.5 x 10^9; Platelets >= 100 x10^9 (without platelet transfusion);Hemoglobin >= 9.0 g/dL (with or without RBC transfusion); Serum creatinine <= 1.5 x upper limit of normal (ULN); Bilirubin <= 1.5 x ULN; AST/ALT <= 2.5 x ULN. * negative pregnancy test for females with childbearing potential. Exclusion Criteria: * receive concurrent therapy with any other investigational anticancer agent while on study. * have a known past or current history of brain metastasis(es). * be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C. * be a pregnant or breast-feeding woman. * have clinically significant cardiac disease. * have dementia or altered mental status that would prohibit informed consent. * have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.

Study Objectives A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint is disease control and the secondary efficacy endpoints include antitumor effect (tumor response), progression-free survival and overall survival. The pharmacokinetic profile and the safety profile are also evaluated. Conditions: Gastric Cancer Intervention / Treatment: DRUG: ARQ 197 Location: Japan, 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: * Japanese or Korean with voluntary written informed consent for study participation * A histologically or cytologically confirmed advanced/recurrent gastric cancer * One or two prior chemotherapy regimens for advanced/recurrent gastric cancer * At least one measurable lesion * ECOG performance status of 0 or 1 * Life expectancy >=3 months Exclusion Criteria: * Surgery for cancer within 4 weeks prior to the first dose of ARQ 197 * Confirmed other tumors than gastric cancer within 5 years prior to the first dose of ARQ 197 * Anticancer chemotherapy, hormone therapy, radiotherapy or immunotherapy within 2 weeks prior to the first dose of ARQ 197 * Positive for HIV antibody * Known symptomatic brain metastasis * Gastrointestinal disorders that could interfere with the absorption of ARQ 197 or operation history for gastrointestinal disorders * Uncontrolled concomitant disease * Patients who wish to have a child and who would not agree to use contraceptive measures * Pregnant or lactating

Study Objectives Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Conditions: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer Intervention / Treatment: DRUG: ixabepilone 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 cancer or primary peritoneal cancer * Recurrent or persistent disease * Platinum AND taxane-resistant or refractory disease * Progressed during therapy * Refractory disease within 6 months of therapy * Measurable disease * At least 20 mm by conventional techniques * At least 10 mm by spiral CT scan * Tumor lesions located within a previously irradiated field are not considered measurable disease unless there is documented tumor progression in these lesions or biopsy confirmation >= 90 days following completion of radiotherapy * Ineligible for higher priority GOG (Gynecologic Oncology Group) protocol * No active brain metastases * Performance status - GOG 0-2 * Absolute neutrophil count >= 1,500/mm^3 * Platelet count >= 100,000/mm^3 * Bilirubin <= 1.5 times upper limit of normal (ULN) * SGOT (serum glutamate oxaloacetate transaminase) <= 2.5 times ULN * Alkaline phosphatase <= 2.5 times ULN * Creatinine <= 1.5 times ULN * No sensory or motor neuropathy > grade 1 * No dementia or altered mental status * No other serious uncontrolled medical disorder * No active infection requiring antibiotics * No prior hypersensitivity reaction to paclitaxel or other therapy containing Cremophor EL * No other malignancy within the past 5 years except nonmelanoma skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * At least 3 weeks since prior biologic therapy * At least 3 weeks since prior immunotherapy * Must have received: * 1 prior combination taxane-based and platinum-based chemotherapy regimen * 1 prior platinum-based chemotherapy regimen AND 1 prior taxane-based chemotherapy regimen * Initial treatment may include high-dose therapy, consolidation, or extended therapy * At least 3 weeks since prior chemotherapy and recovered * No prior ixabepilone * No other prior cytotoxic chemotherapy for recurrent or persistent disease, including treatment with initial regimen * At least 1 week since prior hormonal anticancer therapy * Concurrent hormone replacement therapy allowed * At least 3 weeks since prior radiotherapy and recovered * No prior radiotherapy to site(s) of measurable disease * No radiotherapy to > 25% of marrow-containing areas * Recovered from recent surgery * At least 3 weeks since other anticancer therapy * No prior anticancer therapy that precludes study participation * No concurrent food supplements (e.g., St. John's wort) * No concurrent amifostine or other protective agents

Study Objectives A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot first-in-human study for SPECT imaging of breast cancer was performed in seven healthy volunteers and two breast cancer patients to assess the safety and potential clinical applications of 99mTc-RWY. Conditions: Breast Cancer Intervention / Treatment: DRUG: 99mTc-RWY Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Healthy volunteers. * Body mass index (BMI) at 19 to 25 [Body mass index = body weight (kg)/ height squared (m2)]; * Clinical laboratory tests (heart, liver, kidney, blood) indicators are in the normal range or abnormalities without clinical significance; * Informed written consents were obtained from all 9 subjects before the procedure. * Patients in suspicion of breast cancer by mammography or ultrasonography, and being able to provide basic information. Exclution Criteria: * The investigator judged that it is not suitable for clinical trials based on the overall situation of the volunteers and patients.

Study Objectives High-risk patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) suffer from a high ratio of recurrence after liver transplantation (LT). Lenvatinib, as a novel targeted drug, has shown an excellent effect in the treatment of advanced HCC, but there is no study on its effect in preventing HCC recurrence in the patients undergoing transplantation. Therefore, to evaluate the role of adjuvant lenvatinib in preventing recurrence of high-risk LT recipients with HBV-related HCC, the investigators retrospectively analyzed 23 high-risk patients consisting of lenvatinib group (n=14) and control group (n=9) with HBV-related HCC who underwent LT. Disease-free survival (DFS) and HCC recurrence of the two groups were compared. The adverse events (AEs) and drug tolerance of lenvatinib were evaluated. Conditions: Hepatocellular Carcinoma Intervention / Treatment: DRUG: Lenvatinib Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * The recipients who underwent liver transplantation with the pathologic diagnosis of hepatocellular carcinoma. * The extrahepatic metastasis was excluded preoperatively. * The patients were defined as "high-risk" for recurrence according to the following criteria: (1) beyond Milan criteria confirmed either by radiology before LT or by pathology after LT, (2) tumor with intrahepatic vascular invasion, (3) Alpha-fetoprotein (AFP)>=400ng/L before LT, (4) presence of microvascular invasion (MVI), (5) tumor with histological poor differentiation according to Edmondson-Steiner classification system(21), (6) multiple satellite lesions around the largest tumors detected either by radiology before LT or by histology after LT, (7) tumor penetrating hepatic capsule, (8) recurrent HCC after resection. 4. ECOG score between 0-1 within 1 week before took lenvatinib. 5. The patients have received regular antiviral treatment. 6. Life expectancy more than 3 months. Exclusion Criteria: * The patients took lenvatinib before liver transplantation and assessed as SD or PD according to the mRECIST criteria. * The patients suffered from other incurable malignancies within 5 years or at the same time. * Distant metastasis of tumor was confirmed by imaging before or within 1 month after transplantation. * The patients have not received regular antiviral treatment. * The patients had a history of mental illness or abuse of psychoactive drugs. * The patients deemed unsuitable by attending doctors.

Study Objectives This phase I/II trial studies the side effects and the best dose of sorafenib tosylate and docetaxel when given together with cisplatin and to see how well they work in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also help cisplatin and docetaxel work better by making tumor cells more sensitive to the drugs. Giving sorafenib tosylate, cisplatin, and docetaxel may be an effective treatment for squamous cell carcinoma of the head and neck. Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Salivary Gland Squamous Cell Carcinoma, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Oral Cavity Squamous Cell Carcinoma, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer, Untreated Metastatic Squamous Neck Cancer With Occult Primary Intervention / Treatment: DRUG: sorafenib tosylate, DRUG: cisplatin, DRUG: docetaxel, OTHER: Correlative Studies 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 histologic or cytologic proof of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) of any primary site, including unknown primary cancers of the head and neck excluding nasopharyngeal carcinoma of histologic types World Health Organization (WHO) 2 or 3, paranasal sinuses primary or squamous cell carcinoma that originated in the skin * Patients must have SCCHN that is either (a) recurrent, judged incurable by surgery or (chemo)radiation or (b) metastatic * Patients must not have received prior chemotherapy for recurrent or metastatic disease * Patients may have received one regimen of induction, concomitant chemoradiotherapy and/or adjuvant chemotherapy as part of their initial treatment with curative intent, which must have been completed for a minimum of 4 months prior to study treatment and patient must have been progression-free for at least 4 months since completion of treatment with curative intent * Patients with recurrent disease are allowed a maximum of one prior radiation therapy regimen, either curative or palliative * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 * Patients must have measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) criteria; patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam * Absolute neutrophil count (ANC) 1500/mm^3 * Platelet count 100,000/mm^3 * Creatinine within normal limits (WNL), or creatinine clearance >= 60 ml/min, based on the Cockroft-Gault formula * Total bilirubin WNL * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than twice the upper normal limit * Patients must have controlled blood pressure (150/90) prior to initiation of treatment * Women must not be pregnant or breast feeding; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of sorafenib administration * Patients must be human immunodeficiency virus (HIV)-negative * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 3 months prior to entering the study * Patients who are receiving any other investigational agents * Patients with known brain metastases will be excluded from this clinical trial * History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib, docetaxel, cisplatin * 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 * Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0] on repeated measurement) despite optimal medical management * Evidence or history of bleeding diathesis or coagulopathy * Subject with any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 grade 2 or higher within 4 weeks before randomization; any other hemorrhage/bleeding event of NCI-CTCAE v4.0 grade 3 or higher within 4 weeks before randomization * Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) within 6 months of informed consent * Subjects who have used strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers (e.g., phenytoin, carbamazepine, phenobarbital, St. John's Wort [Hypericum perforatum], or rifampin [rifampicin], and/or rifabutin) within 28 days before randomization * Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from breast cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form) * History of organ allograft; (including corneal transplant) * Any malabsorption condition * Inability to comply with the protocol * Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Study Objectives To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with rectal cancer during and after radiotherapy or combined radiotherapy and chemotherapy. The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response. Study hypothesis The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response. Conditions: Rectum Cancer Intervention / Treatment: DRUG: FDG Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological proven rectal cancer * UICC stage I-IV * WHO performance status 0-2 * Less than 10 % weight loss in the last 6 months * In case of previous chemotherapy, radiotherapy can start after a minimum of 21 days after the last chemotherapy course * No recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure,infarction) * Life expectancy more than 6 months * Measurable cancer * Willing and able to comply with the study prescriptions * >= 18 years * Not pregnant and willing to take adequate contraceptive measures during the study * Have given written informed consent before patient registration * No previous radiotherapy to the pelvis Exclusion Criteria: * Not adenocarcinoma histology * History of prior pelvis radiotherapy * Recent (< 3 months) myocardial infarction * Uncontrolled infectious disease * Less than 18 years old * Pregnant or not willing to take adequate contraceptive measures during the study

Study Objectives This is a pilot study to determine the safety and efficacy of low dose aspirin for the prevention of venous thromboembolism among women with advanced ovarian cancer receiving neoadjuvant chemotherapy. Conditions: Venous Thromboembolism, Ovarian Cancer Intervention / Treatment: DRUG: Aspirin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Khorana score = 1 * Over age 18 * English-speaking female patients * Able to consent * Receiving neoadjuvant chemotherapy Cancer of primary ovarian, fallopian tube, mullerian, or peritoneal origin Exclusion Criteria: * Allergy or intolerance to study medication * Indication for a non-aspirin form of antiplatelet (i.e. cardiac stent) * Already on alternative form of anticoagulation * Active bleeding * High risk for active bleeding (i.e. recent intracranial bleed or gastrointestinal bleed, known brain metastases) * Thrombocytopenia (platelets <50,000) * Unable to complete medication adherence diary * Unable to take oral medications

Study Objectives The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers. Conditions: Advanced Malignant Solid Tumors Intervention / Treatment: DRUG: CM082 tablet (test product), DRUG: CM082 tablet (reference product) Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Male body weight>=50.0kg or female body weight>=45.0kg; BMI between 19.0-26.0 kg/m2(inclusive) * Generally in good health, with no history of chronic disease or sever disease * No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations * No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation * Written informed consent Exclusion Criteria: * History of food or drug allergies * Clinical significant disease or disorders * Received surgery in 3 months before screening, or have plan for surgery during the study * Participated in other clinical trials within 3 months before screening * Intolerant of venipuncture, history of fainting needle and blood * Lactose intolerant * Drug abusing in 3 months * Donated >=200 mL of blood within 3 months before screening * Pregnant or under lactation period (female subjects) * Received any prescription drug, over-the-counter drug, prescription drug and Chinese herbal drug in 2 weeks, with the exception of vitamins and acetaminophen * Received any vaccine in 4 weeks * Excessively smoking, alcohol or coffin-containing beverage drinking in 3 months * Other circumstances that is deemed not appropriate for the study

Study Objectives The main purpose of this study is to evaluate the safety of the study drug known as LY3076226 in participants with advanced or metastatic cancer. Conditions: Advanced Cancer, Metastatic Cancer Intervention / Treatment: DRUG: LY3076226 Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy. * Part B: Have a diagnosis of bladder cancer. * Part B: Have alterations of FGFR3. * Have adequate organ function. * Have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade <=1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (v 4.0). * If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug. If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breastfeeding. Exclusion Criteria: * Have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study) or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * Have preexisting corneal disease that may interfere with assessment for potential eye toxicity during the study. * Have preexisting Grade >=2 skin disorder (for example, erythema, dermatitis). * Have serious preexisting medical conditions (left to the discretion of the investigator). * Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 28 days. * Have current acute or chronic leukemia. * Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required). * Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed. * Have Fridericia-corrected QT interval (QTcF) >480 milliseconds on screening electrocardiogram (ECG). * Have a serious cardiac condition, such as congestive heart failure; New York Heart Association Class III/IV heart disease; unstable angina pectoris; myocardial infarction within the last 3 months; valvulopathy that is severe, moderate, or deemed clinically significant; or arrhythmias that are symptomatic or require treatment (not including participants with rate-controlled atrial fibrillation).

Study Objectives This is the first study to test Sym015 in humans. The primary purpose of this study is to see if Sym015 is safe and effective for patients with advanced solid tumor malignancies without available therapeutic options. Conditions: Oncology, MET Gene Amplification, NSCLC, MET Gene Mutation, Non Small Cell Lung Cancer Intervention / Treatment: DRUG: Sym015 Location: Korea, Republic of, Spain, Denmark, United States, Taiwan, Hong Kong Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Life expectancy >3 months assessed during Screening. * Documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic, and that is refractory to standard therapy or for which no standard therapy is available or accessible. * If female and of childbearing potential: a negative pregnancy test. * Male or female: either not of childbearing potential or agreeing to use a medically effective method of contraception as per institutional standards during the trial and for 4 months after the last dose of trial drug. * Part 1 ONLY: Tumor documented to be KRAS WT by local assessment. * Part 2 ONLY: * Measurable disease according to RECIST v1.1 that has been confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks prior to Cycle 1/Day 1 (C1/D1). * Basket Cohort ONLY: * Tumor documented to be KRAS WT by local assessment according to institutional standards. If KRAS WT is not previously documented and if archival tissue is not available for pretrial assessment, patient must be willing to undergo a tumor biopsy to confirm eligibility. * Confirmed MET-amplification by local assessment. * No prior therapy with MET-targeting agents (except a subset of patients having received prior therapy with a MET-targeting TKI). * Willingness to undergo a pre- and post-dosing biopsy (maximum of 2 biopsies) from primary or metastatic tumor site(s) considered safely accessible for biopsy * NSCLC MET-Amplified Cohort ONLY: * Documented NSCLC meeting disease criteria as defined per protocol. * Documented MET-amplification. * May have received prior therapy with MET-targeting and/or EGFR-targeting agents (antibodies or TKIs). * Willingness to undergo a pre-dosing biopsy (mandatory unless a recent tumor biopsy is available), and potentially a biopsy at the End of Cycle 2 (EOC2) (optional), from a primary or metastatic tumor site considered safely accessible for biopsy. * NSCLC METex14del Cohort ONLY: * Documented NSCLC meeting disease criteria as defined per protocol. * Documented METex14del (tumors need not be MET-amplified). * May have received prior therapy with MET-targeting and/or EGFR-targeting agents (antibodies or TKIs). * Willingness to undergo a pre-dosing biopsy (mandatory unless a recent tumor biopsy is available), and potentially a biopsy at the EOC2 (optional), from a primary or metastatic tumor site considered safely accessible for biopsy. Exclusion Criteria: * Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest, prior to C1/D1, except nitrosoureas and mitomycin C within 6 weeks prior to C1/D1. * Immunosuppressive or systemic hormonal therapy within 2 weeks prior to C1/D1, with exceptions. * Use of hematopoietic growth factors within 2 weeks prior to C1/D1. * Active second malignancy or history of another malignancy within the last 3 years, with exceptions. * Central nervous system (CNS) malignancy including primary malignancies of the CNS and known, untreated CNS or leptomeningeal metastases, or spinal cord compression; patients with any of these not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required. * Inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy. * Major surgical procedure within 4 weeks prior to C1/D1 or inadequate recovery from any prior surgical procedure. * Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 1 month prior to C1/D1, unless adequately treated and stable. * Active uncontrolled bleeding or a known bleeding diathesis. * Significant cardiovascular disease or condition. * Abnormal hematologic, renal or hepatic function. * Part 2 ONLY: * Radiotherapy against target lesions within 4 weeks prior to C1/D1, unless there is documented progression of the lesion following the radiotherapy. * Basket Cohort ONLY: * Prior therapy with MET-inhibiting agents (exceptions will be a subset of patients that will be entered to the Basket Cohort after having received prior therapy with a MET-targeting TKI). * Prior therapy with antibody to hepatocyte growth factor (HGF). * Basket Cohort and NSCLC MET-Amplified Cohort ONLY: * Tumor status demonstrating MET-polysomy in the absence of MET-amplification, as specified per protocol. Patients in the NSCLC METex14del Cohort with polysomy are eligible.

Study Objectives The objective of the TOGETHER (Together Overcome and Get Empowered Through Health Education and Relationships) program was to examine the effectiveness of one of the first linguistically and culturally tailored intervention programs to increase quality of life among Korean American breast cancer survivors. Conditions: Breast Cancer Intervention / Treatment: BEHAVIORAL: Linguistically and Culturally Tailored Information, BEHAVIORAL: Cognitive-Behavioral Stress Management Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Living in Maryland, Northern Virginia, or the Washington D.C. metropolitan area * Have been diagnosed with breast cancer * Have had surgery, completed treatment within the last two years, or still receiving adjuvant therapies Exclusion Criteria: * Unable to understand Korean

Study Objectives The purpose of this study it to evaluate efficacy of gemcitabine with cisplatin and dexamethasone in patients with aggressive non-Hodgkin's lymphoma who have previously progressed on first line of chemotherapy with anthracyclines. Conditions: Non-Hodgkin's Lymphoma Intervention / Treatment: DRUG: gemcitabine, DRUG: cisplatin, DRUG: dexamethasone Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The patients must have a histological diagnosis of aggressive non-Hodgkin's lymphoma including the following sub-categories of the WHO classification: * Diffuse large B-cell lymphoma and its variants (immunoblastic, Burkitt-like, sclerosis of mediastinum, large B-cell MALT, rich in T-cells and anaplastic B-cell lymphoma) * Peripheral T-cell lymphoma * Anaplastic lymphoma of large T-cells /null cells * Patients are eligible if they have documented evidence of progression after prior first-line chemotherapy containing anthracyclines associated or not with Rituximab. Patients with refractory disease to first line of treatment are also eligible. * ECOG PS (performance status) less than or equal to 2 * Presence of bidimensionally measurable disease in accordance with WHO criteria. Exclusion Criteria: * Involvement of the CNS. * Any medical condition which contraindicates the degree of hydration required for the safe use of cisplatin. * Intermediate degree lymphoma derived from the malignant transformation of a previous low-grade lymphoma. * Active infection (in the opinion of the investigator).

