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Study Objectives A growing amount of reports has consistently evidenced that a sustained inhibition of the angiogenesis is an effective therapeutic strategy, able to improve the outcome of metastatic colorectal cancer (mCRC) patients. In the last decade different biologic agents targeting angiogenesis have been approved for the treatment of mCRC, such as bevacizumab, aflibercept and regorafenib, and, more recently, solid evidences have demonstrated the efficacy of a sustained antiangiogenic approach even beyond the first progression to a bevacizumab-containing regimen. In particular, two phase III randomized trials proved the effectiveness of prosecuting bevacizumab in second-line switching the chemotherapeutic regimen in patients already treated with bevacizumab in first-line. Preliminary experiences evidenced that circulating levels of angiogenesis-related markers are significantly modulated during first-line chemotherapy plus bevacizumab. In particular, a wide variability of plasma soluble Vascular Endothelial Growth Factor Receptor-2 (VEGFR-2) levels is observed at the time of disease progression and retrospective data suggest that benefit from the continuation of bevacizumab may be restricted to patients with high levels of soluble VEGFR-2 at the first evidence of disease progression. This study aims at prospectively validating those retrospective data. Conditions: Metastatic Colorectal Cancer Intervention / Treatment: DRUG: chemotherapy plus bevacizumab Location: Italy Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Male or female of ≥ 18 years of age * Progressive disease during or after first-line chemotherapy plus bevacizumab, including fluoropyrimidine alone (5-fluorouracil or capecitabine), fluoropyrimidine in combination with oxaliplatin (XELOX or FOLFOX regimen) or irinotecan (FOLFIRI regimen) or with oxaliplatin and irinotecan (FOLFOXIRI regimen); * No more than 3 months from the last administration of bevacizumab and evidence of progressive disease are allowed; * Measurable disease according to RECIST 1.1. * Indication to second-line treatment with a bevacizumab-containing second-line regimen (second-line XELOX, FOLFOX, FOLFIRI and FOLFOXIRI plus bevacizumab are allowed); * Neutrophils 1.5 x 109/L, Platelets 100 x 109/L, Hgb >9 g/dl * Total bilirubin 1.5 time the upper-normal limits (UNL) of the institutional normal values and ASAT (SGOT) and/or ALAT (SGPT) 2.5 x UNL, or 5 x UNL in case of liver metastases, alkaline phosphatase 2.5 x UNL, 5 x UNL in case of liver metastases * Creatinine clearance >50 mL/min or serum creatinine 1.5 x UNL * Urine dipstick of proteinuria <2+. Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate <1 g of protein/24 hr * Will and ability to comply with the protocol * Written informed consent to study procedures. Exclusion Criteria: * Patient unable to give consent * Absolute contraindications to the use of bevacizumab.

Study Objectives This is a multi-center, open-label, dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of QBS10072S in patients with advanced or metastatic cancers with high LAT1 expression. The MTD of QBS10072S will be confirmed in patients with relapsed or refractory grade 4 astrocytoma. Conditions: Astrocytoma, Brain Cancer, Brain Metastases, Bladder Cancer, Breast Cancer, Cervical Cancer, Cholangiocarcinoma, Colorectal Cancer, Esophagus Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Liver Cancer, Lung Cancer, Melanoma, Ovarian Cancer, Pancreatic Cancer, Pleural Mesothelioma, Prostate Cancer, Sarcoma, Tongue Cancer, Thymic Carcinoma, Urinary Tract Cancer Intervention / Treatment: DRUG: QBS10072S Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Male or female participants aged ≥18 years at the time of informed consent. * Adequate Bone Marrow Function * Adequate renal function * Adequate Liver Function * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1 except for AEs not constituting a safety risk by Investigator judgment. * A histological or cytological diagnosis of a solid tumor that is advanced/metastatic, patients intolerant to standard treatment or, resistant to standard therapy\* (per NCCN guidelines) or for which no curative therapy is available for the following tumor types: - Bladder, Brain, Breast, Cervical, Cholangiocarcinoma, Colorectal, Esophageal, Gastric, Head and Neck, Kidney, Liver, Lung, Melanoma, Ovarian, Pancreatic, Pleural mesothelioma, Prostate, Sarcoma, Tongue cancer, Thymic carcinomas, Urinary tract * At least one measurable lesion (as defined by RECIST version 1.1) that has not been previously irradiated. * An ECOG PS 0 to 2. Exclusion Criteria: * Patients with tumor primarily localized to the brainstem or spinal cord. Presence of known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. * Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \[pleural, pericardial, peritoneal\], pulmonary lymphangitis, and over 50% liver involvement). * Patients with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. * Major surgery within 4 weeks prior to study entry. * Radiation therapy within 4 weeks prior to receiving the first QBS10072S dose (bone lesions requiring radiation may be treated with limited radiation therapy during this period). * Systemic anticancer therapy within 4 weeks prior to study entry * Bleeding esophageal or gastric varices <2 months prior to the date of informed consent. * Unmanageable ascites. * Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect patient safety or interpretation of study results * On therapeutic anticoagulation, except low molecular weight heparin, vitamin K antagonists or factor Xa inhibitors may be allowed following discussion with the Sponsor. * Any of the following in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsade de Pointes, clinically significant arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), left anterior hemiblock, bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism or other clinical significant episode of thromboembolic disease. Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, atrial fibrillation of any grade (Grade ≥2 in the case of asymptomatic lone atrial fibrillation). * Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy) or requiring more than two medications for adequate control.

Study Objectives The aim of the project is to improve the overall treatment and outcome of renal, pancreas or liver transplanted patients who have encountered a malignancy by a structured treatment program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive treatment, follow-up and evaluation of the program. Conditions: Neoplasms Intervention / Treatment: OTHER: Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection, DRUG: Switch from calcineurin inhibitor to an mTOR inhibitor Location: Sweden Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients willing and capable of giving written informed consent of participation in the project * Patients with a previous diagnosed or presently diagnosed or reoccurrence of a malignancy (other then basal cell carcinoma) Exclusion Criteria: * Patients with a primary liver cancer as cause of the transplantation

Study Objectives The purpose of this study is to evaluate the efficacy and safety of KDX-0811(Dexrazoxane) in the treatment of accidental extravasation of anthracycline anti-cancer agents. Conditions: Extravasations of Anthracycline Anti-cancer Agents Intervention / Treatment: DRUG: Dexrazoxane Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Masking: NONE

Inclusion Criteria: * Patients suspected to have been exposed to extravasation of anthracycline Exclusion Criteria: * Patients reasonably suspected to have been exposed to extravasation by other compounds than anthracyclines through the same IV access, e.g. vincristine, mitomycin, and vinorelbine, all of which may cause ulceration

Study Objectives This phase II trial studies how well ribociclib and letrozole work in treating patients with estrogen receptor (ER) positive ovarian, fallopian tube, primary peritoneal, or endometrial cancer that has returned (come back) after a period of improvement. Ribociclib may stop the growth of tumor cells by blocking some enzymes needed for cell growth. Cancer cells that are estrogen receptor positive may need estrogen to grow. Letrozole lowers the amount of estrogen made by the body and this may stop the growth of tumor cells that need estrogen to grow. Giving ribociclib together with letrozole may be an effective treatment in patients with ovarian, fallopian tube, primary peritoneal, or endometrial cancer. Conditions: Estrogen Receptor Positive, Postmenopausal, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Recurrent Uterine Corpus Carcinoma Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, DRUG: Letrozole, DRUG: Ribociclib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document * Post-menopausal * Histologically confirmed recurrent ovarian, fallopian tube or primary peritoneal carcinoma or endometrial cancer in post-menopausal women; NOTE: pure clear cell and pure mucinous carcinomas are ineligible; platinum sensitive, platinum resistant and platinum refractory disease are eligible; no limitations in the number of prior regimens * Patient has disease amenable to biopsy and is agreeable to undergo a biopsy; NOTE: under unusual circumstances, submission of ascites material may be acceptable if a biopsy is not possible; this exception will require approval by one of the study principal investigators * Willing to provide tissue samples for ER and retinoblastoma (RB) staining * Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria * Tumors must stain positive for estrogen receptor (>= 10%) by immunohistochemistry (IHC) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Absolute neutrophil count (ANC) >= 1000/mm\^3 * Platelet count >= 100,000/mm\^3 * Hemoglobin >= 9.0 g/dL * Total bilirubin =< 1 x upper limit of normal (ULN); or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert's syndrome * Aspartate transaminase (aspartate aminotransferase \[AST\]) =< 2.5 x ULN (=< 5 x ULN in patients with liver metastasis) * International normalized ratio (INR) =< 2 * Creatinine =< 1.5 mg/dL * Potassium =< ULN (or corrected to =< ULN with supplements prior to registration) * Total calcium (corrected for serum calcium) =< ULN (or corrected to =< ULN with supplements prior to registration) * Magnesium =< ULN (or corrected to =< ULN with supplements prior to registration) * Sodium =< ULN (or corrected to =< ULN with supplements prior to registration) * Phosphorus =< ULN (or corrected to =< ULN with supplements prior to registration) * Ability to swallow study medication * Provide informed written consent * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Willing to provide tissue samples for correlative research purposes Exclusion Criteria: * Patients who have central nervous system (CNS) involvement unless they meet ALL of the following criteria: * >= 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment * Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases * Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.) * Clinically significant, uncontrolled heart disease or cardiac repolarization abnormalities and/or recent events including any of the following: * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening * History of documented congestive heart failure (New York Heart Association functional classification III-IV) * Documented cardiomyopathy * Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening * Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third-degree AV block) long QT syndrome or family history of long QT syndrome * Idiopathic sudden death or congenital long QT syndrome * Risk factors for torsades de pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia * Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause torsades de pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication * Inability to determine the QT interval on screening (corrected QT interval \[QTcF\], using Fridericia's correction) * Systolic blood pressure (SBP) > 160 mmHg or < 90 mmHg at screening * Bradycardia (heart rate < 50 at rest), by electrocardiogram (ECG) or pulse, at screening * Tachycardia (heart rate > 110 at rest), by ECG or pulse at screening * Inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia's correction); NOTE: all as determined by screening ECG * Patient is currently receiving any of the following medications and cannot be discontinued =< 7 days prior to starting study drug: known strong inducers or inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges or that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5 or herbal preparations/medications or dietary supplements * Patient is currently receiving or has received systemic corticosteroids within =< 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment; NOTE: the following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular) * Patient has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 30% of the bone marrow was irradiated * Patient has had major surgery =< 14 days prior to registration or has not recovered from major side effects (tumor biopsy is not considered as major surgery) * Known to be human immunodeficiency virus (HIV) positive (testing not mandatory) * Patient has a known hypersensitivity to any of the excipients of ribociclib * Patient is currently receiving warfarin or other Coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; NOTE: therapy with apixaban, dabigatran, heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed * Participation in a prior investigational study within 30 days prior to enrollment or =< 5 half-lives of the investigational product, whichever is longer * Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade < 3 (exception to this criterion: patients with any grade of alopecia or neuropathy are allowed to enter the study) * Patient with a Child-Pugh score B or C * Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or significant small bowel resection) * Prior therapy with ribociclib or an aromatase inhibitor (letrozole, anastrozole or exemestane) * Patient has received systemic chemotherapy =< 3 weeks prior to registration

Study Objectives The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral solution containing equivalent amounts FTD and TPI. Conditions: Advanced Solid Tumors (Excluding Breast Cancer) Intervention / Treatment: DRUG: TAS-102 tablets, DRUG: TAS-102 oral solution Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Has provided written informed consent * Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists * ECOG performance status of 0 or 1 * Is able to take medications orally * Has adequate organ function (bone marrow, kidney and liver) * Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control. Exclusion Criteria: * Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration * Certain serious illnesses or medical condition(s) * Has had either partial or total gastrectomy * Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies * Known sensitivity to TAS-102 or its components * Is a pregnant or lactating female * Refuses to use an adequate means of contraception (including male patients)

Study Objectives The purpose of the study is to demonstrate that it is possible to administer chemotherapy prior to and following surgery for pancreatic cancer which is considered operable. The chemotherapy chosen is that which has been shown to be the most effective in treating metastatic disease, and the goal is both to investigate whether this is tolerable and also to investigate the efficacy of this approach in terms of disease response and survival. Conditions: Pancreatic Adenocarcinoma Intervention / Treatment: DRUG: 5 Fluorouracil, DRUG: Leucovorin, DRUG: Irinotecan, DRUG: Oxaliplatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologic or cytologic diagnosis of adenocarcinoma of the pancreas. * Resectable primary tumor of the head, body or tail of the pancreas defined as a visible mass in the pancreas and: * No extrapancreatic disease * A patent superior mesenteric (SMV)- portal vein (PV) confluence (assuming the technical ability to resect and reconstruct this venous confluence if needed) * A definable tissue plane between the tumor and regional arterial structures including the celiac axis, common hepatic artery, and SMA. * Confirmation of resectability by surgical oncology consultation. * Presentation at a multidisciplinary conference at either University of Chicago or NorthShore University * No previous therapy for pancreatic cancer * Short removable metal stents rather than plastic stents are preferred but not required for palliation of initial obstructive jaundice * Karnofsky performance status 80 or better * Age > 21 years * No currently active second malignancy * No CVA within 6 months, no MI within 6 months * The effects of mFOLFIRINOX on the developing human fetus are unknown. For this reason and because chemotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Negative pregnancy test in females of reproductive age * Life expectancy of greater than 3 months. * Anticoagulation is permitted but patients may only be on lovenox for this purpose. * Patients must have normal organ and marrow function as defined below: * absolute neutrophil count >1,500/mcL * platelets >100,000/mcL * total bilirubin <1.5X upper limits of normal * AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal * creatinine within normal institutional limits OR * creatinine clearance >60 mL/min/ per Cockcroft-Gault equation for patients with creatinine levels above institutional normal. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have had previous chemotherapy or radiotherapy for pancreatic adenocarcinoma prior to entering the study. * Pathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligible. * Patients who are receiving any investigational agents. * Patients with borderline resectable, locally advanced or metastatic disease. * History of allergic reactions attributed to 5FU, leucovorin, irinotecan or oxaliplatin or to compounds of similar chemical or biologic composition. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active liver disease including viral or non-viral hepatitis and cirrhosis, chronic diarrhea or inflammatory disease of the colon or rectum, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study. mFOLFIRINOX is a regimen containing more than one chemotherapy 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 FOLFIRINOX, breastfeeding should be discontinued if the mother is treated with these agents. These potential risks may also apply to other agents used in this study. * HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with mFOLFIRINOX. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. * Currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years. * Pre-existing neuropathy greater than grade 1. * Anticoagulants other than low molecular weight heparin.

Study Objectives The purposes of this study are to determine: 1. The safety of pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. 2. Whether pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer. 3. Whether pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long. 4. To see if patients feel better while taking pemetrexed plus Gemcitabine. Conditions: Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: pemetrexed, DRUG: gemcitabine 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: * Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy * Have received no prior chemotherapy for Non-Small Cell Lung Cancer * Have at least one measurable lesion * Have an adequate performance status * Sign an informed consent Exclusion Criteria: * A female who is pregnant or breastfeeding * Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed * Treatment with radiation therapy within the last 1-2 weeks * Brain metastasis that is uncontrolled * Active infection or other serious condition

Study Objectives This study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize patients who previously received and now have failed a platinum based doublet regimen. RRx-001 is administered with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy. Conditions: Small Cell Carcinoma, Carcinoma, Non-Small-Cell Lung, Neuroendocrine Tumors, Ovarian Epithelial Cancer Intervention / Treatment: DRUG: RRx-001, DRUG: Cisplatin, DRUG: Etoposide, DRUG: Carboplatin, DRUG: Irinotecan, DRUG: Vinorelbine, DRUG: Doxil, DRUG: Gemcitabine, DRUG: Taxane, DRUG: Paclitaxel, DRUG: Nab-Paclitaxel, DRUG: Pemetrexed 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 must have histologically or cytologically confirmed advanced or metastatic: * Resistant/Refractory Small Cell Carcinoma (SCC) patients in 3rd line or beyond that have previously received platinum or patients in 2nd line with platinum-refractory or platinum-resistant disease * EGFR mutated non-small cell lung cancer (NSCLC) that has previously received a first line platinum doublet and all applicable EGFR TKIs * Epithelial Ovarian Cancer (EOC), fallopian tube or primary peritoneal cancer and Malignant Mixed Mullerian Tumor (MMMT) of the ovary or uterus. Excludes other non-epithelial ovarian tumors and ovarian tumors with low malignant potential. Patients must have previously received a platinum based regimen for advanced/metastatic disease or have platinum resistant or refractory disease defined as relapse within 6 months. EOC - specific criteria: Patients who progress or have stable disease during first-line treatment or who relapse within 1 month are considered to be 'platinum-refractory'. Patients who respond to primary treatment and relapse within 6 months are considered 'platinum-resistant', and patients who relapse more than 6 months after completion of initial therapy are characterized as 'platinum-sensitive'. Patients who relapse 6-12 months following the end of their initial regimen are classified as 'partially sensitive'. Platinum sensitive patients may be enrolled but must have failed or declined all other lines of FDA approved therapy * High-Grade Neuroendocrine Carcinoma (HGNEC), any organ of origin, including a pathology of neuroendocrine features, in patients previously been treated with chemotherapy Although neuroendocrine tumors may be classified differently based on organ of origin, in the context of this protocol they are defined as high grade on the basis of either 1. Aggressive clinical behavior requiring previous treatment with chemotherapy even if histologic features such as the Ki67 index or mitotic rate corresponds with low or intermediate grade. 2. Histologic features: (a) Neuroendocrine tumors of lung origin are considered high grade if in any part of the tumors, there are >10 mitoses/2mm2 or 10 high power field (HPF). Large zones of necrosis are usually present. This includes small cell lung carcinoma and large cell neuroendocrine lung carcinoma. \[SCLC will not enroll in the HGNEC cohort.\] (b)Neuroendocrine tumors of gastroenteropancreatic origin are considered high grade if in any part of the tumors there are either >20 mitoses/2mm2 or 10 high power field (HPF) OR Ki67. * Radiographically measurable disease by RECIST v1.1 * A washout period of 3-weeks from last treatment. * Patients must have previously received a platinum based regimen for advanced/metastatic disease and progressed or have platinum resistant or refractory disease defined as relapse within 6 months. * Age ≥18 years. * Life expectancy of ≥12 weeks. * ECOG performance status 0-2. * Participants must have adequate organ and marrow function as defined below both prior to administration of RRx-001 and prior to administration of platinum doublet based regimen: * Absolute neutrophil count ≥1,500/mcL * Platelets ≥100,000/mcL (non-transfused platelet count) * Hemoglobin ≥9 g/dL (transfused Hgb allowed) * Creatinine ≤1.5 x the upper limit of normal * Total bilirubin ≤2.0 x the upper limit of normal or <3.0 xULN if patient has a history of Gilbert's syndrome * AST (SGOT)/ALT (SGPT) ≤5 X institutional upper limit of normal if with liver metastases; ≤2.5 X ULN if no liver metastases * Patient must consent to the access, review and analysis of previous medical and cancer history, including tumor archival tissue (if available) and imaging data by the sponsor or a third party nominated by the sponsor. * Ability to understand and sign a written informed consent document. * Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. * Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been postmenopausal for at least 12 consecutive months Exclusion Criteria * Receiving concurrent investigational therapy * Symptomatic central nervous system metastasis (e.g., patients requiring increasing doses of steroids) * History of needing to permanently discontinue prior platinum doublet-based regimen for toxicity (e.g., cisplatin causing renal impairment, ototoxicity, or severe neuropathy). * Known severe hypersensitivity to the platinum agent (i.e., carboplatin or cisplatin) or prior partner of platinum agent (i.e., etoposide for SCC and HGNEC; nab-paclitaxel, paclitaxel, or pemetrexed for NSCLC; paclitaxel, pegylated liposomal doxorubicin, docetaxel or gemcitabine for ovarian) planned for the platinum therapy period. If the patient has had prior hypersensitivity reaction to the drug partner of platinum, a patient may enroll as long as it is acceptable to treat with platinum and one of the alternative chemotherapy partner agents. * Any significant medical diseases or conditions, as assessed by the investigators and sponsor that would substantially increase the medical risks of participating in this study (i.e., uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe chronic pulmonary disease or active uncontrolled infection, uncontrolled or clinically relevant pulmonary edema). * Pregnant or nursing

Study Objectives This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. This study will be conducted at up to three study centers in the United States. Conditions: Solid Cancers Intervention / Treatment: DRUG: MNRP1685A Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age ≥ 18 years * Incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen * Evaluable or measurable disease per RECIST (in certain circumstances, prostate or ovarian cancer patients with non-measurable disease) Exclusion Criteria: * Inadequate hematologic or organ function * Anti-cancer therapy within 4 weeks prior to initiation of study treatment * Recent history of or current clinically significant gastrointestinal, cardiovascular or pulmonary disorders * Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava * Active infection or autoimmune disease * Known human immunodeficiency virus (HIV) infection * Pregnancy or breast feeding

Study Objectives Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. The exploration of new drugs and regimens are warranted. Therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage IB, IIA-B, IIIA. Conditions: Carcinoma, Non-Small-Cell-Lung Cancer Intervention / Treatment: DRUG: Gemcitabine, DRUG: cisplatin Location: Turkey Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * define histologic or cytologic diagnosis of non small cell lung cancer. * determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer. * define performance status of 0-1 on ECOG scale * do not have any prior tumor therapy * to be suitable for curative resection Exclusion Criteria: * to have any treatment within the last 30 days with any investigational drug. * to get concurrent administration of any other tumor therapy * to be pregnant * to have poorly controlled diabetes mellitus * to have serious concomitant disorders.

Study Objectives This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival \[PFS\], disease control rate, best response rate, time to treatment failure \[TTTF\], overall survival \[OS\] and 1-year survival rates) compared to pemetrexed plus erlotinib combination. Conditions: Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy. Intervention / Treatment: DRUG: Pemetrexed, DRUG: Erlotinib, DRUG: Pemetrexed, DRUG: Erlotinib Location: Hungary, Germany, Spain, Austria, Sweden Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy. * Failure of previous treatment with one prior platinum-based chemotherapy regimen. * Good performance status. * Adequate bone marrow reserve, renal and hepatic functions. Exclusion Criteria: * Serious concomitant systemic disease. * Inability to take oral medication. * Inability or unwillingness to take vitamin supplementation and corticosteroids. * Pregnancy / Breast-feeding. * Treatment with certain medicines that prevent blood from clotting.

Study Objectives Patients will be enrolled in two stages: * Dose-escalation stage: Approximately 15-30 patients will be enrolled. * Dose-expansion stage: 6-12 patients will be enrolled. Dose-escalation slots will be filled first, then dose-expansion slots. Conditions: Locally Advanced or Metastatic Solid Tumors Intervention / Treatment: DRUG: GX-I7 Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Signed Informed Consent Form (ICF) * Age ≥ 19 years * Able to comply with the study protocol, in the investigator's judgment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy ≥ 12 weeks * Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1) * Serum pregnancy test for women of childbearing potential (including women who have had a tubal ligation) must be performed and documented as negative within 14 days prior to Cycle 1, Day 1 * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm * Patients with histologic documentation of locally advanced, recurrent, or metastatic incurable solid tumors that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate * Patients with measurable disease per RECIST v1.1 Exclusion Criteria: * Inability to comply with study and follow-up procedures * Pregnancy, lactation, or breastfeeding * Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, and/or unstable angina * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse * Poorly controlled Type 2 diabetes mellitus defined as a screening hemoglobin A1C ≥ 8% or a fasting plasma glucose ≥ 160 mg/dL (or 8.8 mmol/L) * Major surgical procedure within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the study * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment * Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy * History of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis * Primary CNS malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control) * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

Study Objectives Considering synergism between docetaxel (D), capecitabine (X), and oxaliplatin (O) and favourable toxicity profile of oxaliplatin over cisplatin, it is to be expected that combination of docetaxel, capecitabine, and oxaliplatin (DXO) will be more effective than other regimens and feasible in advanced gastric cancer. DXO regimen can be also easily administered on out-patient setting. However, so far, DXO combination has not been tried in advanced gastric cancer. The investigators will determine maximum tolerated dose of DXO regimen in this phase I study. Conditions: Stomach Cancer Intervention / Treatment: DRUG: Docetaxel, Capecitabine and Oxaliplatin Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed unresectable or metastatic advanced gastric adenocarcinoma * Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel, capecitabine, or oxaliplatin as adjuvant chemotherapy should be excluded.) * Age 18 to 70 years old * Eastern Cooperative Oncology Group performance status 0\~2 * Adequate bone marrow function: white blood cell counts >4,000/µL, absolute neutrophil count >2,000/µL, and platelets>100,000/µL * Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance 60ml/min * Adequate hepatic function: bilirubin < 1.5 x UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels < 2.5 x UNL, and alkaline phosphatase < 5 x UNL (except in case of bone metastasis without any liver disease) * Given written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice Exclusion Criteria: * Contraindication to any drug contained in the chemotherapy regimen * Other tumor type than adenocarcinoma * Presence or history of central nervous system (CNS) metastasis * Gastric outlet or bowel obstruction * Evidence of serious gastrointestinal bleeding * Peripheral neuropathy > grade 1 * History of significant neurologic or psychiatric disorders * History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix * Pregnant or lactating women, women of childbearing potential not employing adequate contraception. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential * Sexually active males and females (of childbearing potential) unwilling to practice conception during the study * Clinically significant cardiac disease (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in electrocardiogram) or myocardial infarction within the last 6 months * Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia) * Serious metabolic disease such as severe non-compensated diabetes mellitus * Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease * Positive serology for the human immunodeficiency virus (HIV)

Study Objectives The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme. Conditions: Glioblastoma Intervention / Treatment: DRUG: Gefitinib Location: Sweden Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed informed consent * histologically-or cytologically-confirmed glioblastoma multiforme * age 18 years or older Exclusion Criteria: * Have had prior radiation therapy, immunotherapy, gene therapy and/or chemotherapy for the glioblastoma * co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * known severe hypersensitivity to ZD1839 or any of the excipients of this product.