Study Objectives The purpose of this study is to describe the rate of 3-year progression free survival in men with recurrent PSA-only disease after prostatectomy, who receive combined apalutamide (ARN-509) and standard ADT with salvage radiation therapy followed by docetaxel, ADT, and apalutamide, AND who have had testosterone recovery to \>100 ng/dl at 36 months. The hypothesis is that AR inhibition with apalutamide added to standard salvage external beam radiation with androgen deprivation therapy, as well as the addition of 6 cycles of docetaxel, will further prolong progression free survival. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Apalutamide, DRUG: Androgen deprivation, RADIATION: Salvage radiation therapy, DRUG: Docetaxel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically-confirmed diagnosis of prostate adenocarcinoma. Variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate, are not permitted. * Gleason sum of 7 (with pT3 disease or positive margins or positive nodes [4 or fewer]), 8, 9, or 10 based on the radical prostatectomy specimen * PSA relapse within 4 years of prostatectomy defined by persistently detectable or rising PSA after surgery. * Evidence of disease recurrence or progression as evidenced by a PSA > 0.20. This requires 2 consecutive rises in PSA, at least 1 week apart, over the post-prostatectomy nadir OR one PSA value above 0.20 ng/mL IF the patient failed to achieve a post-prostatectomy nadir of < 0.2 ng/mL. * Age >= 18 years * Karnofsky performance status >= 80 * Adequate laboratory parameters * Adequate bone marrow function: ANC >=1.5 x 109/L, Platelets >=100 x 109/L, Hb >9g/dL * AST/SGOT and ALT/SGPT <= 2.5 x Institutional Upper Limit of Normal (ULN) * Serum bilirubin <= 1.5 x Institutional ULN (In subjects with Gilbert's syndrome, if total bilirubin is > 1.5xULN, measure direct and indirect bilirubin and patient is eligible if direct bilirubin <= 1.5xULN). * Glomerular filtration rate (either estimated or calculated from 24-hour urine collection) >= 45 mL/min * Serum potassium >=3.5 mmol/L * A minimum of 4 weeks from any major surgery prior to Cycle 1 Day 1. * Ability to swallow, retain, and absorb oral medication. * Ability to understand and the willingness to sign a written informed consent document. * Must use a condom if having sex with a pregnant woman. * Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Exclusion Criteria: * Radiographic evidence of metastatic disease. Patients with node-positive disease (<=4 positive nodes) at the time of radical prostatectomy are eligible. Patients with pelvic nodes less than 1.5 cm by short axis at the time of screening are eligible. Patients with any enlarged lymph nodes in the retroperitoneum or above the aortic bifurcation or with pelvic nodes >= 1.5 cm must be excluded. * PSA >= 4.0 ng/mL. * Testosterone level <= 100 ng/dL. * More than 1 month of prior hormone exposure or hormone exposure within 30 days of enrollment (up to 1 month of prior LHRH agonist and/or anti-androgen therapy as neoadjuvant therapy prior to prostatectomy is allowed). Prior enzalutamide, apalutamide, ketoconazole, abiraterone, or TAK700 for prostate cancer are prohibited. Prior antiandrogen therapy (including but not limited to bicalutamide, flutamide, nilutamide, enzalutamide, and apalutamide) and prior estrogen therapy (including estrogen patch) are not allowed. All investigational agents are prohibited within 30 days of enrollment. * The following medications are prohibited within 2 weeks of enrollment and while on study drug: * 5 α-reductase inhibitors (finasteride, dutasteride); * Biologic or other agents with anti-tumor activity against prostate cancer; * Systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone; oPremedication with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone is permitted prior to docetaxel infusions. * Androgens (testosterone, dihydroepiandrosterone [DHEA], etc.) * Prior immunotherapy including sipuleucel-T. * Prior systemic chemotherapy (docetaxel, cabazitaxel, estramustine, other cytotoxic agents) * History of solid organ or stem cell transplantation. * History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, prior head or traumatic brain injury with loss of consciousness, prior or current space-occupying lesion in the brain). Also, history of loss of consciousness or transient ischemic attack within 12 months of Day 1 visit. * Known or suspected brain metastasis or active leptomeningeal disease. * Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol. * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to enrollment * Sustained uncontrolled hypertension (>150/90 average over 1 week) despite optimal medical management * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of apalutamide or increase the risk of radiation (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndromes, prior small bowel resection, or inflammatory bowel disease). * Patients who have received prior prostate or pelvic radiotherapy, including external beam or brachytherapy. * Patients who have not recovered from side effects of prior systemic therapy prior to Cycle 1 Day 1. * Use of medications known to lower the seizure threshold within 4 weeks prior to study entry. * Patients unable or unwilling to abide by the study protocol or cooperate fully with the investigator.

Study Objectives Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma basing on immune microenviroment.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC. Conditions: Hepatocellular Carcinoma Intervention / Treatment: DRUG: Yang Yin Fu Zheng therapy, DRUG: Routine medical care Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Confirmed of stage HBV-HCCⅡb、Ⅲa、Ⅲb; * Ages Eligible for Study: <=75 years old; * TCM syndrome is deficiency of both Qi and Yin; * Confirmed of CHB; * Surgery cannot be allowed; * Informed consent from the patient. Exclusion Criteria: * Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD; * Serious problem of heart, lung, or kidney with severe dysfunction; * Pregnant or child breast feeding women; * Mental or cognitive disorders; * Participating in other drug trials; * Who are allergic to the study drug.

Study Objectives In this national Phase I dose-escalation study the safety and tolerability of AP 12009 is evaluated in adult patients with advanced tumors known to overproduce TGF-β2, who are not or no longer amenable to established therapies. Conditions: Pancreatic Neoplasms, Melanoma, Colorectal Neoplasms Intervention / Treatment: DRUG: AP 12009 Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Written informed consent. * Age: 18-75 years. * Male or non-pregnant, non-lactating female. * a.Pancreatic cancer: Histologically or cytologically confirmed diagnosis, stage IVA or IVB (AJCC, 1997). b. Melanoma: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC). c. Colorectal cancer: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC), excluded from the last cohort. * Patient is not or no longer amenable to established forms of therapy. * At least one measurable lesion. * Karnofsky performance status of at least 80%. * Recovery from acute toxicity caused by any previous therapy. * Adequate organ function as assessed by the following laboratory values: * Serum creatinine and urea < 2 times the upper limit of normal (ULN). * ALT and AST < 3 ULN (in case of a liver metastasis: < 5x ULN); alkaline phosphatase < 3 ULN; and bilirubin < 2.5 mg/dL. * Prothrombin time < 1.5 INR and PTT < 1.5 times the upper limit of normal. * Hemoglobin > 9 g/dL. * Platelets > 100 x 10E9/L. * WBC > 3.0 x 10E9/L. * Absolute Neutrophil Count (ANC) > 1.5 x 10E9/L. Exclusion Criteria: * Patient unable to comply with the protocol regulations. * Pregnant or lactating female. * Antitumor radiation therapy within 12 weeks, tumor surgery within 4 weeks or any other therapy with established antitumor effects within 2 weeks prior to study entry. * The patient takes or is likely to need other prohibited concomitant medication. Administration of corticosteroids should be strictly avoided during the course of the study. * Patient's participation in another clinical trial with investigational medication within 30 days prior to study entry. * History of brain metastases. In the case of suspected brain metastases a CT scan of the skull will be performed (not mandatory in asymptomatic patients). * Clinically significant cardiovascular abnormalities such as refractory hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia, or a myocardial infarction within 6 months prior to treatment. * Gastric or duodenal ulcers within 6 months before study entry or is at risk of gastrointestinal ulceration due to high consumption of NSAIDs. * An active infection with HIV, HBV, or HCV. * Clinically significant acute viral, bacterial, or fungal infection. * Acute medical problems that may be considered to become an unacceptable risk, or any conditions that might be contraindications for starting study treatment. * History of allergies to reagents used in this study. * Drug abuse or extensive use of alcohol. * Significant psychiatric disorders/ legal incapacity or limited legal capacity. * History of Long QT Syndrome or QTc time >= 480 msec in screening/baseline ECGs. The average QTc time is to be calculated from three separate ECGs performed prior to start of infusion: two ECGs performed at Screening/Baseline (with a minimum 1-hour interval in between) and one performed within 1 hour prior to start of infusion.

Study Objectives Phase I trial to study the effectiveness of combining erlotinib with radiation therapy with or without cisplatin in treating patients who have advanced mouth or throat cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with radiation therapy with or without cisplatin may kill more tumor cells. Conditions: Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Oropharynx Intervention / Treatment: DRUG: erlotinib hydrochloride, DRUG: cisplatin, RADIATION: intensity-modulated radiation therapy, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with clinical findings consistent with a diagnosis of squamous cell carcinoma of the OC or OP, as determined by the head and neck surgeon, may be recruited to the study prior to diagnostic biopsy; patients must have a histologically confirmed diagnosis of squamous cell carcinoma of OC or OP prior to proceeding with treatment * Oropharyngeal sites include base of tongue, tonsil, soft palate, and oropharyngeal wall * Oral cavity sites include oral tongue, buccal mucosa, floor of mouth, retromolar trigone, alveolar ridge, hard palate and mucosal lip * Patients must be AJCC stage II (T2N0) or III (T1-2N1) (AJCC fifth edition, 1997) for part A of the study, and must be AJCC stage III (T3N 0-1) or IV (T1-4N2-3M0, T4N0-1M0) for part B of the study * Priority for study entry will be given to patients with easily accessible tumor and who consent to repeat biopsy; study entry will not be restricted to patients who agree to further biopsies; if a patient enrolls on study and later refuses biopsy (excluding diagnostic), he/she may remain on study * Patients with operable or inoperable tumors will be eligible * No prior therapy for the tumor, including chemotherapy, radiation therapy, immunotherapy, EGFR targeted therapies, or any other investigational agents * Prior malignancies of sites other than the head and neck are allowed if disease free interval >= 3 years; basal cell carcinomas of the skin and in situ cervical dysphagias are allowed within this three year interval if completely resected * Documentation of evaluable tumor less than or equal to four weeks before treatment start * ECOG performance status = 0, 1 or 2 (Karnofsky >= 60%) * Life expectancy of greater than or equal to 6 months * Leukocytes >= 3,000 * Absolute neutrophil count >= 1,500 * Platelets >= 100,000 * Total bilirubin within normal institutional limits unless due to hemolysis or Gilbert's syndrome * AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal * Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal * APTT/INR within normal institutional limits; patients who have abnormalities in APTT/INR that are correctable after administration of vitamin K are eligible * No uncontrolled diabetes mellitus as glucose must be within a consistently normal range for each patient in order to standardize PET scan interpretations * No known malabsorption syndrome * G-tube dependent patients are eligible * The effects of OSI-774 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) 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 with known brain involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 or other agents used in study * Major surgery or significant traumatic injury occurring within 28 days prior to treatment * Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjögren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test) * Gastrointestinal tract disease resulting in an inability to take oral or enteral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, untreated or new cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because OSI-774 is an epidermal growth factor inhibitor with the potential for teratogenic or abortifacient effects based on the data suggesting that EGFR expression is important for normal organ development; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with OSI-774 * Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated * Patients on Coumadin are excluded from the study because of reports of interactions between the study drug and Coumadin

Study Objectives The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled gilteritinib, in particular, the routes of excretion and extent of metabolism of gilteritinib following administration of a single dose of 14C-labeled gilteritinib after repeated doses of gilteritinib. This study will also evaluate the safety of repeated oral administration of gilteritinib in subjects with advanced solid tumors as well as identify the metabolic profile of gilteritinib in plasma, urine and feces after a single oral dose of 14C-labeled gilteritinib. Conditions: Advanced Solid Tumors, Pharmacokinetics of 14C-labeled Gilteritinib Intervention / Treatment: DRUG: gilteritinib, DRUG: 14C-labeled gilteritinib 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: * Subject had histologically or cytologically confirmed diagnosis of advanced solid tumor (measurable or nonmeasurable disease) for which no standard therapy is available. * Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status <= 1. * Subject must have a life expectancy > 12 weeks. * Subject must have recovered from the effects of prior systemic antineoplastic or radiation therapy(s) to <= Grade 1 (National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0) severity or to subject's baseline values, excluding alopecia. * Subject has adequate bone marrow, renal and hepatic function at baseline, as demonstrated by the following: * Absolute neutrophil count (ANC) >= 1500 cells/mm3 * Platelet count >= 100,000 cells/mm3 * Hemoglobin (Hb) >= 9 g/dL * Serum creatinine <= 1.5 x upper limit of normal (ULN) or calculated creatinine clearance > 60 mL/min if the serum creatinine is > 1.5 x ULN * Total bilirubin <= 1.5 x ULN * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <= 3 x ULN (or < 5 x ULN in subjects with liver metastases or hepatocellular carcinoma). * Female subject must either: * Be of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile * Or, if of childbearing potential: agree not to try to become pregnant during the study and for 60 days after the final study drug administration and have a negative serum or urine pregnancy test at screening, and if heterosexually active, agree to consistently use 2 forms of birth control (at least one of which must be a barrier method) starting at screening and throughout the study period and for 60 days after final study drug administration. * Female subject must not be breastfeeding at screening or during the study period, and for 60 days after the final study drug administration. * Female subject must not donate ova starting at screening and throughout the study period and for 60 days after final study drug administration. * Male subject and a female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 120 days after the final study drug administration. * Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after final study drug administration. * Subject must be willing to comply with all procedures and assessments. Exclusion Criteria: * Subject has received more than 5 prior cytotoxic agent-containing regimens. * Subject has symptomatic central nervous system (CNS) metastases or leptomeningeal involvement as assessed through medical history review and physical examination. Subject with prior brain metastases must: * have stable neurologic status post administration of local therapy (surgery or radiation) for a minimum of 2 weeks following completion of the definitive therapy. * be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events (AEs). * Subject has had major surgery within 4 weeks prior to the first study dose. * Subject has had chemotherapy within 4 weeks prior to the first study dose. * Subject has had radiation therapy within 4 weeks prior to the first study dose. * Subject with known hepatitis B surface antigen (HBsAg) positive status; or known or suspected active hepatitis C infection; or known human immunodeficiency virus (HIV) positive. * Subject with malabsorption syndrome or disease or condition significantly affecting gastrointestinal function. * Subject with significant or uncontrolled cardiac, renal, hepatic or other systemic disorders; or significant psychological conditions at baseline that in the investigator's opinion, makes the subject unsuitable for study participation. * Subject with electrocardiogram (ECG) abnormalities on a 12-lead ECG performed within 14 days before start of the study drug that are considered by the Investigator to be clinically significant. * Subject who has received strong or moderate inhibitors (e.g., ketoconazole or fluconazole) or inducers (e.g., rifampin or phenytoin) of cytochrome P450 (CYP)3A4 or of P-glycoprotein (P-gp), or substrates of multidrug and toxin extrusion (MATE)1 with the exception of antibiotics, antifungals, and antivirals that are used as standard of care post transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject within 2 weeks prior to start of study treatment and while on study. * Subject requires treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR receptors or sigma nonspecific receptor, with the exception of drugs that are considered absolutely essential for the care of the subject. * Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to the initiation of screening. * Subject has a known history of serious hypersensitivity to ASP2215, or any component of the formulation used. * Subject who has an ongoing toxicity >= Grade 2 (Common Terminology Criteria for Adverse Event [CTCAE] v4.03) attributable to prior medication to treat solid tumor (except alopecia) at the time of screening. * Subject has had any of the following within 14 days prior to the first dose of study drug: * blood transfusion or hemopoietic factor therapy * evidence of active infection requiring systemic therapy.

Study Objectives This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy. Conditions: Hodgkin Lymphoma Intervention / Treatment: DRUG: Doxorubicin, DRUG: Bleomycin, DRUG: Vinblastine, DRUG: Dacarbazine, DRUG: Brentuximab Vedotin Location: Netherlands, Denmark, Belgium, Croatia, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed CD30+ classical Hodgkin lymphoma * Supradiaphragmatic Ann Arbor clinical stage I or II * Previously untreated * PET scan without IV contrast at diagnosis available for central review with at least one hypermetabolic lesion * Unfavourable (U) characteristics according to the classic EORTC/LYSA clinical prognostic factors, including patients with at least one of the following factors: * CSII >= 4 nodal areas * age >= 50 yrs * M/T ratio >= 0.35 * ESR >= 50 (without B-symptoms) or ESR >= 30 with B-symptoms * ECOG performance status 0-2 * Life expectancy > 6 months * Age 18 to 60 years * Availability for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution. * Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, through 6 months after the last dose of study drug, OR agree to completely abstain from heterosexual intercourse * Male patients, even if surgically sterilized (ie, status postvasectomy), who: o Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse. * Written informed consent. * Required baseline laboratory data: * Absolute neutrophil count >= 1,500/µL * Platelet count >= 75,000/ µL * Hemoglobin >= 8g/dL * Serum total bilirubin <= 1.5 X ULN unless the elevation is known to be due to Gilbert syndrome. * Serum creatinine <= 2.0 mg/dL and/or calculated creatinine clearance > 40 mL/minute (Cockcroft-Gault formula or MDRD) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 X ULN Exclusion Criteria: * Histological diagnosis different from classical Hodgkin Lymphoma. Nodular lymphocyte predominant subtypes (nodular paragranuloma or Poppema paragranuloma) are excluded. * Known cerebral or meningeal disease of any etiology, including signs or symptoms of PML * Any sensory or motor peripheral neuropathy >= Grade 2 * Known history of any of the following cardiovascular conditions * Myocardial infarction within 2 years of randomization * New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 14) * Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Recent evidence (within 30 days before first dose of study drug) of a left-ventricular ejection fraction <50% * Unstable diabetes mellitus (to avoid uninterpretable FDG-PET scan). * Known HIV positive * HCV positive * HBV positive. This means: * HBsAg positive * HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA (HBsAg negative patients and viral DNA negative and patients seropositive due to a history of hepatitis B vaccine are eligible). * Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors. Carcinoma in situ of any type not excluded if complete resection. * Dementia or altered mental status * Pregnancy or breastfeeding. * Previous treatment with any anti-CD30 antibody. * Known hypersensitivity to any excipients contained in the BV formulation or known contra-indication to any drug contained in the chemotherapy regimens * Treatment with corticosteroids before baseline PET scan * Known active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy or with untreated known active Grade 3 viral, bacterial, or fungal infection, within 2 weeks prior to the first dose of BV * Treatment with any investigational drug within 30 days before first cycle of treatment

Study Objectives An open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult patients with acute myelogenous leukemia (AML), high-grade myelodysplastic syndrome (MDS). The patient population will consist of adults previously diagnosed with AML including high-grade MDS for which standard curative, life-prolonging treatment does not exist or is no longer effective. Conditions: Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome Intervention / Treatment: DRUG: MLN4924, DRUG: Azacitidine 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: * Age greater than or equal to 18 years * Have the following diagnosis: * AML or ALL (for the dose escalation phase only)including leukemia secondary to prior chemotherapy or resulting from an antecedent hematologic disorder, who have failed to achieve complete response (CR) or who have relapsed after prior therapy and are not candidates for potentially curative treatment. * Acute Promyelocytic Leukemia (APL) patients are not eligible * AML or ALL patients who are over age 60 and have not received prior therapy are also eligible if they are not candidates for standard induction chemotherapy * High-grade MDS, defined as > 10% blasts on bone marrow examination * Low-grade MDS, defined as < 10% blasts on bone marrow examination (Schedule B expansion cohort only) * Patients who are willing to refrain from donating blood for at least 90 days after their final dose of MLN4924 and (for male patients) willing to refrain from donating semen for at least 4 months after their final dose of MLN4924 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Female patients who are postmenopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse * Male patients who agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse * Voluntary written consent * Suitable venous access * Adequate clinical laboratory values during the screening period as specified in the protocol * Patients who are on hydroxyurea may be included in the study and may continue on hydroxyurea while participating in this study. Exclusion Criteria: * Female patients who are lactating or have a positive serum pregnancy test during the screening period * Any serious medical or psychiatric illness * Treatment with any investigational products * Systemic antineoplastic therapy or radiotherapy within 14 days before the first dose of study drug, except for hydroxyurea * Major surgery within 14 days before the first dose of study drug * Life-threatening illness unrelated to cancer * Clinically uncontrolled central nervous system (CNS) involvement * Known human immunodeficiency virus (HIV) positive * Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection * Evidence of uncontrolled cardiovascular conditions as specified in the protocol * Diarrhea > Grade 1, based on the NCI CTCAE categorization * Systemic treatment with prohibited medications * Ongoing anticoagulant therapy (eg, aspirin, Coumadin, heparin) that cannot be held to permit bone marrow sampling * Use of acetaminophen, acetaminophen-containing products, and statins are not permitted on the day before dosing, day of dosing, and day after dosing with MLN4924

Study Objectives This study will be a pilot study of sorafenib 400mg PO twice daily in refractory T-cell lymphomas including peripheral T-cell lymphoma (PTCL), angioimmunoblastic lymphadenopathy (AILD), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and other transformed T-cell lymphomas with the primary objective of studying the biological effects of the multikinase inhibitor, sorafenib. Conditions: T Cell Lymphoma Intervention / Treatment: DRUG: Sorafenib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed T-cell lymphoma including PTCL, AITL, CTCL, ALCL (Alk+, and Alk-), and other transformed T-cell lymphomas * Age > 18 years old * Measureable disease, as defined by the Cheson criteria * ECOG Performance Status of 0 or 1 * Life expectancy > 12 weeks * Adequate bone marrow, liver and renal function * Patients with hemoglobin < 8.5g/dL, or ANC 500-1000/mm3, or platelets 50,000-75,000/mm3 (Grade 3), whose cytopenias are due to bone marrow involvement by T-cell lymphoma will also be eligible Exclusion Criteria: * Prior treatment with sorafenib, or other agents with similar activity, i.e. bevacizumab, imatinib, sunitinib. * Prior treatment with allogeneic stem cell transplant * Cardiac disease: Congestive heart failure > class II NYHA.

Study Objectives This study aims to evaluate the pharmacokinetics (PK) of apixaban when co-administered with cyclosporine and tacrolimus in healthy volunteers. The study participants will receive apixaban alone, cyclosporine followed by apixaban and tacrolimus followed by apixaban. Conditions: Venous Thromboembolism, Pharmacokinetics, Healthy Intervention / Treatment: DRUG: Apixaban alone, DRUG: Cyclosporine, DRUG: Tacrolimus, DRUG: Apixaban, DRUG: Apixaban Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: BASIC_SCIENCE Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Be a healthy male or female between ages 18-55 (inclusive) at the screening visit * Have a body mass index (BMI) >= 19 and <= 33 (inclusive) * Be a female subject, subject 1. Can be of childbearing potential and must demonstrate a urine β-hCG level consistent with the non-pregnancy state and agree to use an acceptable method of birth control throughout the study. 2. Can be of non-childbearing potential. * Be a nonsmoker for at least approximately 6 months * Have serum creatinine level < 1.5 mg/dL * Have a prothrombin time (PT) and activated partial thromboplastin time (PTT) level below the upper limit of normal * Have platelet count within normal limits * Be willing to refrain from the use of anticoagulants and antiplatelet medications including aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) during the entire period of study participation * Be willing to comply with trial restrictions Exclusion Criteria: * Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures), dermatologic or psychiatric abnormalities or diseases * Has history of cancer (excluding treated cutaneous squamous or basal cell carcinoma of >3 years previous) * Has history of venous or arterial thromboembolic disease * Has a history of a major bleeding event (defined as: (i) symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or (ii) a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of two or more units of whole blood or red cells) within 6 months prior to screening visit * Has had major surgery within 6 months prior to screening visit * Is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies for 2 weeks prior to trial start date until the post-trial visit * Is unable to refrain from using any drugs or substance known to be inhibitors or inducers of cytochrome P450 (CYP) enzymes including grapefruit products for 2 weeks prior to dosing and throughout the study, until the post-trial visit * Has a history of illicit drug abuse within six months prior to screening visit * Pregnant or lactating * Consumes greater than 3 glasses of alcoholic beverages per day and cannot refrain from alcohol for the duration of the trial * Has a history of significant multiple and/or severe allergies (e.g. food, drug), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food * Has known anaphylactic or severe systemic reactions to any components of study drugs (including apixaban, cyclosporine or tacrolimus) or contraindication to the administration of study drugs * Has moderate or severe hepatic disease or other clinically relevant bleeding risk * Has positive history for hepatitis B surface antigen, hepatitis C or HIV * Use of any drugs or products which at the discretion of the investigator would increase bleeding risk * Is considered inappropriate for participation by the investigator for any reason

Study Objectives The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography. SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the breast and pulses low-frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device. This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 2 aims to collectively enroll up to 1,000 women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly limited to case collection and is non-interventional; any investigational and/or statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801. Arm 2 is limited to the cohort of diagnostic female patients of any breast density composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after diagnostic imaging, or who have confirmed imaging findings. Matched sets of diagnostic imaging and SV exams, from the same patient, demographic information, and clinical outcome data, will be collected during diagnostic workup. Ultrasound characteristics for all types of lesions, whether they are benign or malignant, will be collected as well as objective and subjective breast density composition data. Ultrasound image data may be acquired with modified SoftVue devices, which have passed safety and quality evaluations per Delphinus' quality management system (QMS) and satisfy design change control standards, at select clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility, validation, and verification testing for engineering and product development purposes. The exams and clinical data accumulated in this prospective case collection (PCC) protocol will populate a database from which future investigations may be designed for peer reviewed publication, development of user training curricula, building teaching case, and creating new marketing materials for SoftVue. Conditions: Breast Neoplasms Intervention / Treatment: OTHER: Non-Interventional, DEVICE: Automated Whole Breast Ultrasound Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria * Female * Any race or ethnicity * Age >= 18 years * Findings of concern on clinical breast exam or imaging * Scheduled for diagnostic imaging, needle biopsy, excisional biopsy, or post-needle-biopsy visit * Diagnostic imaging assessment category BI-RADS 4 or 5 and willing to undergo biopsy(ies) or, per the Principal Investigator, subject's case would be beneficial for use in the lesion atlas or teaching library * Agrees to be contacted by site staff if a recommended biopsy is not completed within the appropriate time frame Exclusion Criteria * Unwilling/unable to comply with the protocol and follow-up recommendations * Lumpectomy or excisional biopsy of the primary region of interest performed prior to SoftVue imaging, such that there are not sufficient findings to make the case useful for the lesion atlas or teaching library * Weight exceeds 350lbs * Currently pregnant or lactating by patient self-report * Weeping rash, open wounds, or unhealed sores on the breast * Bilateral mastectomy * Unable to lay prone on the scan table for up to 15 minutes

Study Objectives RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, 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. PURPOSE: This phase II trial is studying how well giving fluorouracil together with oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or gastroesophageal junction cancer. Conditions: Gastric Cancer Intervention / Treatment: DRUG: fluorouracil, DRUG: leucovorin calcium, DRUG: oxaliplatin, GENETIC: gene expression analysis, GENETIC: polymorphism analysis, GENETIC: protein expression analysis, OTHER: pharmacological study 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: * Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction * Metastatic disease * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan * No known active brain metastases * Patients with treated brain metastases are eligible if stable off steroids for at least 30 days PATIENT CHARACTERISTICS: * ECOG performance status <= 2 (Karnofsky performance status >= 60%) * Life expectancy >= 3 months * WBC >= 3,000/μL * Absolute neutrophil count >= 1,500/μL * Platelets >= 100,000/μL * Total bilirubin <= 1.5 x upper limit of normal (ULN) * AST or ALT <= 2.5 x ULN (< 5 x ULN if known liver metastases) * Creatinine clearance <= 1.5 x ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 21 days after completion of study treatment * No history of allergic reactions to fluorouracil or oxaliplatin * No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * No prior therapy for metastatic disease * Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval has been longer than 6 months * No other concurrent chemotherapy * No concurrent combination anti-retroviral therapy for HIV-positive patients * No concurrent routine prophylaxis with filgrastim (G-CSF) * No other concurrent antineoplastic agents, including chemotherapy, radiation therapy, or biologic agents

Study Objectives The aim of this research project is to determine the amount of capecitabine (Xeloda) which can be given safely with PHY906 (investigational drug) on a novel schedule. It is also the aim of this research project to determine what the effects, good and/or bad, are of combining capecitabine (Xeloda) with PHY906 (investigational drug) in the treatment of advanced pancreatic cancer. PHY906 is a powder from plants sold as a health food supplement in the United States. PHY906 has been used in China, Taiwan and other Asian countries as traditional Chinese medicine for hundreds of years. The other drug involved in this study, capecitabine is an oral form of chemotherapy already approved by FDA in the management of colorectal and breast cancer. Laboratory studies in animal models have shown that the combination of capecitabine and PHY906 shrinks liver cancer, and a pilot clinical study is currently evaluating this combination in patients with liver cancer to define the benefit. PHY906 has also shown to decrease diarrhea related to chemotherapy in a small study performed in patients with colon cancer treated at the Yale Cancer Center. Our recent laboratory studies have also shown that the combination of capecitabine and PHY906 also shrink pancreatic tumors in mouse models. This prompted us to test the combination of capecitabine and PHY906 in patients with advanced pancreatic cancer to assess the benefit in survival as well as any decrease in side effects, such as diarrhea caused by capecitabine. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Capecitabine, DRUG: PHY906 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Men or women >=18 years of age with either a histologic or cytologic diagnosis of locally advanced or metastatic pancreatic adenocarcinoma. However, patients with other solid malignancies will be allowed to participate during the dose escalating Phase I part of the study, who had failed to respond to standard therapy or for which no standard therapy exists. * In the phase I portion, patients may either have had no prior chemotherapy (chemotherapy naive), or have been refractory to or relapsed from standard chemotherapy, including capecitabine-based regimens. However, in the phase II portion of the study, only pancreatic cancer patients with prior gemcitabine therapy will be eligible. No prior 5-FU/capecitabine chemotherapy will be allowed EXCEPT previous adjuvant treatment with 5-FU or capecitabine (radiosensitizing dose) with radiation completed at least 6 weeks prior to study entry. * All patients in both the phase I and phase II portions of this study must have at least one previously unirradiated, unidimensionally measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) scan of >= 20 mm (if conventional CT scan) or >= 10 mm (if spiral CT scan). * Patients with biliary or gastro-duodenal obstruction must have drainage or by pass prior to starting chemotherapy. * Patients with adequate hepatic function defined as * AST/ALT <= 2.5 X ULN; * Total Bilirubin <= 2.0 XULN; * Alkaline Phosphatase <= 5 X ULN (in presence of liver metastasis); or * Alkaline Phosphatase <= 2.5 X ULN (in absence of liver metastasis). * Patients should have an adequate renal function as indicated by a serum creatinine <1.6 mg/dL or calculated creatinine clearance >= 50 mL/min. (Calculated by Cockcroft-Gault equation). * Baseline performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2. * Women patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) within 2 weeks of starting the study; all patients should agree to use adequate non-estrogenic birth control methods, consistent with the institute's standard form of contraception if conception is possible during the study. * Provide written informed consent prior to screening. * Patients with adequate hematologic tests: * Hemoglobin >= 9.0 g/dL; * Absolute neutrophil count (ANC) >= 1.5 x 10 9/L; * Platelet count >= 100.0 x 10 9/L; Exclusion Criteria: * Patients who are pregnant or breastfeeding. * Any prior palliative radiation therapy (other than used in the adjuvant therapy of pancreatic cancer > 6 weeks) must have been completed more than 21 days before entry into the study and evaluable lesions must not have been included in the radiation portal. * Patients with prior capecitabine therapy for pancreatic cancer (Phase II). * Patients with active CNS metastases. * Patients with known hypersensitivity or a history of marked intolerance to 5-FU are ineligible. * Because cimetidine can decrease the clearance of 5-FU, patients should not enter on this study until cimetidine is discontinued. * Patients should not receive concurrent therapy with either sorivudine or brivudine, while receiving capecitabine. If a patient has received prior sorivudine or brivudine, then at least four weeks must elapse before the patient receives capecitabine therapy. * Exclude sexually active males unwilling to practice contraception during the study. * Lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome. * Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias) or myocardial infarction within the last 12 months. * No concurrent radiotherapy is allowed. * Known DPD (dihydropyrimidine dehydrogenase) deficiency. * Patients who have received any previous treatment consisting of standard chemotherapy (gemcitabine in Phase II study; others in Phase I) within 21 days or an investigational agent (Phase I) within 30 days on study. Toxicity related to the previous therapy must have resolved prior to study entry. * Patients with previous or concurrent malignancy except for inactive non-melanoma skin cancer and/or in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence within the last 3 years prior to study entry. * Patients taking herbal medicine(s), including supplement(s), are eligible if they discontinue the herbal medicine(s)/supplement(s) at least 7 days prior to study entry. * Known allergy or hypersensitivity to PHY906 or any of the components used in the PHY906 formulations, or to capecitabine. * Serious concurrent medical illness, which would jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety. * Patients with active infections requiring intravenous antibiotic therapy are not eligible until the infection has resolved.

Study Objectives This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) alone. No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: Bevacizumab, DRUG: Capecitabine Location: Hungary, Mexico, Canada, Korea, Republic of, Italy, Netherlands, Spain, United Kingdom, Greece, Slovenia, Austria, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Adult patients, >= 70 years of age. * Cancer of the colon or rectum. * Metastatic disease diagnosed <= 6 months before enrollment. * >= 1 measurable metastatic lesion. Exclusion Criteria: * Adjuvant anti-vascular endothelial growth factor (VEGF) treatment. * Prior chemotherapeutic treatment for metastatic colorectal cancer. * Past or current history of other malignancies (with the exception of basal and squamous cell cancer of the skin, or in situ cancer of the cervix). * Clinically significant cardiovascular disease. * Current or recent daily use of aspirin (> 325 mg/day) or other non-steroidal anti-inflammatory drug (NSAID), or full dose anticoagulants.

Study Objectives The prognosis of advanced gastric cancer and adenocarcinoma of the gastro-esophageal (GE) junction is poor. Even with modern chemotherapy the median survival ranges around 8-10 months. Inhibition of neoangiogenesis seems to be a very promising approach in gastric cancer. Vascular endothelial growth factor (VEGF) acts as one of the most potent stimulating agents of angiogenesis, and several strategies targeting the VEGF signaling pathway have been developed, including anti-VEGF antibodies, soluble receptors binding directly to VEGF ligand, anti-VEGF receptor (VEGFR) antibodies and VEGFR tyrosine kinase inhibitors. The breakthrough in the clinical development of anti-angiogenic therapy against colorectal cancer came in 2003 with a large prospective, randomized clinical trial of bevacizumab, a monoclonal antibody directed against VEGF. Anti-angiogenic therapy has introduced a highly effective, completely new mode of action in this area and is the new standard of care in advanced colorectal cancer. The concept of VEGF inhibition is also very promising in gastric cancer. Bevacizumab was investigated in combination with irinotecan and cisplatin in a phase-II trial, including 47 patients with gastric and GE-junction carcinoma. Bevacizumab could safely be given and could improve time to tumor progression by 75% compared to historical controls. Several phase-II trials confirm the tolerability and promising efficacy of bevacizumab in gastric cancer (Bevacizumab + Docetaxel/Oxaliplatin; FOLFOX + Bevacizumab; Docetaxel/Cisplatin/Irinotecan + Bevacizumab). These results were so promising that randomized phase-III trials in the 1st-line and perioperative setting are under way (AVAGAST-trial: Cisplatin /Capecitabine +/- bevacizumab 1st line ; MAGIC-B-trial : ECX +/- bevacizumab perioperative). Tyrosin kinase inhibitors which inhibit VEGF receptors and EGFR are also investigated in gastric cancer with promising efficacy. Pazopanib, an orally available tyrosine kinase inhibitor, selectively inhibits vascular endothelial growth factor receptors (VEGFR)-1, -2 and -3, c-kit and platelet derived growth factor receptor (PDGF-R), which results in inhibition of angiogenesis in tumors in which these receptors are upregulated. Pazopanib has the advantage of being an orally available anti-angiogenesis component. Pazopanib shows promising activity in phase-II trials in renal cell cancer, breast cancer, soft tissue sarcoma and non small cell lung cancer. A phase-III trial of pazopanib in renal cell cancer (NCT00334282) is completed and resulted in the approval of Pazopanib for this disease. A phase-III trial in soft tissue sarcoma (NCT00753688) is currently performed. In phase-I trials, pazopanib was investigated in combination with FOLFOX and Capecitabine/Oxaliplatin. FOLFOX could be administered in full dose with 800 mg pazopanib. In Cape/Ox, capecitabine had to be reduced to 850mg/m² bd. 5-FU- and oxaliplatin-based regimens are one of the established treatment standards for 1st-line therapy in metastatic gastric cancer. The efficacy of 5-FU, leukovorin and oxaliplatin (FLO) compared to 5-FU, cisplatin could be confirmed in a randomized phase-III trial of the Arbeitsgemeinschaft Internistische Onkologie (AIO). FLO has a favorable toxicity profile. In Germany, FLO is a widely used combination for advanced gastric cancer and is a recommended regimen in the new German S3-guidelines 2011. The investigators therefore want to examine FLO + pazopanib. Conditions: Advanced Gastric Cancer Intervention / Treatment: DRUG: Pazopanib, DRUG: 5-FU, Oxaliplatin, Leukovorin (FLO) Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. * Age >= 18 years. * Histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction with either metastatic or locally advanced disease, incurable by operation. * Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2 * At least one unidimensional, measurable tumor parameter (according to RECIST 1.1) * No preceding cytotoxic therapy (neoadjuvant or adjuvant treatment allowed if finished > 6 months before inclusion) * Adequate organ system function. * Men and women must perform an adequate contraception. * Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug. Exclusion Criteria: * Prior malignancy, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix. * Overexpression of HER-2, defined as IHC 3+ or IHC 2+ and FISH positive. * Known hypersensitivity against 5-FU, leukovorin, oxaliplatin or other platinum compounds or pazopanib. * History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis. * Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or the absorption of investigational product * Presence of uncontrolled infection. * Corrected QT interval (QTc) > 480 ms using Bazett's formula. * History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, NYHA III or IV congestive heart failure. * Poorly controlled hypertension. * History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. * Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer. * Evidence of active bleeding or bleeding diathesis. * Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels. * Hemoptysis in excess of 2.5 ml within 8 weeks of first dose of study drug. * Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. * Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study. * Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib. A neoadjuvant or adjuvant chemotherapy must be finished at least 6 month before study entry. * Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia. * Grade 3 or 4 diarrhea. * Peripheral polyneuropathy > NCI Grade. * Pregnant or lactating women. * Men or women who are planning a pregnancy within the next six months. * Participation in another clinical trial with investigational agents within the last 30 days prior to study start. * The patient is a colleague or employed by the study investigator or by an involved institution including the sponsor of the study. * Patient is detained in a psychiatric unit or imprisoned.

Study Objectives Breast cancer is one of the commonest types of cancers in females. Treatments include surgery followed by anti-estrogen therapy, radiotherapy and chemotherapy. During breast surgery, the surgeon removes the cancer from the breast and lymph nodes (glands) from the armpit. Historically, all armpit lymph nodes were surgically removed but this approach is associated long term problems of arm swelling. In more recent times, an increasingly more selective approach is used to treat the armpit nodes. In the presence of cancer spreads in the nodes, an axillary clearance surgery is done otherwise, only the first node(s) also called sentinel node(s) that drain fluids from the cancer, is surgically removed. The identification of nodes using the latter approach is helped by injecting a tracer in the breast and via the lymphatic channels, the tracer is then concentrated in the sentinel nodes. Over recent years, neoadjuvant (preoperative) chemotherapy is being increasingly used to treat breast cancers. This treatment approach can lead up to a large of number of complete cancer response. This in turn can cause difficulties in locating the breast cancer / armpit nodes during surgery after the chemotherapy. New developments like superparamagnetic iron oxide nanoparticles (SPIO or MagTrace®) has been used as an alternate liquid tracer to mark sentinel nodes to facilitate armpit surgery. In addition, small magnetic clip called Magseed® has also been developed which can be inserted into the relevant lymph nodes thereby marking their anatomical position to facilitate surgery. Both MagTrace and Magseed can be used to pre-mark the cancer and armpit nodes before the start of neoadjuvant chemotherapy. In theory, premarking armpit nodes using a magnetic approach is associated with better surgical accuracy in the armpit but there is limited supporting data. Therefore, this study aims to investigate the feasibility of premarking armpit nodes, with or without cancer spread, using magtrace and magseed respectively before patients undergo neoadjuvant chemotherapy. Conditions: Breast Cancer Intervention / Treatment: DRUG: MagTrace only, COMBINATION_PRODUCT: MagTrace and Magseed Location: Sweden Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * A patient meeting the following criteria is eligible for participation in the study: * Patients 18 years of age or older * Patients with breast cancer planned to undergo preoperative chemotherapy (NACT) with a) planned sentinel lymph node biopsy (SNB) or b) axillary lymph node dissection, in conjunction with the beast surgery after NACT Exclusion Criteria: * Intolerance / hypersensitivity to iron or dextran compounds or SPIO. * Patients who are required to undergo MR to evaluate tumour response * Pregnancy or breast feeding * Patients with an iron overload disease. * Patient deprived of liberty or under guardianship. * Inability to understand given information, give informed consent, undergo study procedures * MRI (subgroup of patients): Conditions contraindicating MRI including, but not limited to, BMI > 40 kg/m2, claustrophobia, metallic implants or internal electrical devices (e.g. Pacemaker).

Study Objectives The purpose of this research study is to determine the safety and tolerability of sunitinib alternating with regorafenib in participants with advanced gastrointestinal stromal tumor GIST, if the standard approved therapies (imatinib, sunitinib and regorafenib) have failed to control the disease. Additionally, this study seeks to determine the highest dose that can be given safely for this combination of drugs. Conditions: Gastrointestinal Stromal Tumor Intervention / Treatment: DRUG: Sunitinib, DRUG: Regorafenib 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: * At least 18 years of age at the time of study entry. * Histologically confirmed metastatic and/or unresectable GIST. Patients must demonstrate prior failure to at least imatinib, sunitinib and regorafenib (4th line and beyond). Any number of previous therapies for GIST is allowed. * Measurable disease per modified RECIST 1.1. A lesion in a previously irradiated area is ineligible to be considered as measurable disease unless there is objective evidence of progression of the lesion prior to study enrollment. * ECOG performance status 0 or 1 (see Appendix A). * Participants must have adequate organ and marrow function as outlined in the protocol. * Patients must be able to swallow oral medication. * Willingness to use effective means of birth control throughout the duration of clinical study and for at least 3 months after completion of study drug. * Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of study drug administration. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Use of any approved tyrosine kinase inhibitors or investigational agents within 2 weeks or 6 half-lives of the agent, whichever is shorter, prior to receiving study drugs. * Patients with intolerance to sunitinib and/or regorafenib. * Participants who have had radiotherapy within 4 weeks prior to study entry. * Major surgery, or significant traumatic injury within 4 weeks prior to study entry. * Presence of symptomatic or uncontrolled brain or central nervous system metastases. * Known or suspected allergy to the investigational agent or any agent given in association with this trial. * Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR other primary malignancy is neither currently clinically significant nor requiring active intervention. * Clinically significant cardiac arrhythmias and/or patients who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Patients with controlled atrial fibrillation are not excluded. * History of clinically significant cardiac disease or congestive heart failure > NYHA class 2 (See Appendix C). Patients must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months. * Hypertension as defined by systolic blood pressure >140 mmHg or diastolic blood pressure > 90 mmH despite optimal medical management. * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication). * Patients with evidence or history of any bleeding diathesis, irrespective of severity. * Ongoing infection >= Grade 2. * Patients with any seizure disorder requiring medication. * Non-healing wound, ulcer, or bone fracture. * Persistent proteinuria Grade 2 or higher measured by urine protein:creatinine ratio on a urine sample or during 24-hour assessment. * HIV-positive individuals on combination antiretroviral therapy. * Patients with active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy. * Interstitial lung disease with ongoing signs and symptoms at the time of informed consent. * Uncontrolled intercurrent illness. * Pregnant or lactating females. * Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol. * Strong CYP3A4 inhibitors within 28 days or 5 drug half-lives, whichever is longer, before start of study drug.