Study Objectives To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors. To assess the safety of the combination. To investigate the PK characteristics of docetaxel or gemcitabine and of oral afatinib (BIBW2992) in the tested treatment schedule. To assess antitumor activity. Conditions: Neoplasms Intervention / Treatment: DRUG: Afatinib, DRUG: Afatinib, DRUG: docetaxel, DRUG: gemcitabine Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion criteria: * histologically or cytologically confirmed diagnosis of any advanced or metastatic relapsed or refractory solid tumor. Exclusion criteria: * Active brain metastases * Patients with known pre-existing interstitial lung disease

Study Objectives 20 mg or 40 mg of quizartinib will be given to Chinese patients who were just diagnosed with AML. The study drug will be given to them along with standard therapies. The purpose is to find out the highest dose they can stand. Conditions: Acute Myeloid Leukemia (AML) Intervention / Treatment: DRUG: Quizartinib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion criteria: * Has provided written informed consent for participation in the study * Is aged 18 to 70 years at the time of enrollment into the study * Has newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008 classification (at Screening) * Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at enrollment * Has all of the required laboratory test results performed within 14 days prior to enrollment in the study. * Is capable of orally taking quizartinib * Is capable of being admitted to the hospital during the dose limiting toxicity (DLT) evaluation period * If a woman of childbearing potential, has a negative serum pregnancy test upon entry into this study and is willing to use highly effective birth control upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (having undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy). * If male, is surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. Exclusion criteria: * Has diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis). Subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy). * Has a diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms * Had prior treatment for AML, except for the following allowances: 1. Leukapheresis 2. Treatment for hyperleukocytosis with hydroxyurea 3. Cranial radiotherapy for central nervous system (CNS) leukostasis 4. Prophylactic intrathecal chemotherapy 5. Growth factor or cytokine support * Has received prior treatment with any investigational product or device within 30 days prior to enrollment in the study or is currently participating in other investigational procedures * Has a history of other malignancies excluding the following: 1. Adequately treated non-melanoma skin cancer 2. Curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for at least two years * Has a past or current history of the following cardiovascular diseases: 1. Heart rate of < 50 beats/min performed with 12-lead ECG within 14 days prior to enrollment in the study (excluding patients using a heart pacemaker) 2. QT interval corrected by Fridericia (QTcF) of ≥ 450 msec performed with 12-lead ECG within 14 days prior to enrollment in the study 3. Congenital long QT syndrome diagnosed or suspected (including family history of long QT syndrome) 4. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg measured within 7 days prior to enrollment in the study 5. History of clinically significant ventricular arrhythmias \[such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes (TdP)\] 6. History of second (Mobitz II) or third-degree heart block (patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker) 7. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to enrollment in the study 8. History of heart failure according to New York Heart Association (NYHA) Functional Classification: Class 3 or 4 heart failure 9. Left ventricular ejection fraction (LVEF) of ≤ 45% or lower than the institutional lower limit of normal value per multi-gated acquisition scan (MUGA) or echocardiogram done within 30 days prior to enrollment 10. Complete left bundle branch block * Has active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial, or antiviral therapy * Has active clinically relevant liver disease (such as active hepatitis B or active hepatitis C). * Has a history of human immunodeficiency virus (HIV). Patients will be tested for HIV prior to enrollment in the study, if required by local regulations or the Ethics Committee. * Has a history of hypersensitivity to any excipients in the quizartinib tablets * Is a female who is pregnant or breastfeeding * Is considered inappropriate for the study by the investigator

Study Objectives The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in combination with ifosfamide, carboplatin, etoposide (ICE) or dexamethasone, cytarabine, cisplatin (DHAP) salvage chemotherapy regimens in subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are eligible for autologous stem cell transplant. Conditions: Lymphoma, Large-Cell, Diffuse Intervention / Treatment: DRUG: ofatumumab + ICE, DRUG: ofatumumab + DHAP Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects with CD20 positive aggressive non-Hodgkin's lymphoma (NHL) including DLBCL, transformed follicular lymphoma (FL) \& grade 3b FL. Refractory to, or relapsed following, first-line treatment with rituximab combined with anthracycline- or anthracenedione-based chemotherapy as defined by the protocol. * Computed tomography (CT) with involvement of 2 or more clearly demarcated lesions with a long axis > 1.5 centimeters (cm) and short axis ≥ 1.0 cm or 1 clearly demarcated lesion with a long axis >2.0 cm and short axis ≥1.0 cm. * Baseline \[18F\] fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans must demonstrate positive lesions compatible with CT defined anatomical tumor sites. * Age 18 yrs or older. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. * Eligible for high dose chemotherapy and autologous stem cell transplant (ASCT). * Resolution of toxicities from first-line therapy to a grade that in the opinion of the investigator does not contraindicate study participation. * Signed written informed consent. Exclusion Criteria: * Previous cancer therapy for lymphoma, with the exception of required rituximab/ anthracycline- or anthracenedione-based chemotherapy, monotherapy rituximab prior to first-line therapy and / or as a maintenance therapy, or limited field radiotherapy (as defined by the protocol). * Any anti-cancer therapy, except limited field radiotherapy, within 2 weeks prior to start of study therapy. * Chronic Glucocorticoid use (limited acute use is allowed and defined by the protocol). * History of significant cerebrovascular disease. * Abnormal/ inadequate white blood cell (WBC) count, liver, and kidney function. * Clinically significant cardiac disease, active or chronic infections, serious significant diseases, other cancer within last 5 years. * Known or suspected hypersensitivity to study treatments. * Prior treatment with anti-CD20 monoclonal antibodies, at any time, or treated with other monoclonal antibodies within 3 months prior to start of study therapy, with the exception of rituximab in both instances. * Inability to comply with the protocol activities. * Pregnant or lactating women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception during and up to 1 year following dosing completion.

Study Objectives This randomized clinical trial studies a palliative care program in improving the quality of life of patients with high-risk gynecologic malignancies that is original or first tumor in the body (primary) or has come back (recurrent). Palliative care is care given to patients and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual. Studying a palliative care program may help doctors learn more about patients quality of life, use of healthcare services, and the relief of pain. Conditions: Cervical Carcinoma, Ovarian Carcinoma, Primary Peritoneal Carcinoma, Recurrent Cervical Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Uterine Corpus Carcinoma, Recurrent Vulvar Carcinoma, Uterine Corpus Cancer, Vulvar Carcinoma, Peritoneal Neoplasms Intervention / Treatment: OTHER: Palliative Therapy, OTHER: Palliative Therapy + idiographic Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Women with of primary or recurrent diagnosis of ovarian, uterine, peritoneal, cervical or vulvar cancer with any of the following: * < 30 % projected 5 year survival based on histopathological stage * Non-pelvic recurrent malignancy * Persistent or progressive disease despite primary treatment with surgery, chemotherapy or * Palliative performance scale < 60 * Enrollment within 6 weeks of tumor board review

Study Objectives The objective of this registry is to collect data on patient demographics, medical history, change in prostate, bone and overall health of the patients receiving androgen ablation treatment using Eligard. Data collected through this national registry program provides an opportunity to increase knowledge of efficacy and safety of the long term treatment with Eligard, provide a platform to better identify patient segments for the therapy with Eligard®. Furthermore registries are the only tools to accurately capture rare adverse events. Conditions: Cancer of the Prostate Location: Canada Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients > 18 years of age. * Histologically confirmed diagnosis of locally Advanced or Metastatic Prostate Cancer. * Patient starting an androgen deprivation therapy with Eligard at 3 or 4 month treatment frequency per standard of care. * Signed written informed consent. Exclusion Criteria: * Prior ADT (within 6 months). * Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol. * Life expectancy less than 2 years.

Study Objectives Cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor prognosis. Chemotherapy is the most common treatment for advanced disease. On the basis of a phase III clinical study, cisplatin plus gemcitabine is considered standard first-line treatment in advanced cholangiocarcinoma patients, but there is no established second line therapy. Since fluorouracil and leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) appears to be safe and demonstrated efficacy in clinical studies of advanced pancreatic cancer, colorectal cancer and a phase I study in cholangiocarcinoma, this combination could be an effective second-line treatment for patients with advanced cholangiocarcinoma. Conditions: Cholangiocarcinoma Intervention / Treatment: DRUG: FOLFIRINOX Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological or cytological diagnosis of cholangiocarcinoma. * Metastatic disease or irresectable locally advanced cholangiocarcinoma. * Measurable disease according RECIST criteria version 1.1. * Age from 18 to 75 year. * WHO/ECOG performance status 0-2. * Patients who received at least 3 cycles of gemcitabine/cisplatin in the first line. * Adequate hematological function (WBC > 3.0 x 109/L, platelets > 100 x109/L) * Adequate hepatic function (bilirubin ≤ 1.5 x upper normal limit (ULN); ALAT or ASAT <5x ULN in case of liver metastases and < 2.5 x ULN in absence of liver metastases. * Adequate renal function (creatinine clearance > 60 ml/min; creatinine <120 µmol/L) * Absence of cardiac insufficiency, chest pain (not medically controlled) and myocardial infarction in the 12 months preceding study entry. * Signed informed consent. Exclusion Criteria: * Concurrent secondary malignancies or other malignancies within 3 years prior to enter this study with the exception of non-metastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection * Presence of cerebral or meningeal metastases * Contraindication to any of the substances of the planned treatment. * History of chronic diarrhea or colorectal inflammatory conditions, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered * Active infection or other serious underlying conditions which may prevent the patient from receiving the planned treatment. For example: prolonged unresolved bacterial cholangitis with destruction of bile duct branches (e.g. after endoprosthesis insertion) or two or more cholangitis in the last 6 months. Patients with other active or uncontrolled severe infection, cirrhosis or chronic active hepatitis will be excluded. * Presence of cardiac insufficiency, unstable angina pectoris, symptomatic congestive heart, failure myocardial infarction 6 months prior to randomization, serious uncontrolled cardiac arrhythmia. * Inclusion in another investigational clinical trial * Women who are pregnant, breast-feeding or not using adequate contraceptive * Age younger than 18 or older than 76 years * Individuals under correctional supervision or guardianship

Study Objectives The purpose of the study is to find out if the small dose of radioiodine, that is used for the dosimetry study on patients with differentiated thyroid cancer, may stun the cancer cells and make the thyroid cancer treatment less effective. Conditions: Differentiated Thyroid Cancer Intervention / Treatment: DRUG: rhTSH Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient must be 21-years-old or greater. * Patient must be status post near total thyroidectomy for differentiated thyroid cancer without known distant metastases and who are planning to undergo routine remnant thyroid tissue ablation with I-131. * Patients must qualify for thyroid ablation with I-131. Exclusion Criteria: * Women who are pregnant or breastfeeding. * Prior bovine TSH use. * Known metastatic thyroid cancer. * History of cardiovascular disease that may adversely affect patient participation at the discretion of the primary investigator. * Patients on hemodialysis. * Patients with acute serious illnesses at the discretion of the primary investigator.

Study Objectives Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer Conditions: Esophageal Cancer, Gastric Cancer Intervention / Treatment: DRUG: Cetuximab,Paclitaxel, 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: * Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach. * Patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric lymphadenopathy. * There must be no evidence of distant organ metastases. * No prior radiation for gastric or esophageal cancer. * Patients must be > 18 years of age, and nonpregnant * Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2 x upper limit normal (ULN) and bilirubin < 1.5 x ULN, and AST < 3 x ULN. * ECOG performance status 0-2. * Patients must not have significant infection or other coexistent medical condition that would preclude protocol therapy. * Female patients, must either be not of child bearing potential or have a negative pregnancy test within 7 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible. * All patients must sign informed consent Exclusion Criteria: Any of the following criteria will make the patient ineligible to participate in this study: * Acute hepatitis or AIDS. * Active or uncontrolled infection. * Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. * Prior therapy which specifically and directly targets the EGFR pathway. * Prior severe infusion reaction to a monoclonal antibody. * Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).

Study Objectives Randomized phase III trial to compare the effectiveness of hyperthermic isolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have locally advanced melanoma of the arm or leg. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Heating melphalan to several degrees above body temperature and infusing it only to the area around the tumor may kill more tumor cells. It is not yet known whether combining melphalan with tumor necrosis factor is more effective than melphalan alone in treating melanoma. Conditions: Recurrent Melanoma, Stage III Melanoma Intervention / Treatment: DRUG: isolated limb perfusion, DRUG: melphalan, BIOLOGICAL: recombinant tumor necrosis factor family protein, OTHER: pharmacological study, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically proven locally advanced melanoma of an extremity * One or more evaluable in-transit metastases * All disease within the perfusion field of the extremity (with no local resection options short of amputation) * Disease outside of perfusion field (with no local resection options short of amputation) if all the following are true: * High tumor burden (more than 10 lesions or any single lesion greater than 3 cm) * Presence of pain, edema, skin breakdown, or decreased mobility * Greater than 80% of known tumor is within extremity perfusion field * Life expectancy more than 6 months * No brain metastases * At least 1 bidimensionally measurable lesion * Patients who received prior prophylactic isolated limb perfusion (ILP) must have 1 of the following: * Disease-free interval for at least 6 months after prior ILP with melphalan * Disease-free interval for at least 3 months after prior ILP with an agent other than melphalan * Patients who received prior therapeutic ILP must have 1 of the following: * Partial response of at least 3 months duration after prior ILP with melphalan * Stable response or disease progression after ILP without melphalan (performed at least 3 months prior to study) * Performance status - ECOG 0-2 * Performance status - Zubrod 0-2 * See Disease Characteristics * Platelet count at least 100,000/mm\^3 * WBC greater than 2,500/mm\^3 * Hemoglobin greater than 9 g/dL * Bilirubin less than 1.25 times ULN * AST and ALT less than 2 times ULN * Alkaline phosphatase less than 2 times ULN * Coagulation studies normal or within 1 second of upper limit of normal (ULN) * Creatinine less than 1.5 mg/dL * Creatinine clearance greater than 50 mL/min * Calcium less than 12 mg/dL * No severe peripheral vascular disease (claudication or other ischemic peripheral vascular disease \[e.g., venous thrombosis or occlusive peripheral arterial disease\]) * No New York Heart Association class II-IV heart disease (congestive heart failure) * No uncontrolled or life-threatening cardiac arrhythmia * No myocardial infarction within the past year * No unstable angina * No symptomatic cerebral or carotid artery disease * No pulmonary embolism within the past year * Other prior malignancy allowed if completed curative therapy, disease-free for at least 5 years, and at low risk for recurrence * No active peptic ulcer disease within the past year * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known melphalan hypersensitivity * No known hypersensitivity to any component of tumor necrosis factor alpha formulation * No contraindications to ionotropic agents (e.g., dopamine or neosynephrine) * No concurrent infections uncontrolled with antibiotics * HIV negative * At least 1 month since prior biologic therapy * See Disease Characteristics * At least 1 month since prior chemotherapy * At least 4 months since prior isolated limb perfusion * At least 1 month since prior radiotherapy * See Disease Characteristics * At least 12 months since prior coronary artery surgery or angioplasty

Study Objectives Postoperative Neurocognitive Disorders are the most common neurological complications after major surgery, which are associated with higher increased mortality and morbidity in elderly patients undergoing major surgery. Until now highly effective intervention has not been established yet. Recent preclinical studies suggest mithochiondrial dysfunction may be linked to pathogensis of (postoperative delirium) POD and postoperative cognitive dysfunction (POCD). As Methylene blue(MB) is a mitochondrial protective agent and a safe drug with long history of clinical use, we propose that mitochondrial-targeted interventions may be useful to prevent POD/POCD in surgical patients. Conditions: Postoperative Delirium, Postoperative Cognitive Dysfunction Intervention / Treatment: DRUG: Methylene Blue, DRUG: Placebo Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * aged 18-80 years old * planning to undergo pancreatic tumor surgery. * MMSE ≥ 24 * Patients have the ability to act in full spirit, understand and sign the informed consent, and are willing to complete the whole research process. Exclusion Criteria: * preexisted dementia, major depression or other serious mental or neurological disorders * history of allergy to MB or 6-phospho-glucose dehydrogenase deficiency (favism) * pregnant or lactating women * illiterate patients * patients diagnosed with rheumatoid diseases such as systemic lupus erythematosus, rheumatoid arthritis and ankylosing spondylitis * drug or alcohol abuse or recent drug administration that may lead to drug interactions, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) * history of major head trauma * serious medical diseases (ie. heart failure, pulmonary hypertension, acute stage of myocardial infarction or respiratory failure, liver and kidney dysfunctions) * severe language, visual or auditory deficiency * participated in other clinical trials within 3 months.

Study Objectives This is planned to be a 5-part dose-escalation study to determine the safety and tolerability of MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy, and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) of MK-4166 and MK-4166 plus pembrolizumab by defining dose-limiting toxicities (DLTs) in participants with advanced solid tumors. Conditions: Solid Tumor Intervention / Treatment: BIOLOGICAL: MK-4166, BIOLOGICAL: Pembrolizumab Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria: * Has a histologically- or cytologically-confirmed metastatic solid tumor for which there is no available therapy which may convey clinical benefit. Part E: Has advanced malignant melanoma. * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale * Adequate organ function * Female participants of childbearing potential must have a negative urine or serum pregnancy test and must be surgically sterile or willing to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after last dose of study drug * Male participants must agree to use an adequate method of contraception during sexual contact with females of childbearing potential starting with the first dose of study drug through 180 days after the last dose of study drug * Submit an evaluable tumor sample for analysis. Exclusion criteria: * Chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier * Currently participating or has participated in a study of an investigational agent or using an investigational device within 28 days of administration of MK-4166 * Expected to require any other form of antineoplastic therapy while on study * On chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication * History of a malignancy for which potentially curative treatment has been completed, with no evidence of malignancy for 5 years excepting successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Severe hypersensitivity reaction to treatment with another monoclonal antibody * Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy * Active infection requiring therapy * Current pneumonitis, or a history of (non-infectious) pneumonitis that required steroids * Prior stem cell or bone marrow transplant * Positive for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Regular user (including "recreational use") of any illicit drugs or recent history (within the last year) of substance abuse (including alcohol) * Symptomatic ascites or pleural effusion * Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study * Clinically significant heart disease * Major surgery in the past 16 weeks * Received a live vaccine within 30 days prior to first dose of study drug

Study Objectives In patients with unresectable advanced pancreatic cancer, non-inferiority of TS-1 monotherapy and superiority of GEM + TS-1 combination therapy to gemcitabine (GEM) will be verified using survival time. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Gemcitabine plus TS-1, DRUG: TS-1, DRUG: Gemcitabine Location: Japan, Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamous carcinoma. * Advanced unresectable pancreatic (including pancreatic cancer with local progression and recurrent pancreatic cancer).Presence/absence of measurable lesions is not considered. Patients with measurable lesions must undergo diagnostic imaging tests within 28 days before registration. * Patients with no previous treatment (radiotherapy,chemotherapy etc) for pancreatic cancer, except resection. Intra-operative radiotherapy during resection of pancreatic cancer will be permitted, although registration must occur at least 4 weeks after the radiotherapy. Patients that have undergone preoperative/postoperative adjuvant chemotherapy may be enrolled if relapse is diagnosed beyond week 24 after the final administration (on day 169 when the day following the final day is set as day 1). * Age: 20 years to 79 years. * ECOG Performance Status (PS) of 0 or 1. * Sufficient function of major organs as defined below. (The following criteria are satisfied in laboratory tests conducted within 14 days before registration. Laboratory tests conducted 2 weeks before registration (on the same weekday) will be included.) White blood cell count≥ 3500/mm3 Neutrophil count≥ 2000/mm3 Hemoglobin≥9.0 g/dL Platelet count≥100000/mm3 Total bilirubin≤ 2.0 mg/dL\* \*≤ 3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice. AST and ALT≤ 150 U/L Serum creatinine≤1.2 mg/dL Creatinine clearance≥50mL/min.\*\* \*\*Measured values will be used if available. Otherwise, values calculated by the Cockcroft-Gault method will be used.Formula for estimation:body weight (kg) x \[140 - age (years) / 72 x serum creatinine (mg/dL)\] \*Estimated value will be multiplied by 0.85 for females. * Able to take capsules orally. * No clinically abnormal ECG findings within 28 days (4 weeks)before registration. * Voluntarily signed the written consent form. Exclusion Criteria: * Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28 days before enrollment). * Watery diarrhoea. * Active infections (e.g. patients with pyrexia of 38°C or greater), excluding viral hepatitis. * Serious complications (e.g. heart failure, renal failure,hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes). * Moderate or severe (requiring drainage) ascites or pleural effusion requiring treatment. * Metastasis in the CNS. * Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 3 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration. * Patients under treatment with flucytosine, phenytoin or warfarin potassium. * Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. * Severe mental disorder. * Judged ineligible by physicians for participation in the study from a safety viewpoint.

Study Objectives The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan. Conditions: Small-cell Lung Cancer Intervention / Treatment: DRUG: Berzosertib, DRUG: Berzosertib, DRUG: Topotecan Location: Japan, Italy, Spain, United States, Belgium, China, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Dose level 1 participants with histologically proven advanced solid tumors, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated * Dose level 1 participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to (<=) 1 and Karnofsky Scale greater than or equal to (>=) 70 percent (%) * Dose level 2 and main part participants with ECOG PS <= 2 and Karnofsky Scale >= 60% * Dose level 2 and main part participants with histologically confirmed SCLC * Dose level 2 and main part participants with radiologically confirmed progression after first-line or chemoradiation platinum-based treatment (carboplatin or cisplatin), with or without immunotherapy, for treatment of limited or extensive stage SCLC, with a Platinum-free interval (PFI) less than (<) 90 days. The PFI is measured by the elapsed time from the last day of the regimen of a platinum-based treatment until the first day of documented disease progression * Dose level 2 and main part participants with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (RECISTv1.1) at Screening. Evidence of measurable disease must be confirmed by the IRC prior to start of treatment * Tumor tissue provision: archival (collected within 12 months before date of informed consent form \[ICF\]) signature for Screening) or fresh biopsy specimen, if medically feasible * Have adequate hematologic and renal function * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Clinically relevant (that is \[i.e.\], active), uncontrolled intercurrent illness including, but not limited to, severe active infection including, severe acute respiratory syndrome coronavirus-2 infection/coronavirus disease 2019, immune deficiencies, uncontrolled diabetes, uncontrolled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification greater than or equal to \[>=\] Class III), unstable angina pectoris, myocardial infarction, uncontrolled cardiac arrhythmia, cerebral vascular accident/stroke. Calculated corrected QT interval (QTc) average (using the Fridericia correction calculation) of greater than \[>\] 450 millisecond (msec) for males and > 470 msec for females. Any psychiatric illness/social situations that would limit compliance with study requirements * Unstable brain metastases; however, participants with known brain metastases may be enrolled in this clinical study if they are clinically stable (without evidence of progression by imaging for at least 2 weeks prior to the first study intervention dose and any neurologic symptoms have returned to baseline), have no evidence of new brain metastases, and are on a stable or decreasing dose of steroids for at least 14 days prior to study intervention Participants with carcinomatous meningitis are excluded regardless of clinical stability. Screening central nervous system imaging is not mandatory * Prior malignant disease within the last 3 years. Exceptions include fully resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ cervical cancer, fully resected ductal carcinoma in situ of the breast, superficial or noninvasive bladder cancer, and Stage IA, Grade I endometrioid endometrial cancer with no myometrial invasion, that has undergone curative therapy. Participants with other localized malignancies treated with curative intent need to be discussed with the Medical Monitor * Participants not recovered from adverse events (AEs) Grade > 1 from prior anticancer therapies, including surgeries. Exception: Grade 2 AEs not constituting a safety risk (for example \[e.g.\], alopecia), based on the Investigator's judgment; must consult with the medical Monitor prior to enrollment. * Other protocol defined exclusion criteria could apply

Study Objectives The administration of allogeneic third party derived LMP specific-CTLs (special peripheral blood cells from another person) that are made specific to fight EBV infection) in Children, Adolescents and Young Adults (CAYA) with EBV-associated refractory or relapsed lymphoma will be feasible ( able to be done), safe and well tolerated (no unexpected serious events will occur). In addition, potential donors who are EBV positive will be enrolled to donate peripheral blood to help build a bank of these specific EBV fighting cell lines. Conditions: Non-Hodgkins Lymphoma, Hodgkins Lymphoma, Lymphoproliferative Disorder Intervention / Treatment: DRUG: EBV CTL's, OTHER: Peripheral Blood Donor 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: Patient must be at least 1 year of age. Patient or the patient's legally authorized guardian must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent in accordance with the institutional policies approved by the U.S. Department of Health and Human Services. Patients should have been off other investigational therapy for one month prior to entry in this study. Patient must have adequate organ function as below: Adequate renal function defined as: * Serum creatinine <2.0 x normal, or * Creatinine clearance or radioisotope GFR > 40 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range Adequate liver function defined as: * Total bilirubin <2.0 x normal; and * SGOT (AST) or SGPT (ALT) <5.0 x normal Adequate pulmonary function defined as: * Pulse oximetry >94% in room air. Lansky (< 16yr) or Karnofsky (> 16 yrs) performance status ≥ 50% Life expenctancy ≥ 6 weeks. Women of child bearing age require a negative urine pregnancy test. Clinical status at enrollment to allow tapering of steroids to less than 0.5mg/kg/day prednisone at time of treatment. *5 Disease Status (Eligibility) 4.5.1 Any patient, with one or more of the following EBV-positive type II latency or associated disorders, regardless of the histological subtype: Hodgkin lymphoma Non-Hodgkin lymphoma Lymphoproliferative disorder Severe chronic active EBV infection syndrome (SCAEBV), defined as high EBV viral load in plasma or PBMC (> 4000 genomes per μg PBMC DNA) and/or biopsy tissue positive for EBV The disease needs to be in one of the following stages: At diagnosis who would be unable to receive conventional chemotherapy or in first relapse AND the patient is not a candidate for HSCT Partial response after conventional therapy. Refractory to conventional therapy for his/her condition. In second or subsequent relapse. Residual disease after autologous, syngeneic or allogeneic HSCT. All patients entered into the study ideally will have tumor tissue from the original diagnostic specimen and/or relapse reviewed centrally for confirmation of EBV positive disease. If no specimen is available, local pathology report documenting EBV positivity is acceptable. Appropriate immunophenotyping to confirm the diagnosis will be performed. In addition, in situ hybridization for EBV (LMP1, and/or EBER positivity) will be performed. All central morphologic analysis and immunohistochemical/insitu hybridization staining will be performed in the laboratory of Sherrie Perkins and Rodney Miles at the University of Utah. Donor Eligibility for LMP-CTL Third Party Banking (Aim 2.1.2) * Donor must be HIV negative. * Donors must have adequate hematopoietic function defined as absolute neutrophil count > 1000/mm3, hemoglobin > 10 g/dl, and platelet count >50,000/mm3 and be EBV IgG seropositive. * Donors will have peripheral blood collected for LMP specific CTL production. A minimum of 60 cc of peripheral blood x 2 for a total maximum amount of blood of 120cc, will be collected from the donor (subjects must be at least 12 kg or 24 pounds). (See Appendix B) For donors <18 years a maximum of 3cc/kg blood will be taken in an 8 week period. * For donors that are to undergo stem cell collection, the peripheral blood for LMP specific CTL production will be collected prior to the stem cell collection and without a specific day specification. * Donor eligibility must meet criteria as per 21 CFR 1271. Exclusion Criteria: Currently receiving any investigational agents or have received any tumor vaccines within previous 4 weeks. Active acute grade III-IV graft-versus-host disease. Severe refractory intercurrent infection other than EBV. Received alemtuzumab or other anti-Tcell antibody within 28 days. HIV seropositivity. Pregnancy (due to unknown effects of this therapy on a fetus) or lactation. Patients with PTLD post solid organ transplantation eligible for the COG PTLD LMP/CTL protocol.