Study Objectives This phase I trial studies the side effects and the best dose of lenalidomide when given together with cetuximab in treating patients with colorectal cancer or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. Giving lenalidomide together with cetuximab may be a better treatment for colorectal cancer or head and neck cancer. Conditions: Recurrent Colon Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary, Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Recurrent Rectal Carcinoma, Recurrent Salivary Gland Carcinoma, Salivary Gland Squamous Cell Carcinoma, Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary, Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Laryngeal Verrucous Carcinoma AJCC v7, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Major Salivary Gland Cancer AJCC v7, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVA Oral Cavity Cancer AJCC v6 and v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Rectal Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7, Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Laryngeal Verrucous Carcinoma AJCC v7, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVB Major Salivary Gland Cancer AJCC v7, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVB Oral Cavity Cancer AJCC v6 and v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Rectal Cancer AJCC v7, Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVC Laryngeal Verrucous Carcinoma AJCC v7, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVC Major Salivary Gland Cancer AJCC v7, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVC Oral Cavity Cancer AJCC v6 and v7, Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7, Tongue Carcinoma Intervention / Treatment: BIOLOGICAL: Cetuximab, OTHER: Laboratory Biomarker Analysis, DRUG: Lenalidomide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; eligible malignancies include: colorectal cancer KRAS wild-type and squamous cell head and neck cancer * No curative intent therapy available; there is no limit on prior number of therapies; prior epidermal growth factor receptor (EGFR)-directed therapy (tyrosine kinase inhibitors and monoclonal antibodies - including cetuximab, panitumumab, or investigational EGFR directed monoclonal antibodies) will be allowed in the phase I dose escalation; patients who have received monoclonal antibody therapy must be off all monoclonal antibodies four weeks (28 days) prior to study treatment; no chemotherapy within 28 days of trial medication * There will be an expansion cohort for colorectal cancer patients only; for the expansion cohort, there is no limit on prior chemotherapy; the colorectal expansion cohort will include patients with cetuximab or panitumumab-resistant or refractory disease (progression during cetuximab/panitumumab therapy or within 3 months of cetuximab/panitumumab therapy * Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky > 60%) * Life expectancy of greater than 3 months * Leukocytes > 3,000/mcL * Absolute neutrophil count > 1,500/mcL * Platelets > 100,000/mcL * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal * Creatinine clearance > 60 mL/min/1.73 m^2 as calculated using modified Cockcroft-Gault formula * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure * Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy * All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure * Able to take aspirin (81 or 325 mg) daily for prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin) 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 (>= grade 3) due to agents administered more than 4 weeks earlier * Patients may not be receiving any other investigational agents * Uncontrolled brain metastases; patients who have received definitive therapy, including radiation, and are not requiring ongoing medical therapy (i.e. steroids) for brain metastases will be allowed * History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide or cetuximab or other agents used in study * Patients with a recent history of deep vein thrombosis (DVT)/pulmonary embolism (PE) requiring therapy (within 3 months) * Patients with history of toxicity >= grade 3 with prior EGFR directed therapy * Patient with confirmed history of interstitial lung disease * Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with either agent * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Study Objectives The purpose of this pilot phase II trial is to identify the molecular and genetic mechanisms by which statins influence breast cancer cell proliferation. Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and reduce the aggressiveness of breast cancer cells. Conditions: Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7 Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, DRUG: Simvastatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * Histologic confirmation of invasive breast cancer with any measures of ER, PR and HER2neu * Clinical stage I or II breast cancer for which there will be at least a 2 week period of time between diagnosis and definitive surgery * Performance status (Eastern Cooperative Oncology Group [ECOG] 0-1) * Not currently pregnant during the study; participants will be informed that the use of contraceptive pills is contraindicated because it may interfere with the study drug and it may be harmful to the woman who has been diagnosed with breast cancer Exclusion Criteria: * Plans for administration of neoadjuvant chemotherapy or hormonal therapy * Insufficient tissue on diagnostic core breast biopsy for analysis * Previous or concurrent malignancy (with the exception of non-melanomatous skin cancer) * Severe gastrointestinal disorder * Current use of statins or fibrates for any time during the 3 months prior to the study * Proven hypersensitivity to statins * White blood cell (WBC) < 3,500/mm^3 * Platelet (Plt) < 120,000/mm^3 * Hemoglobin (HgB) < 10 g/dL * Aspartate aminotransferase (AST) > 45 U/L * Alanine aminotransferase (ALT) > 45 U/L * Creatinine > 1.5 mg/dL * Bilirubin > 1.15 mg/dL * Creatine kinase measurement (CPK) > or = 250 mg/dL * Central nervous system (CNS) diseases and major psychiatric diseases or inability to comply to the protocol procedures * Active infections * Cardiac failure, class I-IV * Current anticoagulant or antiplatelet aggregation therapy * Mitral and/or tricuspid valvopathy or valvular prosthesis; angina; severe arterial hypertension; chronic and/or paroxysmal atrial fibrillation; previous myocardial infarction * Current lactation

Study Objectives An open clinical trial not randomized, multicentric. This study search to evaluate vitamin D supplementation efficacy at high dose (UVEDOSE, colecalciferol, oral solution at 100 000 UI) of vitamin D on day 1 of each cycles for breast cancer treated adjuvant chemotherapy. A calcium supplementation will be prescribed in parallel. An initial dosage of 25OH vitamin D rate will be done and a vitamin-calcic dosage will done on day 1 of every cycles of chemotherapy Conditions: Breast Cancer Intervention / Treatment: DIETARY_SUPPLEMENT: VITAMIN D Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Breast adenocarcinoma should receive 6 cycles of adjuvant chemotherapy * Women >= 18 years old (no age limit) * Performance status :0 or 1 * Patients must be affiliated to a Social Security System * Signed informed consent obtained before any study specific procedures. * Vitamin D deficiency confirmed ( vitamin D result must be < at 30 ng/ml) Exclusion Criteria: * Metastatic disease * Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years * calcium or colecalciferol contraindications (vitamin D hypersensitivity - disease or an other condition result in hypercalcaemia or hypercalciuria -Calcic lithiasis- high vitamin D level) * Presence of the following diseases in the last 3 years : endocrinal disease, A phosphor calcic disorder treated by vitamin D supplementation at 1000 UI/day or more (this patient who have received a dose < 1000 UI/day, will be included after have to stop Vitamin D at least 48 hours ) - Osteopenia or osteoporosis confirmed treated * Concomittant treatment with an other experimental product * Pregnant or breastfeeding women * Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

Study Objectives This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy Conditions: Prostate Cancer Intervention / Treatment: DRUG: Orteronel, DRUG: Prednisone, DRUG: Orteronel Placebo Location: Finland, Hungary, Estonia, Canada, Italy, Netherlands, Spain, United States, Belgium, Australia, Greece, Czechia, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: Each participant must meet all of the following inclusion criteria: * Voluntary written consent * Male >= 18 years * Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma * Radiograph-documented metastatic disease * Progressive disease * Prior surgical castration or concurrent use of an agent for medical castration * Progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1 of which must have included docetaxel. Must have received greater than or equal to (>=) 360 milligram per square meter (mg/m^2) of docetaxel within a 6-month period. Participants who were clearly intolerant to docetaxel or develop progressive disease before receiving >= 360 mg/m^2 are also eligible if they have received at least 225 mg/m^2 of docetaxel within a 6-month period and meet the other study entry criteria. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Even if surgically sterilized, participants must practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse * Screening laboratory values as specified in protocol * Stable medical condition * Life expectancy of 6 months or more * Participants who have had up to 2 prior chemotherapy treatments are eligible to participate Exclusion Criteria: Participants meeting any of the following exclusion criteria are not to be enrolled in the study: * Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue * Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone * Any other therapies for prostate cancer, except for GnRH analogue therapy, must be discontinued 2 weeks before the first dose of study drug * Radioisotope therapy or external beam radiation therapy within 4 weeks of first dose of study drug * Documented central nervous system metastases * Treatment with any investigational compound within 30 days prior to first dose of study drug (Participants who are in long-term follow-up following active treatment in other trials are eligible) * Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected * Uncontrolled cardiovascular condition as specified in study protocol * Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C * Unwilling or unable to comply with protocol * Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel * Uncontrolled nausea, vomiting, or diarrhea despite appropriate medical therapy * Prostate cancer confined to just the prostrate bed or immediate adjacent tissue

Study Objectives Study 4975-MN-202 is a double-blind, placebo-controlled, parallel group, single-injection study in which subjects will be randomized to receive three doses of CNTX-4975 or placebo injected into the intermetatarsal space around a Morton's neuroma. The injection of study medication will be administered by ultrasound-guided needle placement following ankle block anesthesia. The study staff will telephone subjects at Week 1 postinjection and subjects will return to the clinic postinjection at Weeks 2, 4, 8, and 12 for study assessments. Conditions: Painful Intermetatarsal Neuroma (Morton's Neuroma) Intervention / Treatment: DRUG: CNTX-4975, OTHER: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion criteria: * Male or female aged >18 years at the time of the Screening Visit. * Pain associated with intermetatarsal neuroma (Morton's neuroma) for a minimum of 3 months prior to Screening. * Diagnosis of Morton's neuroma, confirmed by evidence of focal tenderness and pain in the distal third intermetatarsal space, AND either * Presence of neuroma on ultrasound, or * Elicitation of Mulder's sign or a positive Gauthier's test. * A mean neuroma foot pain score of 4 or greater during the 7 days prior to dosing (NPRS, 0-10) as rated daily at bedtime (9:00 PM ± 3 hours) for average pain with walking in the last 24-hours. At least 5 of 7 scores during the week prior to dosing must be recorded. * Tried conservative treatment with analgesics (acetaminophen or nonsteroidal anti-inflammatory drugs) and non-pharmacologic therapy (such as wide shoes, orthotics, and/or arch supports) without complete success. * Female not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing one of the following medically acceptable methods of birth control throughout the study period: * Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before investigational product (IP) administration. * Total abstinence from sexual intercourse since the last menses before IP administration. * Intrauterine device. * Double barrier method (condoms, sponge, diaphragm, with spermicidal jellies or cream). * Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and daily IWRS/IVRS entries, and to communicate meaningfully with the study personnel. * Signed an Informed Consent Form approved by the Institutional Review Board. * Subject agrees to take only the rescue medications for neuroma foot pain from the time of screening through study completion, and agrees to discontinue all topical medications for neuroma pain after Screening. Exclusion criteria: * Clinically significant bursitis in either foot. * The subject has more than one painful intermetatarsal neuroma in the affected foot which, in the opinion of the Investigator, would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma in the affected foot. * Radiography within 6 months of the Treatment Visit (Day 1) to exclude musculoskeletal pathology must be performed, to include any osseous abnormality such as stress fracture, osteophyte, tumor, or cyst in the bones or toes adjacent to the third inter-metatarsal space or any significant evidence of arthritis in the joints of the 3rd and 4th metatarsal-phalangeal joints or inter-phalangeal joints of the 3rd and 4th toes. * Previous neurectomy in the same nerve. * Any painful condition or prior surgery on the affected ankle or foot, which, in the judgment of the investigator, might adversely impact the interpretation of study data. * Other painful foot pathology (e.g., bunion, hammertoe, plantar fasciitis etc.) or evidence of clinically meaningful ischemia which, in the judgment of the investigator and the medical monitor, would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma. * Other chronic pain anywhere in the body that is greater than or equal to the intensity of foot pain from intermetatarsal neuroma. * Signs of arterial insufficiency in the feet, including clinically meaningful edema. * Current use of opioids for any condition. * Corticosteroid injection in the affected foot within 30 days of Screening. * History of clearly documented allergic reaction to local anesthetics or capsaicin. * Prior use of injection with a sclerosing agent, such as alcohol or phenol, in the affected foot for Morton's neuroma. * Presence of any medical condition or unstable health status that, in the judgment of the investigator, might adversely impact the conduct of the study or resulting data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study medication, such as uncontrolled diabetes mellitus or vascular disease. * Regular use of anticoagulant blood thinners (except low-dose aspirin or Plavix which are allowed). * Active cutaneous disease at the anticipated site of study drug injection that would prevent the safe administration of study drug. * Ulcer or open wound anywhere on the affected foot. * Clinically significant abnormal laboratory result at the Screening Visit (in the opinion of the investigator). * Has diabetic neuropathy or other peripheral neuropathy in the affected foot. * Use of an investigational medication in the 30 days prior to the current study or scheduled to receive such an agent while participating in the current study. * Prior participation in an ALGRX-4975 or CNTX-4975 study. * Has a history of substance use disorder within the previous year as defined by the Diagnostic and Statistical Manual for Mental Health Disorders, fifth edition, has current evidence for a substance use disorder, is receiving medicinal treatment for drug abuse, or tests positive upon urine drug screen for a substance of abuse. * Has a positive pregnancy test at the Screening or Treatment Visit. * Has any condition or is taking any medication that would be contraindicated for study participation.

Study Objectives Multicentric and prospective epidemiological study (NON INTERVETIONAL) to identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in metstatic renal cell carcinoma. Molecular determinations will be developed ay CIMA and CNIO. Conditions: Metastatic Renal Cell Carcinoma Intervention / Treatment: DRUG: Sunitinib Location: Spain Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Locally avanced or metastatic renal cell carcinoma with clear-cell component histology candidates to recieve sunitinib or pazopanib in fisrt line under standard clinical practice. * Measurable disease by CT or MRI * Life expectancy >3 months * Written informed consent. * Performance Status 0-2 Exclusion Criteria: * Any patients who does not fulfill the inclusion criteria.

Study Objectives This phase I trial studies the side effects and best dose of autologous T-antigen-presenting cells (T-APC) vaccine following therapeutic autologous lymphocytes (CTL) and cyclophosphamide in treating patients with metastatic melanoma. Aldesleukin may stimulate lymphocytes, such as CTL, to kill melanoma cells. Treating lymphocytes with aldesleukin in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body. Vaccines made from melanoma antigen may help the body build an effective immune response to kill tumor cells and may boost the effect of the CTL. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving T-APC vaccine after CTL and cyclophosphamide may be an effective treatment for melanoma Conditions: Recurrent Melanoma, Stage IV Melanoma Intervention / Treatment: DRUG: cyclophosphamide, BIOLOGICAL: aldesleukin, BIOLOGICAL: autologous tumor cell vaccine, OTHER: laboratory biomarker analysis, OTHER: immunologic technique, OTHER: immunohistochemistry staining method, GENETIC: polymerase chain reaction, BIOLOGICAL: therapeutic autologous lymphocytes 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: * Histopathological documentation of melanoma concurrent with the diagnosis of metastatic disease * Tumor expression of melanocyte differentiation antigen (MDA: MART-1 = 2+ staining or > 25%) by immunohistochemistry (IHC) * Expression of human leukocyte antigen (HLA)-A201 * Zubrod performance status of '0-1' at the time of treatment * Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, computed tomography [CT] scan) * Normal cardiac stress test will be required for all patients with any history of cardiac disease Exclusion Criteria: * Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to entry * Serum creatinine > 1.6 mg/dL or Creatinine clearance < 75 ml/min * Serum glutamic oxaloacetic transaminase (SGOT) > 150 IU or > 3x upper limit of normal * Bilirubin > 1.6 mg/dL * Prothrombin time > 1.5 x control * Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in one second (FEV1) < 2.0 L or carbon monoxide diffusing capacity (DLco) (corr for hemoglobin [Hgb]) < 75% will be excluded * Congestive heart failure * Clinically significant hypotension * Symptoms of coronary artery disease * Presence of cardiac arrhythmias on electrocardiograph (EKG) requiring drug therapy * Ejection fraction < 50 % (echocardiogram or multi gated acquisition scan [MUGA]) * Symptomatic central nervous system metastases greater than 1 cm at time of therapy; patients with 1-2 asymptomatic, less than 1 cm brain/central nervous system (CNS) metastases without significant edema may be considered for treatment * Patients with active infections or oral temperature > 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy * Chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapies less than 3 weeks prior to T cell therapy; (patients with bulky disease may undergo cytoreductive chemotherapy but treatment will be discontinued at least 3 weeks prior to T cell therapy) * Clinically significant autoimmune disorders or conditions of immunosuppression; patients with acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV)-1 associated complex or known to HIV antibody seropositive or known to be recently polymerase chain reaction (PCR)+ for hepatitis are not eligible for this study; virology testing will be done within 6 months of T cell infusion; the severely depressed immune system found in these infected patients and the possibility of premature death would compromise study objectives * Chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapies less than 3 weeks prior to T cell therapy * Current treatment with steroids * Patients must not be receiving any other experimental drugs within 3 weeks of the initiation of the protocol and must have recovered from all side effects of such therapy * Patients for whom we are unable to generate MART-1 specific T cells

Study Objectives A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer. Conditions: Pancreatic Neoplasms Intervention / Treatment: DRUG: Gemcitabine, DRUG: Oxaliplatin, PROCEDURE: Radiotherapy Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pathologically confirmed adenocarcinoma of the pancreas * Patient have undergone a potentially curative resection * No previous irradiation to the planned field * Negative pregnancy test for child bearing women Exclusion Criteria: * Non-adenocarcinoma pancreatic cancer * Treatment with any drug within the last 30 days that has not received regulatory approval. * Serious systemic disorder * Metastatic disease * Pregnancy, breast feeding

Study Objectives BRF112680 is a first-time-in-human study to establish the recommended dose and schedule of the orally administered GSK2118436. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after the treatment of subjects with solid tumors. This is a two-part study. Part 1 will identify the recommended Part 2 dose using a dose-escalation procedure. Escalation may proceed until either a maximum tolerated dose is established, or the toxicokinetic safety limit is reached. The recommended Part 2 dose will be expanded to up to 12 patients. Part 2 will explore further the safety, tolerability, and clinical activity of GSK2118436 in subjects with BRAF mutation-positive tumors. In addition, the effect of GSK2118436 on midazolam will be assessed in a subset of patients in Part 2. Biologically active doses will be identified by measurement of pharmacodynamic markers in tumor tissue and blood across a range of doses and these doses may be explored in Part 2. Conditions: Cancer Intervention / Treatment: DRUG: GSK2118436, DRUG: GSK2118436, DRUG: Midazolam Location: United States, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Written informed consent provided. * 18 years old or older. Subjects enrolled in the midazolam cohort need to be younger than 65 years old. * Histologically or cytologically confirmed diagnosis of a solid tumor that is not responsive to standard therapies or for which there is no approved or curative therapy. Subjects must have BRAF mutant positive tumors. * Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. * Able to swallow and retain oral medication. * Male subjects must agree to use one of the contraception methods listed in the protocol. The criterion must be followed from the time of the first dose of study medication until 16 weeks after the last dose of study medication. * A female subject is eligible to participate if she is of non-childbearing potential or postmenopausal as defined in the protocol. A female of child-bearing potential may participate if she agrees to use one of the contraception methods listed in the protocol. * Adequate organ system function as defined in the protocol. * Part 2/Cohorts A, B and C: Must have radiologically and/or clinically documented disease with at least one measurable lesion as defined by RECIST criteria. * Part 2/Cohort C only: Must have BRAF positive melanoma with the V600E mutation. Exclusion Criteria: * Currently receiving cancer therapy (chemotherapy, radiation therapy, immuno-therapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization). * Use of an investigational anti-cancer drug within 28 days preceding the first dose of GSK2118436. * Current use of a prohibited medication as defined in the protocol or requires any of these medications during treatment with GSK2118436. * Current use of therapeutic warfarin. * Any major surgery, radiotherapy, or immunotherapy within 4 weeks prior to first dose. Limited radiotherapy within 2 weeks prior to first dose. * Chemotherapy regimens with delayed toxicity within four weeks prior to first dose (6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within 2 weeks prior to first dose. * Unresolved toxicity greater than National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 Grade 1 from previous anti-cancer therapy except alopecia unless agreed to by a GSK Medical Monitor and the investigator. * Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs. * A history of known HIV infection. * Primary malignancy of the central nervous system. * Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Subjects previously treated for these conditions that are asymptomatic and off corticosteroids for at least two weeks are permitted. Brain metastases must be stable for at least 3 months with verification by imaging (brain MRI completed at screening). Subjects are not permitted to receive enzyme inducing anti-epileptic drugs (EIAEDs). In Part 2 of the study, subjects with asymptomatic, untreated brain metastases that have not been stable for 3 months may be enrolled with approval of the GSK medical monitor. These subjects can be on a stable dose of corticosteroids. * History of alcohol or drug abuse within 6 months prior to the screen visit. * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. * Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol. * QTc interval greater than or equal to 480 msecs. * History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within 24 weeks prior to the first dose. * Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. * Abnormal cardiac valve morphology (subjects with minimally abnormalities can be entered on study with approval from the GSK medical monitor). * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug, or excipients as described in the protocol (to date there are no known FDA approved drugs chemically related to GSK2118436). * Pregnant or lactating female. * Unwillingness or inability to follow the procedures outlined in the protocol. * Subjects with known glucose 6 phosphate dehydrogenase (G6PD) deficiency. * Patients positive for HPV. Entry on study allowed only at the discretion of subject and investigator after informed consent regarding discussion of the risk of papillomavirus infection. If enrolled, these subjects must use condoms for sexual activity, regardless of the use of other contraceptive measures and childbearing status. * Prior treatment with a BRAF or MEK inhibitor unless approved by the GSK medical monitor.

Study Objectives Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery. Conditions: Malignant Neoplasm of Breast Intervention / Treatment: DRUG: Saline, DRUG: Ropivacaine Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by: * either breast-conserving surgery with axillary lymph node dissection * either radical surgery with or without axillary lymph node dissection. * 18 years <= Age >= 85 years. * ASA class 1, 2 or 3. * No analgesic treatment for 2 days (no pre-existing chronic pain) * If a biological control has been requested recently or deemed necessary by the Investigator, then it should be satisfactory : Adequate hematologic and hemostasis: neutrophil count (ANC) > 1500/mm3, haemoglobin > 9 g/dl and platelets > 75 000/mm3, prothrombin time > 70%, activated partial thromboplastin time < 1.5 X Upper Limit of Normal (ULN) * Life expectancy >= 2 years. * Signed informed consent form. * Patient able to meet the self-assessments questionnaires (sufficient understanding assessments, proficiency in French) * Patient affiliated with a health insurance scheme (beneficiary or legal) There is no prohibition for people to take part simultaneously in another search and there is no exclusion cause at the end of the research period. Exclusion Criteria: * Ongoing neoplasm or history of malignancy other than breast cancer with the exception of: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that has not relapsed during the 5 years preceding inclusion in the trial. * Bilateral breast carcinoma at the inclusion * Male subjects. * Metastatic breast carcinoma at diagnosis (M1). * Severe heart, liver and respiratory failure (ASA 4) * Allergy to local anesthetics and morphine. * Use of analgesics during the 48 hours preceding the surgical procedure. * History of breast surgery with painful sequelae * Major deformation of the spine * Puncture site infection * History of substance abuse. * Pregnant or lactating women, or women of childbearing potential without effective contraception * Subjects deprived of their liberty or under guardianship (including temporary guardianship). * Subjects unable to comply with medical follow-up of the trial for geographical, social or psychological reasons.

Study Objectives The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors. Conditions: Advanced Solid Tumor Intervention / Treatment: DRUG: LY3039478 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic. * In the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate. * Performance status of <=1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Adequate organ function, including hematologic, hepatic, and renal. * Estimated life expectancy of >=12 weeks. Exclusion Criteria: * Received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively. * Have serious preexisting medical conditions. * Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea. * Have an active bacterial, fungal, and/or known viral infection. * Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results.

Study Objectives Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of these normal tissues. Standard radiation treatment techniques using three or four radiation beams cannot avoid delivering some dose of radiation to these normal tissues that do not need to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of computer-controlled radiation beams aimed at your cancer to try to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that your doctor thinks may have cancer cells. The doctors at Princess Margaret Hospital are conducting this study in order to test whether the use of IMRT techniques can improve the chance of controlling your cancer in the head and neck region. Conditions: Nasopharyngeal Neoplasms Intervention / Treatment: PROCEDURE: intensity modulated radiation therapy, DRUG: cisplatinium and fluorouracil - standard treatment 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: * Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma requiring primary radiation * less than 70 yrs of age * Stage T1-T4; N0-N3; M0 * KPS less than 70 * no prior RT to H&N or chemotherapy for H&N * no other malignancy except non-melanomatous skin cancer * no distant mets * no contraindication to RT or chemotherapy * adequate organ function * informed consent Exclusion Criteria * Major medical or psychiatric illness, which would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.

Study Objectives The results of recent research on cervical cancer and its precancerous lesions have linked the expression of IMP3 protein to cervical dysplasia and the possibility of severe cervical dysplasia (CIN III) progressing to squamous cell carcinoma. A higher expression of IMP3 protein was found in the cytoplasms of severe cervical dysplasia (CIN III) cells and invasive tumor cells compared to CIN I and CIN II change cells. The sensitivity of IMP3 expression in tumor cells was 96%. In preparations that were IMP3 negative, no further monitoring and treatment revealed squamous cell carcinoma. Further analyzes indicated the possibility of determining IMP3 expression on first cervical biopsy specimens in patients with HSIL ( high grade squamous intraepithelial lesion) lesions as a biomarker to detect a subset of patients in whom lesion invasiveness can be expected. Conditions: Cervical Carcinoma Intervention / Treatment: OTHER: immunohistochemical analysis with murine monoclonal antihuman antibodies IMP3 Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * operated women diagnosed with squamous cell carcinoma of the cervix at the figo stage 1a1, 1a2, 1b1 and 1b2 Exclusion Criteria: * patients who underwent preoperative chemo and / or radiotherapy * patients with associated gynecological or other malignant diseases * patients with other histological types of tumors (adenocarcinoma, adenosquamous, neuroendocrine, etc.)

Study Objectives The goal of this clinical research study is to learn if a chemotherapy combination called modified Folfirinox (or mFolfirinox), followed by a combination of gemcitabine and radiation therapy, followed by surgery, can help to control pancreatic cancer. The safety of this treatment will also be studied. mFolfirinox consists of 5-FU, oxaliplatin, and irinotecan. These 3 drugs, along with gemcitabine, are each designed to block the growth of cancer cells, which may lead to cancer cell death. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Oxaliplatin, DRUG: Irinotecan, DRUG: 5-FU, DRUG: Gemcitabine, RADIATION: Radiation Therapy 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: * Cytologic or histologic proof of adenocarcinoma of the pancreas is required prior to treatment. Patients with Islet cell tumors are not eligible. * Only untreated patients with high risk pancreatic adenocarcinomas will be eligible for the study. For this study, such patients are defined as those who meet one or more of the following radiographic or serologic criteria: a)Primary tumor that involves the superior mesenteric vein causing a vein deformity or segmental venous occlusion with a patent vessel above and below suitable for reconstruction. b)Primary tumor that involves <= 180 degrees of the superior mesenteric artery (SMA), celiac axis or any of its branches on CT or MRI. c) Primary tumor that abuts or encases (>= 50% of the vessel circumference) a short segment of the common hepatic artery (typically at the gastroduodenal artery origin) * (continuation of #2). d) Patients with a high CA19-9 (=/>500mg/dl) in the presence of a bilirubin =/< 2.0 mg/dL. e) Radiographic findings consistent with malignant peripancreatic lymphadenopathy outside the planned field on CT or MRI f) Radiographic findings of indeterminate liver or peritoneal lesions on CT or MRI concerning but not diagnostic of metastatic disease. * Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, MRI or laparotomy. * There will be no upper age restriction; patients with Eastern Cooperative Oncology Group (ECOG) 0-1 are eligible. * Adequate renal, and bone marrow function: a) Leukocytes >= 3,000/uL. b) Absolute neutrophil count >=1,500/uL.c) Platelets >=100,000/Ul. d) Serum creatinine <= 2.0 mg/dL. * Hepatic function (endoscopic or percutaneous drainage as needed). a)Total bilirubin <= 2 X institutional upper limits of normal (ULN). b) AST (SGOT)/ALT (SGPT) <= 5 X institutional ULN. * Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy. * Women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding. * Patients must sign a study-specific consent form. Exclusion Criteria: * Patients whose tumors are defined as locally advanced cancer or metastatic cancer are not eligible. * Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure; multiple comorbidity that preclude a major abdominal surgery. * Known presence of metastases. * Inability to comply with study and/or follow-up procedures. * Patients < 18 years of age. * Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this study. * Patients with an active second malignancy with the exception of non-melanoma skin cancer.

Study Objectives The purpose of this study is to find out how safe and effective the combination of Mylotarg in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and advanced Myelodysplastic Syndrome over the age of 60 years. Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome Intervention / Treatment: DRUG: Mylotarg, DRUG: Cytarabine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologic diagnosis of AML or advanced MDS * No prior cytotoxic treatment for AML. (patients may have been treated with prior biologic therapy) Patients with MDS or AML that has evolved from MDS, could have received prior low-dose cytotoxic therapy (i.e. azacytidine or low-dose ara-C). Exclusion Criteria: * Uncontrolled or severe cardiovascular disease or pulmonary disease

Study Objectives The study team will be performing a study comparing the use of Heparin Flushes vs. Normal Saline Flushes in making sure central lines stay open. The participants will be placed in a group to receive the University of Texas Southwestern Medical Center (UTSW) Standard of Care (control group) for maintaining central lines, or a group to receive Normal Saline Flushes only (experimental group) to keep their central line open. The participants electronic medical record will be reviewed by study team members for the inclusion/exclusion criteria, the participants central line will be assessed by an 11 Blue BMT nurse every 12 hours, and they may be asked questions regarding their medical history during their stay on 11 Blue BMT. If a participant is discharged or transferred off of the 11 Blue BMT unit, they will no longer be included in the study and their central line maintenance will return to the UTSW Standard of Care. Participants in this study may be at risk for central line occlusion (a blood clot) which could require intervention to regain the free flow of fluids and use of the central line. The study team predicts there will be no increase in the rate of line occlusion when using Normal Saline Flushes only to maintain the free flow of fluids through participants central line. The study team also hopes the results of this study will help to improve patient outcomes by decreasing risk of infection, heparin associated complications, and costs. Conditions: Cancer Intervention / Treatment: DRUG: Normal Saline Group, DRUG: Heparin Group Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Oncology patients * Admitted to 11Blue Bone Marrow Transplant Unit at Clements University Hospital University of Texas Southwestern Medical Center * Ages 18-80 years * Pre-existing or newly placed PICC line * PICC line with good blood return (defined as: "brisk blood return of 3cc") * Flushes without difficulty Exclusion Criteria: * Patient less than 18 years of age or greater than 80 years of age * Refused or unable to give consent to the study * Patient admitted to the 11Blue BMT unit with any line other than a PICC line, or multiple lines * Patient admitted to 11Blue BMT for active transplant * Patient with a coagulopathy diagnosis * Patient on therapeutic dose of anticoagulants for documented Deep Vein Thrombosis or Pulmonary Embolism * Patient on inpatient hospice/comfort care * Patient transferred off 11B BMT unit onto another floor

Study Objectives The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Vatalanib, DRUG: Gemcitabine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria * Histologically or cytologically confirmed adenocarcinoma of the pancreas * Unresectable (due to involvement of critical vasculature, adjacent organ invasion, or presence of metastasis) * If > 5 years between the primary surgery and the development of metastatic disease, then separate histological or cytological confirmation of metastatic disease * Primary or metastatic lesion within 4 weeks prior to entry of study * WHO performance status of 0 to 2 * <= 18 years of age * Absolute Neutrophil Count (ANC) >= 1.5 x 10e9/L (>= 1500/mm3) * Platelets (PLT) >= 100 x 10^9/L (>= 100,000/mm3) * Hemoglobin (Hgb) >= 9 g/dL * Serum creatinine <= 1.5 upper limit of normal (ULN) * Serum bilirubin <= 1.5 ULN * Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase * (ALT/SGPT) <= 3.0 x ULN OR * <= 5 x ULN if liver metastases present * Proteinuria: * Negative for proteinuria based on dip stick reading OR * If dip stick reading is +1 result, then total urinary protein <= 500 mg and measured creatinine clearance (CrCl) >= 50 mL/min from a 24-hour urine collection * Life expectancy >= 12 weeks * Ability to give written informed consent Exclusion Criteria * For the "phase 1" portion of the study: prior gemcitabine will be therapy. * For the "phase 2" portion of the study: any prior chemotherapy {except for low-dose 5-fluorouracil (5-FU)as a radiosensitizer] * Radiotherapy (RT). The site of previous RT must have progressive disease if the only site of disease). * Prior full field radiotherapy <= 4 weeks prior to enrollment OR * Limited field radiotherapy <= 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities. * Prior biologic or immunotherapy <= 2 weeks prior to registration. * Prior therapy with anti-VEGF agents * History or presence of central nervous system (CNS) disease * Patients with a history of another primary malignancy <= 5 years (Exception: inactive basal or squamous cell carcinoma of the skin) * Major surgery <= 4 weeks prior to enrollment. (Exception: insertion of a vascular access device) * Minor surgery <= 2 weeks prior to enrollment. (Exception: insertion of a vascular access device) * Concurrent use of other investigational agents and patients who have received investigational drugs <= 4 weeks prior to enrollment. * Pregnant, or breast-feeding, not employing an effective method of birth control. * Pre-existing peripheral sensory neuropathy with functional impairment (>= CTCAE grade 2 neuropathy) * Respiratory compromise due to pleural effusion or ascites (>= CTCAE grade 2 dyspnea) * QTc > 450 ms (male) or > 470 ms (female) * Uncontrolled high blood pressure * History of labile hypertension * History of poor compliance with an antihypertensive regimen * Unstable angina pectoris * Symptomatic congestive heart failure * Myocardial infarction <= 6 months prior to registration / randomization * Serious uncontrolled cardiac arrhythmia * Uncontrolled diabetes * Active or uncontrolled infection * Interstitial pneumonia * Extensive and symptomatic interstitial fibrosis of the lung * Chronic renal disease * Acute or chronic liver disease * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib * Human immunodeficiency virus (HIV) infection (confirmed), if there is potential for interaction between vatalanib and any anti-HIV medication * HIV infection (confirmed) judged to increase subject risk due to the pharmacologic activity of vatalanib * Receiving warfarin sodium (Coumadin) or similar. Heparin is allowed. * Unwilling to or unable to comply with

Study Objectives This study plans to learn more about a drug called bexarotene for the treatment of advanced thyroid cancer. Subjects are asked to be in this study because they have thyroid cancer that will not respond to radioactive iodine therapy and shows signs of aggressive behavior. Bexarotene has been FDA approved for the treatment of a type of skin cancer called cutaneous T-cell lymphoma, but has not been FDA approved for this use. Bexarotene is investigational in the treatment of thyroid cancer. The purpose of this research study is to test how well the study drug works in humans. The study doctors want to know if: 1. The subjects thyroid cancer gets smaller while you are taking the study drug. 2. The subjects thyroid cancer takes up radioactive iodine better after treatment with the study drug than before treatment. Conditions: Thyroid Cancer Intervention / Treatment: DRUG: Bexarotene Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subject must have a histologically/cytologically confirmed diagnosis of papillary, follicular, or anaplastic thyroid cancer (any follicular cell derived thyroid cancer). * Subjects must have evidence of follicular cell-derived thyroid cancer progression. In patients with anatomically stable disease, PET positive lesions will also be eligible given the poor prognostic risk for PET positive thyroid cancer. * Subjects must not be eligible for surgical resection. * Subjects must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * Subjects must have laboratory values that fall within certain ranges. * Subjects must be age >= 18 years. * Subjects must provide written informed consent prior to any study procedures being performed. * Females of childbearing potential must have a negative pregnancy test prior to enrollment. * All eligible subjects must be willing to use adequate contraception throughout the duration of the study. * Subjects must be willing to submit a primary tumor tissue sample for immunohistochemical analysis. * Subjects have the option of providing one additional test tube of blood taken at baseline, 6 months and 1 year for banking of plasma for potential future studies (no genetic testing will be conducted). The current planned analysis is for the assessment of a potential peripheral marker for rexinoid responsive cancer - leukemia inhibitory factor (LIF) Exclusion Criteria: * Subjects with a known history of hyperlipidemia refractory to treatment. * Subjects with a known history of hypertriglyceridemia refractory to treatment. * Subjects with leukopenia below the reference range for the University of Colorado Hospital (UCH) laboratory. * Subjects, who are pregnant, have a desire to become pregnant or are breastfeeding. * Subjects who are unwilling or unable to comply with study medication administration, or study guidelines, as determined by the investigator. * Subjects with any prior history of malignancy with the exception of adequately treated basal cell skin cancer, in situ cervical cancer or other cancer for which the subject has been disease free for 3 years or more. * Subjects without radiographically assessable disease

Study Objectives This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce inflammatory responses and deep vein thrombosis formation when given in high doses in the perioperative period. Conditions: Gynecologic Oncological Pelvic/Abdominal Surgery Intervention / Treatment: DRUG: atorvastatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * gynecologic tumor scheduled for resection Exclusion Criteria: * prior reaction to statins * renal insufficiency * liver disease * h/o alcoholism * prior h/o DVT or hypercoagulability * concurrent medications that significantly affect cytochrome P450 3A4 * breast feeding or pregnancy

Study Objectives The purpose of this study is to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients. Conditions: Melanoma Intervention / Treatment: DRUG: VESANOID, DRUG: Ipilimumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients over the age of 18 year. * Patients diagnosed with advanced melanoma. * Patients that are considered candidates for ipilimumab therapy. * Patients able to understand and willing to sign a written informed consent documents. * Patients willing to have regular blood draws, one before treatment and four during or after treatment. Exclusion Criteria: * Patients under the age of 18. * Patients with Stage I or II, melanoma who are not candidates for Ipilimumab. * Patients that have received systemic treatments within four weeks prior to the beginning of treatment. * Women that are pregnant or nursing. * Patients taking immunosuppressive medications. * Patients with active autoimmune disease. * Patients with known sensitivity to retinoic acid derivatives. * Patients with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin > 2.5 × ULN.

Study Objectives This Phase 1 study in patients with newly diagnosed malignant glioma is designed to determine the highest dose of IL13-PE38QQR that can be safely administered by Convection Enhanced Delivery (CED) to the area around the tumor site after the tumor is surgically removed (resection). In addition, the patient will receive radiation therapy and may or may not be treated with oral temozolomide. Conditions: Glioblastoma Multiforme, Anaplastic Astrocytoma, Oligoastrocytoma Intervention / Treatment: DRUG: IL13-PE38QQR, PROCEDURE: Surgery for placement, PROCEDURE: Radiation therapy, DRUG: Temozolomide with radiation therapy 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 must be >=18 years old. * Patients must have undergone a gross total resection of the solid contrast-enhancing lesion(s) > 1.0 cm in diameter. * Patients must be able to have catheters placed within 14 days of tumor resection (including a planned Gross Total Resection following an initial biopsy or subtotal resection) * Patients must have histopathologic confirmation of malignant glioma from resection specimen. Diagnosis must be consistent with either GBM, AA, or malignant mixed OA. * Patients must be in adequate general condition and meet the following criteria: * a. Karnofsky Performance Scale score >= 70 * b. Adequate hematologic status: * Absolute neutrophil count >= 1,500/mm³ * Hemoglobin >= 10 gm/dL * Platelets >= 100,000/mm³ * PT & aPTT within institutional limits of normal * Female patients must not be pregnant or breast-feeding. * Patients must practice an effective method of birth control during the study and for 60 days beyond the last day of infusion. * Patients must understand the investigational nature of this study and its potential risks and benefits, and sign an approved written informed consent prior to performance of any study-specific procedure. Exclusion Criteria: * Patients with residual contrast-enhancing tumor crossing the midline, multifocal tumor not amenable to gross total resection or non-parenchymal tumor dissemination (e.g., subependymal or leptomeningeal). * Patients with clinically significant increased ICP (e.g., impending herniation), uncontrolled seizures or requirement for immediate palliative treatment. * Patients who have received any prior anti-tumor treatment (other than corticosteroids) including any investigational agents. * Patients with any metallic prosthesis that would prevent MRI and/or MRS scanning procedures of the brain. * Patients unwilling or unable to follow protocol requirements.

Study Objectives A multi-center, open label, single dose Phase I pharmacokinetic (PK) characterization of weekly IV (intravenous) topotecan given at 4mg/m2. 15 patients will be evaluated. Conditions: Cancer Intervention / Treatment: DRUG: topotecan 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: * Written informed consent * Performance status of 0, 1, or 2 on the Eastern Co-operative Oncology Group (ECOG) Scale * Predicted life expectancy of at least 3 months * Subjects with histologically or cytologically confirmed advanced solid tumors who have failed conventional therapy for their tumor type or have a tumor type for which no standard effective therapy exists; OR Patients for whom single-agent topotecan therapy is suitable * At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery * Must be free of post-treatment side effects (with the exception of alopecia) * No concurrent chemotherapy, biologic therapy or radiotherapy is allowed * Hemoglobin = 9.0 g/dL * WBC = 3,500/mm3 [= 3.5 x 109/L] * Neutrophils = 1,500/mm3 [= 1.5 x 109/L] * Platelets = 100,000/mm3 [= 100.0 x 109/L] * Calculated creatinine clearance=60 mL/min using the Cockcroft-Gault formula * Serum bilirubin < 2.0 mg/dL (34 µmol/L) AST, SGPT/ALT and alkaline phosphatase < 2 times the upper limit of normal if liver metastases cannot be visualized by abdominal computed tomography (CT) or magnetic resonance imaging (MRI scan) * If liver metastases are present, subjects with < 5 times the upper limit of normal are eligible to participate Exclusion criteria: * Women who are pregnant or lactating * Women subjects of childbearing potential who refuse to abstain from sexual intercourse or practice adequate contraception. Childbearing potential is defined as women who are not surgically sterilized (i.e. have not had a hysterectomy, bilateral oophorectomy [ovariectomy], or bilateral tubal ligation) or post-menopausal (i.e., documented absence of menses for one year prior to entry into the study). * Men unwilling to abstain from sex or use effective contraception during the study and for 3 months following completion of topotecan treatment * Subjects with uncontrolled emesis, regardless of etiology * Active infection * Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk * Treatment with another investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer) * History of allergic reactions to compounds chemically related to topotecan.