Study Objectives The study aimed to pilot the viability of a full scale randomised comparison of 2 steroid doses in malignant spinal cord compression, to establish safety of high dose dexamethasone in this setting in Australia, to test web registration and randomisation and to compare different functional outcome measures. Conditions: Spinal Cord Compression From Neoplasm Metastasis Intervention / Treatment: DRUG: Dexamethasone Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Malignant spinal cord compression with at least one of pain, weakness, sensory disturbance or sphincter disturbance * Histology not required if prior biopsy proven malignancy * Any stage * Age >16 years * ECOG 1-3 prior to cord compression event * Minimum power 1 of 5 point scale Must not be paraplegic * Minimum expected survival 2 months * Relevant minimum lab values * Patients capable of childbearing using adequate contraception * Written informed consent Exclusion Criteria: * Prior radiotherapy to within vertebral±one level affected by cord compression * Prior treatment for spinal cord compression at the current level * Histology is lymphoma or myeloma * Power less than 1 of 5 * More than 12 hours after initiation of dexamethasone>4mg/24hr * Pre-existing co-morbid conditions - peptic ulceration or cardiac failure * Allergy to study medications * Multilevel cord compression or meningeal carcinomatosis * Pregnant or lactating

Study Objectives Studies on the effect of sibutramine, an anti-obesity drug, on hormonal and metabolic features of women with polycystic ovary syndrome (PCOS) are lacking. The objective of this study is to examine the effect of sibutramine plus hypocaloric diet on body composition, hormonal and metabolic parameters and insulin resistance in obese patients with PCOS. Overweight and obese women with PCOS were placed in a hypocaloric diet plus sibutramine (10 mg/day) for the first month and then on a hypocaloric diet plus sibutramine (10 mg/day) or hypocaloric diet only for the subsequent 6 months. The main outcome measures are: Body composition, hormonal and metabolic features and insulin sensitivity (OGTT) at baseline, at 3 and 6 months of treatment. Conditions: Obesity, Polycystic Ovary Syndrome Intervention / Treatment: DRUG: Sibutramine Location: Greece Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * overweight and obese women with PCOS Exclusion Criteria: * Nonclassical 21-hydroxylase deficiency, hyperprolactinemia, adrenal or ovarian tumor and Cushing's disease, hypertension, thyroid dysfunction, overt diabetes mellitus and concomitant treatment such as antihypertensive drugs, SSRI or other SNRI drug, oral contraceptive pills or any other antiandrogen treatment (cyproterone acetate, spirolactone, LHRH agonist) and insulin sensitizing agents (metformin, pioglitazone, roziglitazone) that may interact with insulin sensitivity and lipid profile.

Study Objectives There is a need for more effective therapy for patients following surgery for esophageal carcinoma. Docetaxel and Irinotecan, independent of each other, have demonstrated activity in this disease. There is interest in the combination of these two active agents plus radiotherapy. Conditions: Esophageal Cancer, Cancer of the Esophagus, Esophagus Cancer, Esophageal Neoplasm, Cancer of Esophagus Intervention / Treatment: DRUG: Irinotecan (drug), DRUG: Taxotere (drug), PROCEDURE: Radiotherapy (procedure), PROCEDURE: Esophagectomy (procedure) 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: * Histological confirmation of adenocarcinoma/squamous cell carcinoma of the esophagus. Patients should be considered resection candidates, Clinical Stages II- IV (For GE junction tumors 50% of the tumor must be within the esophagus) * Age 19 years * Male or female gender (not pregnant or lactating). If the subject is fertile, use of medically acceptable contraception will be required, and women with reproductive potential shall have a negative pregnancy test. * Patient should be able to understand and offer signed written informed consent prior to study entry. * No prior receipt of surgery, chemotherapy, radiotherapy or immunotherapy. * Patients must demonstrate a ECOG P.S. ≤ 1 * Minimum life expectancy of 12 weeks * End Organ function must be adequate meeting the below criteria at baseline: WBC 3000/mm3, ANC 1500/mm3 , Hgb 9.0 g/dL, PLT 100,000mm3 Normal serum creatinine ( 1.5 mg/dL) Total Bilirubin ULN, Transaminases (SGOT and/or SGPT) may be up to 1.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN. PT/PTT below the upper limit of normal (patients may be on 1mg of Coumadin for line patency) Peripheral neuropathy must be < Grade 1 Exclusion Criteria: * Diagnosis of active, invasive (treated in past 5 years) concomitant malignancy except non-melanotic skin cancer * Patients must be fully recovered from any reversible side effects of prior intervention * Presence of an underlying disease state associated with impairment of performance status * New York Heart Association Class IV congestive heart failure * Limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events cannot be provided History of non-compliance with prescribed medical care. * Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.

Study Objectives The investigators design a phase IIB clinical study to explore the efficacy and safety of lenvatinib plus pembrolizumab as a second-line treatment in patients with advanced hepatobiliary malignant tumors and to analyze potential biomarkers of therapeutic response. Conditions: Liver Neoplasm Malignant Primary, Cholangiocarcinoma, Combinational Immunotherapy, Biomarker Intervention / Treatment: DRUG: Lenvatinib plus Pembrolizumab Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Subjects must meet all of the following criteria * Subjects volunteer to participate in the study and agree to sign the informed consent with good compliance and follow-up. * Subjects are 18 years old or older when signing the informed consent and gender is not limited. * Subjects were diagnosed with advanced hepatobiliary malignant tumors (clinical stage IV) by imaging and histological examination, including hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, gallbladder carcinoma and mixed carcinoma. * The disease is not suitable for radical surgery and/or topical treatment, or disease progression occurs after surgery and/or local treatment. * At least one measurable lesion (according to RECIST version 1.1): the measurable lesion has a long diameter ≥ 10 mm or lymphadenpathy has a short diameter ≥ 15 mm in spiral CT scan. * Patients fail after at least one systemic failure, including surgery, intervention, radiotherapy, chemotherapy and targeted therapy and require palliative treatment. * Definition of treatment failure: Disease progression during treatment or relapse after treatment, such as after at least once radical or palliative resection surgery, revenue recurrence or progression after intervention therapy or radiotherapy. Intervention therapy or oxaliplatin treatment must be more than 1 cycle, and molecular targeted therapy must more than ≥14 days. * Definition of intolerance: Grade ≥IV hematologic toxicity, or grade ≥III non- hematologic toxicity, or grade ≥ II damage of heart, liver and kidney during treatment. * The ECOG score is 0-2 within 1 week before enrollment. * Liver function assessment: Child-Pugh Grade A or mild Grade B (≤ 7 points), BCLC stage B-C. * More than 2 weeks from first-line system treatment failure to sign informed consent for this study, and adverse events returned to normal (NCI-CTCAE ≤ I). * Estimated survival time ≥ 6 months. * HBV DNA <2000 IU/ml (104 copies/ml). * Hematology and organ function are sufficient based on the following laboratory results within 14 days prior to the treatment of this study: * Whole blood cell examination (no blood transfusion within 14 days, no G-CSF use and no drugs use): Hb≥90g/L, ANC≥1.5×10\*9/L, PLT≥80×10\*9/L. * Biochemical examination (no ALB infused within 14 days): ALB≥29 g/L, ALT and AST<5×ULN, TBIL≤1.5×ULN, creatinine≤1.5×ULN (only one of albumin and bilirubin has 2 points with Child-Pugh score). * Tumor tissue must be available for biomarker analysis prior to the first dose of treatment, If not available, participants can consult the investigator for enrollment agreement. * Note: If an unstained section is submitted, the new section should be submitted to the laboratory within 14 days. Exclusion Criteria: Subjects with one or more than one of the following criteria should be excluded * Clinical stage I-III, and/or with any of the following: * Suitable for radical surgery, * Or, without an assessment lesion after radical surgery, * Or, never receive any first line treatment, * Or, liver transplantation history or ready for liver transplantation. * ECOG score ≥ 3 points. * Received any topical treatment within 4 weeks prior to the study, including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection. * Ascites with clinical symptoms which requires abdominal puncture or drainage therapy, or Child-Pugh score >2. * With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable. * Already known active central nervous system metastasis and/or cancerous meningitis. Subjects with stable brain metastases after previous treatment may participate as long as no radiologic evidence of progression lasts for at least four weeks prior to this trial and any neurological symptoms have returned to baseline, and no new or enlarged metastatic evidence in brain and no steroids use for at least 7 days prior to trial treatment. Cancer meningitis should be excluded regardless of clinical stability. * Surgery was performed within 4 weeks prior to the trial and patients must be * evaluated after wound healing. * Hepatic and renal dysfunction evidence: jaundice, ascites, and/or bilirubin ≥ 1.5 × ULN, and/or alkaline phosphatase ≥ 3 × ULN, and/or ≥ 3 grade (CTC-AE 5.0) proteinuria (> 3.5g /24 hours), or renal failure requiring blood dialysis or peritoneal dialysis. * Urine examination shows urinary protein ≥ ++ or 24 hours urine protein >1.0g. Persistent >2 grade (CTC-AE5.0) infection. * History of allogeneic tissue transplantation or solid organ transplantation. * History of active tuberculosis, such as mycobacterium tuberculosis. * Intolerant of any drug (or any excipient) in this trial. * Female patients who are pregnant, breastfeeding or refuse contraception. * Known or untreated brain metastases, or patients with epilepsy who need medication treatment. * Patients with bone metastases received palliative radiotherapy (radiation area > 5% bone marrow area) within 4 weeks prior to this study, or there were wounds, ulcers or fractures that could not be healed, or patients have organ transplantation history. * Gastrointestinal bleeding history in the past 6 months or tendency to gastrointestinal bleeding, such as esophageal varices, local active ulceration lesions, fecal occult blood ≥ (++) (gastroscopy is required when fecal occult blood is (+)). * Evidence or history of ≥3 grade (CTC-AE5.0) bleeding events. * History of human immunodeficiency virus infection. * History of hepatitis B virus or hepatitis C virus infection, and not receive regular treatment. * Severe non-healing wounds, ulcers or fractures. * Prior treatment with either lenvatinib or any kind of anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs. * There were no active autoimmune diseases that require systemic treatment such as disease modifying drugs, corticosteroids or immunosuppressants in the past 2 years. Alternative therapies with thyroxine, insulin or corticosteroid are not considered as systemic therapy. * Diagnosis of immunodeficiency or systemic steroid therapy or any form of immunosuppressants therapy within 7 days prior to this study. A physiological dose of corticosteroids (no more than 7.5 mg/d prednisone or equivalent) can be approved after clinical evaluation. * There exists drug abuse, or any medical, psychological or social condition which might affect the study, the compliance or even the safety of patients. * Variable factors which significantly affect drug use and absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction. * Any >1 grade (CTC-AE5.0) unresolved toxicity due to previous treatment or operation, except for hair loss, anemia, and hypothyroidism. * Vaccination of any live virus vaccine within 30 days prior to this study, except for seasonal flu vaccines without live virus. * Previous and current evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia and severe impairment of lung function. * Received a potent CYP3A4 inhibitor treatment within 7 days prior to the study, or received a potent CYP3A4 inducer within 12 days prior to the study. * Women with fertility agree to abstinence during the treatment period and at least 6 months after the last dose (avoiding heterosexual intercourse) or using a contraceptive method with an annual contraceptive failure rate <1%. * If a female patient has menstruation and not reached the postmenopausal state (continuously no menstruation ≥ 12 months and no other causes), and has not undergone sterilization by removing the ovaries and/or uterus), then the patient has fertility. * Contraceptive methods with a contraceptive failure rate <1% include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices. * The reliability of sexual desire should be evaluated relative to the duration of the clinical trial and lifestyle of patient. Periodic abstinence (eg. calendar days, ovulation, symptomatic body temperature or post-ovulation methods) and in vitro ejaculation are unacceptable methods of contraception. * Male patients agree to abstinence (no heterosexual intercourse) or use of contraceptive measures and no sperm donation, as defined below: * When a female partner has fertility, male patients must abstinence from sex during treatment and at least 6 months after the last dose of treatment, or use condoms and other contraceptive methods with contraceptive failure rate <1%. At the same time, male patients must also agree not to donate sperm. * When a female partner is pregnant, the male patient must abstinence or using a condom during the treatment period and at least 6 months after the last dose of treatment to prevent the fetus from being affected by the study. * The reliability of sexual desire should be evaluated relative to the duration of the clinical trial and lifestyle of patient. Periodic abstinence (eg. calendar days, ovulation, symptomatic body temperature or post-ovulation methods) and in vitro ejaculation are unacceptable methods of contraception. * Patients are unsuitable for participation in this research after comprehensive assessment by the researchers. * Patients participate in another clinical study at the same time.

Study Objectives Evaluation of the safety and efficacy of 3 x 10, 3 x 12 or 3 x 14 g/m² Treosulfan resp., combined with 5 x 30 mg/m² fludarabine prior to allogeneic, hematopoietic stem cell transplantation of patients with hematological malignancies, but non-eligible to standard conditioning treatment. Conditions: Hematological Malignancies Intervention / Treatment: DRUG: Treosulfan, DRUG: Treosulfan, DRUG: Treosulfan Location: Poland, Finland, Sweden, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with a haematological chemosensitive malignancy indicated for an allogeneic transplantation, but presenting an increased toxicity risk for classical (high-dose busulfan or standard-dose total body irradiation) conditioning therapies (remission criteria ref. to Appendix L): * CML in first or subsequent chronic phase * NHL in 2nd CR/PR, chemosensitive PR after autologous transplantation ; CLL in 2nd or subsequent CR/PR * Relapsed Morbus Hodgkin (MH) after autologous transplantation * Multiple Myeloma (MM) stage II and III according to Durie and Salmon * AML in 2nd CR/PR or high-risk AML in 1st CR/PR High-risk defined for example by the following: * Cytogenetics: -5/5q, -7/7q, del(5q), abnormalities of 3q, complex karyotype (> 3 abnormalities), or * PR after 1 cycle of induction therapy * ALL in 2nd CR/PR or high-risk ALL in 1st CR/PR High-risk defined as follows: * Leukocytes > 3000/µl (B-Linage) or > 100000/µl (T-Linage); * Pro-B-ALL, pre-T-ALL * Cytogenetics: t(9;22)/BCR-ABL; t(4;11)/ALL1-AF * MDS (patients without prior chemotherapy may be included) * Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD) or one mismatch (out of the 6 standard markers) sibling donor (1 misMRD): * HLA-identity defined by the following markers: A, B, DRB1. DQB1 must be recorded. * Age > 18 years * Karnofsky Index > 80 % * Adequate contraception in female patients of child-bearing potential * Co-operative behavior of individual patients * Written informed consent Exclusion Criteria: * Completely chemotherapy-resistant disease * Severe cardiac insufficiency, severe cardio-vascular or other severe concomitant diseases * Symptomatic malignant involvement of the CNS * Active infectious disease * HIV-positive or active hepatitis infection * Impaired liver function (Bilirubin > 1.5 x upper normal limit; Transaminases > 3.0 x upper normal limit) * Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit). * Pleural effusion or ascites > 1.0 L * Pregnancy or lactation * Known hypersensitivity to fludarabine and/or treosulfan * Parallel participation in another experimental drug trial

Study Objectives This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer. Conditions: Cervical Intraepithelial Neoplasia, Uterine Neoplasms, Genital Neoplasms, Female Intervention / Treatment: DRUG: Pemetrexed 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: * Recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression * Measurable disease * Gynecologic Oncology Group (GOG) performance status 0-2 * Patients must have received one prior systemic chemotherapy for persistent or recurrent disease * Patients with mild to moderate renal insufficiency should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs_ with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed. * All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration. * Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior to first does of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy. * Vitamin B12 (1000 ug) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy Exclusion Criteria: * Prior Pemetrexed * Patients who have received radiation to more than 25% of marrow bearing areas * Any evidence of other malignancy within last 5 years, with exception of non-melanoma skin cancer

Study Objectives This clinical trial is looking at a drug called BT1718 in adult patients with advanced solid tumours. The main aim of the study is to find the maximum dose of BT1718 that can be given safely to patients; learn more about the potential side effects of BT1718 and how they can be treated and also what happens to BT1718 inside the body. Conditions: Advanced Solid Tumours, Non-Small Cell Lung Cancer, Non-Small Cell Lung Sarcoma, Oesophageal Cancer Intervention / Treatment: DRUG: BT1718 Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up * Phase I, dose escalation phase (Stages 1 and 2): * Histologically or cytologically proven advanced solid tumour, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient. Phase IIa, expansion phase: * Histologically or cytologically proven advanced solid tumour of particular interest based on pre-clinical and clinical data, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient. Phase IIa expansion cohorts will be: 1. Squamous NSCLC cohort - retrospective MT1-MMP testing. 2. Basket cohort (advanced solid tumours, excluding patients eligible for one of the other recruiting expansion cohorts) - high MT1-MMP expression by IHC assay using archival tumour sample (mandatory fresh tumour samples for those patients without available archival tumour samples or additional analysis is deemed necessary). Retrospective testing may be permitted for tumour types estimated to have high MT1-MMP positivity rates as per the Laboratory manual. 3. Additional expansion cohort(s) of squamous oesophageal cancer if confirmed as recruiting by the Sponsor. * At least one measurable lesion according to RECIST criteria Version 1.1, that has had objective radiological progression on or after the last therapy. * Consent for pre-treatment and post-treatment fresh tumour biopsy sample in a minimum of eight patients in the squamous NSCLC cohort, squamous oesophageal cohort (if confirmed as recruiting by the Sponsor) and all patients in the basket cohort (except patients with a very high MT1-MMP H-score if agreed with the Sponsor and PI as defined in the Laboratory Manual). * Consent for pre-treatment and post-treatment non-tumour sample (optional) for patients having a pre and post treatment tumour biopsy. * Consent for pre and post treatment skin punch biopsy (optional). * Life expectancy of at least 12 weeks. * World Health Organisation (WHO) performance status of 0 - 1. * Haematological and biochemical indices within the ranges shown below. These measurements should be performed to confirm the patient's eligibility. Haemoglobin (Hb): ≥90.0 g/L, or ≥100.0 g/L if transfusion within last four weeks Absolute neutrophil count (ANC): ≥1.5 x 10\^9/L Platelet count: ≥100 x 10\^9/L Bilirubin: ≤1.5 x upper limit of normal (ULN). NB: >1.5 ULN, acceptable if conjugated bilirubin is ≤1.5x ULN Alanine amino-transferase (ALT), aspartate amino-transferase (AST) and alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) : ≤2.5 x ULN (or ≤5 x ULN if has liver metastases) Renal function Either: Serum creatinine: ≤1.5 x ULN Or: Calculated creatinine clearance (using the Wright or Cockcroft \& Gault \[C\&G\] formula): GFR ≥50 mL/min (uncorrected value) Or: Isotope clearance measurement: GFR ≥50 mL/min (corrected value) * 16 years or over at the time consent is given * Consent to access and analyse any available archival tissue. Exclusion Criteria: * Radiotherapy (except for palliative reasons), systemic anti-cancer therapy (with the exception of life-long hormone suppression such as LHRH agents in prostate cancer) or investigational medicinal products during the previous four weeks (six weeks for nitrosoureas, mitomycin-C) before treatment (or first dose of an immunotherapy during the previous 12 weeks). * Prior bone marrow transplant, myeloablative conditioning, or extensive radiotherapy to greater than 25% of bone marrow, within previous eight weeks of first BT1718 dose. * Ongoing toxic manifestations of previous treatments greater than NCI CTCAE Grade 1. Exceptions to this are alopecia, amenorrhea/oligospermia and any other ongoing toxic manifestation which in the opinion of the Investigator and the Medical Advisor should not exclude the patient. * Any CNS metastases (unless had local therapy and are asymptomatic and radiologically-stable off steroids for the last four weeks). * Current or prior malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively-treated non-melanoma skin cancer, non-muscle-invasive bladder cancer, or carcinomas-in-situ are generally eligible. * Female patients who are able to become pregnant (or are already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) \[oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom\] or agree to sexual abstinence, effective from the first administration of BT1718, throughout the trial and for six months afterwards are considered eligible. * Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception \[condom plus spermicide\] or to sexual abstinence effective from the first administration of BT1718, throughout the trial and for six months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate. * Surgery from which the patient has not yet recovered. * At high medical risk because of non-malignant systemic disease including active uncontrolled infection. * Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV). * Patients with significant cardiovascular disease are excluded as defined by: 1. Current congestive heart failure requiring therapy (NYHA III or IV - Appendix 3) or known LVEF <40% (moderate to severe) 2. History of unstable angina pectoris or myocardial infarction up to six months prior to trial entry, or of current poorly controlled angina (symptoms weekly or more) 3. Presence of symptomatic or severe valvular heart disease (severe by local echographic criteria or AHA/ACC Stage C or D - Appendix 4) 4. History of a clinically significant cardiac arrhythmia up to six months prior to trial entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block are permitted) * Previous known allergy to one of the constituents or excipients of BT1718. * Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I/IIa study of BT1718. Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the patient in the opinion of the Investigator and Medical Advisor would be acceptable. * Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.

Study Objectives Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Bortezomib, DRUG: Granulocyte colony-stimulating factor (G-CSF), DRUG: Mozobil Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects must meet all of the inclusion criteria to participate in this study. * Ability to understand, and the willingness to sign a written Informed Consent Form * Diagnosis of multiple myeloma undergoing planned autologous stem cell transplantation * Age ≥ 18 years * Karnofsky Performance Status (KPS) 70 or above, Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 * Adequate organ and marrow function as defined below: * leukocytes ≥ 3,000/micro Liter (mcL) * absolute neutrophil count ≥ 1,500/mcL * platelets ≥ 100,000/mcL * total bilirubin within normal institutional limits NOTE: For this study, subjects with bilirubin levels > 1.5 Upper Limit of Normal (ULN) are excluded from enrollment in this study. * Aspartate Aminotransferase (AST) ( Serum Glutamic Oxaloacetic Transaminase \[SGOT\]) ≤ 2.5 X institutional upper limit of normal * Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase \[SPGT\]) ≤ 2.5 X institutional upper limit of normal * creatinine within normal institutional limits * Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately. * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) Exclusion Criteria: * Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation. * Current or anticipated use of other investigational agents. NOTE the following clarification for this study: Prohibited Concurrent Therapy: Participation in clinical trials with other investigational agents that are not included in this trial, within 14 days of the start of this trial until 2 weeks after participant has received the last dose of bortezomib for mobilization. * Hypersensitivity to bortezomib, boron or mannitol or Granulocyte colony-stimulating factor (G-CSF) * Subject has received > 6 months of lenalidomide (Revlimid®) therapy prior to stem cell collection * Subject has known brain metastases. Presence of brain metastases should be excluded from this clinical trial because of poor prognosis and because patients often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Grade 3 or higher peripheral neuropathy * Bilirubin levels > 1.5 ULN * Uncontrolled inter-current illness including, but not limited to * ongoing or active infection * symptomatic congestive heart failure * unstable angina pectoris * cardiac arrhythmia * psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing: There is a potential for congenital abnormalities and for this regimen to harm nursing infants.