Study Objectives The purpose of this study is to determine whether stem cells collected from a donor's blood stream will be as safe and effective as using bone marrow collected from a donor's pelvic bone. Conditions: Leukemia, MDS, Myelofibrosis, Lymphoma Intervention / Treatment: DRUG: Fludarabine, DRUG: Cyclophosphamide, DRUG: Mesna, RADIATION: Total Body Irradiation, OTHER: Hematopoietic stem cell infusion, DRUG: Tacrolimus, DRUG: Mycophenolate, DRUG: G-CSF Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Subject * Age< 70. * Molecular based HLA typing will be performed for the HLA-A, -B, -Cw, DRB1 and -DQB1 loci to the resolution adequate to establish haplo identity. A minimum match of 5/10 is required. An unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant. Clinical urgency is defined as 6-8 weeks from referral or low-likelihood of finding a matched, unrelated donor. * Subjects must meet one of the disease classifications listed below: Acute leukemias (includes T lymphoblastic lymphoma). Remission is defined as < 5% blasts with no morphological characteristics of acute leukemia (e.g., Auer Rods) in a bone marrow with > 20% cellularity, peripheral blood counts showing ANC >1000/ul, including patients in CRp. Acute Lymphoblastic Leukemia in high risk CR1 as defined by at least one of the following: Adverse cytogenetics such as t(9;22), t(1;19), t(4;11), MLL rearrangements White blood cell counts >30,000/mcL Patients over 30 years of age Time to complete remission >4 weeks Presence of extramedullary disease Acute Myelogeneous Leukemia in high risk CR1 as defined by at least one of the following: Greater than 1 cycle of induction therapy required to achieve remission Preceding myelodysplastic syndrome (MDS) Presence of Flt3 abnormalities FAB M6 or M7 leukemia or Adverse cytogenetics for overall survival such as: those associated with MDS Complex karyotype (>= 3 abnormalities) Any of the following: inv(3) or t(3;3), t(6;9), t(6;11), + 8 [alone or with other abnormalities except for t(8;21), t(9;11), inv(16) or t(16;16)], t(11;19)(q23;p13.1) Acute Leukemias in 2nd or subsequent remission Biphenotypic/Undifferentiated Leukemias in 1st or subsequent CR. High-risk MDS status-post cytotoxic chemotherapy Myelofibrosis Burkitt's lymphoma: second or subsequent CR. Lymphoma. Chemotherapy-sensitive (complete or partial response; see response criteria Appendix C) large cell, Mantle Cell or Hodgkin's lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are ineligible for an autologous transplant or relapsed/progressed after autologous stem cell transplant. Marginal zone B-cell lymphoma or follicular lymphoma that has progressed after at least two prior therapies (excluding single agent Rituxan) and are ineligible for an autologous transplant or relapsed/progressed after autologous stem cell transplant.. * Patients with adequate physical function as measured by: Cardiac: left ventricular ejection fraction at rest must be >= 35%. Hepatic: bilirubin <= 2.5 mg/dL; and ALT, AST, and Alkaline Phosphatase < 5 x ULN. Renal: serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function(creatinine clearance or GFR) > 40 mL/min/1.73m2. Pulmonary: FEV1, FVC, DLCO (diffusion capacity) >= 40% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then O2 saturation > 92% on room air. Performance status: Karnofsky/Lansky score >= 60%. * Patients who have received a prior allogeneic HSCT and who have either rejected their grafts or who have become tolerant of their grafts with no active GVHD requiring immunosuppressive therapy. Donor * Donors must be HLA-haploidentical first-degree or second degree relatives of the patient. * Age >= 18 years * Weight >= 40 kg Exclusion Criteria: Subject * HLA-matched donor able to donate. * Pregnancy or breast-feeding. * Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings). Donor 1) Positive anti-donor HLA antibody.

Study Objectives Heparinized solution has been used for maintenance of arterial catheter during perioperative period. Although the infused dose of heparin is very low, the investigators examine whether the heparin effect is remained or not in blood using rotational thromboelastometry (ROTEM) analysis. Conditions: Brain Tumor, Spinal Stenosis, Cerebral Artery Anuerysm Intervention / Treatment: DRUG: Heparin Location: Korea, Republic of Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management. Exclusion Criteria: * heparin hypersensitivity * hematologic disease * anticoagulant medication

Study Objectives The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer. Conditions: Small Cell Lung Cancer Intervention / Treatment: DRUG: LY3295668 Erbumine Location: Japan, Korea, Republic of, Turkey, Spain, United Kingdom, United States, Belgium, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Have histological or cytological evidence of a diagnosis of platinum sensitive small cell lung cancer that is extensive stage. * Have adequate organ function. * Have a performance status (PS) of <=1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Have discontinued previous treatments for cancer. * Are able to swallow capsules. Exclusion Criteria: * Currently enrolled in a clinical study. * Have a serious concomitant systemic disorder. * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C. * Have a significant cardiac condition. * Have previously received an aurora kinase inhibitor.

Study Objectives In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Thalidomide Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Stage II or III multiple myeloma according to Durie and Salmon criteria. * Patients between 65 and 75 years of age * Previously untreated patients Exclusion Criteria: * Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma) * Primary or associated amyloidosis * World Health organisation performance index of at least 3 * Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more * Cardiac or hepatic dysfunction * Cerebral circulatory insufficiency * Absolute contraindication to corticosteroids * Peripheral neuropathy * HIV or hepatitis B or C positivity * Patients who had geographic, social or psychological conditions which might prevent adequate follow-up

Study Objectives This is a multicenter, open-label study of safety and efficacy of Quisinostat in combination with Paclitaxel + Carboplatin chemotherapy in patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy. The study will be carried out in 5-8 Russian and Belarusian sites. A maximum of 32 patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy, will be enrolled in the study. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Quisinostat, DRUG: Paclitaxel, DRUG: Carboplatin Location: Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed patient's information sheet and informed consent form to participate in the study. * Histological confirmed diagnosis of serous epithelial ovarian, primarily peritoneal or fallopian tube carcinoma. * Females aged >= 18 years. * Patients must have an ECOG status of 0 or 1. * Patients must have received only 1 prior line of platinum and Paclitaxel based chemotherapy. * Tumor progression observed not less than 1 month and no more than 6 months after completion of the planned number of cycles of first line platinum/Paclitaxel based chemotherapy (Carboplatin in the dose AUC5-6 or Cisplatin in the dose >= 75 mg/m2, in combination with paclitaxel for 6 q3-4 wk cycles) and indications for undergoing the second line chemotherapy. * The patients must have at least one measurable lesion according to RECIST 1.1 criteria. * Tissue block from archived material at diagnosis must be available and be submitted for predictive biomarker analysis. * Patient's ability to carry out visits and study procedures and to comply with the protocol. * Requirements for laboratory parameters determined below: Hematology: Absolute neutrophil count: Platelets: Hemoglobin: >= 1,500/mm3 (1.5 x 109 cells/L) * 100,000/mm3 (100 x 109 cells/L) * 9.0 g/dl Liver function: Total bilirubin: <= 1.5x upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): Alkalinephosphatase: * 2.5x ULN, or <= 5.0 x ULN in the case of liver metastasis * 5.0 x ULN Renal function: Serum creatinine: <=2 mg/dL Coagulation panel: Activated partial thromboplastin time (aPTT): <= 1.5 x ULN * The expected survival time not less than 6 months. * Women of childbearing potential (not sterile or in menopause less than 2 years) must be practicing an effective method of birth control during the whole period of the study and 6 months after the last administration of the investigational product. Effective methods include usage of a condom or diaphragm (barrier method) with spermicide. Exclusion Criteria: * Patients previously treated with an HDAC inhibitor. Patients, who have been treated with Valproate for convulsions can be included, however only if the treatment has taken place > 30 days before the screening. * Have received treatment for ovarian cancer with any other prior chemotherapy than platinum (Carboplatin (AUC 5-6) or Cisplatin (>= 75 mg/m2)) and paclitaxel (175-200 mg/m2) q3-4 wk for 6 cycles. Additional first line chemotherapy or prior treatment with additional investigational anticancer therapy is also an exclusion criterion. * Presence of specific toxicities of >= I grade, according to the NCI-CTCAE v.4.3, related to any prior anti-cancer therapy (excluding alopecia) * Patients with subsequent debulking operation (after first line chemotherapy) or radiotherapy due to the disease recurrence. * Patients who have undergone lower pelvis radiotherapy. * Patients with active or uncontrolled infection. * Patients with antibodies to human immunodeficiency virus (HIV), or hepatitis C virus (HCV), active hepatitis B virus (HBsAg). * History of other malignancies with the exception of basal cell carcinoma of the skin or cervical cancer in situ, that had undergone surgical removal or treatment within >= 5 years before the screening. * Patients with known cerebral metastases or clinical signs of cerebral metastases. * Have a history of severe hypersensitivity reaction to carboplatin, paclitaxel or agents within the histone deacetylase inhibitor group. * History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess during the year prior to inclusion. * Clinically significant cardiovascular diseases including: * Myocardial infarction within 12 months before screening * Unstable angina within 12 months before screening * Congestive heart failure Class III or IV according to the New York Heart Association criteria (NYHA) * Clinically significant ventricular arrhythmia including ventricular tachycardia, ventricular fibrillation, history of cardiac arrest, atrioventricular block (Mobitz II or III), use of cardiostimulator * QTc interval > 470 ms (ECG) (calculated according to Fredericia formula), or a diagnosis of long QTc syndrome * Hypotension (systolic blood pressure < 86 mm Hg) or bradycardia with a heart rate of < 50 beats per minute (ECG) except when caused by medications (e.g. beta-blockers) * Uncontrolled arterial hypertension (systolic arterial pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg) * Pregnancy and lactation * Drug or alcohol abuse at the moment of screening or in the past which according to the opinion of the Investigator makes the patient unsuitable for participation in the study * Inability to read or write; inability to understand and comply with the procedures of the study protocol; failure to comply with the treatment, which, in opinion of the Investigator, may affect the results of the study or the patient's safety and prevent the patient from further participation in the study; any other associated medical or serious mental conditions that make the patient unsuitable for participation in the clinical study, limit the validity of informed consent or may affect the patient's ability to participate in the study

Study Objectives The purpose of this study is to evaluate the overall response rate of Obinutuzumab (GA101) in combination with Pixantrone in patients with relapsed aggressive B-cell lymphoma. 70 patients with diffuse large B-cell lymphoma, follicular lymphoma grade IIIB or transformed indolent lymphoma will receive up to 6 cycles of the described combination regimen. Follow up visits are scheduled for up to 3 years. Conditions: Lymphoma, Non-Hodgkin Intervention / Treatment: DRUG: Obinutuzumab and Pixantrone Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients aged >= 18 years * Histologically proven diagnosis of diffuse large cell B-cell lymphoma (DLBCL), follicular lymphoma (FL) IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review) * Relapsed disease * Eastern Cooperative Oncology Group (ECOG) performance Status <=2, unless tumor associated * Adequate cardiac reserve: Serum Troponin level must be consistent with no significant acute or chronic myocardial damage and there should be no evidence of symptomatic disease * No curative option available * At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration * Adequate bone marrow (BM) reserve: Platelets of at least 100.000/µl (in case of extensive BM-infiltration 75.000/µl may be acceptable after discussion with the coordinating investigator), absolute neutrophil count of at least 1000/µl. Adequate hepatic and renal function: Alanine aminotransferase <2.5 x upper limit of normal (ULN); Aspartate aminotransferase <2.5 x ULN, total bilirubin <1.5 x ULN * No active Hepatitis B or C or HIV-infection * Measured or calculated creatinine clearance >30 mL/min * Fresh tumor biopsy or archived tissue available * Ability of patients to understand nature, importance and individual consequences of clinical trial. * Signed informed consent * Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (serum or urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment. Reliable contraception comprises systematic contraceptives (oral, implant, injection) or diaphragm / condoms / intrauterine devices (IUP) with spermicide. * Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment Exclusion Criteria: * Lymphoma other than DLBCL, FL IIIB, transformed indolent Non-Hodgkin's lymphoma (NHL) * Central nervous System (CNS) involvement (brain MRI (Magnetic resonance Imaging) is required only in cases of clinically suspicious involvement) * Pregnant or breast-feeding women * Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinaemia) * Myocardial infarction within the last 6 months * Active uncontrolled infections including HIV-positivity, active Hepatitis B or C * Vaccination with live vaccine within last 4 weeks * Mental status precluding patient's compliance * Known CD20 negativity * Diagnosed or treated for a malignancy other than NHL except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ (DCIS) of the breast, or other solid tumors curatively treated with no evidence of disease for >3 years, or prostate cancer with a life expectancy of more than 2 years * Treatment with any approved anticancer agent within last 2 weeks. Any agents must have been stopped at least 2 weeks prior to day 1 of GOAL treatment and all treatment related adverse events must have returned to Grade 1. * Prior exposition to Obinutuzumab or Pixantrone * History of hypersensitivity to medicinal products with similar chemical structure as the trial medication * Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation. Concurrent participation in non-treatment studies is not excluded * Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.

Study Objectives Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of treatment Conditions: Prostate Cancer Intervention / Treatment: OTHER: Data Collection on Depo-Eligard exposure Location: Belgium Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization * Patients on treatment with Depo-Eligard® for at least six months * Written consent has been obtained

Study Objectives Patients ≥ 70 years of age with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) frequently do not receive systemic cytotoxic chemotherapy due to concerns regarding their inability to tolerate treatment. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are agents with favorable toxicity profiles that have shown activity in patients with NSCLC. Erlotinib as a single-agent is currently approved for the treatment of patients with NSCLC whose disease has progressed following one prior course of chemotherapy and is currently being evaluated in NSCLC patients who have not received prior systemic treatment. However, when studied with combination chemotherapy in the first-line setting, continuous daily administration of erlotinib did not result in improved patient survival. Further clinical and in vitro data suggest that the sequencing of cytotoxic chemotherapy with EGFR TKIs is important to maximize their therapeutic potential when administered in combination. Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally and is currently being evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone refractory prostate cancer. The rationale for this study is to develop an active and well-tolerated oral regimen for patients ≥ 70 years of age with NSCLC. Administration of the study drugs will be sequenced with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle. The primary endpoint will be progression-free survival (PFS). Patients will be randomized to treatment with either the experimental regimen or single-agent continuous erlotinib. Conditions: Lung Cancer Intervention / Treatment: DRUG: Erlotinib, DRUG: Satraplatin Location: United States, Chile, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, or large cell carcinoma). Cytologic specimens obtained by brushings, washings or needle biopsy with aspiration are acceptable. Mixed tumors with small cell anaplastic elements are not eligible. * Patients who have unresectable stage III or stage IV disease are eligible. Patients with stage III disease should be ineligible for combined modality therapy (i.e. pleural effusions, pericardial effusions, etc.). Patients with earlier stage NSCLC that has recurred after prior surgery are eligible. * Age >= 70 years old. * ECOG performance status 0-1 * Prior treatment with systemic therapy is allowed provided the following criteria are met: * No EGFR targeted therapy (TKI or antibody) * No prior platinum agent. * Neoadjuvant, adjuvant, or part of a combined modality regimen (i.e., not for metastatic disease) * Completion > 6 months prior to enrollment onto this study. * Patients who have had previous radiation therapy (RT) as definitive therapy for locally NSCLC are eligible only if the following criteria are met: * Site of tumor recurrence is outside of the original RT port unless there is incontrovertible evidence of disease progression within the portal * All side effects from RT must have resolved prior to enrollment. * Completion of RT >= 4 weeks prior to enrollment. * Previous radiation must have treated < 30% of active bone marrow. * Patients who have undergone thoracotomy must have fully recovered from surgery and cannot start treatment until at least three weeks after their operative procedure. * Adequate hematological function as noted by: * Absolute neutrophil count (ANC) > 1,500/ L * Platelets > 100,000/ L * Hemoglobin > 10 g/dl. Patients may be transfused or receive erythropoietin to maintain or exceed this level. * Adequate hepatic and renal function as noted by: * Bilirubin < 1.5 x ULN * Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 x ULN. * Serum creatinine <= 1.5mg/dL or calculated (or measured) glomerular filtration rate >= (GFR)50 ml/min. * Patients with both measurable and non-measurable disease (as per Response Criteria in Solid Tumors (RECIST)) may be enrolled. Exclusion Criteria: * Concurrent invasive malignancy requiring ongoing therapy. * Metastatic brain or meningeal tumors, unless the patient is > 1 month from definitive therapy, is clinically stable with respect to the tumor at the time of study entry, is not receiving steroid therapy or taper, and is not receiving anti-convulsant medications (that were started for the brain metastases). * Previous treatment with either platinum-based chemotherapy agents or prior EGFR targeting agents. * Peripheral neuropathy > grade 1. * Hearing loss or tinnitus > grade 2 * Obstructive pulmonary disease or symptoms > grade 3. * A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous six months, or symptomatic uncontrolled cardiac arrhythmias.

Study Objectives The purpose of this study was to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis. Conditions: Acute Pancreatitis (AP), Gallstone Pancreatitis, Alcoholic Pancreatitis, Trauma Acute Pancreatitis, Hypertriglyceridemia Acute Pancreatitis, Idiopathic (Unknown) Acute Pancreatitis, Medication Induced Acute Pancreatitis, Cancer Acute Pancreatitis, Miscellaneous (i.e. Acute on Chronic Pancreatitis) Intervention / Treatment: DRUG: Pentoxifylline, DRUG: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion criteria * Enrollment within 72 hours of diagnosis of acute pancreatitis (AP) * Ability to give informed consent or a Legal Adult Representative (LAR) able to give informed consent for subject when needed as defined buy LAR use guidelines. * Adult subjects of age >=18 years. Exclusion Criteria: * Moderate or severe congestive heart failure * History of seizure disorders or demyelinating disease * Nursing mothers * Pregnancy * History of prior tuberculosis or risk factors for tuberculosis * Evidence of non- corticosteroid immunosuppression (such as malignancy, chronic renal failure, chemotherapy within 60 days, and HIV) * Evidence of active hemorrhage * Paralytic ileus with severe nausea and vomiting

Study Objectives This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At least 14 to a maximum of 40 patients, who have not previously received treatment for their stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously. Conditions: Cancer, Malignant Melanoma Intervention / Treatment: DRUG: recombinant interleukin-21 Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed surgically incurable metastatic melanoma * Patients must have measurable disease * ECOG performance status of 0 or 1 * Expected life expectancy at least 4 months Exclusion Criteria: * History of and signs/symptoms of uncontrolled brain metastases or edema. * Previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.) * Radiotherapy: Radiation therapy within 4 weeks prior to entering the study. * Receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.

Study Objectives This is a Phase I trial. Some specific protocol information is proprietary and is not publicly available at this time. Full information will be provided to trial participants. Conditions: Solid Tumors Intervention / Treatment: DRUG: AS703569, DRUG: AS703569, DRUG: AS703569 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: * Histopathologically confirmed locally advanced or metastatic solid tumour that is either refractory after standard of care therapy for the disease or for which standard of care therapy is not reliably effective or has a cancer for which no standard therapy exists * Age greater than or equal to 18 years * Has read and understands the informed consent form and is willing and able to give informed consent, and subject authorization under Health Insurance Portability and Accountability Act (HIPAA). Fully understands requirements of the study and willing to comply with all study visits and assessments * Subjects and their partners must be willing to avoid pregnancy during the study and until 1 month after the last study drug administration. Males with female partners of childbearing potential and female subjects of childbearing potential must therefore be willing to use adequate contraception such as, intra uterine device, diaphragm, or condom, for the duration of the study. For the purposes of this study, childbearing potential is defined as: "All female subjects unless they are post- menopausal for at least two years, are surgically sterile or sexually inactive" * Negative serum pregnancy test at the screening visit for women of childbearing potential Exclusion Criteria: * Bone marrow impairment as evidenced by Hb < 9.0 g/dl, ANC < 1.5x 109/L, platelets < 75 x 109/L. Subjects may be transfused. * Renal impairment as evidenced by serum creatinine > 1.5 x ULN (upper limit of normal), and/or calculated creatinine clearance < 60 ml/min * Liver function abnormality as defined by total bilirubin > 1.5 ULN, or AST or ALT > 2.5x ULN at screening; for subjects with liver involvement AST or ALT > 5x ULN at screening * INR (blood coagulation) > 1.5 x ULN for subjects not on therapeutic doses of coumadin * History of CNS metastases, unless subject has been previously treated for CNS metastases, is stable by CT scan without evidence of cerebral edema, and has no requirements for corticosteroids or anticonvulsants * History of difficulty swallowing, malabsorption or other chronic gastro- intestinal disease or conditions that may hamper compliance and/or absorption of the tested product * Eastern Cooperative Oncology Group Performance Status (ECOG PS) > 2 * Known HIV, hepatitis C, or hepatitis B positivity * Has received chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anticancer therapy or surgical intervention within 28 Days of Day 1 of study drug treatment (6 weeks for nitrosureas or mitomycin C), and must have fully recovered * Has received extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation * Has received any investigational agent within 28 days of Day 1 * Has history of any other significant medical disease or intervention including major gastric or small bowel surgery or has a psychiatric condition that might impair the subjects well-being or preclude full participation in the study * Is a pregnant or nursing female

Study Objectives The purpose of the study is to find out the highest dose per fraction of hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) that can be safely given with temozolomide chemotherapy. Conditions: Glioblastoma Multiforme Intervention / Treatment: RADIATION: Hypofractionated Intensity-Modulated Radiation Therapy, DRUG: Temozolomide 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: * Histopathologically confirmed WHO grade IV astrocytoma (GBM), tumor can be supra- or infra-tentorial in location but not located in the brain stem. * Solitary or multifocal tumor. * Tumor can be biopsied or resected, either totally or sub-totally. * A pre-radiation therapy brain MRI is mandatory. * Surgical cavity or surgical cavity + T1 enhancing residual tumor <= 6 cm in the largest diameter on the pre-radiation therapy MRI. In the case of multifocal tumor, the combined largest diameter of T1 enhancing tumor + surgical cavity <= 6 cm. * Placement of bis-chloronitrosourea (BCNU) wafers at the time of surgery is allowed. * Age > 18 years at time of registration. * Estimated survival of at least 3 months. * Zubrod Performance Scale of 0-2 (Karnofsky performance scale >= 60). * Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/ul; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value. * Patients must sign study-specific informed consent form prior to registration. * Men and women and members of all ethnic groups are eligible for this trial. * Radiation therapy and chemotherapy must start within 8 weeks of tumor resection or biopsy Exclusion Criteria: * Patients with contraindications for MRI scanning. * Prior temozolomide chemotherapy. * Prior brain irradiation. * Evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator. * Acquired Immune Deficiency (HIV (+)/AIDS) * Patients being treated on any other clinical protocols within 30 days prior to study entry or during participation in the study. * Pregnant women or breast feeding women. Women of childbearing potential must practice medically approved contraceptive precautions. Men should be counseled and agreeable to follow acceptable birth control methods. * Active connective tissue disorders, such as active lupus or scleroderma. * Concurrent active malignancy at other sites. * Frequent vomiting of medical condition which could interfere with oral medication intake (e.g. partial bowel obstruction).