Study Objectives This study will assess alternative formulations of lapatinib for relative bioavailability and bioequivalence (BE) with the current commercial formulation (reference). Subjects will be dosed for at least one week (7 days) on each formulation and PK samples will be collected after each lapatinib formulation dosing Period on Period 1 Day 7 and Period 2 Day7 at pre-dose and up to 24 hrs post dose. The study may evaluate up to three alternative test formulations. After subjects complete the PK evaluation at the End of Study Visit, if they are eligible, they will have the option to enter EGF111767, an open-label, Phase Ib continuation study of lapatinib monotherapy or lapatinib in combination with other anti-cancer treatments. Conditions: Neoplasms, Breast Intervention / Treatment: DRUG: lapatinib Location: United States, Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of: Metastatic breast cancer that over-expresses ErbB2 (3+ by IHC; FISH or CISH positive)and the subject has received prior therapy including an anthracycline, a taxane, and trastuzumab OR Recurrent, advanced, or metastatic solid tumor malignancy (including breast cancer that does not over-express ErbB2) that is refractory to standard therapies, for which there is no approved therapy, or for which lapatinib in combination with one of the permitted anti-cancer regimens specified in the continuation study EGF111767 may provide clinical benefit. * Is at least 18 years of age. * A female is eligible to enter and participate in the study if she is of: Non-childbearing potential (i.e. physiologically incapable of becoming pregnant), including any female who is: Pre-menopausal with a documented bilateral oophorectomy (ovariectomy), bilateral tubal ligation, or hysterectomy. Post-menopausal defined as total cessation of menses for >=12 months (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml \[< 140 pmol/L\] is confirmatory). Childbearing potential, has a negative serum pregnancy test at Screening and agrees to one of the contraception methods listed in the protocol for the time period from 14 days prior to the first dose of study drug until 30 days post the last dose of study drug to sufficiently minimize the risk of pregnancy at that point. * Subject is a man with a female partner of childbearing potential who agrees to use contraception. * Is able to swallow and retain oral medication and does not have uncontrolled emesis regardless of etiology. NOTE: If subject has a current or recent (within 14 days) history of nausea or emesis, the subject must be reviewed by the Investigator and the GSK medical monitor. Prophylactic antiemetic therapy may be appropriate. * ECOG performance status 0 to 1. * Adequate bone marrow function: Hemoglobin >= 9 gm/dL, Absolute granulocyte count >=1,500/mm3 (1.5 x 109/L), Platelets >=75,000/mm3 (75 x 109/L). NOTE: Transfusions of blood and blood products as well as growth factor support are prohibited within 14 days prior to the first dose of study drug. * Calculated creatinine clearance (CrCl) >= 50 ml/min based on Cockcroft and Gault. * Total bilirubin <= 1.5 X upper limit of normal (ULN). * Alanine transaminase (ALT) <= 3 times the upper limit of normal (ULN) with or without liver metastases. * Has a LVEF within the normal institutional range (or >= 50%) based on ECHO or MUGA. * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: * Is pregnant or lactating. * Has malabsorption syndrome, a disease affecting gastrointestinal function, a GI tract bypass in place, or has undergone a resection of the distal stomach and pylorus, small bowel, or ascending or transverse colon that could impact lapatinib absorption. NOTE: Resection of the gastric antrum, the appendix, descending colon, sigmoid colon and rectum are permitted if there is no overt evidence of malabsorption. * Has acute or currently active (e.g.,requiring anti-viral therapy) hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment). * Has evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease. Subjects with brain metastases treated by surgery and/or radiotherapy are eligible if neurologically stable and do not require steroids or anticonvulsants for at least 28 days prior to the first dose of study drug. * Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations. * Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product such as gefitinib \[IRESSA\] and erlotinib \[TARCEVA\]. * Has received anti-cancer therapy (including chemotherapy, radiation therapy, immunotherapy, biologic therapy, investigational therapy, surgery, or hormonal therapy) within 14 days prior to the first dose of lapatinib. NOTE: Any ongoing potentially reversible toxicity from prior anti-cancer therapy that is > Grade 1 (except alopecia or Grade 2 neuropathy that has been stable for at least 4 weeks) or any toxicity from prior anti-cancer therapy that is progressing in severity will render the subject ineligible unless agreed to by the GSK Medical Monitor and the Investigator. * Is receiving any prohibited medication or consuming any food or beverage within the timeframe indicated on the prohibited medication list. * Has physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. * Clinically significant ECG abnormality including baseline QTc prolongation >480msec.

Study Objectives This phase I trial is studying the side effects and best dose of sorafenib in treating patients with metastatic or unresectable solid tumors, multiple myeloma, or non-Hodgkin's lymphoma with or without impaired liver or kidney function. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Sorafenib may have different effects in patients who have changes in their liver or kidney function Conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Multiple Myeloma, Splenic Marginal Zone Lymphoma, Stage II Multiple Myeloma, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Multiple Myeloma, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific, Waldenström Macroglobulinemia Intervention / Treatment: DRUG: sorafenib tosylate, OTHER: pharmacological study 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 cytologically or histologically confirmed tumors that are metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; Patients with solid tumors, multiple myeloma, or non-Hodgkin's lymphoma are eligible * Lesions 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 * All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions; Lesions that are considered non-measurable include the following: * Bone lesions * Ascites * Pleural/pericardial effusion * Lymphangitis cutis/pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * ≥ 4 weeks since major surgery * ≥ 4 weeks since completion of radiation or chemotherapy except for ≥ 6 weeks for nitrosoureas, L-PAM or mitomycin-C * ECOG Performance Status of 0-2 * Non-pregnant and non-nursing because the effects of BAY 43-9006 on the fetus/infant are unknown; in addition, women of child-bearing potential and men must agree to use an appropriate method of birth control throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier methods (diaphragm plus condom) * No patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements * No concomitant medications known to cause hepatic or renal toxicity, including anti-seizure medications, non-steroidal anti-inflammatory agents, and steroids * No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease * No HIV-positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with BAY 43-9006; however, patients who are HIV+ but without AIDS defining diagnosis and not on combination anti-retroviral therapy are eligible * No patients with evidence of biliary or renal obstruction; patients should be observed for at least one week after treatment (i.e. stents or drains) for biliary or renal obstruction to ensure their organ dysfunction has stabilized before registration to this protocol * No current treatment with other investigational agents * No evidence of bleeding diathesis * No patients on therapeutic anticoagulation; prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices is allowed provided that the requirements for PT, INR or PTT is met * No treatment with cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or Phenobarbital), rifampin or St. John's wort * Patients with brain metastases are eligible if they meet all of the following criteria: * Asymptomatic * Radiographically stable disease for at least 2 months * Previously received treatment for the brain metastases * Not currently receiving steroid therapy or enzyme-inducing anticonvulsants (e.g. phenytoin, phenobarbital, or carbamazepine) * Granulocytes ≥ 1,500/μl * Platelet count ≥ 75,000/μl * Normal or abnormal organ function

Study Objectives This study is aimed to study the impact of wheatgrass juice and lifestyle recommendations (diet, physical activity and breathing exercises) on the well being, fatigue and hematological parameters of chemotherapy-naive patients with no evidence for symptoms of active oncological disease.The researchers hypothesize that both wheatgrass juice and lifestyle recommendations can improve patient's well-being during chemotherapy. Conditions: Fatigue Intervention / Treatment: DIETARY_SUPPLEMENT: Wheatgrass juice Location: Israel Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Clinical diagnosis of cancer with no sign of active disease * First-time treatment with chemotherapy Exclusion Criteria: * Treatment with per os administration of chemotherapy

Study Objectives Primary Objective: - To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel Secondary Objective: - To assess the safety of cabazitaxel in patients with various degrees of renal impairment Conditions: Neoplasm Malignant Intervention / Treatment: DRUG: Cabazitaxel XRP6258 Location: Italy, Netherlands, United Kingdom, Spain, Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria : * Diagnosis of histologically or cytologically proven non-hematologic malignancy. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. Cabazitaxel is an adequate treatment option, as judged by investigator. * Eastern Cooperative Oncology Group performance status 0 - 2 * Stable renal function * Patients must have adequate liver and marrow function as defined below: * Absolute neutrophil count ≥ 1.5x10\^9/L * Platelets ≥ 100x10\^9/L * Total bilirubin ≤ 1.0 x the institutions upper limit of normal * AST (SGOT)/ALT (SGPT) ≤ 2.5 x the institutions upper limit of normal * Alkaline phosphatase ≤ 2.5 x the institutions upper limit of normal * Patient may have a Grade 1 or less neurotoxicity at study entry. * Life expectancy > 3 months * Age ≥ 18 years old * If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal. * Having given written informed consent prior to any procedure related to the study Exclusion criteria: * Less than 4 weeks have elapsed from prior anticancer therapy (surgery, chemotherapy, radiation therapy, hormonal therapy and immunotherapy). Prior isotope therapy and radiotherapy to ≥ 30% of bone marrow are not allowed. * Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, class III or IV congestive heart failure, stroke or transient ischemic attack. * Any of the following within 3 months prior to study start: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event. * Active hepatitis * Acute renal failure (new or superimposed to pre-existing chronic renal impairment), nephrotic syndrome. * Patients requiring dialysis during the study. * History of hypersensitivity to docetaxel or polysorbate 80. * Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment. * Known brain metastases. * If female, pregnancy or breast-feeding. * Any treatment known to induce CYP isoenzymes (e.g., phenobarbital, phenytoin, carbamazepine, rifampicin, St John's Wort) or to strongly inhibit CYP3A4 activities (e.g., ketoconazole, itraconazole, macrolides, antiprotease agents, etc) is not allowed within 2 weeks before or during the test period of the pharmacokinetic sampling The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives Assessment of patients response and expression levels of CITED2 and HIF2a genes on adding pioglitazone to imatinib therapy. Conditions: Chronic Myelogenous Leukemia, BCR-ABL Positive, CML, Chronic Phase Intervention / Treatment: DRUG: Pioglitazone 15mg Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * CML cases (BCR-ABL1 positive) Exclusion Criteria: * Accelerated or blastic crisis * Atypical CML (BCR-ABL1 negative) * Chronic myelomonocytic leukemia (CMML) * Pregnant or breastfeeding females. * Patients with severe organ dysfunction

Study Objectives This is a multi-center, open-label, dose escalation and phase I/II study, consisting of dose escalation in Part A and phase II study in Part B. Conditions: Non Small Cell Lung Cancer Intervention / Treatment: DRUG: AZD3759 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Subjects must provide written informed consent before any study related procedure. * Male or female Chinese patients ≥18 years old. * Histologically or cytologically confirmed non-small cell lung cancer with activating mutation in EGFR gene (including Exon19Del and/or L858R). A validated and robust test method reviewed and approved by the regulatory authority should be used to determine EGFR mutation status in tissue or plasma locally. * Patients with advanced non-small cell lung cancer (stage IV) with documented BM and/or LM. Part A dose escalation can include EGFR TKI-naïve NSCLC patients with measurable lung lesion and no BM. Patients with BM and/or LM in each dose group shall account for at least one-third. * According to Eastern Cooperative Oncology Group (ECOG) Scale, performance status is grade 0 to 1, without worsening in the past 2 weeks, and life expectancy of at least 3 months. If ECOG performance status is grade 2 due to LM disease, the patient can also be enrolled. * Non-surgical sterilized women of child-bearing potential and male subjects shall agree to take medically acceptable contraception measures during dosing of investigational drug and 3 months after completion of study treatment. Non-surgical sterilized women of child-bearing potential must have negative blood pregnancy test at screening. * Asymptomatic BM patients who have not received prior treatment with any EGFR TKI or symptomatic BM patients who are not warranted temporally for definitive local treatment (surgery or radiotherapy). For patients with prior local treatment for BM lesion (surgery or radiotherapy), intracranial lesion progression is required. * BM patients must have at least one measurable intracranial lesion; in case of prior radiotherapy for BM lesion, progression is required and must meet measurable lesion criteria again. Measurable extracranial disease is not required. * LM patients must be confirmed by the presence of malignant cells by cerebrospinal fluid (CSF) cytology. Diagnosis of LM disease by MRI alone does not meet inclusion criteria. Patients with both BM and LM are considered as LM. * LM patients must have at least one leptomeningeal lesion which shows visible abnormality by MRI. Measurable extracranial disease is not required. Exclusion criteria: Patients meeting any of the following criteria cannot participate in the study: * Have taken any other investigational drug in a clinical trial within 30 days prior to initial dose. * Prior treatment with any EGFR TKI within 8 days or 5 half-lives of the drug (see table 19 Washout of EGFR TKIs) prior to initial dose of study drug. If the washout period for the EGFR TKI cannot be reached due to schedule or pharmacokinetic properties, an alternative washout period can be proposed based on recovery period of known adverse drug reactions, which must be agreed to in advance by the Investigator and the Sponsor. * T790M mutation positive patients. * Have received previous treatment regimen including any cytotoxic chemotherapy or other anti-cancer drugs (other than EGFR TKIs) for treatment of advanced non-small cell lung cancer within 14 days prior to initial dose of study drug. * Patients with medically uncontrollable seizures and/or untreated (eg., requiring mannitol and/or placement a VP shunt) intracranial hypertension are excluded. * Have undergone major surgical procedure (excluding placement of vascular indwelling needle) or serious trauma within 4 weeks prior to initial dose of study drug, or major surgical procedure is expected during the study. * Patients who have received radiotherapy for a large area within 4 weeks, or local palliative radiotherapy for a small area within 1 week prior to initial dose of study drug (for subjects requiring radiotherapy for more than 30% bone marrow, the radiotherapy must be completed before 4 weeks prior to initial dose). * BM and LM patients who have received whole-brain radiotherapy. * Patients with a history of allergy to AZD3759 and its structural analogues (Gefitinib) or pharmaceutical excipients (whether active or not). * Subjects who are receiving (or cannot discontinue at least 1 week prior to initial dose of study drug) any drug or traditional Chinese medicine known to inhibit or induce CYP3A4 or CYP3A5 activity.

Study Objectives Phase 1 study to determine safety, tolerability, dose-limiting toxicities (DLTs), and recommended Phase 2 dose of AV-299 administered IV as monotherapy to patients with relapsed or refractory solid tumors, lymphoma, or multiple myeloma. The study will also determine the safety, tolerability and DLTs of AV-299 in combination with erlotinib in patients with relapsed or refractory solid tumors. Conditions: Malignant Solid Tumor, Lymphomas, Multiple Myeloma Intervention / Treatment: BIOLOGICAL: AV-299, BIOLOGICAL: AV-299 + erlotinib 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: * Diagnosis of an advanced solid tumor malignancy or lymphoma (non-Hodgkin's or Hodgkin's lymphoma). * Histological or cytological evidence of malignancy. * Advanced malignancy, metastatic or unresectable, that has recurred or progressed following standard therapy or failed standard therapy; or for which no standard therapy currently exists, or for which subject is not a candidate for, or is unwilling to undergo, standard therapy. * Disease that is currently not amenable to curative surgical intervention. * ECOG performance status of 0-1. Subjects with performance status of 2 will be considered only after discussion between the investigator and medical monitor. * 18 years or older, of either sex, and of any race. * Subject (and/or parent/guardian for subject who otherwise is unable to provide independent consent, if acceptable to and approved by the site and/or site's IRB) must be willing to give written informed consent and be able to adhere to dose and visit schedules. * Female subjects of childbearing potential must have negative pregnancy test within 5 days prior to first dose of study drug. * Female subjects of childbearing potential and male subjects whose sexual partners are of childbearing potential must agree to abstain from sexual intercourse or to use an effective method of contraception during the study and for 60 days after the last dose of AV-299 (formerly SCH 900105). Examples of effective methods of contraception include, but are not limited to, oral contraceptives or double barrier methods such as condom plus spermicide or condom plus diaphragm. * Adequate hematologic function as evidenced by Hg ≥ 9g/dL, WBC ≥ 3000 per mm3, ANC ≥ 1500 per mm3 and platelet count ≥ 100,000 per mm3. * Adequate hepatic function as evidenced by a serum bilirubin level ≤1.5 × ULN (except with known Gilbert's Syndrome) and * For subjects in the dose-escalation cohorts and the Phase 1b evaluation of AV-299 (formerly SCH 900105) in combination with erlotinib: -- Serum AST/ALT levels ≤3 × ULN for the reference laboratory * For subjects in the RP2D safety expansion cohort: * Without known hepatic metastasis serum AST/ALT levels ≤3 × ULN for the reference laboratory * With known hepatic metastasis serum AST/ALT levels ≤5 × ULN. * Adequate renal function as evidenced by a serum creatinine level ≤ 1.5 × ULN or a calculated creatinine clearance > 60 mL/min. * Adequate coagulation function as evidenced by PTT ≤ 1.5 × ULN and INR ≤ 1.5 × ULN * Recovery from the effects of any prior surgery, radiotherapy, or systemic antineoplastic therapy. * Subjects with abnormal liver function tests (LFTs) who have not been screened for Hepatitis B or C within the past 6 months prior to study enrollment, will need to be screened for Hepatitis B and C and can only be enrolled if the screening is negative. Diagnosis and Main Criteria for Inclusion for the Multiple Myeloma Exploratory Cohort Subjects to be Included * Diagnosis of symptomatic relapsed or refractory multiple myeloma. Note: For relapsed disease, subject must have PD after having achieved at least stable disease for ≥ 1 cycle of treatment to ≥ 1 prior regimen. For refractory disease, subject must have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry. * Measurable disease assessed by one of the following: * Serum monoclonal protein ≥ 1.0 g/dL by protein electrophoresis; * > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis; * Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio; or, * Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease). Note: All above evaluations, for which there are measurable results at screening, will be repeated as indicated in the visit schedule and the schedule of assessments, with the exception of bone marrow plasmacytosis. Bone marrow plasmacytosis will be repeated for disease/response assessment according to the visit schedule and the schedule of assessments if it is the only measurable result at screening. If both serum and urine M-proteins are present, both must be followed in order to evaluate response. * At least 2 prior therapies * ECOG performance status of 0, 1, or 2. * 18 years or older, of either sex, and of any race. * Subject (and/or parent/guardian for subject who otherwise is unable to provide independent consent, if acceptable to and approved by the site and/or site's IRB) must be willing to give written informed consent and be able to adhere to dose and visit schedules. * Female subjects of childbearing potential must have negative pregnancy test within 5 days prior to first dose of study drug. * Female subjects of childbearing potential and male subjects whose sexual partners are of childbearing potential must agree to abstain from sexual intercourse or to use an effective method of contraception during the study and for 60 days after the last dose of AV-299 (formerly SCH 900105). Examples of effective methods of contraception include, but are not limited to, oral contraceptives or double barrier methods such as condom plus spermicide or condom plus diaphragm. * Adequate hematologic function as evidenced by Hg ≥ 9g/dL, ANC ≥ 1000 per mm3, and platelet count ≥ 50,000 per mm3. Screening platelet count should be independent of platelet transfusions for ≥ 2 weeks. * Adequate hepatic function as evidenced by a serum bilirubin level ≤ 1.5 × ULN (except with known Gilbert's Syndrome) and serum AST and ALT levels ≤ 3 × ULN. * Adequate renal function as evidenced by a serum creatinine level ≤ 3.0 mg/dL. * Adequate coagulation function as evidenced by PTT ≤ 1.5 × ULN and INR ≤ 1.5 × ULN. * All previous cancer chemotherapy, including radiation, hormonal therapy, and surgery, must have been discontinued ≥ 2 weeks prior to first dose of study drug. * Subjects with abnormal liver function tests (LFTs) who have not been screened for Hepatitis B or C within the past 6 months prior to study enrollment, will need to be screened for Hepatitis B and C and can only be enrolled if the screening is negative. * Subject willing to provide blood and if feasible, bone marrow samples for research purposes. Exclusion Criteria: * Women who are breast-feeding, pregnant, or intend to become pregnant. * Subjects with primary CNS malignancy or symptomatic CNS metastases, with the exception that subjects with glioblastoma multiforme may be enrolled in the RP2D Safety Expansion Cohort and in the Phase 1b evaluation of AV-299 (formerly SCH 900105) in combination with erlotinib. Subjects with treated brain metastases that have remained stable for at least 3 months without steroids are allowed. Subjects with signs or symptoms or history of brain metastasis must have a CT or MRI scan of the brain within 1 month prior to the first dose of study drug. Subjects with spinal cord or nerve root compression who have completed treatment at least 4 weeks prior to the first dose of study drug and are stable without steroid treatment for at least 1 week prior to the first dose of study drug are allowed. Subjects with leptomeningeal metastases are not allowed. * Hematologic malignancies other than lymphoma * Any of the following within 6 months prior to administration of study drug: Myocardial infarction (MI), severe /unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or seizure disorder. * Serious and/or symptomatic active infection within 14 days prior to first dose of study drug. Subjects who have asymptomatic or mild infection and taking a short course of antibiotics (ie, UTI, bronchitis) may be allowed after discussion with the medical monitor. * Baseline QTc interval as follows per Bazett's formula: Females > 470 msec; Males > 450 msec. * Persistent, unresolved CTCAE v3.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, and decreased libido) associated with previous treatment. * Inadequate recovery from any prior surgical procedure or major surgical procedure performed within 4 weeks prior to administration of first dose or major surgery within 3 weeks prior to first dose of study drug. * Any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results. * Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy. * Known active hepatitis B or C. * Known hypersensitivity to any of the components of AV-299 (formerly SCH 900105). * Radiotherapy within 3 weeks prior to first study drug administration. * Inability to comply with the protocol requirements or participation in any other clinical study. * Any medications listed in the table on "Prohibited Medications". * Active alcohol abuse. * Stem cell/bone marrow transplant within 6 months of first dose of study drug. Additional Exclusion Criteria for Subjects Enrolled in the Phase 1b Evaluation of AV-299 (formerly SCH 900105) in Combination with Erlotinib: * Inability to take oral medications * Grade 2 or higher diarrhea at baseline, or inflammatory bowel disease * Any gastrointestinal disorder that may interfere with the absorption of oral medications * Acute onset of new or progressive pulmonary symptoms, such as dyspnea, cough or fever within 4 weeks prior to first study treatment, or diagnosis of interstitial lung disease (ILD) Exclusion for the Multiple Myeloma Exploratory Cohort * Women who are breast-feeding, pregnant, or intend to become pregnant. * Active malignancy of any kind requiring or likely to require treatment within the next 12 months, with the exception of basal cell skin cancer, in situ cervical cancer, in situ breast cancer and asymptomatic prostate cancer. * Any of the following prior to first dose of study drug: POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), plasma cell leukemia, Waldenstrom's macroglobulinemia. * Any of the following within 6 months prior to administration of study drug: Myocardial infarction (MI), severe /unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or seizure disorder. * Serious and/or symptomatic active infection within 14 days prior to first dose of study drug. Subjects who have asymptomatic or mild infection and taking a short course of antibiotics (ie, UTI, bronchitis) may be allowed after discussion with the medical monitor. * Baseline QTc interval as follows per Bazett's formula: Females > 470 msec; Males > 450 msec. * Persistent, unresolved CTCAE v3.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, and decreased libido) associated with previous treatment. * Inadequate recovery from any prior surgical procedure or major surgical procedure performed within 4 weeks prior to administration of first dose or major surgery within 3 weeks prior to first dose of study drug. * Any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results. * Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy. * Known active hepatitis B or C. * Known hypersensitivity to any of the components of AV-299 (formerly SCH 900105). * Radiotherapy within 3 weeks prior to first study drug administration, except when used as palliative treatment for pain control. * Inability to comply with the protocol requirements or participation in any other clinical study. * Any medications listed in the table on "Prohibited Medications". * Active alcohol abuse. * Maintenance steroid therapies of > 20 mg/day prednisone, > 4 mg/day dexamethasone, > 80 mg/day hydrocortisone, or equivalent. NOTE: Maintenance steroid therapies of ≤ 20 mg/day prednisone, ≤ 4 mg/day dexamethasone, ≤ 80 mg/day hydrocortisone, or equivalent are allowed provided that the subject is on a stable dose for at least 2 weeks prior to first dose of study drug or the dose has not been adjusted upwards in the 2 weeks prior to first dose of study drug. * Prior therapy involving anti-HGF antibody or c-Met small molecule inhibitor. * Allogeneic stem cell/bone marrow transplant within 12 months of first dose of study drug.

Study Objectives Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma. Primary Objective(s): Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX. Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS). Conditions: Esophagogastric Junction Adenocarcinoma, Gastric Cancer, Esophageal Cancer Intervention / Treatment: DRUG: Capecitabine, DRUG: Epirubicin, DRUG: AMG 102, DRUG: Cisplatin, DRUG: Placebo Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Pathologically confirmed unresectable locally advanced or metastatic gastric or esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus within 5 cm of the EGJ are eligible * ECOG performance status 0 or 1 * Male or female ≥ 18 years of age Exclusion Criteria: * Previous systemic therapy (chemotherapy or biologic therapy) for locally advanced or metastatic gastric or esophagogastric adenocarcinoma * Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy. * Subjects with resectable disease or suitable for definitive chemoradiation * Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy * Tumors of squamous cell histology * Known central nervous system metastases * Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment or randomization * Serious or non-healing wound

Study Objectives Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an important cause of mortality for this surgical population. In addition to tumor characteristics, It has been suggested that pre-treatment and sirolimus-based immunosuppression may affect recurrence and survival. With data from the European Liver Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival after liver transplantation for HCC. Conditions: Liver Transplantation Intervention / Treatment: PROCEDURE: Pre-treatment, DRUG: Sirolimus based immunosuppression Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Hepatocellular carcinoma within transplantation criteria Exclusion Criteria: * Disseminated disease

Study Objectives This is a phase I, open-label, dose-escalation study of SB-485232. Subjects will receive SB-485232 administered as subcutaneous injections daily for 14 days. Dose escalation (enrollment into the next cohort) cannot occur until all three subjects have completed the previous cohort; 5 doses will be tested. An additional dosing regimen has been added to evaluate higher doses given twice weekly for 7 weeks. Therefore, the full evaluation period for each patient will extend out to approximately eleven weeks after the first day of SB-485232 dosing. Conditions: Solid Tumor Cancer Intervention / Treatment: DRUG: SB-485232 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of malignancy. * Subjects with solid tumors must have locally advanced or metastatic disease at the time of enrollment. * Measurable or evaluable disease that is refractory or resistant to standard therapy or for which there is no effective standard therapy. * Predicted life expectancy of at least 12 weeks. * Kinesin spindle protein (KPS) of greater than 70%. * No chemotherapy, immunotherapy, hormonal therapy, or biological therapy for cancer, radiotherapy, or surgical procedures (except for minor surgical procedures) within 4 weeks before beginning treatment with SB-485232 (6 weeks for nitrosoureas and mitomycin C). * Subjects must have recovered from toxicities (incurred as a result of previous therapy) sufficiently to be entered into a Phase I study. * Provide written informed consent. * Absence of anti-SB-485232 antibodies. * Hemoglobin greater than or equal to 9 g/dL. * Absolute neutrophil count greater than or equal to 1.5 X 109 /L. * Platelet count greater than or equal to 100 X 109 /L. * Partial thromboplastin time (PTT) and prothrombin time/international normalized ratio (PT/INR) within normal limits. * Serum creatinine less than or equal to 1.5 mg/dL (135 µmol/L) or estimated creatinine clearance greater than 50 mL/min (calculated by the Cockcroft-Gault Formula). * Total serum bilirubin less than or equal to 1.5 mg/dL. * Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3 X ULN. * Sexually active males or females of reproductive capacity must use adequate contraception. * For subjects with a history of coronary artery disease, stress test must be within normal limits. * Subjects with a history of congestive heart failure, myocardial infarction or prior anthracycline chemotherapy must have a Multiple Gated Acquisition (MUGA) scan with a left ventricular ejection fraction of greater than 40%. Exclusion Criteria: * Women who are pregnant or are breast-feeding. * Severe or uncontrolled infections requiring systemic antibiotic therapy. * Any serious medical or psychiatric disorder that would interfere with subject safety or informed consent. * Known leptomeningeal disease or evidence of prior or current metastatic brain disease. * Receiving concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy. * Receiving concurrent systemic steroids. * History of ventricular arrhythmias requiring drug or device therapy. * Any severe concurrent disease or condition, including significant autoimmune diseases, which in the judgment of the principal investigator, would make the subject inappropriate for study participation. * Any unresolved or unstable serious toxicity from prior administration of another investigational drug. * Any investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of SB-485232. * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the study. * Received prior treatment with SB-485232. * Poor venous access.

Study Objectives The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization, assess plasma drug levels, asses serum copper levels, and assess drug levels in urine. Efficacy and Safety will be assessed in all patients enrolled to the study. Conditions: Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS) Intervention / Treatment: DRUG: CPX-351 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Ability to understand and voluntarily sign an informed consent form * Age ≥ 18 to ≤ 80 years at the time of signing the informed consent form * Life expectancy of at least 3 months * Pathological confirmation by bone marrow documenting the following: * Newly Diagnosed De novo AML according to WHO criteria except for Acute Promyelocytic Leukemia or patients with known favorable cytogenetics (see exclusion) * Newly Diagnosed Secondary AML age <60 years and ≥76 to 80 years, defined as having a history of an antecedent hematologic disorder (myelodysplastic syndromes \[MDS\], myeloproliferative disease \[MPD\]or history of cytotoxic treatment for non-hematologic malignancy) * Patients with relapsed/refractory AML regardless of cytogenetic risk * Patients with relapsed/refractory ALL * Patients with MDS (IPSS score ≥ 1.5) * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 * Able to adhere to the study visit schedule and other protocol requirements * Laboratory values fulfilling the following: * Serum Creatinine ≤ 2.0mg/dL * Hepatic function with a score of < 7 points according to the Child-Pugh System * Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN. Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss. * Cardiac ejection fraction ≥50% by ECHO or MUGA * Screening and Baseline QTcF (Fridericia's) less than 470 msec * Patients with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible. * All men and women must agree to practice effective contraception during the study period if not otherwise documented to be infertile. Exclusion Criteria: * Patients eligible for participation in Study CLTR0310-301 (Phase III study of CPX-351 NCT01696084) or who have already participated in that study are not eligible for this study. * Patients taking medications known to prolong the QTc interval directly or that interact pharmacodynamically with medicines to prolong the QTc interval. * Rhythm abnormalities (other than sinus bradycardia with HR < 50 bpm) * AV block (other than 1o AV Block with PR > 200 msec) * Bundle branch block or QRS ≥ 120 msec * Abnormal T wave morphology (other than slight flattening) * Pathological U waves * Other QRS or T/U morphology preventing accurate determination of QT interval * Patients with unexplained syncope, history of or known risk factors for torsade des pointes, including congenital long QT syndrome, or family history of LQTS. * Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV staging) * Newly diagnosed patients with Acute promyelocytic leukemia \[t(15;17)\] or favorable cytogenetics, including t(8;21) or inv16 * Clinical evidence of active CNS leukemic involvement * Chemotherapy or other investigational anticancer therapeutic drugs within 1 week prior to study entry unless AEs have resolved and there is no interference with the assessment of efficacy or safety; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 12 hours before study entry. Patients with prior bone marrow or stem cell transplant, considered for inclusion, should be discussed with the medical monitor first. * Any serious medical condition or psychiatric illness that would prevent the patient from providing informed consent * Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent) * Active or uncontrolled infection. Patients with any infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥72 hrs. Patients with fevers believed to be due to leukemia or MDS are eligible provided a thorough infection work-up is negative and the patient is clinically and hemodynamically stable. * Pregnant or lactating women * Hypersensitivity to cytarabine, daunorubicin or liposomal products * History of Wilson's disease or other copper-related metabolic disorder

Study Objectives At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression. In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological. The question is to know if this strategy is feasible in lung cancer. Conditions: Non-small Cell Lung Cancer Metastatic, Nonsquamous Nonsmall Cell Neoplasm of Lung Intervention / Treatment: DRUG: Cisplatin, DRUG: Bevacizumab, DRUG: Pemetrexed Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation. * Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic. * Measurable disease (recist criteria) * Age ≥18 years * PS0 or 1 Exclusion Criteria: * Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer * History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years. * Tumor invaded the big vessels or the proximal visible in TDM. * History of adjuvant or neoadjuvant chemotherapy

Study Objectives This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Whole Brain Radiation Therapy (WBRT) in treating patients with brain metastases. Conditions: Brain Diseases, Brain Neoplasms, Central Nervous System Diseases, Neoplasm Metastasis, Nervous System Neoplasms Intervention / Treatment: DRUG: ABT-888, RADIATION: Whole Brain Radiation Therapy Location: United States, Puerto Rico, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age is greater than or equal to 18 years. * Histologically or cytologically confirmed non-CNS primary solid malignancy. * Pathologically or radiographically confirmed metastatic disease in the brain. Subjects with non-measurable lesions, including leptomeningeal carcinomatosis, are eligible. * WBRT is clinically indicated, with the exception of prophylactic treatment. * Karnofsky Performance Status (KPS) greater than or equal to a score of 70. * Adequate hematology, renal and hepatic function. * Both men and women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and up to 2 months following completion of protocol therapy. * Total abstinence from sexual intercourse (minimum one complete menstrual cycle) * A vasectomized partner \* Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration * Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream) * Subject is capable of understanding and complying with parameters as outlined in the protocol. * Subject or the subject's legally acceptable representative has voluntarily signed and dated the informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Exclusion Criteria: * Brain metastases secondary to germ cell tumor or lymphoma malignancy. * Primary central nervous system (CNS) neoplasm. * Prior or concurrent administration of the following therapies or treatments: * Prior treatment with WBRT * SRS performed less than 14 days prior to WBRT D1, or is scheduled to occur within 30 days of the last WBRT session * Last dose of chemotherapy, immunotherapy, biologic therapy, or investigational therapy was less than 14 days prior to WBRT D1. Bisphosphonates, hormone modification therapy, and trastuzumab are permitted without restriction * Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment. * Known seizure disorder (status epileptics) that is uncontrolled, or seizures occurring greater than or equal to 3 times a week over the past month. * If female, subject is pregnant or breast-feeding. * Clinically significant and uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder, including but not limited to: * Active uncontrolled infection * Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia * Any other illness condition(s) that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit compliance with study requirements * Unable to swallow and retain oral medications. * Known contraindication to enhanced MRI and CT, including but not limited to: * Presence of metal objects within the body such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel * History of immediate or delayed hypersensitivity reaction or other contraindication to contrast agents including but not limited to gadolinium and iodine * Previous enrollment in this study or another study involving the investigation of ABT-888, with the exception of receiving a single dose of study drug. * Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-888 and/or WBRT.

Study Objectives The purpose of this study is to evaluate the efficacy and safety of Apatinib for patients with Relapsed Refractory Diffuse Large B Cell Lymphoma. Conditions: Relapsed and Refractory, Diffuse Large B Cell Lymphoma Intervention / Treatment: DRUG: Apatinib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age range 14-70 years old; ECOG performance status 0-2. * Estimated survival time > 6 months. * Histological confirmed diffuse large B cell lymphoma. * Have taken first-line chemotherapy regimen and failed. * None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal. * At least one measurable lesion. * None of other serious diseases, cardiopulmonary function is normal. * Pregnancy test of women at reproductive age must be negative. * Patients could be followed up. * None of other relative treatments including the traditional Chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments. * Volunteers who signed informed consent. Exclusion Criteria: * Disagreement on blood sample collection. * Patients allergic of any of drug in this regimen or with metabolic disorder. * Pregnant or lactating women. * Serious medical illness likely to interfere with participation. * Serious infection. * Primitive or secondary tumors of central nervous system. * Chemotherapy or radiotherapy contraindication. * The evidence of CNS metastasis. * History of peripheral nervous disorder or dysphrenia. * Patients participating in other clinical trials. * Patients taking other antitumor drugs. * Patients estimated to be unsuitable by investigator.

Study Objectives To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC). Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DRUG: Pemetrexed 500 mg/m2, DRUG: Pemetrexed 1000 mg/m2 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Clinical stage III or IV * Previously treated with one or two chemotherapeutic regimens * Performance status: 0-2 Exclusion Criteria: * Inability or unwillingness to take folic acid or vitamin B12 supplementation

Study Objectives Total intravenous anaesthesia using propofol and remifentanil are routinely used drugs for this purpose. The hemodynamic stability and at the same time early emergency are the main goals following neurosurgery. However there is no standard for discontinuation time for manually controlled systems today. The investigators aimed to study the effect of remifentanil infusion alone for early emergence and hemodynamic stability during the closure period in patients undergoing supratentorial craniotomy. Conditions: Supratentorial Neoplasms Intervention / Treatment: DRUG: Remifentanil, DRUG: Propofol Location: Turkey Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * American Society of Anaesthesiologist physical status I-II * Glasgow Coma Scale score of 15 points * Elective supratentorial craniotomy for tumor resection * Supine position Exclusion Criteria: * Obese patient * Brain tumor greater than 30 mm in diameter * Postoperative cranial drainage * Hypertension * Diabetes mellitus * Reoperation * Pregnant * Breast feeding * Allergy to the study medications * History of cranial radiotherapy * Frontal bone flap * Intraoperative neuromonitoring

Study Objectives Breast cancer is a devastating disease. Some women with breast cancer undergo surgery to remove the breast and lymph nodes in the axilla (armpit). Unfortunately, surgery of this type is associated with pain both in the days immediately following the operation and in the long term. Pain that continues for more than three months after surgery is known as chronic pain and affects as many as 1/5 to more than ½ of patients having this surgery. Often this pain is of a particular type known as neuropathic pain. There have been studies demonstrating that the intensity of pain after surgery may be related to the likelihood of developing chronic pain. It is important to develop methods to reduce acute pain after breast cancer surgery and to reduce chronic pain for breast cancer survivors. Pregabalin is a medication used in the treatment of chronic pain. It has been shown to be effective for neuropathic pain. There has also been one study demonstrating its effectiveness in reducing pain after dental extraction. We are interested in determining whether pregabalin taken for 14 days starting the day of surgery will reduce acute (short term) pain and chronic pain from this type of breast cancer surgery. In order to test ability of pregabalin for the reduction of chronic pain it may be necessary to follow a large number of patients for up to one year after surgery. This may require studying patients in more than one institution. Prior to starting such a large study we are proposing a pilot or preliminary study. This study will follow a smaller group of participants (68) for 6 months. From the pilot study we will determine the effect of pregabalin on acute pain and logistic and statistical information required for the full study. We will randomly assign participants to receive pregabalin or placebo (sugar pills) for twice daily for 14 days starting one hour before surgery. We will monitor the participants' pain at one hour after surgery, 24 hours after surgery, one week, two weeks, three months and six months after surgery. We will also monitor for a number of other parameters such as medication side effects and the need for other pain medications. Recruitment of study participants is expected to take 6-7 months. Conditions: Breast Cancer Surgery, Post Operative Pain Intervention / Treatment: DRUG: Pregabalin, DRUG: Placebo Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Patients 18-60 years of age, ASA I-III undergoing breast surgery with axillary dissection for the treatment of breast cancer will be considered eligible for the study. * Informed consent for the study will be obtained prior to surgery. Exclusion Criteria: The following persons will not be considered for inclusion in the study: * Persons undergoing breast surgery for breast cancer without axillary dissection. * Persons undergoing cosmetic breast surgery. * Persons undergoing concurrent breast reconstruction. * Persons undergoing reconstruction within 12 months of surgery. * Persons with a history of allergy to gabapentin or pregabalin. * Persons with a history of allergy to morphine, nonsteroidal antiinflammatory drugs, acetaminophen or oxycodone. * Persons who are or may be pregnant. * Persons with a BMI >40. * Persons with severe organ dysfunction such as liver and renal failure. * Persons receiving greater than or equal to 30 mg per day of morphine (or equivalent opioid) for pre-existing pain conditions. * Persons previously on gabapentin or pregabalin within 3 months of surgery. * Persons with a history of drug abuse. 13) Persons who are unable to communicate in English.

Study Objectives This is an international, open-label, non-controlled, multicenter phase II clinical trial with two different primary objectives: a biological and a clinical objective. From a clinical point of view, the objective is to assess the clinical benefit of the combination of palbociclib and hormonotherapy in patients with advance breast cancer that had previously received endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib treatment with subsequent disease progression. From a biological point of view, the challenge is to define a molecular profile that allow identifying patients that could benefit more from continuing on palbociclib after progression on a prior palbociclib-containing regimen Conditions: Metastatic Breast Cancer Intervention / Treatment: DRUG: Palbociclib, DRUG: Endocrine therapy (non IMP) Location: Italy, Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pre- and postmenopausal women age ≥ 18 years (Premenopausal women must be treated with LHRH analogues for at least 28 days prior to study entry) * Hormone receptor-positive \[estrogen receptor (ER) and/or progesterone receptor (PR)\] and HER2-negative * Locally advanced or mBC that had previously received no more than two prior lines of endocrine therapy and no more than one prior line of chemotherapy for advanced disease. * Inmmediate previous treatment with palbociclib in combination with endocrine therapy had achieved clinical benefit during palbociclib-based treatment * Evidence of measurable and biopsable metastatic disease is required * Confirmed disease progression on immediate previous palbociclib plus endocrine therapy. * Last dose of palbociclib administered no later than eight weeks and not earlier than three weeks from study entry. * No prior use of at least one of the reasonable endocrine therapy options: tamoxifen, fulvestrant, letrozole/anastrozole, or exemestane. * Patients agree to collection of blood samples (liquid biopsy) and collection of metastatic tumour sample (biopsy) at the time of inclusion and progression (if appropriate). * Adequate organ function. * Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures Exclusion criteria * HR or HER2 unknown disease. * HER2-positive disease based on local laboratory results \[performed by immunohistochemistry/fluorescence in situ hybridization (FISH)\]. * Locally advanced breast cancer candidate for a local treatment with a radical intention. * Formal contraindication to endocrine therapy. * Progressing central nervous system (CNS) disease. * Patients with exclusive non-measurable/evaluable disease. * Other malignancies within the past five years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix. * Major surgery (defined as requiring general anaesthesia) or significant traumatic injury within four weeks of start of study drug, or patients who have not recovered from the side effects of any major surgery, or patients that may require major surgery during the course of the study. * Patients with an active bleeding diathesis, previous history of bleeding diathesis, or anti-coagulation treatment (the use of low molecular weight heparin is allowed as soon as it is used as prophylaxis intention). * Have a serious concomitant systemic disorder (i.e., active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator). * Are unable to swallow tablets. * History of malabsorption syndrome or other condition that would interfere with enteral absorption. * Chronic daily treatment with corticosteroids with a dose of ≥10 mg/day methylprednisolone equivalent (excluding inhaled steroids). * QTc >480 msec on basal assessments, personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP). * Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug (i.e., hypocalcemia, hypokalemia, or hypomagnesemia). * Known hypersensitivity to any palbociclib excipients.

Study Objectives This is a Phase Ib, open-label, multicenter, global study designed to assess the safety and tolerability of RO6870810 as monotherapy and in combination with daratumumab in participants with relapsed/refractory multiple myeloma. Each treatment cycle will be 21 days in length. There are two parts to this study. A dose-escalation phase (Part I) will be used to evaluate the safety and tolerability and dose limiting toxicities, and to establish the maximum tolerated dose (MTR)/optimum biological dose (OBD) of RO6870810 when given as monotherapy or in combination with daratumumab. A dose-expansion phase (Part II) will further characterize the safety, tolerability and activity of RO6870810 as monotherapy or in combination with daratumumab at the defined expansion dose-levels. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: RO6870810, BIOLOGICAL: daratumumab Location: United States, Australia, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Performance status <=2 on the Eastern Cooperative Oncology Group (ECOG) scale * Life expectancy > 3 months * Relapsed or refractory multiple myeloma. Participants with primary refractory myeloma only allowed in dose-escalation phase of the study. * Prior treatment: Treated with at least three prior lines of multiple myeloma therapy including a proteasome inhibitor and an immuno modulatory agent or who are double refractory to a proteasome inhibitor and an immuno modulatory agent. Prior anti-CD38 antibody (e.g., daratumumab, isatuximab) treatment is acceptable only for participants receiving monotherapy treatment. * Prior treatment: Treated with two or more lines of prior therapy, with disease refractory to both a proteasome inhibitor and an immunomodulatory agent, and disease progression (as defined by International Myeloma Working Group (IMWG) criteria) following treatment with an anti-CD38 monoclonal antibody given as monotherapy or in combination therapy. The most recent treatment regimen must have contained an anti-CD38 monoclonal antibody. * Treatment with prior autologous transplant is permitted * Documented diagnosis of symptomatic multiple myeloma, as defined by the IMWG * Measurable disease defined as at least one of the following: serum M-protein >=1 grams/deciliter (g/dL), urine M-protein >= 200 milligrams/24 hours (mg/24h), serum free light chain (SFLC) assay: involved SFLCs >= 10 mg/dL (>= 100 mg/L) and an abnormal SFLC ratio (<0.26 or >1.65). * Female participants of childbearing potential must have a negative serum pregnancy test within the 7 days prior to the first study drug administration. * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 2 months after the last dose of RO6870810 as monotherapy, or for at least 3 months after the last dose of daratumumab. * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 4 months after the last dose of RO6870810 as monotherapy, or for at least 3 months after the last dose of daratumumab. Exclusion Criteria: * Plasma cell leukemia defined as peripheral plasma cell count > 2000/cubic millimeter (mm\^3) * For expansion cohorts only: Primary refractory multiple myeloma defined as disease that is non-responsive in participants who have never achieved a minimal response or better with any therapy * History of other malignancy within 2 years prior to screening, except for ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer (Gleason score <= 7) not requiring treatment or appropriately treated Stage I uterine cancer * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) * Current or prior disease or treatment that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor * Pregnant or breastfeeding female. * Consumption of agents which strongly inhibit CYP3A4 enzyme, within 7 days prior to the first dose of study treatment and during the study. * Consumption of agents which strongly induce CYP3A4 enzyme, within 14 days prior to the first dose of study treatment and during the study. * Surgery within 21 days prior to study entry. * Prior treatment with small molecule BET family inhibitor or receiving steroids >the equivalent of 10mg prednisone daily * participants who are currently receiving any other investigational agent or have received an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to study entry * Uncontrolled cancer pain * Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and immunotherapy) within 14 days except for alkylating agents (e.g., melphalan) within 28 days.

Study Objectives This is an approach which can inflict significant toxicity. An alternative is to block expression of oncogenes which are over-expressed only in cancer cells, a therapeutic approach which could reduce toxicity to the host while maximizing destruction of the oncogene-dependent malignant cells. Conditions: Leukemia, Lymphoma, Non-Hodgkin Intervention / Treatment: DRUG: Atorvastatin 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: * > 18 years old * Disease criteria: Confirmed by Stanford Pathology to be one of the following Non-Hodgkin's Lymphoma (NHL) subtypes: * Chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL) * Extranodal marginal zone B-cell lymphoma * Nodal marginal zone B-cell lymphoma * Splenic marginal zone B-cell lymphoma * Treatment criteria * Untreated: watchful waiting currently appropriate (includes CLL stage 0) o OR * Prior treatment: watchful waiting currently appropriate o OR * Refractory disease * Staging within 4 weeks prior to enrollment (SLL, marginal zone lymphoma) * CT chest (date) * CT abdomen (date) * CT pelvis (date) OR * Staging within 4 weeks prior to enrollment (CLL: CT not required) * Total white blood cell count (WBC) (Value) (date) * Absolute lymphoma cell count (ALC) (Value) (date) * Measurable disease (Site) (Size) OR * CLL (only): elevated absolute lymphoma cell count * Disease amenable to biopsy (must check at least one): * Circulating tumor cells * Positive bone marrow * Palpable involved site (such as lymph node) measuring > 1.5 cm * Eastern Cooperative Oncology Group performance status <2 (Karnofsky >60) * Life expectancy of greater than 3 months * Patients must have adequate organ and marrow function * Absolute neutrophil count > 1,000/uL * Platelets > 30,000/uL * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ratio < 2.5 x institutional upper limit of normal * Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal. * 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. Women of child-bearing potential must have negative BetaHCG at enrollment Exclusion Criteria: * Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study * Not recovered from adverse events due to agents administered more than four weeks earlier * Has stable low grade lymphoma has had rituximab within 3 months Patient with relapsed or refractory disease has had rituximab within 1 month * Not recovered from adverse events due to surgery performed 4 weeks earlier * Receiving any other investigational agent. Known brain metastases * Taken any statin within the past 6 months prior to enrollment in the trial * Currently abuses alcohol * Currently takes cyclosporin or gemfibrozil Patient has a prior history of rhabdomyolysis * Has uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant: Patients are not excluded if they are breastfeeding at the time of enrollment, but breastfeeding should be discontinued if the mother is treated with atorvastatin. * HIV-positive patients receiving combination anti-retroviral therapy

Study Objectives The primary objective of the study is to determine the overall response rate (ORR), which includes complete response (CR) and partial response (PR), to bendamustine treatment in participants with indolent non-Hodgkin lymphoma (NHL) that has progressed after rituximab or a rituximab-containing therapy. Conditions: Non-Hodgkin Lymphoma Intervention / Treatment: DRUG: Bendamustine hydrochloride Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The participant has documented relapse from indolent B-cell NHL. Participants with the following subtypes of indolent NHL are eligible for this study: i) small lymphocytic lymphoma (peripheral B cell count <5000 cells/cubic millimeters \[mm\^3\]) ii) lymphoplasmacytic lymphoma iii) splenic marginal zone B-cell lymphoma (±villous lymphocytes) iv) extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type v) nodal marginal zone lymphoma (±monocytoid B-cells) vi) follicle center lymphoma vii) follicular (grade 1, 2, or 3a) lymphoma * The participant has disease documented to have progressed despite rituximab treatment. The participant's disease is considered to be rituximab refractory if any of the following criteria are met at any time during the participant's treatment history (progression must be documented by computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\] or biopsy) or if a participant has palpable lymph nodes that were well documented in size and, after rituximab treatment, palpable disease remains or comes back \[CT, MRI, or biopsy is preferred and performed whenever possible to document progressive disease (PD)\]: i) rituximab-only regimen: Participants who receive a full course of single-agent rituximab (at least 2 doses of 375 mg/m\^2 \[or a therapeutically-active dose\] weekly) and have no response (do not obtain a PR or better) to treatment or progress after a full regimen of rituximab was given. ii) rituximab maintenance therapy or extended schedule: Participants who have a history of a full course of rituximab (at least 2 doses of 375 mg/m\^2 \[or a therapeutically-active dose\] as a single agent \[weekly\] or in combination with chemotherapy \[day 1 of each of 4 cycles\]) and are on a maintenance regimen, and progress before the next scheduled rituximab dose or after completing a maintenance rituximab regimen. iii) rituximab-chemotherapy combination regimen: Participants who receive a full course of rituximab (at least 2 doses of 375 mg/m\^2 or a therapeutically-active dose \[on day 1 of each of 2 cycles\]) in combination with chemotherapy and have no response (do not obtain a PR or better) to treatment or progress after the last dose of rituximab in a regimen. iv) full rituximab exposure treatment: Participants who have a history of a full course of rituximab treatment (at least 2 doses of 375 mg/m\^2 \[or a therapeutically-active dose\] as a single agent or in combination with chemotherapy) and, in a subsequent rituximab/chemotherapy combination regimen, have no response (do not obtain a PR or better) to treatment or progress after the last dose of rituximab in a given regimen, even if the subsequent regimen included less than 2 doses of rituximab. Participants could receive additional systemic treatment after the qualifying rituximab regimen. * The participant has received treatment with at least 1, but no more than 3, previous chemotherapy regimens. A regimen is defined as a new treatment combination or agent. Retreatment with the identical regimen or agent does not count as a new regimen; however, change from cyclophosphamide, vincristine, and prednisolone (CVP) to cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) is counted as a new regimen. Rituximab, radioimmunotherapy, or other biologic treatments not combined with chemotherapy are not counted as a regimen. * The participant has a bidimensionally measurable disease with at least 1 lesion measuring 2.0 centimeters (cm) or more in a single dimension. Participants who have previous involved-field irradiation can be included, provided the irradiated area is not the only source of measurable disease. * The participant has a World Health Organization (WHO) performance status of 0, 1, or 2. * The participant has absolute neutrophil count (ANC) 1000 cells/mm\^3 or more and platelet count 85000 cells/mm\^3 or more. * The participant has a creatinine clearance of more than 30 mL/min as determined by the Cockcroft-Gault calculation. * The participant has adequate hepatic function (no more than 2.5 times the upper limit of normal (ULN) for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), and no more than 1.5 times the upper limit of the normal range (ULN) for total bilirubin). Participants with nonclinically significant elevations of bilirubin due to Gilbert's disease are eligible. * The participant has had a bone marrow biopsy within 6 weeks before the 1st dose of bendamustine. * Women of childbearing potential (not surgically sterile or 1 year postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method starting 2 weeks before the start of study drug treatment, during study drug treatment, and for 3 months after the end of study drug treatment. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. * Women of childbearing potential must have a negative serum or urine pregnancy test. * Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method starting 2 weeks before the start of study drug treatment, during study drug treatment, and for 3 months after the end of study drug treatment. * The participant has an estimated life expectancy of at least 3 months. * The participant (or participant's legal representative) provides written informed consent. Exclusion Criteria: * The participant has received previous radiotherapy, radioimmunotherapy, chemotherapy, or immunotherapy within 4 weeks before day 1 of cycle 1 or has failed to recover (to Common Terminology Criteria for Adverse Events \[CTCAE\] toxicity grade 1 or 2) from clinically significant nonhematologic adverse events due to any agents administered previously. * The participant has received treatment with an investigational agent within 4 weeks of day 1 of cycle 1. * The participant has received hematopoietic growth factors within 4 weeks of day 1 of cycle 1. However, participants receiving chronic erythropoietin treatment are eligible for inclusion in this study. * The participant has a history of previous high-dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible). * The participant is receiving or has received treatment with therapeutic doses of systemic steroids within 4 weeks of day 1 of cycle 1. (Low doses of chronic steroids \[prednisone or equivalent\] up to 20 mg/day for non-neoplastic disorders or for indications other than lymphoma or lymphoma-related complications are permitted.) * The participant has transformed disease. * The participant has any history of central nervous system (CNS) or leptomeningeal lymphoma. * The participant has, or has had within the past 5 years, an active malignancy other than the target cancer. The exceptions are prostate cancer (Gleason grade <6 with prostate specific antigen \[PSA\] levels within the normal range), in situ cervical or breast carcinoma, and nonmelanoma skin cancer that have received definitive treatment. * The participant is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study immediately.) * The participant has a serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of the study objectives. * The participant is known to be positive for human immunodeficiency virus (HIV), have active hepatitis B, or active hepatitis C (anti-hepatitis C virus \[HCV\] positive). Hepatitis B surface antigen must be tested. The determination of active disease is left up to the Investigator. * The participant has a known hypersensitivity to mannitol. * The participant has used bendamustine previously.