Study Objectives This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer. Only patients with limited extrahepatic disease are included. Conditions: Metastatic Breast Cancer, Liver Metastases Intervention / Treatment: DRUG: oxaliplatin, capecitabine, trastuzumab Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Informed consent * Age > 18 years * Performance status 0-1; expected survival >= 3 months * Patient with histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the breast * Liver metastases not suitable for local treatment * Extrahepatic disease should be determined by PET-CT-scan. * No progression on treatment with capecitabine. * Prior treatment with taxane (adjuvant or for metastatic disease) * Metastases < 70 % of the liver * Neutrophile granulocytes > 1.5 x 109/l og thrombocytes > 100 x 109/l * Bilirubin < 2.0 x UNL (upper normal limit). * Creatinine-clearance > 30 ml/min. * INR < 1.6. * If the patient is HER2-positive:Baseline LVEF >= 50 % Exclusion Criteria: * History of chemotherapy within the 4-week period prior to the start of trial medication * Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin. * Previous treatment with oxaliplatin * Cytotoxic or experimental treatment within a 14 days period before start of trial medication * The patient is not allowed to participate in other clinical trials. * Any clinical symptoms suggesting peripheral neuropathy < or equal to grade 2 or CNS metastases (In case of clinical suspicion on CNS metastases a MR or CT scan should be performed within 4 weeks before inclusion * Other severe medical conditions e.g. severe cardial disease or AMI < 1 year * Presence of diseases which prevent oral therapy. * Patients with uncontrolled infection * Pregnant or lactating women * Women capable of childbearing not using a sufficient non-hormonal method of birth control * Patients not able to understand the treatment or to collaborate. * Prior serious or unsuspected reaction after treatment with fluoropyrimidine * Known prior hypersensitivity reactions to the agents If the patient is HER2-positive: * Dyspnoea in due to complication related to malignant disease e.g.lung metastases with lymphangitis or other conditions with need of supportive oxygen.

Study Objectives Melanoma is a life-threatening cancer which poses a significant health burden, especially when metastatic or spreading to areas other than the original tumor growth. Although various treatment options are currently available for melanoma, melanomas that have metastasized widely to the skin pose a significant clinical challenge as the available therapies have limited effect. This study proposes the use of a topically applied compound named diphenylcyclopropenone (DPCP) which has been shown to be effective in treating melanoma patients whose diseases have spread widely throughout the skin. DPCP works by having a patient's own immune system, which is usually used to fight infections, attack cancerous cells. This compound has commonly been used to treat other conditions such as warts and hair loss throughout the world for many years and is known to cause limited side effects. Altering a patient's own immune system through topical treatments has also been shown to benefit patients with other cancers that have metastasized to skin such as breast cancer. In this study, the investigators will use DPCP to treat cutaneous metastases of various cancers including melanoma. Our overall intention is to get a better understanding of effective immune responses in the skin that may mediate metastatic cancer regression or cure. Conditions: Neoplasm Metastasis, Melanoma Intervention / Treatment: DRUG: Diphenylcyclopropenone (DPCP) 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: * male or female at least 18 years of age, up to 99 years of age * able to give verbal and written informed consent * clinically diagnosed cancer with multiple cutaneous metastases that are able to be biopsied. The subject may or may not be on concomitant cancer treatments/have internal metastases. * for women of childbearing potential (WOCBP) or in men whose partners may become pregnant, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study (while receiving study medication and for one month following the last dose of study medication). Acceptable forms of contraception are listed in the informed consent form. * must have a negative urine pregnancy test (for WOCBP) * must be willing and able to have the therapy applied by the investigator, must be willing and able to self-apply the therapy, and must be willing and able to comply with study instructions and return for required clinic visits. * clinically diagnosed melanoma with multiple cutaneous metastasis that are able to be biopsied. The subject will be on concurrent PD-1 checkpoint inhibitor therapy (standard nivolumab or pembrolizumab, not on another clinical trial) and may or may not have internal metastasis. Exclusion Criteria: * subjects taking any of the following systemic or topical therapies within 4 weeks of enrollment: corticosteroids, immunosuppressants, and/or any other medications that may affect the outcome of the study * subjects who have active localized or systemic medical conditions that, in the opinion of the investigator, would preclude or make unsafe their participation in the study * subjects with any underlying diseases or dermatological conditions of the affected areas that require the use of interfering topical or systemic therapy * subjects who are nursing mothers, pregnant, or planning to become pregnant at anytime during the course of the study or within 30 days of study completion * subjects who are unable to comply with study procedures, communicate effectively, cooperate with the investigator, or are unable to understand the study * history, physical, social, or lab findings suggestive of any medical or psychological condition that would, in the opinion of the PI, make the candidate ineligible for the study * HIV positive as determined by self-reported history and/or a HIV point-of-care test at screening

Study Objectives In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site. Conditions: Neoplasms, Unknown Primary Intervention / Treatment: DRUG: Etoposide, DRUG: Gemcitabine, DRUG: Irinotecan, DRUG: Paclitaxel, DRUG: Carboplatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: To be included in this study, you must meet the following criteria: * Carcinoma of unknown primary site * Biopsy-proven metastatic carcinoma * Able to perform activities of daily living with minimal assistance * No previous treatment with any systemic therapy * Measurable or evaluable disease * Adequate bone marrow, liver and kidney function * Understand the nature of this study and give written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: * Age < 18 years * Uncontrolled brain metastases and meningeal involvement * Other uncontrolled malignancies * Women pregnant or lactating * Recent history of significant cardiovascular disease * Severe or uncontrolled systemic disease * Other significant clinical disorder * Clinically active interstitial lung disease 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 To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies. Conditions: Advanced Malignancies Intervention / Treatment: DRUG: Patupilone 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 * Age >= 18 years of age * Life expectancy >=3 months * Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist * Agents containing warfarin or heparin must be discontinued 7 days prior to enrollment in the study Exclusion criteria * History of/or active bleeding disorders * Known hypersensitivity to warfarin or related compounds * The use of vitamin K * Central lines that require anticoagulant maintenance * The use of agents containing warfarin and heparin * Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives Compare the therapeutic effects of exenatide, metformin and their combination for 3 months on reproductive and metabolic improvements of overweight/obese PCOS patients with impaired glucose regulation. Conditions: Polycystic Ovary Syndrome, Overweight and Obesity, Disorder of Glucose Regulation Intervention / Treatment: DRUG: Exenatide, DRUG: Metformin Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * have PCOS which is diagnosed according to 2003 Rotterdam criteria; * overweight / obesity diagnostic criteria is based on WHO-WPR ; * IGR diagnostic criteria is based on 1999 WHO diagnostic criteria; * have been treated with dietary and behavioral intervention for 3 months but are ineffective; * have no use of other hypoglycemic drugs before 3 months of treatment. Exclusion Criteria: * Except for serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months) * high blood pressure (>160/100mmHg) * active infection * secondary diabetes * pregnancy * alcohol abuse * allergic to GLP-1 receptor agonist or metformin

Study Objectives The purpose of this study is to evaluate the safety and tolerability of JNJ-56021927 in Japanese participants with metastatic castration-resistant prostate cancer (mCRPC- prostate cancer that is resistant to medical \[for example. hormonal\] or surgical treatments). Conditions: Prostatic Neoplasms, Castration-Resistant Intervention / Treatment: DRUG: JNJ-56021927 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with metastatic disease * Castration-resistant prostate cancer (CRPC) demonstrated during continuous androgen deprivation therapy (ADT)/post orchiectomy * Maintain castrate levels of testosterone (less than [<] 50 nanogram per deciliter (ng/dL) [1.72 nanomol per liter {nmol/L}]) within 4 weeks before enrollment * Prostate-specific antigen (PSA) evidence for progressive prostate cancer consists of a PSA level of at least greater than or equal to (>=) 2 nanogram per milliliter (ng/mL) within 2 weeks before enrollment which has risen on at least 2 successive occasions, at least 1 week apart. If the confirmatory PSA value is less than the last PSA value, then an additional test for rising PSA will be required to document progression * Participants who received a first generation anti-androgen [for example, bicalutamide, flutamide, nilutamide (not approved in Japan)] as part of an initial combined androgen blockade therapy or as second-line hormonal therapy must show continuing disease progression off the anti-androgen for at least 4 weeks prior to the first dose of study drug Exclusion Criteria: * History of, or current metastases in the brain or untreated spinal cord compression * Participants with progressive epidural disease * Participants has a history of another malignancy within 5 years before screening * Prior treatment with second generation anti-androgens ( for example, enzalutamide) or Cytochrome P450 17 (CYP 17) inhibitors [for example, abiraterone acetate, orteronel, galeterone, systemic ketoconazole (not approved in Japan, respectively)] * Participants had used radiopharmaceutical agents (for example, Strontium-89) or investigational immunotherapy (for example, sipuleucel-T) within 12 weeks before the first dose of study drug

Study Objectives This study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone. Conditions: Hematologic Diseases, Neoplasms Intervention / Treatment: DRUG: Remifentanil, DRUG: Remifentanil Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Clinical diagnosis of a hemato-oncological disorder * Scheduled to undergo a lumbar puncture * Aged 4-11 years * Male or female * Unpremedicated * Willing and able to provide informed consent (or informed consent by parents) Exclusion Criteria: * Children who are known or suspected to be difficult to ventilate by face mask * Children who are deemed medically unfit to receive either of the two study medications * Children who are obese (weight for height > 95th percentile, * Children who do not have an indwelling intravenous line

Study Objectives INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280 Conditions: Advanced Solid Tumor Intervention / Treatment: DRUG: INC280 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available. * Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2 * Good organ (hepatic, kidney, BM) function at screening/baseline visit. Exclusion criteria: * Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease. * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC280. * Undergone a bone marrow or solid organ transplant. * Women who are pregnant or breast feeding. Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to a typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. The chalazion may cause tearing, pressure on the cornea, and irritation, all of which contribute to its morbidity. There are many anecdotal first line treatments for this condition, including warm compresses to the eyelid, topical antibiotics, topical steroids, topical combination antibiotic/steroid, and oral antibiotics. There have been no clinical trials to compare the efficacy of any of these conservative treatments. We wish to determine the most effective conservative medical treatment for chalazia. Conditions: Chalazion Unspecified Eye, Unspecified Eyelid, Chalazion Left Eye, Unspecified Eyelid, Chalazion Right Eye, Unspecified Eyelid, Chalazion Both Eyes Intervention / Treatment: DRUG: Hot Compress plus Tobramycin Drops and Ointment, DRUG: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment, OTHER: Hot Compresses Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Patients age 18 and above * Patient with a palpable chalazion on any eyelid * Patients with multiple chalazia but only a single one on each lid * Normal lid anatomy enabling lid eversion Exclusion Criteria * Patients with chalazia with atypical features (recurring chalazion, abnormal surrounding lid tissue, associated loss of lashes) that may indicate suspicion of malignancy * Patients allergic to any agents being used in the study (tobramycin, dexamethasone) * Patients who have had previous eyelid surgery to the same eyelid as the chalazion * Patients under 18 years of age * Patients without palpable lid chalazion * Patients with multiple chalazia on one eyelid * Patients with concurrent eyelid infection (cellulitis or conjunctivitis) * Patients unable to give consent

Study Objectives The primary objective of the proposed trial is to assess. The efficacy and the safety of a daily administration of nimesulide or simvastatin to change the expression of a large set of tissue and circulating surrogate endpoint biomarkers (SEBs) of breast carcinogenesis in women at higher risk of developing a hormone non-responsive (ER neg) breast cancer. The primary endpoint is the change in prevalence of atypical cells and cellular proliferation (Ki-67), after 12 months of treatment. Conditions: Breast Cancer Intervention / Treatment: DRUG: nimesulide, DRUG: Simvastatin, OTHER: Placebo Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Female, 18-65 years old inclusive * Histologic confirmation of hormone non-responsive DCIS (ER<5%, PgR<5%), or AH or LIN, radically excised in the previous 12 months; * Positivity for BRCA1 mutation; * >10% probability of being a BRCA1/2 mutation carrier, according to Berry Parmigiani and/or Couch model; * Performance Status (SWOG) = 0; * Unwillingness to be pregnant during the study and three months after drug suspension. Women will be informed that the use of contraceptive pill is contraindicated because it may interfere with the study drugs and may be harmful to a woman who has been diagnosed with breast cancer; * Willingness to sign the informed consent form Exclusion Criteria: * Evidence of residual disease as documented by mammograms, histologic confirmation of margin involvement or distant disease; * Previous or concurrent malignancy (with the exception of basal cell carcinoma and CIN); * Severe gastrointestinal disorders; * Current use of NSAIDs; * Current use of statins * Current use of fibrates * Current use of potent CYP3A4 inhibitors (ciclosporin, mibefradil, itraconazole, ketoconazole, erythromycin, clarithromycin) * Proven hypersensitivity to nimesulide and/or simvastatin; * Mild or higher alterations of hematologic, liver and renal function (i.e., WBC <3,500/mm3, Plt <120,000/mm3, HgB <10 g/dL, AST >45 U/L, ALT >45 U/L, creatinin >1.5 mg/dL, bilirubin >1.15 mg/dL, CPK 250 mg/dL); * CNS diseases and major psychiatric diseases or inability to comply to the protocol procedures; * Active infections; * Cardiac failure, class I-IV ; * Current anticoagulant or antiplatelet aggregation therapy; * Mitral and/or tricuspid valvulopathy or valvular prosthesis; Angina; Severe arterial hypertension; Chronic and/or paroxysmal atrial fibrillation; Previous myocardial infarction; * Current childbearing and inability to prevent it during the intervention period and for at least 3 months after cessation of treatment; * Current lactation. * Any other factor that in the investigator's discretion contraindicates the use of one or both drugs.

Study Objectives The purpose of this study is to determine the efficacy and tolerability of an investigational drug for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy. Conditions: Nausea, Vomiting, Breast Neoplasms Intervention / Treatment: DRUG: MK0869, aprepitant / Duration of Treatment: 3 days Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy. * Patient must have completed participation in the main study for this protocol. Exclusion Criteria: * Patient has a central nervous system malignancy. * Patient will receive radiation to the abdomen or pelvis.

Study Objectives Vibrent Health is partnering with Stanford Cancer Center to conduct a randomized control trial (RCT) using mobile health technology to enhance adherence and improve swallowing outcomes in patients undergoing radiation therapy for head and neck cancer. Conditions: Head Neck Cancer Intervention / Treatment: OTHER: Virtual Coach Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Study subjects >= 18 years of age. * Fluent English speaking subjects. * Study subjects capable of providing informed consent. * Patients with newly diagnosed non-metastatic head and neck cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx, and larynx that require bilateral neck radiation. Individuals with unknown primary head and neck cancer with nodal disease necessitating bilateral radiation will also be included. * Study subjects with a previously untreated head and neck cancer diagnosis requiring a definitive course of radiotherapy requiring a prescribed dose of 60Gy or greater. * Study subjects who have either an Android or Apple iOS-based smartphone or tablet compatible with the Vibrent application. * Study subjects who have access to a sufficient monthly data plan (approximately 200 MB/month), or Internet connection. Exclusion Criteria: * Non-English speaking, or incapable of providing informed consent. * Lack of smartphone, tablet, or Internet connection. * Inability to use the Vibrent application. * Patients being treated for head and neck cancer who do not receive some form of primary, adjuvant, or neo-adjuvant radiation therapy will not be considered for the study. * Patients with recurrent disease. * Pregnant women. * Individuals under the age of 18. * Individuals with contraindications to radiation therapy.

Study Objectives This is an open-label, single arm, phase 2 trial that will include pre or post-menopausal female subjects, that have ER-positive, HER2-negative early breast cancer. Subject will receive 4 cycles of palbociclib 125 mg (each cycle of palbociclib consists of treatment from D1 to D21 followed by a week of rest) combined with endocrine therapy given continuously (each cycle of endocrine therapy consists of treatment from D1 to D28). The endocrine therapy will be determined according to the menopausal status of the subject evaluated at the study screening. Conditions: Breast Cancer Female Intervention / Treatment: DRUG: Palbociclib Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Female * Age >= 18 years * Histological diagnosis of breast adenocarcinoma that is estrogen receptor-positive, and HER2- negative as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing. * Multifocal unilateral or bilateral breast adenocarcinoma tumours are allowed provided that all tested foci are ER-positive and HER2-negative. * ER-positive (ER+ is defined as having a IHC of 1% or more and/or and Allred of 2 or more and HER2-negative. * HER2 negative (HER2 negative is defined as having an IHC of 1+ without ISH OR IHC 2+ and ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells OR ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells (without IHC) * A primary non metastatic or locally advanced tumour of more than 2 cm (T2 or T3), N0 or N1 without prior treatment candidate for preoperative treatment * ECOG Performance Status (PS) 0 or 1. * Adequate Bone Marrow Function including: 1. Absolute Neutrophil Count (ANC) >=1500/μL or >=1.5 x109/L; 2. Platelets >=100000/μL or >=100 x 109/L; 3. Hemoglobin >= 9 g/dL. * Adequate Renal Function including: Serum creatinine <= 1.5 x upper limit of normal (ULN) or estimated creatinine clearance >= 60 ml/min as calculated using the method standard for the institution. * Adequate Liver Function, including all of the following parameters: 1. Total serum bilirubin <= 1.0 x ULN unless the subject has documented Gilbert syndrome (in which case up to 3 x ULN is acceptable) ; 2. Aspartate and Alanine Aminotransferase (AST and ALT) <= 1.5 x ULN; 3. Alkaline phosphatase <= 2.5 x ULN. * Signed consent form * Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests, radiological exams, tumour and blood specimen collection and other procedures. * Women who are not postmenopausal or have not undergone hysterectomy must have documented negative pregnancy test (serum) prior to inclusion. * Female subjects of child bearing potential and their partners, who are sexually active, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 90 days after last dose of study drug, or they must totally/truly abstain from any form of sexual intercourse. Use of oral hormonal contraceptive agents in this study is not permitted. Exclusion Criteria: * Clinical T4 disease including inflammatory breast cancer. * Prior history of invasive cancer including breast cancer except basal or squamous cell carcinoma of skin that has been definitively treated. * Known hypersensitivity to the study drugs or excipients. * Any illness or medical condition that is unstable or could jeopardize the safety of the subject or her compliance with study requirements. * Subjects unable to swallow oral medications. * Prior intake of letrozole, or any CDK inhibitor or anti-cancer therapy. * Concurrent treatment with any of the drugs not permitted, i.e. strong CYP3A inhibitors/inducers and drugs known to cause QTc interval prolongation (see section 5.7 for specific instructions). * QTc exceeding 480 msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP). * Uncontrolled diabetes, according to investigator's clinical judgment. * Pregnant or lactating women.

Study Objectives This study looks to enroll subjects with ovarian cancer who will be having standard of care surgery to remove ovarian cancer tumors. The main aim of this study is to be able to observe how EC1456 has been taken in and broken down inside tumors. The effect of EC1456 on the tumor will also be studied. This study will also help us compare the amount of EC1456 seen in tumors and how the tumors are imaged by the 99mTc-etarfolatide single-photon emission tomography (SPECT) or single-photon emission tomography with in-line x-ray computed tomography (SPECT/CT). All subjects will undergo a 99mTc-etarfolatide SPECT or SPECT/CT scan within 2 weeks prior to EC1456 administration. Individual subjects will then receive 1 of the following 2 doses of EC1456 pre-operatively: * 4 mg/m2 * 8 mg/m2 EC1456 will be administered at 1 of the following 2 time points: * \<8 hours before planned surgery * 48±4 hours before planned surgery Blood will be collected for pharmacokinetic (PK) studies right after EC1456 dosing and again right before surgery. At the time of surgery, tumor samples will be removed and sent to Endocyte for analysis. Conditions: Ovary Cancer Intervention / Treatment: DRUG: EC1456, DRUG: 99mTc-Etarfolatide Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: BASIC_SCIENCE Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subject must have the ability to understand, and have signed an approved informed consent form (ICF). * Subjects must have cytologically or pathologically confirmed advanced ovarian cancer and be scheduled for primary, interval, or secondary, cytoreductive surgery as a part of standard of care for treatment of ovarian cancer, and have at least 1 lesion that can be removed at surgery. * Subject must be >=18 years of age. * Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subjects with central nervous system (CNS) metastases must be neurologically stable and off of steroids for at least 14 days before pre-registration. Subjects with asymptomatic CNS metastatic disease without associated edema, shift, and a requirement for steroids or anti-seizure medications may be eligible after discussion with the sponsor's medical monitor. * Subjects must have recovered (to baseline/ stabilization) from prior chemo- or radiotherapy and associated acute toxicities must have resolved to a NCI CTCAE v4 Grade 1 or less, with the exception of alopecia. * Subject must have adequate organ function: * Bone marrow reserve: * Absolute neutrophil count >=1.5 × 109/L. * Platelets >=100 × 109/L. * Hemoglobin >=9 g/dL. * Cardiac: * Left ventricular ejection fraction (LVEF) >= the institutional lower limit of normal. LVEF must be evaluated within 28 days prior to the dose of EC1456. * Cardiac Troponin I within normal limits. * Electrocardiogram QT segment corrected by the method of Fridericia QTcFridericia (QTcF) < 450 msec on at least 2 of 3 screening ECG's. On site determination of QTcF may be used for screening purposes. * Hepatic: * Total bilirubin <=1.5 × the upper limit of normal (ULN). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST * 3.0 × ULN, or <=5.0 × ULN for subjects with liver metastases. * Renal: Serum creatinine <=1.5 × ULN, or for subjects with serum creatinine >1.5 × ULN, creatinine clearance >=50 mL/min. * Subjects of childbearing potential: * All women of childbearing potential MUST have a negative urine or serum pregnancy test within 1 week prior to the 99mTc-etarfolatide imaging procedure and within 1 week prior to the dose of EC1456. * Women of childbearing potential must practice an effective method of birth control (e.g., oral, transdermal or injectable contraceptives, intrauterine device [IUD], or double-barrier contraception, such as diaphragm and spermicidal jelly) for the duration of their participation in Exclusion Criteria: * In the opinion of the investigator, a subject's physical condition might create a hardship for tolerating the radionuclide imaging procedures or a single administration of EC1456 (e.g., due to pain or dyspnea in prolonged supine positions). * Use of the following medications within 6 months prior to EC1456 administration: amiodarone, disopyramide, dofetilide, dronedarone, flecanamide, ibutilide, quinidine, or sotalol. * Subject has a co-morbid medical condition that, in the opinion of the investigator, is known to have a major impact on the pharmacokinetics (PK), distribution, metabolism, or elimination of either small molecule drug conjugate (SMDC). * Subject has known active hepatitis B or hepatitis C. * Subject has active uncontrolled infection(s).