Study Objectives Primary Objective: Participants Achieving an Objective Response Rate (Cheson 2007) Secondary Objectives: * Progression Free Survival * Overall Survival * Response Duration Conditions: Diffuse Large B-Cell Lymphoma Intervention / Treatment: DRUG: SAR3419, DRUG: rituximab Location: Norway, France, Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Histological diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) * Relapsed or refractory after at least one standard treatment including rituximab * CD19 and CD20 positive disease Exclusion criteria: * No bi-dimensionally measurable lesion by CT scan (defined as presence of at least one tumor mass measuring >1.5 x 1.5 cm) * The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives Primary Objective: * To determine the maximum tolerated doses (MTDs) of pemetrexed when given with dexamethasone. (Please note: One of the three treatment groups will not receive dexamethasone) Secondary Objectives: * To assess dose limiting toxicity (DLT), which is defined as grade 4 neutropenia \> 7 days duration, neutropenic fever, grade 4 thrombocytopenia, or any grade 3 or 4 non-hematologic toxicity excluding nausea/vomiting and excluding grade 3 transaminase toxicity. * To determine objective response rate, as defined as complete response (CR) or partial response (PR), confirmed by 2 CT scans at least 6 weeks apart in patients treated with pemetrexed as a single agent with advanced squamous cell carcinoma of the head and neck. Conditions: Head and Neck Cancer Intervention / Treatment: DRUG: Pemetrexed, DRUG: Dexamethasone 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 have histologically or cytologically confirmed metastatic or recurrent head and neck squamous cell carcinoma from the primary lesions and/or lymph nodes of the oral cavity, oropharynx, hypopharynx, or larynx. * 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. * Patients have received one or more chemotherapy regimens. * Age >= 18 years. * Life expectancy of greater than 3 months. * No acute intercurrent illness or infection. * ECOG performance status <= 2 (Karnofsky >= 60%) * Laboratory parameters: white blood count (WBC) >3,000/mL; Neutrophils >1,500/mL; Hemoglobin >8g/dL; Platelets >100,000/mL; Bilirubin <1.5 times the upper limit of normal (ULN); Serum creatinine: within normal institutional limits; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) < 3 times institutional ULN if alkaline phosphatase is < ULN, except in known hepatic metastasis, wherein ALT/AST may be <= 5 times ULN * Creatinine clearance: The standard Cockcroft and Gault formula or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA) must be used to calculate CrCl for enrollment or dosing. The same method used at baseline should be used throughout the study. No dosage adjustment is needed in patients with CrCl >= 45 mL/min. * Patients with a history of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Acute intercurrent illness or infection * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients who are receiving any other investigational agents * Patients who have known brain metastases * Patients who have signs or symptoms of acute infection requiring systemic therapy. * Patients having a history of non-melanoma skin cancer, or other malignancies, treated less than 5 years or more prior to the current tumor * Patients requiring total parental nutrition with lipids. * Patients exhibiting confusion, disorientation, or having a history of major psychiatric illness that may impair the understanding of the informed consent. * Patients refusing to sign the informed consent. * Histology other than squamous cell carcinoma. * Inability or unwillingness to take folic acid or vitamin B12 supplementation * Inability to take corticosteroids * Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (for short-acting NSAIDs) or 8-day period (for long-acting NSAIDs, such as piroxicam).

Study Objectives Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) from rhumatologic, endocrinologic, cardiac or other system origin. This study investigates reports of drug induced irAEs with treatment including anti-PD1, Anti-PDL-1, and Anti-CTLA4 classes using the World Health Organization (WHO) database VigiBase and the french database Base Nationale de PharmacoVigilance (BNPV). Conditions: Arthritis, Cancer, Cardiac Disease, Endocrine System Diseases, Autoimmune Diseases, Ophthalmopathy, Myositis, Neuropathy Intervention / Treatment: DRUG: Immune checkpoint inhibitor Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Case reported in the World Health Organization (WHO) database and Base Nationale de Pharmacovigilance (BNPV) of individual safety case reports to 01/05/2018 * Adverse events reported * Patients treated with ICIs, in monotherapy or combination, included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32). Exclusion Criteria: * Chronology not compatible between the drug and the toxicity

Study Objectives This trial studies how well dual energy computed tomography (DECT) works in imaging patients with solid organ cancer that has spread to the brain. Imaging techniques, such as DECT, may help find and diagnose tumor cells and find out how far the tumor cells have spread in the brain. Conditions: Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain Intervention / Treatment: PROCEDURE: Dual-Energy Computed Tomography Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Adult patient with pathology-proven solid organ cancer * MRI of the brain with contrast, positive for two or more metastatic lesions * One lesion with a single greatest diameter on contrast-enhanced MRI of 1 cm or greater * Planned treatment with stereotactic radiosurgery Exclusion Criteria: * Known allergy to iodine-based contrast agents * Patients with glomerular filtration rate (GFR) less than 30 or use of hemodialysis * If prior nephrectomy, GFR less than 60 * Prior central nervous system malignancy * Prior brain radiation * Pregnant women are excluded

Study Objectives EGFR is a potential target for new anticancer therapy in head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of this study are the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety. Conditions: Locally Advanced Malignant Neoplasm, Oral Cancer, Oropharyngeal Carcinoma, Effects of Chemotherapy Intervention / Treatment: DRUG: Neo-adjuvant Erbitux-based chemotherapy Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Written informed consent prior to any study activities * Age 18-75 * Histological/cytological and iconography confirmed squamous-celled oral/oropharyngeal cancer * Stage Ⅲ/Ⅳa (T1-2, N1-2, M0 or T3-4, N0-2, M0, AJCC 2010), operable disease * Karnofsky performance status (KPS) ≥70 * Adequate hematologic function: Neutrophils ≥1,500/mm\^3, WBC >4,000/mm\^3, Hb > 10 g/dL, platelet count >100,000/mm\^3 * Hepatic function: ALAT/ASAT <2.5 times the upper limit of normal (ULN), bilirubin <1.5 x ULN * Renal function: serum creatinine <1.5 x ULN * Life expectancy ≥6 months Exclusion Criteria: * Evidence of distant metastatic disease and other oropharyngeal cancers * Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment * Previous radiotherapy for the primary tumor or lymph nodes * Previous exposure to epidermal growth factor-targeted therapy * Prior chemotherapy or immunotherapy for the primary tumor * Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix * Any investigational agent prior to the 1st study medication * Participation in another clinical study within the 30 days prior to Inclusion in this study. * Peripheral neuropathy >grade 1 * Known grade 3 or 4 allergic reaction to any of the study treatment * History of severe pulmonary or cardiac disease * Creatinine Clearance <30 ml/min * Know drug abuse /alcohol abuse * Legal incapacity or limited legal capacity * Active systemic infection * Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study * Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol * Pregnancy (confirmed by serum or urine β-HCG) or lactation period * Severe cardiac disease such as heart failure, clinical relevant cardiac dysrhythmias, coronary artery disease or myocardial infarction within the last 12 months

Study Objectives This study is to determine the Maximal Tolerated Dose (MTD), the Dose Limitant Toxicities (DLTs) and the safety profile of S-1 combined with fixed doses of Irinotecan (SIRI schedule) and fixed doses of Irinotecan and Oxaliplatin (SIRINOX schedule). Conditions: Digestive Cancer Intervention / Treatment: DRUG: S-1, DRUG: Irinotecan, DRUG: Oxaliplatin, OTHER: G-csf Location: France 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 ≥ 18 years old * Histologically confirmed diagnosis of advanced or metastatic digestive adenocarcinoma (gastroesophageal adenocarcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma, cholangiocarcinoma, hepatocarcinoma) * Metastatic or advanced disease not eligible for curative surgery * No active biliary obstruction * Previous adjuvant chemotherapy is allowed. It must be completed at least 6 months before the start of the study treatment * First line chemotherapy is allowed (excluding chemotherapy with Capecitabine or 5 FU or Irinotecan or Oxaliplatin). Previous Oxaliplatin is allowed in patients receiving SIRI * A four-week washout period since prior treatment * One or more measurable metastatic lesions * ECOG status ≤ 1 * Total bilirubin ≤ 1.5 Upper limit of normal (ULN), ALT or AST ≤ 2.5 ULN (or < 5 in case of liver impairment) * Haemoglobin ≥ 10 g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and white blood cells > 3000 /mm3 * Lipase < 1.5 ULN, serum creatinine ≤ 1.5 ULN * Negative pregnancy test in women of childbearing potential * Use of an effective contraceptive method during the whole treatment and up to 3 months after the completion of treatment * Life expectancy > 3 months * Informed consent form (ICF) signed prior to any study specific procedures * Patients must be affiliated to a Social Security System Exclusion Criteria: * History of previous treatment with Oxaliplatin except for SIRI, Irinotecan, 5 FU or Capecitabine as first-line chemotherapy * Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF * Known central nervous system metastases * Unique bone metastasis * History or presence of other cancer within the past 5 years (except curatively treated non-melanoma skin cancer) * Patients with a known deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), as well as patients who, within the previous four weeks, have been treated with a medicine that inhibits this enzyme * Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose or galactose malabsorption * Malabsorption syndrome or disease significantly affecting gastro-intestinal function * Patient with dysphagia or inability to swallow the tablets * Inflammatory bowel disease with chronic diarrhoea (Grade ≥ 2 NCI CTC V4.03) * History of organ transplantation with use of immunosuppression therapy * Concomitant severe infection (> grade 2 NCI.CTCAE v4.03) or major organ failure * Active cardiac disease, angina pectoris or myocardial infarction in the last 6 months * Renal disease * Unstable diabetes * Creatinine clearance < 50 ml/min calculated using the MDRD formula * Pregnant or breastfeeding women * Participation in another clinical trial within 30 days prior to study entry * Psychological, social, geographical or any other condition that would preclude study compliance (treatment administration and study follow-up) * 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 Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Conditions: Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Waldenström Macroglobulinemia Intervention / Treatment: DRUG: oxaliplatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype * Indolent * Follicular small cleaved cell * Follicular mixed cell * Small lymphocytic * Mucosa-associated lymphoid tissue (MALT) * Monocytoid B-cell * Waldenstrom's macroglobulinemia * Aggressive * Follicular large cell * Diffuse large cell * Immunoblastic * Mantle cell * Ki-1+ NHL * Peripheral T-cell * Angiocentric and angioimmunoblastic * Transformed lymphoma * Bidimensionally measurable disease * No more than 3 prior treatment regimens as follows: * Primary radiotherapy is 1 regimen * Combined therapy with radiotherapy and chemotherapy is 1 regimen * Alternating therapy is 1 regimen * No known brain metastases * Performance status - ECOG 0-2 * Performance status - Karnofsky 50-100% * WBC count at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin normal * SGOT/SGPT no greater than 2.5 times upper limit of normal * Creatinine normal * Creatinine clearance at least 60 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No neuropathy greater than grade 1 * No history of allergy to platinum compounds or antiemetics * No uncontrolled illness * No active infection * Not pregnant or nursing * Fertile patients must use effective contraception * No concurrent colony-stimulating factors during first course of therapy * At least 4 weeks since prior chemotherapy * At least 4 weeks since prior radiotherapy * No other concurrent investigational drugs * No concurrent antiretroviral therapy for HIV-positive patients

Study Objectives The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DRUG: Satraplatin in combination with Paclitaxel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed advanced NSCLC * Patients must not have received any prior antineoplastic chemotherapy or investigational product for lung cancer prior to study entry. * Patients must have at least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan. * ECOG performance status of ≤ 2.

Study Objectives This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in combination with metronomic temozolomide in terms of progression-free survival. Conditions: Glioblastoma Multiforme Intervention / Treatment: DRUG: Bevacizumab, DRUG: Metronomic Temozolomide 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 histologically confirmed diagnosis of WHO grade IV primary malignant glioma * Karnofsy Performance Status (KPS) >= 60% * Evidence of measurable primary CNS neoplasm on contrast-enhanced MRI. * An interval of at least 4 weeks between prior surgical resection or 1 week from a biopsy and enrollment on this protocol * An interval of at least 4 weeks from the end of prior radiotherapy or one week from the end of a cycle of chemotherapy and enrollment on this protocol. * No evidence of CNS hemorrhage on the baseline MRI or CT scans Exclusion Criteria: * Life expectancy < 8 weeks * Pregnancy or breast feeding * Progression to metronomic temozolomide, defined as tumor progression while taking daily temozolomide or progression within 4 weeks of stopping metronomic temozolomide * Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)

Study Objectives A feasibility study of neoadjuvant chemotherapy (NAC) followed by interval cytoreductive surgery (ICS) and postoperative chemotherapy for stage III/IV mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas. Conditions: Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms Intervention / Treatment: DRUG: Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Stage III or IV müllerian carcinoma by prelaparoscopic clinical findings including imaging studies (CT, MRI or ultrasonography) * Cytology of ascites, pleural effusions, or fluids obtained by tumor centesis * Malignancies of other origins, such as breasts and digestive tract, should be excluded by endoscopy, opaque enema, or ultrasonography when these malignancies are suspected from symptoms, physical examinations or imaging diagnosis. * CA125>200U/ml and CEA<20ng/ml. * Clinically deemed to be a candidate for debulking surgery without evidence of brain, bone, bone marrow metastases, multiple lung, or multiple liver metastases * Presence of at least one measurable lesion * Previously untreated for these malignancies and no history of treatment with chemotherapy or radiotherapy even for other diseases * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3, * Adequate bone marrow, hepatic, renal, cardiac and respiratory functions, and * Written informed consent. Exclusion Criteria: * Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ * Pregnant or nursing * Severe mental disorders * Systemic and continuous use of steroidal drugs * Active infections * Uncontrolled hypertension * Diabetes mellitus, uncontrolled or controlled with insulin * History of cardiac failure, unstable angina, myocardial infarction within 6 months prior to the registration * Liver cirrhosis or bleeding tendency contraindicating debulking surgery * Intestinal occlusion necessary for surgical treatment * Hypersensitivity to alcohol

Study Objectives The goal of this clinical research study is to find out how treatment with abiraterone acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH) analogue changes the tumor in comparison to treatment with an LHRH analogue alone. Objectives: Primary Objective: To assess the difference in pathologic stage \< pT2 between Group A and Group B. Secondary Objective: * To assess and compare the changes in levels of androgens (pre, during, and post treatment) in the serum, primary tumor microenvironment and bone marrow between Group A and Group B. * To assess changes in biomarkers related to androgen signaling and other cancer-related pathways between Group A and Group B. * To assess the difference in rate of positive surgical margins between Group A and Group B. * To assess the safety profile of abiraterone acetate and low dose prednisone in a preoperative setting. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Abiraterone Acetate, DRUG: Prednisone, DRUG: LHRHa Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological proof of prostatic adenocarcinoma via a minimum of 6 core biopsy samples * Clinical stage T1c or T2 with high-grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade >= 7 and PSA > 10ng/ml. * No evidence of metastatic disease as determined by CT scans and bone scans. * Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1 * Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (ANC) > 1,500 and platelet count of > 100,000. * Normal pituitary and adrenal function * Patients should be deemed to be candidates for radical prostatectomy. Exclusion Criteria: * Histological variants in the primary tumor (histological variants other than adenocarcinoma); neuroendocrine tumor * Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection * Uncontrolled hypertension * Abnormal Liver function * Active or symptomatic viral hepatitis or chronic liver disease * Clinically significant heart disease * Other active malignancy * History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug * Previous treatment with abiraterone acetate * Patients who are not appropriate surgical candidates for radical prostatectomy * Prior chemotherapy or radiation therapy for prostate cancer. * Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Study Objectives This randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia Gravis score (QMG score) as primary endpoint, and in addition, to assess the safety of GB-0998 Conditions: Generalized Myasthenia Gravis Intervention / Treatment: BIOLOGICAL: GB-0998 (Intravenous immunoglobulin), PROCEDURE: Plasmapheresis Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Patients diagnosed as generalized myasthenia gravis * Patients who are not controlled by current therapy and need plasmapheresis therapy * Patients who have the high-dose steroid therapy for over a month in past years, and also who take steroid or immunosuppressant on the day of consent * Patients who had not any dose increase or new dosing of steroid or immunosuppressant within 4 weeks prior to enrollment Exclusion Criteria: * Patients who received steroid pulse therapy, globulin therapy or plasmapheresis therapy within 12 weeks prior to enrollment * Patients who had undergone thymectomy within 24 weeks prior to enrollment * Patients with 3 points item in bulbar symptom of MG-ADL scale * Patients with severe hepatic disorder, severe renal disorder or severe heat disorder * Patients who have received treatment of malignant tumors * Patients who have the anamnesis of shock or hypersensitivity to this drug * Patients who have been diagnosed as hereditary fructose intolerance * Patients who have the anamnesis of cerebral infarction or symptom of these diseases * Patients who have been diagnosed as IgA deficiency in their past history * Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant * Patients who were administered other investigational drug within 12 weeks before consent

Study Objectives The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chiauranib and Chidamide administered orally over a range of doses in patients with relapsed or refractory non-Hodgkin's lymphoma, in the meantime, exploring the pharmacodynamic profile and latent biomarkers accompany with Chiauranib and Chidamide , as well as the relevancy of which and clinical benefit. Conditions: Non-hodgkin's Lymphoma Intervention / Treatment: DRUG: Chiauranib, DRUG: Chidamide Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or Female, aged ≥ 18 yrs and ≤70 yrs; * Patients with NHL refractory to at least 2 different chemotherapies , for which no standard therapy exists; * At least 1 lesion can be accurately measured, as defined by Lugano 2014 criteria. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; * Subjects received anti-cancer therapy (including chemotherapy, radiotherapy, immunotherapy and surgical therapy, et al) should beyond 4 weeks prior to study entry; Subjects received mitomycin chemotherapy should beyond 6 weeks prior to study entry; Subjects received autologous stem cell transplantation should beyond 3 months prior to study entry; * Laboratory criteria are as follows: Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets >=90×109/L Biochemistry test: total bilirubin≦1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≦1.5×ULN; (ALT,AST≦5×ULN if liver involved) ;serum creatinine(cr)≦1.5×ULN; Coagulation test: International Normalized Ratio (INR) < 1.5 * Life expectancy of at least 3 months. * Willingness to sign a written informed consent document. Exclusion Criteria: * Clinical evidence of central nervous system involvement * Patients with prior invasive malignancies with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, unless received curative treatment and with documented evidence of no recurrence in the past five years; * Previous treatment with HDAC inhibitors(include Chidamide) or aurora kinase(include Chiauranib) inhibitors; * Have uncontrolled or significant cardiovascular disease, including: 1. Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) < 50% requiring treatment with agents during screening stage. 2. primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al) 3. History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 450 ms prior to study entry 4. Symptomatic coronary heart disease requiring treatment with agents 5. Uncontrolled hypertension (> 140/90 mmHg) by single agent; * Have active bleeding current thrombotic disease, patients with bleeding potential ,or receiving anticoagulation therapy; within 2 months prior to screening; * Proteinuria positive(≥1g/24h); * History of deep vein thrombosis or pulmonary embolism; * Have unsolved toxicities (> grade 1) from prior anti-cancer therapy; * Have clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, that would impair the ingestion,transportation or absorption of oral agents, or patients undergone gastrectomy; * History of organ transplantation ，Allogeneic bone marrow transplantation or autologous stem cell transplantation; * High-risk surgery for vital organs within 6 weeks prior to screening or the investigators determined that other surgical wounds did not heal well; * Serologically positive for HIV, hepatitis B or C, or other serious infectious diseases; * History of interstitial lung disease(ILD); * Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study; * Candidate with drug and alcohol abuse; * Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study (both male and female participants).Pregnant or breastfeeding women. Female participants must have a negative urinary or serum pregnancy test when done or have evidence of post-menopausal status (Defined as absence of menstruation for greater than 12 months, bilateral oophorectomy or hysterectomy); * Any other condition which is inappropriate for the study in the opinion of the investigators.

Study Objectives This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer. Conditions: Neoplasms, Breast Intervention / Treatment: DRUG: lapatinib, DRUG: bevacizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Masking: NONE

Inclusion criteria: * Females that are at least 18 years of age. * Women of childbearing potential must have a negative serum pregnancy test at screening. * Documented evidence of HER2-overexpressing unresectable or metastatic breast cancer. Disease may/may not have been treated in metastatic setting. * Subjects are permitted (but not required) to have previously-treated brain metastases that are stable and asymptomatic. * Adequate hepatic, renal and cardiac function * ECOG score 0-1 and a life expectancy of at least 12 weeks. * Able to swallow oral medication * Signed informed consent Exclusion criteria: * Pregnancy * Unstable or symptomatic CNS metastases * Major surgery within 28 days of enrollment (minor surgery within 7 days). * Prior anti-cancer treatment within 14 days of enrollment, or unresolved treatment-related toxicities. * A serious non-healing wound, ulcer, or bone fracture at baseline. * Class II, III or IV heart failure as defined by the NYHA functional classification system * History of significant vascular disease, arterial thrombosis, unstable INR, hypertensive crisis, or uncontrolled hypertension. * History of myocardial infarction, stenting procedure, or angioplasty within 6 months of enrollment. * History of abdominal fistulae, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment. * History of malabsorption syndrome, ulcerative colitis, or bowel obstruction. * Proteinuria * Requires concurrent anti-cancer treatment or investigational treatment. * Known hypersensitivity to either study medication * Received investigational treatment within 28 days or 5 half-lives, whichever is longer * Concurrent disease or circumstances that would lead the investigator would consider the subject an inappropriate candidate for the study * Requires medication that has been excluded during study participation

Study Objectives This study is to determine first the appropriate dose of lenalidomide to administer in combination with fixed doses of obinutuzumab in relapsed/refractory follicular lymphoma patients. In a second step, this study aims to determine the efficacy of this combination in 3 separate populations: relapsed/refractory aggressive lymphoma (diffuse large B-cell lymphoma and mantle cell lymphoma: cohort 1), relapsed/refractory follicular lymphoma (cohort 2) and previously untreated follicular lymphoma (cohorts 3 and 4). Conditions: Follicular Lymphoma Patients (Phase IB), Follicular and Agressive (DLBCL&MCL) B-cell Lymphoma Patients (Phase II) Intervention / Treatment: DRUG: Lenalidomide and GA101 Location: Belgium, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Phase IB only: Histologically documented CD20-positive follicular lymphoma (WHO grade 1, 2, or 3a) patients * Phase II: Patients with either histologically documented CD20-positive Diffuse large-cell lymphoma or Mantle cell lymphoma (cohort 1) or follicular lymphoma, WHO grade 1, 2 or 3a (cohort 2-3-4) * Phase IB and II: * Relapsed/refractory NHL after ≥1 prior R-containing regimen with no curative option (cohort 2 only) * Aged 18 years or more * ECOG performance status 0, 1 or 2 * At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter > 1.5 cm and a short axis ≥ 10mm * Signed inform consent * Life expectancy ≥ 3 months. * All subjects must be able to understand and fulfill the lenalidomide Pregnancy Prevention Plan requirements (see in appendix) * Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 2 months after discontinuation of all study treatments. Exclusion Criteria: * Previous treatment with obinutuzumab or lenalidomide * Known CD20 negative status at relapse/progression. Biopsy at relapse/progression is recommended but not mandatory * Central nervous system or meningeal involvement by lymphoma * Contraindication to any drug contained in the study treatment regimen * Known HIV or HTLV-1 infection, positive serology to HB surface antigen \[HBsAg\] or total HB core antibody \[anti-HB-c\]) and Hepatitis C (Hepatitis C virus \[HCV\] antibody) * Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision) * Any of the following laboratory abnormalities unless secondary to underlying lymphoma: * Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L). * Platelet count < 100,000/mm3 (100 x 109/L) unless due to lymphoma for phase II part. * Serum SGOT/AST or SGPT/ALT 3.0 x upper limit of normal (ULN) unless disease involvement. * Serum total bilirubin > 2.0 mg/dL (34 μmol/L), except if disease related or in case of Gilbert syndrome * Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of < 50 mL /min. For phase II part of the study, patients with calculated creatinine clearance between 30 and 50ml/min can be included and lenalidomide dose will be adjusted as follows (10mg once daily) * Prior history of malignancies other than lymphoma unless the subject has been free of the disease for ≥ 5 years * Any serious medical condition, laboratory abnormality (other than mentioned above), or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or lactating females. * Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide. * Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide. * Subjects with ≥ Grade 2 neuropathy. * Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy * Patients taking corticosteroids during 4 weeks before inclusion, unless administered at a dose equivalent to ≤ 10 mg/day prednisone (over these 4 weeks) * Prior history of Progressive Multifocal Leukoencephalopathy (PML)

Study Objectives Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. This randomized phase III trial is studying giving combination chemotherapy together with PSC 833 followed by a peripheral stem cell transplant with or without interleukin-2 to see how well it works compared to combination chemotherapy alone followed by a peripheral stem cell transplant with or without interleukin-2 in treating patients with acute myeloid leukemia. Conditions: Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Erythroid Leukemia (M6), Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Childhood Acute Basophilic Leukemia, Childhood Acute Eosinophilic Leukemia, Childhood Acute Erythroleukemia (M6), Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Minimally Differentiated Myeloid Leukemia (M0), Childhood Acute Monoblastic Leukemia (M5a), Childhood Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5), Childhood Acute Monocytic Leukemia (M5b), Childhood Acute Myeloblastic Leukemia With Maturation (M2), Childhood Acute Myeloblastic Leukemia Without Maturation (M1), Childhood Acute Myelomonocytic Leukemia (M4), Childhood Myelodysplastic Syndromes, de Novo Myelodysplastic Syndromes, Untreated Adult Acute Myeloid Leukemia, Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies Intervention / Treatment: DRUG: cytarabine, DRUG: daunorubicin hydrochloride, DRUG: etoposide, DRUG: valspodar, BIOLOGICAL: filgrastim, DRUG: busulfan, PROCEDURE: autologous hematopoietic stem cell transplantation, PROCEDURE: peripheral blood stem cell transplantation, BIOLOGICAL: aldesleukin, OTHER: clinical observation, OTHER: pharmacological study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Unequivocal histologic diagnosis of AML (> 20% blasts in the bone marrow based on the World Health Organization \[WHO\] and/or French-American-British Cooperative group \[FAB\] classifications), excluding M3 (acute promyelocytic leukemia); patients with antecedent myelodysplasia are eligible for treatment on this trial only if there was no bone marrow biopsy showing myelodysplastic syndrome (MDS) > 3 months prior to enrollment; patients with therapy-related MDS or therapy-related AML or a chronic myeloproliferative disorder are not eligible * No prior treatment for leukemia or myelodysplasia with four permissible exceptions: * Emergency leukapheresis * Emergency treatment for hyperleukocytosis with hydroxyurea * Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only) * Growth factor/cytokine support

Study Objectives The study allowed continued safety follow-up of patients who were on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which had met its primary endpoint and were benefiting from the treatment as judged by the investigator. Conditions: Solid Tumors Intervention / Treatment: DRUG: dovitinib, DRUG: fulvestrant Location: Japan, Italy, Spain, Denmark, United States, Belgium, Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * patient was currently enrolled in Novartis sponsored study, which had met its endpoint and was receiving single agent oral dovitinib or dovitinib and fulvestrant coadministration * patient was currently benefiting from treatment with single agent oral dovitinib or dovitinib and fulvestrant coadministration as determined by the guidelines of the parent protocol and according to the investigator's clinical judgment. * patient had demonstated compliance * patient had given written informed consent. Exclusion Criteria: * patient had been permanently discontinued from oral dovitinib study treatment, either alone or in combination with fulvestrant, in the parent study * patient was pregnant or nursing at the time of entry * women of child-bearing potential and male patients with sexual partners of child-bearing potential unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment

Study Objectives This study is to investigate blood and urine kidney injury markers (especially Uromodulin) in pediatric cancer patients treated with nephrotoxic chemotherapy. Uromodulin is a marker to detect and monitor tubular injury and renal function. Conditions: Kidney Impairment Intervention / Treatment: OTHER: blood test for renal biomarkers, OTHER: urine test for renal biomarkers Location: Switzerland Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * signed informed consent by their-selves (≥ 14 years) or their legal representatives (< 14 years or in case of lacking capacity of judgement) * cancer diagnosis, that indicates a nephrotoxic chemotherapy including the drugs High Dose MTX (HD-MTX), ifosfamide, cis- and carboplatin. Exclusion Criteria: * critically-ill patients with inotropic and/or vasopressor drugs * signs of severe Sepsis * receiving other nephrotoxic drugs parallel to the chemotherapy cycle

Study Objectives This phase I/II trial studies the best dose and side effects of mogamulizumab in combination with pembrolizumab and to see how well they work in treating patients with diffuse large B cell lymphoma that have come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as mogamulizumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Conditions: Recurrent Diffuse Large B-Cell Lymphoma, Recurrent High Grade B-Cell Lymphoma, Recurrent Transformed B-Cell Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory High Grade B-Cell Lymphoma, Refractory Transformed B-Cell Non-Hodgkin Lymphoma Intervention / Treatment: BIOLOGICAL: Mogamulizumab, BIOLOGICAL: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must have histologically confirmed diffuse large B-cell lymphoma; all subtypes of diffuse large B-cell lymphoma are eligible, including high-grade B-cell lymphoma and diffuse large B-cell lymphoma (DLBCL) that has transformed from a prior indolent B-cell non-Hodgkin lymphoma * Patients must have measurable disease per 2014 Lugano Classification Criteria which is defined as at least one nodal lesion measuring > 1.5 cm in greatest diameter or at least one extranodal lesion measuring > 1.0 cm in greatest diameter * For phase 2: patients and received at least 2 prior lines of therapy and must have previously received, refused, or been deemed ineligible for autologous stem cell transplantation * Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%) * Absolute neutrophil count >= 1,500/mcL (if neutropenia is related to bone marrow involvement with lymphoma, the absolute neutrophil count must be >= 1,000/mcL) * Platelets >= 75,000/mcL (if thrombocytopenia is related to bone marrow involvement with lymphoma, the platelet count must be >= 50,000/mcL) * Hemoglobin >= 9 g/dL (if anemia is related to bone marrow involvement with lymphoma, the hemoglobin must be >= 8 g/dL) * Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN) or < 3 x the ULN for indirect bilirubin in patients with Gilbert's disease * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal * Creatinine =< 1.5 x institutional upper limit of normal OR measured or calculated creatinine clearance if creatinine > 1.5 x ULN then creatinine clearance >= 40 mL/min/1.73 m\^2 as calculated by Cockcroft and Gault equation * Life expectancy of greater than 3 months * The effects of MK-3475 (pembrolizumab) in combination with KW-0761 (mogamulizumab) on the developing human fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and 6 months after completion of MK-3475 (pembrolizumab) in combination with KW-0761 (mogamulizumab) administration; 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 6 months after completion of MK-3475 (pembrolizumab) in combination with KW-0761 (mogamulizumab) administration * Submit adequate archival tissue specimen (25+ unstained slides or 2 tissue blocks) from a biopsy performed after progression of disease on most recent therapy OR subject is willing to undergo a new core or excisional biopsy to obtain evaluable tumor tissue sample for immunohistochemical assessment and sequencing for B2M loss; repeat samples may be required if adequate tissue is not provided, however, patients may still be considered for enrollment on a case by case basis following consultation with the principal investigator (PI) * Ability to understand and the willingness to sign a written informed consent document * Subjects with prior history of chemotherapy-induced or radiation-induced pulmonary toxicity require confirmation of diffuse capacity of the lung for carbon monoxide (DLCO) over 60% (adjusted for hemoglobin) by a pulmonary function test prior to study enrollment Exclusion Criteria: * Patients who have had previous systemic anti-cancer therapy within 3 weeks of registration or those who have not recovered from adverse events due to agents administered previously * Note: Patients are considered enrolled on the study after protocol registration and not after signing consent * Patients who are receiving any other concurrent investigational agents * Patient is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment; the use of physiologic doses of corticosteroids (e.g. prednisone =< 20 mg/d) may be approved after consultation with the study PI; topical or inhaled corticosteroids are allowed * Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer * Patients with active cerebral or meningeal involvement by lymphoma should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound evaluation of neurologic and other adverse events * History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-3475 (pembrolizumab) or KW-0761 (mogamulizumab) * Subject with active autoimmune disease; subjects with vitiligo, eczema, alopecia, type I diabetes mellitus, psoriasis not requiring systemic treatment, or endocrine deficiencies (such as hypothyroidism) managed with replacement hormones, including physiologic corticosteroid replacement therapy are eligible * Has a history or currently active (non-infectious) pneumonitis that required steroids unless prior history of chemotherapy or radiotherapy induced pneumonitis meeting the eligibility criteria * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator * Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) * Prior allogeneic stem cell transplant (SCT) * Patients who are planning to receive allogeneic SCT in the near future as preliminary reports suggest added toxicity in patients undergoing allogeneic stem cell transplantation after having received mogamulizumab * Autologous SCT =< 90 days prior to first dose of study drug * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because MK-3475 (pembrolizumab) is an 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 MK-3475 (pembrolizumab), breastfeeding should be discontinued if the mother is treated with MK-3475 (pembrolizumab); these potential risks may also apply to KW-0761 (mogamulizumab) * MK-3475 (pembrolizumab) and KW-0761 (mogamulizumab) may have adverse effects on a fetus in utero; furthermore, it is not known if MK-3475 (pembrolizumab) or KW-0761 (mogamulizumab) has transient adverse effects on the composition of sperm; patients are excluded from this study if pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of trial treatment * Patients with human immunodeficiency virus (HIV) are excluded if they have a detectable viral load, are not on a stable antiretroviral regimen, have a decreased CD4+ T-cell count (< 500), or require prophylactic antibiotics for the prevention of opportunistic infections * Has a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection * Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority * Has a known history of active tuberculosis (TB) * Patients with significant cardiac disease (e.g., New York Heart Association \[NYHA\] class III-IV congestive heart failure, unstable angina, recent myocardial infarction within the last 6 months, etc.)

Study Objectives The study evaluates the protective effect of low-dose aspirin use on gastrointestinal cancers (colorectal, esophageal and gastric cancers) in long-term users, episodic users and non-users of aspirin in Taiwan. Conditions: Colorectal Neoplasms Intervention / Treatment: DRUG: Aspirin (Acetylsalicylic Acid, BAYE4465), OTHER: No drug Location: Taiwan Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age 40 or older at the cohort entry date. * Taiwanese National Health Insurance enrollees with non-missing and consistent age and gender information. Exclusion Criteria: * Subjects with any cancer diagnosis before cohort entry date. * No use of National Health Insurance before the cohort entry date. * Low dose aspirin prescription before cohort entry date. * Subjects with conditions contra-indicated for low dose aspirin use before cohort entry date.

Study Objectives The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities. Conditions: Keratosis, Actinic Intervention / Treatment: DRUG: Aminolevulinic Acid (ALA), DEVICE: BLU-U Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * At least 6 Grade 1/2 AKs on one upper extremity AND * At least 12 Grade 1/2 AKs on the OTHER upper extremity Exclusion Criteria: * Pregnancy * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area * Body Mass Index (BMI) > 32.0 kg/m2 * skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline) * tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV * a history of lead poisoning or a history of a significant exposure to lead or a screening lead level above 6μg/dl * tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result * positive drug screen at Screening * Screening safety labs are clinically significant in the opinion of the investigator * major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study * Subject is immunosuppressed * currently enrolled in an investigational drug or device study * has received an investigational drug or been treated with an investigational device within 30 days prior to Visit 2 (Baseline) * known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol) * use of the following topical preparations on the extremities to be treated: * Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment * Cryotherapy within 2 weeks of initiation of treatment * Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment * use of systemic retinoid therapy within 6 months of initiation of treatment

Study Objectives A study to look at the effectiveness of a drug called APD515, designed to be applied to the lining inside the mouth, at relieving dryness of the mouth. Study will compare one week of treatment with APD515 to one week of treatment with matching placebo to see which has better effect on patient's mouth dryness, according to their own score. Conditions: Xerostomia in Advanced Cancer Patients Intervention / Treatment: DRUG: APD515, DRUG: Placebo Location: Denmark, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: DOUBLE

Inclusion Criteria: * Aged ≥ 18 years * Able and willing to give written informed consent. * Confirmed primary neoplasm at any site (apart from non-melanoma skin cancers), for which first-line cytotoxic therapy has been completed more than one month prior to study entry. Ongoing palliative, hormonal, cytostatic or "targeted" (e.g., monoclonal antibody, tyrosine kinase inhibitor, etc) therapy is permitted, provided that the risk of oral mucositis in the subject is not judged to be significant. * Subjective complaint of dry mouth, ongoing for at least two weeks prior to study entry. * Capacity for salivary stimulation, as demonstrated by stimulated whole saliva flow rate > unstimulated whole saliva flow rate. * Karnofsky performance score ≥ 60% or ECOG performance status ≤ 2. * Adequate renal and hepatic function and hydration status: * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5 \* upper limit normal (ULN); * Serum urea < 1.5 \* ULN and serum urea:creatinine ratio < 100 (where urea and creatinine expressed in the same units); * Plasma sodium ≤ ULN. * Adequate haematological function: * Haemoglobin ≥ 9 g/dL; * White blood count ≥ 1.0 \* 10\^9/L; * Platelet count ≥ 50 \*x 10\^9/L. * For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) during the study and for a period of at least 48 hours afterwards. Exclusion Criteria: * Confirmed diagnosis of Sjögren's syndrome. * Prior radiotherapy for head \& neck cancer, or other substantial doses of radiation delivered to the area of the mouth or salivary glands. * Significant, symptomatic disease of the oral cavity, including oral candidosis or oral mucositis. * Allergy to active ingredient or any of the excipients of APD515. * Use of oral or topical (including ocular) pilocarpine or cevimeline in the two weeks prior to enrolment. * Concomitant use of procainamide, quinidine or ganglionic blocking agents such as mecamylamine, pentolinium and trimethaphan. * Intestinal or urinary obstruction. * Myocardial infarction or intestinal anastomosis within the previous 6 months. * Participation in an investigational drug or device study within 1 month prior to study entry. * For female subjects only, a positive pregnancy test. * Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.

Study Objectives This phase II trial studies how well exemestane and cyclophosphamide work in treating patients with estrogen receptor (ER) -positive, progesterone receptor (PR) -positive, and human epidermal growth factor receptor (HER)2-negative stage IV breast cancer. Conditions: Metastatic Beast Cancer Intervention / Treatment: DRUG: Exemestane, DRUG: Cyclophosphamide 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 histologically confirmed breast cancer that is ER positive and/or PR positive, and HER2/neu negative and have disease that is metastatic (stage IV) * HER2/neu negative disease determined using commercially available/approved assay in local institutional or reference laboratory, according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (IHC 0-1+ or 2+ with HER2/17 ratio on FISH <= 1.8). * ER/PR expression performed by standard immunohistochemical assay and classified as ER and/or PR-positive according to ASCO/CAP guidelines (1-100% expression) * Histologic and/or cytologic confirmation of metastatic disease is encouraged whenever feasible, furthermore, if feasible, the biopsy should confirm that the metastatic tumor is ER and/or PR positive and HER2/neu negative. For patients in whom histologic biopsy confirmation and/or assessment of ER/PR/HER2 of metastatic disease is not feasible, it is required that the primary tumor be ER and/or PR-positive and HER2/neu negative. * Measurable disease (RECIST 1.1) or non-measurable (assessable) disease * Patients must have had progressive disease during at least one line of endocrine therapy for metastatic disease or have recurrent disease while or within 12 months of receiving adjuvant endocrine therapy. Prior treatments accepted include a non-steroidal aromatase inhibitor, tamoxifen, fulvestrant or combinations. * Patients taking bisphosphonates for bone disease are permitted to enter the trial, but their bone lesions are not considered to be assessable for response, although they are assessable for progression. * Female or male subjects age >= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. * Patients must have normal organ and marrow function as defined below: * absolute neutrophil count >= 1,200/mcL * platelets >= 100,000/mcL * hemoglobin >= 9g/dl * total bilirubin <= 2 X upper limit of normal (ULN) \[unless due to Gilbert's disease\] * AST(SGOT) <= 2.5 X ULN * ALT(SGPT) <= 2.5 X ULN * creatinine <= 1.5 X ULN * Patients must be able to swallow and tolerate oral medications. * Postmenopausal status, defined as 60 years and older, being 45 years and older and having amenorrhea x 12 months or follicle stimulating hormone levels within postmenopausal range, OR having undergone a bilateral oophorectomy. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients may not be receiving any other investigational agents. * Prior treatment for breast cancer with a steroidal aromatase inhibitor; with the exception of patients who were started on the combination of exemestane with everolimus less than 4 weeks prior to study entry and discontinued everolimus due to poor tolerability. * Presence of life threatening metastatic visceral disease (defined as extensive hepatic involvement or symptomatic pulmonary lymphangitic spread) or uncontrolled brain metastases. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Study Objectives The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the Optional Treatment Phase. Conditions: Advanced Solid Tumors, Pharmacokinetics of 14C-OSI-906 Intervention / Treatment: DRUG: radio-labeled OSI-906, DRUG: OSI-906 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The subject has histologically or cytologically confirmed diagnosis of advanced solid tumor (measurable or non-measurable disease) for which no conventional therapy is available * The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 * The subject has a predicted life expectancy ≥12 weeks * The subject has a fasting glucose ≤125 mg/dL (7 mmol/L) at Screening, Day -1 and pre-dose Day 1 * The subject has adequate organ function defined by the following laboratory parameters: * absolute neutrophil count (ANC) ≥1.5 x 10 9/L * platelet count ≥100 x 10 9/L * total bilirubin ≤1.5 x upper limit of normal (ULN) * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if subject has documented liver metastases * serum creatinine ≤1.5 x ULN * potassium, calcium, and magnesium within normal limits or determined by the investigator to be not clinically significant (NCS) * The subject has a negative cotinine test * If male, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method while participating in the study and for 90 days after the last dose of study medication * If female, the subject is surgically sterile or status post hysterectomy, post-menopausal, or is using 2 forms of medically acceptable methods of birth control, one of which must be a barrier method to prevent pregnancy and agrees to continue using this method from screening until 90 days after the last dose of study medication * If female, the subject must not be breastfeeding at Screening, during the study period and for 90 days after last dose of study drug administration * If female, the subject must not donate ova starting at Screening, and throughout the study period and for 90 days after last dose of study drug administration * Female subject of child bearing potential has a negative pregnancy test at Screening and Day -1 Exclusion Criteria: * The subject has Type 1 or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy * The subject has a history of poorly controlled gastrointestinal disorder (s) that could affect the absorption or metabolism of study drug * The subject has used IGF-1R inhibitor therapy in last 6 months * The subject has hepatocellular carcinoma * The subject has used a CYP1A2 inhibitor or inducer within 14 days prior to Day 1 * The subject has used drugs with a risk of causing QTc interval prolongation and Torsade de Pointes (TdP) within 14 days prior to Day 1 * The subject has a history (within last 6 months) of significant cardio-vascular disease * The subject has a history (within the last 6 months) of significant arrhythmia disease, unless the disease is well-controlled with medication per the Principal Investigator's clinical judgment * The subject has had major surgery ≤ 3 weeks prior to Day 1 * The subject has had radiation ≤ 3 weeks prior to Day 1 * The subject has had chemotherapy ≤ 3 weeks prior to Day 1 * The subject has participated in a radiolabeled study in the last 12 months * The subject has a history of cerebrovascular accident (CVA) within 6 months prior to Day 1 or that resulted in ongoing neurologic instability * The subject has an active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to Day 1) that would impair the ability of the subject to receive study drug * The subject has participated in any interventional clinical study within 21 days or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening * The subject has a history of any psychiatric condition that might impair the subject's ability to understand or to comply with the requirements of the study or to provide informed consent * The subject is pregnant or lactating * The subject has symptomatic brain metastases that are not stable, require steroids, or that have required radiation and/or other related treatment, (i.e., anti-epileptic medication) within 28 days prior to Day 1 * The subject has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug

Study Objectives The main purpose of this study is to begin to collect information and to try to learn whether or not cetuximab works in treating patients with unresectable or metastatic hepatocellular carcinoma. Conditions: Hepatocellular Carcinoma Intervention / Treatment: DRUG: Cetuximab 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: * Unresectable or metastatic hepatocellular carcinoma * Measurable tumor * Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7 x upper limit of normal (ULN). * Adequate renal function: serum creatinine < 2.0mg/dl * Adequate bone marrow function: absolute neutrophil count (ANC) > 1,000/mm3; platelets > 75,000/mm3. * 0-2 prior systemic chemotherapy regimens for hepatocellular carcinoma * 18 years of age and older * ECOG performance status of 0-2 * Life expectancy > 12 weeks Exclusion Criteria: * Surgery, excluding prior diagnostic biopsy or venous access device placement, within 28 days of study entry * Uncontrolled serious medical or psychiatric illness * Irradiation or chemotherapy for disease within 28 days of study entry * Clinically apparent central nervous system metastases or carcinomatous meningitis * Received an investigational agent within 30 days * Cancer of the Liver Italian Program (CLIP) score > 3 * Acute hepatitis * Active or uncontrolled infection * Significant history of cardiac disease * Prior cetuximab or other therapy which specifically and directly targets the EGFR pathway * Prior allergic reaction to chimerized or murine monoclonal antibody therapy

Study Objectives The goal of this study is to determine the dose of LY573636-sodium (hereafter referred to as LY573636) that can be administered safely in combination with liposomal doxorubicin in patients with advanced cancer who have failed a prior treatment. The study consists of a dose escalation phase to the maximum tolerated dose (MTD) and a dose confirmation phase in patients with platinum resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have never been treated with doxorubicin. Conditions: Solid Tumors Intervention / Treatment: DRUG: LY573636-sodium, DRUG: Liposomal Doxorubicin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * You must have a histologically confirmed solid malignancy that is unresectable and/or metastatic which has progressed after receiving standard approved chemotherapy * You must have a solid malignancy for which an anthracycline-based regimen is felt to be a reasonable treatment option * You must have measurable disease or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) * You must have a serum albumin level greater than or equal to 3.0 grams/deciliter (g/dL) (30 g/L) * You must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale * You must have tumor progression after receiving standard/approved chemotherapy * You must be reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures * Women must be sterile, post-menopausal or on a contraception and men must be sterile or on contraception * Your test results assessing the function of your blood, kidneys, liver, and heart are satisfactory * Ovarian patients in the confirmation phase must have failed to achieve at least a partial response to a first-line platinum-based therapy (platinum-refractory) or have progression in less than 6 months after a response to a first-line platinum-based therapy (platinum-resistant) * Ovarian patients in the confirmation phase must have measurable disease by RECIST * Ovarian patients in the confirmation phase must be liposomal doxorubicin or doxorubicin naive and not amendable to curative therapy Exclusion Criteria: * You cannot have received other investigational drugs within the last 28 days * You cannot have other on-going serious illnesses including active bacterial, fugal, or viral infections * You cannot have current hematologic malignancies, acute or chronic leukemia, or brain metastasis * You cannot currently be receiving warfarin (Coumadin®) therapy * You cannot have known positive test results in human immunodeficiency, hepatitis B surface antigen or hepatitis C antibodies * You cannot have a history of cardiac disease or clinical evidence of congestive heart failure * Ovarian patients in the confirmation phase who have received 2 or more cytotoxic regimens for platinum-resistant disease * You cannot currently be receiving amiodarone, quinidine, propofol, and clozapine * If you are taking esomeprazole or pantoprazole you must be able to stop taking this medication within 72 hours before and after LY573636 administration

Study Objectives A Phase I study of SH003 for evaluate safe dose range in patients with solid cancer. The first dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated. The second dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated. The third dose group receives SH003 for 3 weeks. Conditions: Solid Tumor, Adult Intervention / Treatment: DRUG: SH003 Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * 19 years or older * Patients with histologically and cytologically confirmed solid tumor * Patients who have failed standard treatments, such as previous chemotherapy or radiotherapy, or who are inoperable, refractory, or progressive. * ECOG score 0-2 * Patients with a minimum life expectancy of 12 weeks at the scheduled starting date of the study drug * Previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects. * Patients who can swallow pills. * Patients who provide written informed consent for participation in the trial Exclusion Criteria: * Known hypersensitivity to any study drug component, including Astragalus membranaceus, Angelica gigas, or Trichosanthes Kirilowii Maximowicz * Patients with pre-existing cardiac conditions: * Prior documented myocardial infarction within the last 6 months * Pre-existing cardiac failure (NYHA class III-IV) * Atrial fibrillation on anti-coagulants * Unstable angina * Severe valvulopathy * Cardiac angioplasty or stenting with in the last 6 months * Pregnant or lactating females * Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety * Active uncontrolled infection, including known history of AIDS or hepatitis B or C * Any psychological, sociological, or geographical condition that could potentially interfere with compliance with the study protocol * Concurrently receiving any other investigational agents while on study

Study Objectives The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks. Conditions: Lymphoma Intervention / Treatment: DRUG: Inotuzumab Ozogamicin (CMC-544) Location: Hungary, Germany, Japan, Korea, Republic of, Netherlands, United States, Belgium, Singapore, Hong Kong Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Masking: NONE

Inclusion Criteria: * Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies. * Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy. * Measurable disease with adequate bone marrow function, renal and hepatic function Exclusion Criteria: * History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse. * Prior allogeneic hematopoietic stem cell transplant (HSCT). * Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.