Study Objectives Breast cancer is the most common malignant tumour among females with an incidence of about 2.1 million women every year.Nearly about 40-60% of breast surgery patients develop severe acute postoperative pain.⁴ Opioids are the current best standard drugs for postoperative pain relief, however, exposure to large doses of opioids leads to multiple side effects like prolonged sedation, respiratory depression, nausea, and vomiting.We are comparing two different drugs and their combination for perioperative analgesia for MRM. This work is a comparative study that aims to compare the analgesic effects of perioperative IV infusion of dexmedetomidine, preoperative oral gabapentin, and their combination in patients undergoing modified radical mastectomy surgery regarding the time of first rescue analgesia, postoperative morphine consumption, and possible complications. Conditions: Breast Cancer, Pain, Postoperative, Pain, Acute Intervention / Treatment: DRUG: Dexmedetomidine Hydrochloride 0.5 MG/ML, DRUG: Gabapentin Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * ● Female physical status ASA I, II. * Body mass index (BMI): 20 kg/m2- 40 kg/m2. * A patient undergoing modified radical mastectomy under general anaesthesia. Exclusion Criteria: * ● Patient refusal. * Known sensitivity or contraindication to study drugs (e.g.: dexmedetomidine, gabapentin, or morphine ). * History of psychological disorders, chronic pain, and/or sympathetic disorders. * Patients receiving medications that are considered to result in tolerance to opioids as those who are receiving medications for cancer pain (e.g. tramadol and hydromorphone). * Significant liver insufficiency (liver enzymes more than two folds or severe liver cirrhosis) or renal insufficiency (plasma creatinine more than 1.5 mg/dl). * Severe respiratory disorders (e.g. Chronic obstructive pulmonary disease, Bronchial asthma), or cardiac disorders (e.g. ischemic heart disease, regional motion wall abnormality, EF< 50%). * Pregnancy.

Study Objectives The objective of this non-interventional study (NIS) is to gain comprehensive insights into the practicability of ADL-PDT with Metvix® in patients with actinic keratoses under real-world conditions. Conditions: Actinic Keratoses Intervention / Treatment: DRUG: Metvix® 160 mg/g Creme Location: Germany Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Written informed consent to participate in the study * Age >=18 years * Thin or non-hyperkeratotic and non-pigmented actinic keratoses (AK) on the face or scalp (Olsen grade 1 or Olsen grade 2) * The decision to undergo ADL-PDT with Metvix® was made independently of this study * No contraindication (according to the SmPC) Exclusion Criteria: * Hypersensitivity to the active substance or to one of the other ingredients listed in section 6.1 of the SmPC or other ingredients, including peanut oil, peanut or soy. * Morpheaform basal cell carcinoma * Porphyria * Pregnancy

Study Objectives This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals. Conditions: Breast Cancer Intervention / Treatment: DRUG: Standard chemotherapy, DRUG: bevacizumab [Avastin], DRUG: trastuzumab [Herceptin] Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * adult females, >=18 years of age; * inflammatory breast cancer; * HER2-positive tumors; * performance status 0-2. Exclusion Criteria: * metastases; * previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor; * clinically significant cardiovascular disease, or history of thrombotic disorders.

Study Objectives RATIONALE: Classically the evaluation of response in lung cancer has been based in comparing pre \& post treatment tumour volume by means of studying changes in the diameter of the selected target lesions by RECIST. The introduction of new targeted drugs creates the need of a different response assessment. Functional imaging techniques are able to study in vivo physiological processes of angiogenesis. Therefore, dynamic techniques may be more appropriate for assessing response to antiangiogenic drugs, whose mechanism of action is focused on tumor's vasculature normalization. Preliminary studies have demonstrated significant and very early changes in indirect vasculature parameters such as flow, blood volume and tumor perfusion with vascular-targeting agents. These techniques may be useful for selecting patients who are going to benefit from antiangiogenic therapy by an early evaluation of response by means of functional imaging method. PURPOSE: IMPACT is an open-label, single arm phase II/IV study to evaluate the predictive value and early radiologic response or perfusion computed tomography (CT) in patients diagnosed with unresectable advanced, metastatic or recurrent non-squamous NSCLC treated with bevacizumab in combination with chemotherapy. Conditions: Non-Small Cell Lung Cancer (NSCLC) Intervention / Treatment: DRUG: gemcitabine, cisplatin and bevacizumab Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Give the written informed consent to participate in the trial before carrying out any specific study procedure. * Histological or cytological non microcytic lung cancer (NMLC) and non squamous advanced locally or metastatic (IIIB/IV) lung cancer confirmation * Capability to take on the obligations with study protocol requirements. * Patients 18 years old. * ECOG functional status 0 or 1. * At least a measurable lung lesion with conventional TAC (i.e. >= 1cm) in at least one dimension its RECIST criteria (v.1.1) which has not been irradiated. * Appropriate bone marrow function. * Appropriate hepatic function. * International normalized ratio (INR) <= 1.5 and activate partial thromboplastin time (aPTT) <= 1.5 x UNL 7 days previous to the first study drug administration, unless patients have been used prophylactic anticoagulant treatment 11. Patients with brain metastasis which had been treated and also asymptomatic , they are eligible to participate in the study. * Female patients cannot be pregnant nor lactating. 13. Male fertile patients have to use a high effective method of contraception. Exclusion Criteria: * Previous treatment with systemic chemotherapy for advance NMLC * Non microcytic- microcytic mix histology or adeno-squamous mix carcinomas with a predominant squamous component * Hemoptysis history >= grade 2 (defined as at least 2.5 ml of bright red blood) in a period of 3 months prior to receive the study drugs * Surgery (including open biopsy) or significant traumatic injury in a period of 28 day prior to receive the study drugs. * Minor surgery including a catheter insertion in a period of 24h prior to the first infusion of bevacizumab * Proof that the tumor can compress or invade a main vessel in image tests * Radiotherapy in any site for any reason in a period of 28 days prior to receive the study drugs. It is permitted palliative radiotherapy to bone lesions . * Aspirin based medication (> 325 mg/day or clopidogrel > 75mg/day) present or recent (in a period of 10 days from the first bevacizumab infusion). Medication with oral anticoagulants agents or parenteral medication on full doses (e.g. in a therapeutic range) or the use of thrombolytic agents with present and recent therapeutic intentions (in a period of 10 days prior to the first bevacizumab infusion). The prophylactic medication with anticoagulants is permitted * History or evidence of inheritance bleeding diathesis or coagulopathy with bleeding risk * Active gastrointestinal bleeding * Inadequate controlled hypertension . * Cardiovascular disease . * Wounds that do not heal, active peptide ulcer or non treated bone fractures. * History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess in the 6 months prior to receive the study drugs * Known hypersensitivity to bevacizumab, cisplatin or gemcitabine or any of its excipients * Important known hypersensitivity to iodated contrast agents * Another neoplastic disease other than NMLC in a period of 5 years prior to receive the study drugs with exemption of in situ cervix carcinoma, basal or squamous skin cancer, prostate cancer treated with curative intention and in situ breast ductal carcinoma treated with curative intention * Proof of any other disease, neurologic or metabolic dysfunction, lab abnormality or physical test that can reasonably make suspect circumstances that would contraindicate the use of a certain investigational or the standard treatment used in this study or that puts the patient into a greater risk to suffer complications related to the treatment

Study Objectives The purpose of this study is to determine if BMS-986310 administered in combination with nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing. Conditions: Advanced Cancer Intervention / Treatment: DRUG: BMS-986310, BIOLOGICAL: Nivolumab Location: United States, Belgium, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with measurable disease per RECIST v1.1 and have at least one lesion accessible for biopsy. * ECOG performance status less than or equal to 1 Part 1 and Sub-study B: i) Part 1 participants must have advanced or metastatic disease where no other standard of care treatment option is possible. ii) Sub-study B participants must have advanced or metastatic disease where no other standard of care treatment is possible, in one of the following tumor types: Renal cell carcinoma, Melanoma, colorectal cancer (CRC) microsatellite instability (MSI)-High (determined by Clinical Laboratory Improvement Amendments (CLIA) validated assay, testing methodology must be provided), Bladder cancer, Squamous Cell Carcinoma of the Head and Neck (SCCHN), and they must have had disease progression on an anti-PD-(L)1 based regimen as their most recent prior therapy Sub-study A: i) Participants must be newly diagnosed, no prior history of treatment for bladder cancer ii) Participants must not meet criteria for standard of care neoadjuvant therapy and must be candidates for SOC surgical resection of primary tumor. iii) Histologically confirmed muscle-Invasive bladder cancer (MIBC) pure or mixed histology urothelial carcinoma Part 2 - Patients with relapsed / refractory solid tumors where no other standard of care treatment option is available. Exclusion Criteria: * History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) or Cyclooxygenase-2 (COX-2) inhibitors. * Participants with an active, known or suspected autoimmune disease. * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population

Study Objectives Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to determine if any of three new GVHD prophylaxis approaches improves the rate of GVHD and relapse free survival at one year after transplant compared to the current standard prophylaxis regimen. Conditions: Acute Leukemia, Chronic Myelogenous Leukemia, Myelodysplasia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Hodgkin's Lymphoma Intervention / Treatment: DRUG: Tacrolimus (ARM with Methotrexate), DRUG: Tacrolimus (ARM with MMF and Cyclophosphamide), DRUG: Methotrexate (ARM with Maraviroc), DRUG: Methotrexate (ARM with Bortezomib), DRUG: Maraviroc, DRUG: Bortezomib, DRUG: Mycophenolate mofetil, DRUG: Cyclophosphamide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age 18-75 years (patient is older than 18.0 and less than 76.0 years old) * Patients with acute leukemia, chronic myelogenous leukemia or myelodysplasia with no circulating blasts and with less than 5% blasts in the bone marrow. * Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B-cell, Hodgkin's Lymphoma,or mantle cell lymphoma with chemosensitive disease at time of transplantation * Planned reduced intensity conditioning regimen (see eligible regimens in Table 2.4a) * Patients must have a related or unrelated peripheral blood stem cell donor as follows: 1. Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. 2. Unrelated donor must be a 7/8 or 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donor must be willing to donate peripheral blood stem cells and be medically cleared to donate stem cells according to National Marrow Donor Program (NMDP) criteria. * Cardiac function: Ejection fraction at rest >= 45% * Estimated creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight) * Pulmonary function: Diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% (adjusted for hemoglobin) and forced expiratory volume in one second (FEV1) >= 50% * Liver function: total bilirubin < 1.5 x the upper limit of normal and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5x the upper normal limit. Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal. * Female subjects (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 12 months post transplant (see Section 2.6.4 for definition of postmenopausal). * Male subjects (even if surgically sterilized), of partners of women of childbearing potential must agree to one of the following: practice effective barrier contraception (see Section 2.6.4 for list of barrier methods), or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post transplant. * Signed informed consent Exclusion Criteria: * Prior allogeneic transplant * Karnofsky Performance Score < 70% * Active central nervous system (CNS) involvement by malignant cells * Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment. * Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated * Patients with transformed lymphoma (e.g., Richters transformation arising in follicular lymphoma or chronic lymphocytic leukemia) * Patients seropositive for the human immunodeficiency virus (HIV) * Patient with active Hepatitis B or C determined by serology and/or nucleic acid amplification tests (NAAT) * Patients with hypersensitivity to bortezomib, boron or mannitol * Patients with >= grade 2 sensory peripheral neuropathy * Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix D), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant. * Female patients who are lactating or pregnant * Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study * Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent >= 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. * Planned use of anti-thymocyte globulin (ATG) or alemtuzumab in conditioning regimen. * Planned post-transplant therapy, including use of tyrosine-kinase inhibitors (TKI). * Inability to withhold agents that may interact with hepatic cytochrome P450 enzymes (CYP3A4), or glutathione S-transferases involved in bortezomib and/or busulfan metabolism during day -5 through day +7. It is acceptable to use alternative non-interacting medications during this period, and then resume prior medications. * Patients with secondary acute myeloid leukemia arising from myeloproliferative disease, including Chronic myelomonocytic leukemia (CMML), with evidence of active myeloproliferative features or myelofibrosis in the background.

Study Objectives To evaluate the effect of collagenase clostridium histolyticum treatment at the Department of Orthopaedic surgery at Horsens Regional Hospital after minimum one-year follow-up (FU). Conditions: Dupuytren Contracture Intervention / Treatment: DRUG: Xiapex Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * dupuytrens disease * xiapex treatment Exclusion Criteria: * demens/other psychiatric diseases

Study Objectives This is a compassionate use protocol for patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity or intolerance to E. coli L-asparaginase and/or PEG-L-asparaginase. Conditions: Acute Lymphoblastic Leukemia, Non Hodgkins Lymphoma Intervention / Treatment: DRUG: Erwinase Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients on treatment for acute lymphoblastic leukemia or non-Hodgkins lymphoma receiving ALL-type therapy who have developed hypersensitivity or intolerance to E. coli L-asparaginase or PEG-L-asparaginase or both. * Informed consent explained to and signed by parent/legal guardian, with emphasis that although approved for use in Europe and Canada, Erwinase is NOT approved by the United States Food and Drug Administration Exclusion Criteria: * Documented history of severe hypersensitivity or intolerance to Erwinase

Study Objectives This phase II trial is studying how well giving imatinib mesylate together with paclitaxel works in treating older patients with stage IIIB or stage IV non-small cell lung cancer. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with paclitaxel may kill more tumor cells Conditions: Malignant Pleural Effusion, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV 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: * Histologic or cytologic diagnosis of non-small cell lung cancer * At least one site of measurable disease, as defined by the modified RECIST criteria * 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 * Total bilirubin < 1.25 x upper limit of normal (ULN) * Baseline absolute neutrophil count >= 1500/uL * Baseline platelet count >= 100,000/uL * ECOG Performance Status 0, 1 or 2 at the time of informed consent * 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 * AST and ALT =< 2.5 x ULN * Creatinine =< 1.5 x ULN 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 * The administration of any other anticancer agents including chemotherapy and biologic agents is NOT permitted * The use of other concurrent investigational drugs is not allowed * Participants in this study must avoid grapefruit juice or other grapefruit-containing products for the duration of treatment with imatinib

Study Objectives The goal of this clinical research study is to evaluate the effectiveness of Avastin® in combination with docetaxel and carboplatin in the treatment of lung cancer. The safety of this combination will also be studied. Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Bevacizumab (Avastin), DRUG: Carboplatin, DRUG: Docetaxel 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: * Men and women, at least 18 years old, with histologically confirmed, advanced stage IIIB or IV NSCLC for whom no curative options exist and for whom docetaxel and carboplatin is a reasonable treatment option; * At least 1 target lesion that is unidimensionally measurable as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) and has not been previously irradiated; * Eastern Cooperative Oncology Group Performance Status of 0 or 1, (determined within 2 weeks prior to receiving study medication; * Ability to understand and adhere to the protocol requirements, and give informed consent * Use of effective means of contraception (men and women) in subjects of child-bearing potential. Child-bearing potential is defined as follows: A woman of childbearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses at any time in the preceding 12 consecutive months). Exclusion Criteria: * Patients who have had docetaxel in nonradiosensitizing therapy * Patients who have received prior full dose systemic chemotherapy for NSCLC (ie neoadjuvant, adjuvant, or metastatic) within the last 6 months. * Eastern Cooperative Oncology Group (ECOG) status of 2 or greater * Screening clinical laboratory values:*absolute neutrophil count (ANC) of <1,500/µL *Platelet count of <75,000/µL * international normalized ratio (INR) >= 1.5 *T bilirubin elevation above normal (MDACC upper normal limit is 1.0 mg/dL) *Serum creatinine of >2.0 mg/dL *Hemoglobin of <9 mg/dL (may be transfused or receive epoetin alfa [e.g., Epogen®] to maintain or exceed this level) *The pt is ineligible if: 1.alk phos>5xULN; 2.AST or ALT >5xULN; 3.alk phos >1xULN but <= 2.5xULN AND AST or ALT >1.5xULN but <=5xULN;4.alk phos >2.5xULN but <=5xULN AND AST or ALT > 1xULN but<= 1.5xULN; 5.alk phos >2.5xULN but<=5xULN AND AST or ALT >1.5xULN but <=5xULN * Inability to comply with study and/or follow-up procedures * History of other disease, active infection, metabolic dysfunction , physical examination finding, or clinical laboratory finding which is uncontrolled requiring medical intervention giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications. * Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a bevacizumab cancer study * Prior exposure to anti-VEGF therapy * Blood pressure of > 140/90 mmHg as documented in two consecutive blood pressure readings within 4 hours * Any prior history of hypertensive crisis or hypertensive encephalopathy * New York Heart Association (NYHA) Grade II or greater congestive heart failure * History of myocardial infarction or unstable angina within 6 months * History of stroke or transient ischemic attack within 6 months * Significant vascular disease (e.g., aortic aneurysm, aortic dissection) * Evidence of bleeding diathesis or coagulopathy * Presence of central nervous system or brain metastases at any time * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study * Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0 * Pregnant (positive pregnancy test) or lactating * Proteinuria at screening as demonstrated by either: Urine protein:creatinine (UPC) ratio > 1.0 at screening OR Urine dipstick for proteinuria > 2+ (patients discovered to have > 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate < 1g of protein in 24 hours to be eligible). * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0 * Serious, non-healing wound, ulcer, or bone fracture * Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, cavitation. * History of hemoptysis (bright red blood of 1/2 teaspoon or more) * Full dose anticoagulation, chronic use of Aspirin (>325 mg/day) or NSAIDs * Inability to comply with study and/or follow-up procedures

Study Objectives Primary objective: To determine the Phase II doses and to evaluate the safety of administering bexarotene (Targretin®) daily in combination with oral erlotinib (Tarceva™) to patients with advanced aerodigestive tract cancers. Secondary objectives: To evaluate the response rates, progression-free survival and overall survival of patients with advanced aerodigestive tract cancers treated with bexarotene (Targretin®) in combination with erlotinib (Tarceva™). To investigate the activity of this targeted combination therapy by evaluating changes in molecular markers from pre- and post-treatment buccal swab samples. Conditions: Advanced, Malignant Aerodigestive Tract Tumor (Lung, Head and Neck and Esophagus) Intervention / Treatment: DRUG: Bexarotene (Targretin®), DRUG: Erlotinib (Tarceva™) 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: * Pathological confirmation of advanced malignant aerodigestive tract tumo(lung, head and neck and esophagus) * No known curative treatment. * Age >18 years * Karnofsky performance status >= 60%. * Prior chemotherapy or radiotherapy is allowed. * Fasting triglycerides equal or less than upper limit of normal * Female patients and male patients with female partners of childbearing potential must agree to sexual abstinence or to practice effective contraception (recommended to be two reliable forms of non-hormonal contraception used simultaneously) during the entire period of Targretin capsule treatment and for at least one (1) month after treatment is discontinued. Male patients with female sexual partners who are pregnant, or possibly pregnant or who could become pregnant during the study must agree to use condoms during sexual intercourse during the entire period of Targretin capsule treatment and for at least one (1) month after the last dose of Targretin capsules. * All patients must give informed consent indicating they are aware of the investigational nature of this treatment. Exclusion Criteria: * Organ dysfunction that precludes use of bexarotene or erlotinib: * hepatic dysfunction, as evidenced by either: * transaminase (SGOT or SGPT) > 2.5 X upper limit of normal (ULN) or > 5 X ULN if known liver metastases * bilirubin > upper limit of normal * renal dysfunction, as evidenced by calculated creatinine clearance < 30 ml/min * A serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded. * Significant cardiac disease, including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 3 months or serious cardiac arrhythmias will be excluded. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded. * Concurrent use of other anti-cancer investigational agents is not allowed * Women who are pregnant or breast-feeding and women of childbearing potential or fertile males not using an adequate method of birth control will be excluded. * Known hypersensitivity to bexarotene, erlotinib or other components of the capsules. * Risk factor for pancreatitis (e.g., prior pancreatitis, uncontrolled hyperlipidemia,excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract 10 disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity). * Systemic anticancer therapy of any kind within 14 days prior to initiating study medications. * Investigational therapy of any kind within 30 days prior to initiating study medications. * Systemic vitamin A in doses exceeding 15,000 IU/day within 14 days prior to initiating study medications. * Unwillingness or inability to minimize exposure to sunlight and artificial ultraviolet light while receiving the capsules.