Study Objectives This phase II MATCH treatment trial identifies the effects of AZD4547 in patients whose cancer has genetic changes called FGFR gene alterations. AZD4547 may stop the growth of cancer cells by blocking FGFR proteins which may be needed for cell growth. Researchers hope to learn if AZD4547 will shrink this type of cancer or stop its growth. Conditions: Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Plasma Cell Myeloma Intervention / Treatment: DRUG: FGFR Inhibitor AZD4547 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 met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol * Patients must have FGFR 1-3 mutation or translocation as determined by the MATCH screening assessment * Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block) * Patients must have an echocardiogram (ECHO) or a nuclear study (multigated acquisition scan \[MUGA\] or First Pass) within 4 weeks prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50% for the patient to be eligible * Patients must have a pre-study eye exam by an ophthalmologist. Patients with current evidence of corneal or retinal disorder/keratopathy are excluded Exclusion Criteria: * Patients must not have known hypersensitivity to AZD4547 or compounds of similar chemical or biologic composition * Patients must not have received prior FGFR specific inhibitors (e.g. BGJ398, erdafitinib, BAY1163877, LY2874455). Prior non-selective FGFR inhibitor treatment (e.g. pazopanib, dovitinib, ponatinib, brivanib, lucitanib, lenvatinib) will be allowed * Patients must not have any history of or current evidence of renal or endocrine alterations of calcium/phosphate homeostasis, or history of or current evidence of extensive tissue calcification (by evaluation of the clinician), including but not limited to, the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic vascular calcification per investigators' judgment * Patients must not be currently using medications that can elevate serum phosphorous and/or calcium levels * Medications that increase serum calcium should be avoided. Over the counter calcium supplements, antacids that contain calcium (Tums) and vitamin D supplements (cholecalciferol and ergocalciferol) should be avoided. Prescription medications including lithium, hydrochlorothiazide and chlorthalidone must be used with caution * Medications that increase serum phosphate should be avoided. Over the counter laxatives that contain phosphate such as Fleets Oral or Fleets enema and Miralax should be avoided

Study Objectives Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is more effective with or without zosuquidar in treating acute myeloid leukemia. Conditions: Leukemia, Myeloid Intervention / Treatment: DRUG: Zosuquidar, DRUG: gemtuzumab ozogamicin Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Morphologic evidence of acute myeloid leukemia in first relapse. * Phase I: 18 years or older, Phase II: 50 years or older Exclusion Criteria: * Prior treatment with zosuquidar * Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents * History of stem cell transplant

Study Objectives This randomized phase II trial studies how well docosahexaenoic acid works in preventing recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence in breast cancer survivors. Conditions: Benign Breast Neoplasm, Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Lobular Breast Carcinoma In Situ, Paget Disease of the Breast, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer Intervention / Treatment: DRUG: Docosahexaenoic Acid, OTHER: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Participants must have a history of histologically-confirmed stage I-III invasive breast cancer or ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease * No evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigator * >= 6 months from all previous breast cancer treatment (including surgery for invasive cancer, chest wall radiotherapy, chemotherapy, trastuzumab and endocrine therapy) * Participants must have a body mass index (BMI) >= 25, defined as (weight in kilograms/\[height in meters\]\^2) * Participants must have adequate accessible breast tissue as determined by the treating physician, consisting of one breast unaffected by invasive cancer, which has not been radiated; a history of prior pre-invasive breast cancer or benign biopsy of this breast will be permitted * Daily DHA consumption =< 200 mg/day in the month prior to screening estimated by an abbreviated DHA food frequency questionnaire * Mammogram within no more than 6 months prior to the date of informed consent (normal/benign Breast Imaging-Reporting and Data System \[BI-RADS\] 1 or 2) and no further routine breast imaging planned during the course of the study (12 weeks DHA/placebo) * Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%) * Absolute neutrophil count >= 1,500/uL * Platelets >= 75,000/uL * White blood cells >= 3,000/uL * Hemoglobin >= 10 g/dL * Total bilirubin within 1.5 times the institution's upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) within 1.5 times the institution's ULN * Serum creatinine within 1.5 times the institution's ULN * Pregnant women will be excluded; for women of childbearing potential; negative pregnancy testing within 72 hours prior to or on study visit #1 (day 0) and willingness to use adequate contraception during the study intervention OR post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy * Willingness to comply with all study interventions and follow-up procedures including the ability to swallow the study drug * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Any type of active invasive cancer (excluding breast and non-melanoma skin cancer) within the preceding 18 months * A history of histologically-confirmed bilateral invasive breast cancer * Bilateral mastectomy * Prior history or evidence of metastatic breast cancer * Prior radiation therapy to the contralateral (unaffected) breast * Prior history of contralateral (unaffected) breast augmentation with breast implant placement * History of daily use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) in the week preceding study entry * History of DHA supplementation > 200 mg/day in the month preceding study entry * History of autoimmune disorder or any illness that requires therapy with chronic steroids or immunomodulators * History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolism) in the preceding year * Participants may not be receiving any other investigational agents during the study * Women who have received cancer surgery, chemotherapy, biological therapy (e.g., trastuzumab), or radiotherapy for the treatment of any cancer within 6 months of study participation * Women who are receiving endocrine therapy for breast cancer treatment or chemoprevention including tamoxifen, letrozole, anastrozole, fulvestrant, or exemestane at the time of screening * Individuals with severe underlying chronic illness, such as uncontrolled diabetes; ongoing or active infection, psychiatric illness or social situations which in the opinion of the investigator would interfere with study participation * History of allergic reactions attributed to compounds of similar chemical or biologic composition to DHA or corn/soy oil in placebo agent * Pregnant, breastfeeding, or women of childbearing potential unwilling to use a reliable contraceptive method

Study Objectives A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors Conditions: Urothelial Bladder Cancer, Triple-negative Breast Cancer, Pancreatic Ductal Adenocarcinoma Intervention / Treatment: BIOLOGICAL: Tremelimumab monotherapy, BIOLOGICAL: MEDI4736 monotherapy, BIOLOGICAL: MEDI4736 + tremelimumab combination therapy Location: Korea, Republic of, Netherlands, United States, Belgium, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for accurate repeated measurements. Exclusion criteria: * Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2. History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient

Study Objectives This phase II trial studies how well nivolumab works with radiation therapy in treating patients with urothelial bladder cancer that has spread from its original site of growth to nearby tissues or lymph nodes and are ineligible for chemotherapy. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab and radiation therapy may work better in treating patients with urothelial bladder cancer. Conditions: Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7 Intervention / Treatment: DRUG: Nivolumab, RADIATION: Radiation 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: * Localized urothelial cancer of bladder with presence of transitional cell carcinoma (TCC) component; mixed histologies are allowed Clinical or pathologic stage T2 -T4 disease including T4a and 4b if feasible to treat with radiation therapy Locoregional lymph node metastases are permitted but patients with distant metastases are ineligible; imaging to evaluate for distant metastases should consist of a minimum of computed tomography (CT)/magnetic resonance imaging (MRI) of abdomen/pelvis or CT urogram and a chest x-ray (CXR) or CT chest; patients for which there is clinical suspicion or symptoms of bone metastasis should have a bone scan completed to rule out metastatic disease prior to enrollment on study Agreeable to consider radiation therapy (RT) for the urothelial cancer: patients have to be evaluated by a radiation oncologist and deemed to be candidates for RT The patients must not be candidates for chemotherapy due to at least one of the following reasons: * Performance status of 2 * Creatinine clearance =< 60 ml/min as calculated by the Cockcroft-Gault formula * Cardiac disease such as New York Heart Association (NYHA) class III or IV heart failure or cardiac ischemia within the last 12 months, grade 2 or greater neuropathy, or other comorbidities based on which patient is not considered a candidate for chemotherapy Alkaline phosphatase =< 3 x upper limit of normal Aspartate aminotransferase (AST) =< 3 x upper limit of normal Alanine aminotransferase (ALT) =< 3 x upper limit of normal Bilirubin < 1.5 x upper limit of normal (ULN) Absolute neutrophil count >= 1500/mm\^3 Hemoglobin >= 9 g/dL Platelets >= 100 K/mm\^3 Performance score (PS) of 0-2 by Zubrod score Life expectancy of 12 months Willingness to sign informed consent Patients cannot have active autoimmune disease or immunosuppressive conditions Serum creatinine =< 1.5 X institutional ULN or creatinine clearance > 40 ml/min as calculated by the Cockcroft-Gault formula In females with childbearing potential, or men with partners of child bearing potential, willingness to use adequate contraception for a minimum duration of 155 days in females and 215 days in males, after last dose of nivolumab Maximal tumor resection has been performed as feasible Exclusion Criteria: * The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) for urothelial cancer within 4 weeks, or intravesical Bacillus Calmette-Guerin (BCG) within 6 weeks of the first dose of study treatment Prior treatment with any PD-1 or PDL-1 inhibitor The subject has received therapeutic radiation: * To the bladder/prostate/rectum pelvis * To any other site(s) within 28 days of the first dose of study treatment Obstructive renal failure that is not relieved with stents or nephrostomy tube/s The subject has received any other type of investigational agent within 28 days before the first dose of study treatment Steroid doses greater than an equivalent of prednisone 10 mg daily The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 2 x the laboratory ULN Uncontrolled hematuria The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: * Cardiovascular disorders such as uncontrolled arrhythmias or uncontrolled congestive heart failure * Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including: * Any of the following at the time of screening * Active peptic ulcer disease, * Active inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis * Any of the following within 6 months before the first dose of study treatment: * History of abdominal fistula * Bowel perforation The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee Presence of another invasive malignancy, which required systemic therapy within 12 months of protocol enrollment, except for resected skin cancers or prostate cancer that is in remission Pregnant or nursing women Patient is a candidate for radical cystectomy as a potentially curative option. The patient may not be a candidate for radical cystectomy due to any of the following reasons: comorbidities, patient preference, or physician discretion. Patients with inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., ataxia-telangiectasia, Nijmegen breakage syndrome)

Study Objectives This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL). Conditions: Neoplasms Intervention / Treatment: DRUG: GSK3326595, DRUG: Pembrolizumab Location: United States, Netherlands, France, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria: * Males and females greater than or equal to (>=)18 years of age (at the time consent is obtained) * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2 * Diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or NHL * Presence of evaluable disease * Adequate organ function (as defined in the protocol) * Reproductive criteria (as defined in the protocol). Exclusion Criteria: * Malignancy attributed to prior solid organ transplant * Leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (CNS)-specific treatment in the opinion of the Investigator (for example \[e.g.\], for symptomatic disease) * History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years * Evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator * Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels. * Select cardiac abnormalities (as defined in the protocol) * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. * History of optic nerve neuropathy or neuritis.

Study Objectives The purpose of this study is to find out how effective an investigational drug named ZK-Epo is against melanoma. Although ZK-Epo has been studied in the treatment of cancer, it is not approved for use in treating melanoma. This research is being done because currently there are only a limited number of treatment options for patients who have melanoma that has spread to distant organs. We expect each patient to be in this study for at least 2 cycles. One cycle lasts for 21 days. If their tumor does not grow after 2 cycles and they do not have any major side-effects, they may receive up to 6 cycles of ZK-Epo. If after they have received 6 cycles of ZK-Epo and their doctor determines that the tumor is continuing to shrink, they will continue treatment with ZK-Epo. The number of treatments the patient receives after 6 cycles will depend upon when their doctor feels there has been maximum tumor response (tumor shrinkage). Two treatments will be given beyond what their doctor considers the point of maximum shrinkage. We estimate that they will spend anywhere from 1 1/2 months to 5 months taking part in this study. Conditions: Melanoma Intervention / Treatment: DRUG: ZK-EPO Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed Malignant Melanoma. * Unresectable Stage III or Stage IV disease. * At least 1 measurable lesion. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Adequate function of major organs and systems as measured by the following criteria: Bone Marrow: * Hemoglobin ≥ 10 g/dL * White blood count (WBC) ≥ 3,000/mm\^3 * Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic: * Bilirubin within 1.5 times normal limit * aspartate transaminase (AST)/Alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN) Renal: * Creatinine ≤ 2 mg/dL Cardiovascular: * No New York Heart Association (NYHA) class III or IV Congestive heart failure * No unstable angina pectoris * No arrhythmia needing continuous treatment Nervous system: * No Grade ≥ 2 peripheral neuropathy Exclusion Criteria: * More than 2 previous chemotherapy regimens. * Any prior treatment with Epothilones, Epothilone analogues, taxanes, or vinca alkaloids. * Any progressive central nervous system (CNS) metastatic disease. Patients with CNS metastases may be allowed if stable for 8 weeks or more and patient is neurologically intact and off of steroids. The stability must be documented by MRI/CT over a period of 8 weeks or greater. * Any radiotherapy, chemotherapy, or immunotherapy within 3 weeks prior to first dose of ZK-Epo. If patients were previously on temozolomide with extended dose schedule, they must be off 1 week prior to the first dose of ZK-Epo.

Study Objectives A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum) Conditions: Chalazion, Hordeolum Intervention / Treatment: DRUG: loteprednol etabonate/tobramycin opthalmic suspension, DRUG: vehicle Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Child, 0 to 6 years of age, any sex and race * Subject must have a clinical diagnosis of lid inflammation (e.g. Chalazion/Hordeolum) in at least one eye. If both eyes are diagnosed with lid inflammation, both eyes will be treated * In good health (no current or past relevant medical history), based on the judgment of the investigator * Parent/guardian is able and willing to follow instructions and provide informed consent Exclusion Criteria: * Known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication * Known hypersensitivity to aminoglycosides, tobramycin, or any component of the study medication * Use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (NSAID), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study * Use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study * Use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration * Use of topical ophthalmic antibiotics (other than the study medication) within 72 hours before and during the study * History of ocular surgery, including laser procedures, within the past six months * Anticipation that surgical intervention for lid inflammation will be required prior to completion of the study * Subjects with suspected vernal conjunctivitis, glaucoma of any kind, viral or bacterial conjunctivitis, preseptal cellulitis requiring systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication * History of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study * Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study * Unlikely to comply with the protocol instructions for any reason

Study Objectives The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of superficial basal cell carcinoma. Conditions: Basal Cell Carcinoma Intervention / Treatment: DRUG: PEP005 Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Male or female patients at least 18 years of age * One sBCC on the arm, shoulder, chest, face, neck, abdomen, leg, back or scalp suitable for surgical excision * Histological confirmation of sBCC based on the central dermatopathologist's evaluation of the punch biopsy * Longest pre- and post-biopsy diameter of the sBCC lesion between 4 mm and 15 mm * Maximum thickness of 4 mm of the sBCC lesion * Laboratory values within the reference ranges as defined by the central laboratory or "out of range" test results that are clinically acceptable to the Investigator * Ability to follow study instructions and likely to complete all study requirements * Written informed consent * Male patients with a female partner of childbearing potential must use an approved form of contraception during the study and for 4 weeks after the last visit * Agreement from the patient to allow photographs of all selected lesions (including the face) to be taken and used as part of the study data package Exclusion Criteria: * Location of the outside margin of the anticipated treatment area of the sBCC selected for treatment: 1. within 10 cm of a malignant lesion that will require treatment during the study 2. within 5 cm of an incompletely healed wound 3. within 2 cm of a pre-malignant lesion (e.g. actinic keratosis lesion) 4. within 2 cm of the open eyelid margins 5. within 1 cm of a scar or an area previously treated with surgical excision 6. on the lips 7. on the breast 8. on the hand or foot 9. in a skin crease * sBCC lesion selected for treatment requiring Mohs micrographic surgery * Presence of known or suspected metastatic disease * Histological evidence of actinic keratoses or nBCC in the screening visit biopsy sample * Histological evidence of BCC with micro-nodular features or squamous metaplasia, sclerosing BCC (i.e. desmoplastic or morphoeic), or BCC with perineural involvement in the screening visit biopsy sample * History of recurrence of the sBCC lesion * History or evidence of skin diseases which would interfere with evaluation of the treatment area (e.g. eczema, unstable psoriasis, xeroderma pigmentosa) * Known sensitivity to any of the ingredients in the study medication * A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within 10 cm of the selected sBCC lesion during the 3 months prior to study entry or anticipated treatment within 10 cm of the selected lesion during the study * Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy: 1. of lesions located within 10 cm of the selected sBCC lesion during the 3 months prior to study entry or 2. anywhere during the 4 weeks prior to study entry or anticipated treatment during the study * Use of acid-containing products (e.g. salicylic acids or fruit acids, such as alpha and beta hydroxy acids and glycolic acids), topical retinoids or light chemical peels within 10 cm of the selected sBCC lesion during the 3 months prior to study entry or anticipated treatment in this same area during the study * Treatment with immuno-modulators (e.g. cyclosporine, prednisone, methotrexate, infliximab or other biological agents), cytotoxic drugs (e.g. vinblastine, cyclophosphamide, azathioprine, chlorambucil, methotrexate), or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study * Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study * Use of systemic retinoids (e.g. isotretinoin, acitretin) during the 6 months prior to study entry or anticipated treatment during the study * Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight, tanning beds) or use of topical salves, creams or ointments to the selected lesion during the study * Anticipated need for hospitalization or non-dermatological surgery during the study * Concurrent disease that suppresses the immune system (e.g. HIV) or uncontrolled systemic disease (e.g. uncontrolled hypertension, poorly controlled diabetes) * Current evidence of chronic alcohol or drug abuse * Current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study * Diagnosis of xeroderma pigmentosa or Gorlin Syndrome (i.e. Basal Cell Nevus Syndrome) * A condition or situation which in the Investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study * Females of child bearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus)

Study Objectives The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet. Conditions: Advanced Malignant Solid Tumors Intervention / Treatment: DRUG: CM082 with fed or fasting Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * age: 18 - 45 years; * sex: male and female; * body weight: Male ≥ 50 kg,female ≥ 45 kg, body mass index BMI (weight (kg)/height 2 (m2)) between 19-26 kg/m2 (including border); * Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests; * Abstinence or physical contraception approved by researchers must be approved during and within three months after the trial is completed; and no sperm and egg donation plan is available； * Written informed consent; Exclusion Criteria: * Received any investigational drugs within 14 days before the screening test; * Donated 200 mL of whole blood within 30 days before the screening test,or donated 200 mL of whole blood during the study or within 30 days after completion of the study; * Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period; * History of drug or food allergies; * Abnormal blood pressure or pulse，Abnormal laboratory tests; * Participated in other clinical trials within 3 months before screening; * Smoking and drinking within 3 months before screening or test results of smoke, alcohol, and drug abuse are positive; * Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody; * Clinically apparent disease/infection within 1 month before screening; * The researchers determined that there were other conditions that were not suitable for the trial;

Study Objectives To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally. Conditions: Uterine Fibroids Intervention / Treatment: DRUG: Proellex Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Healthy adult females between 18 and 47 years of age with uterine fibroids confirmed by ultrasound. * Normal transvaginal ultrasound (other than for presence of fibroids) * History of menstrual events occurring in regular cycles * Agreement not to attempt to become pregnant * Agreement to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours before each visit * Ability to complete a daily subject diary * Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study. * Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history * A Body Mass Index (BMI) between 18 and 39 inclusive * Is available for all treatment and follow-up visits. Exclusion Criteria: * Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy * Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 6 month study period * Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 1.5xULN AND total bilirubin exceeding 1.5xULN at screening and confirmed on repeat). * Received an investigational drug in the 30 days prior to the screening for this study * Women with a history of PCOS * Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study. * Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the preceding 6 months. * Has an IUD in place * Women currently using narcotics * Women currently taking spironolactone * Infectious disease screen is positive for HIV or Hepatitis A, B or C * Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study

Study Objectives The goal of this clinical research study is to learn if the combination of AvastinTM (bevacizumab) and Tarceva (erlotinib hydrochloride) can help to control advanced liver cancer. The safety of this drug combination will also be studied. Conditions: Liver Cancer Intervention / Treatment: DRUG: Bevacizumab, DRUG: Erlotinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histological or cytologically documented HCC not amenable to curative resection (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is required. For subjects without cirrhosis, histological or cytological confirmation is mandatory. * Patients must have measurable disease as per the modified RECIST criteria. Measurable target lesions are defined at baseline as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) >= 20 mm using conventional techniques (CT or MRI) or >= 10 mm using spiral CT scan. Lesion must not be chosen from a previously irradiated field, unless there has been documented disease progression in that field after irradiation. * Patients who have progressed on, or were intolerant to, one prior systemic therapy with sorafenib, completed ≥ 14 days prior to treatment day 1. Previous treatments also allowed that do not count as systemic therapy include: surgical resection, transarterial embolization/chemoembolization (TAE/TACE), radiofrequency ablation (RFA), percutaneous ethanol injection (PEI), provided that the lesion(s) to be evaluated in this study are separate from the previously treated lesions(s). * Eastern Cooperative Oncology Group (ECOG) performance status of <= 2. * Childs-Pugh liver function status of A or B (only 7 points allowed). * Organ function: Absolute peripheral granulocyte count of >= 1500 mm\^3, platelet count of >= 40,000 mm\^3, hemoglobin >= 10 gm/dL. Total bilirubin <= 2.0 gm/dL; serum albumin >= 2.5 gm/dL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) up to 5 X the upper limit of institutional normal (AST - 46 and ALT - 56); and prothrombin time prolonged not more than 3 seconds greater than institutional normal, once attempts to correct a prolonged PT have been made. * (Continuation of # 6) Patients who require full dose anticoagulation, who are otherwise eligible for this trial, are allowed to have an appropriately prolonged International Normalized Ratio (INR). * Negative serum pregnancy test in women with childbearing potential (those who are not surgically sterilized or who are not amenorrheic for >= 12 months), within one week prior to initiation of treatment. * Men and women of childbearing potential must agree to use effective means of contraception prior to study entry and for at least 180 days after the last dose of study treatment. They must agree to use two forms of birth control, for example, barrier methods (such as a diaphragm, cervical cap, contraceptive sponge, female condom, or male condom), and an intrauterine device (IUD). * Age >= 18 years. The agents bevacizumab and erlotinib have not been studied in pediatric patients, thus the doses to be used in this study cannot be assumed to be safe in children. * Radiographic evidence of disease progression during or following prior treatment with sorafenib. * Patients must have proteinuria < 2+ or a urine protein:creatinine (UPC) ratio < 1.0. Patients who have proteinuria >= 2+ and UPC ratio >= 1.0 must undergo a 24 hour urine collection and must demonstrate <= 1g of protein in 24 hours to be eligible. Exclusion Criteria: * Patients who have had prior systemic therapy other than sorafenib. Patients may not have received any systemic chemotherapy <=14 days of Treatment Day 1. * Active malignancy other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years. * Current, recent (within 4 weeks of Treatment Day 1) or planned participation in an experimental drug study, other than this study. * Gastrointestinal disease resulting in an inability to take oral medication or a requirement for intravenous hyperalimentation. * History of rupture of existing HCC lesion, or HCC lesion with large necrotic areas seen on conventional imaging studies, as determined by the Principal Investigator, if there is no measurable solid tumor area > 1.5 cm. * Inadequately controlled hypertension (defined as systolic blood pressure >140 and/or diastolic blood pressure > 90). * Prior history of hypertensive crisis or hypertensive encephalopathy. * New York Heart Association Class II or greater congestive heart failure. * Cardiac arrhythmia not controlled by medication. * History of myocardial infarction or unstable angina within 6 months of Treatment Day 1. * History of stroke or transient ischemic attack within 6 months prior to Day 1 of treatment. * Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1. * Evidence of clinically significant \[Common Terminology Criteria (CTC) Grade 3 or 4\] venous or arterial thrombotic disease within previous 6 months. * Radiographic evidence of major tumor thrombus in the vena cava. * History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1. * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation). * History of significant gastrointestinal bleeding requiring procedural intervention (eg variceal banding, Transjugular Intrahepatic Portosystemic Shunts (TIPS) procedure, arterial embolization) within three months prior to treatment day 1. Patients at risk for varices (based on the following: known history of esophageal or gastric varices; evidence of hepatic cirrhosis and/or portal hypertension including biopsy-proven cirrhosis, radiographic evidence of cirrhosis, hypersplenism, or radiographic findings of varices) will be screened for esophageal varices. * (Continuation of # 17) If varices are identified that require intervention (banding), that patient will not be eligible for the trial until the varices have been adequately treated. * Known CNS disease, except for treated brain metastases. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator (LINAC), or equivalent) or a combination as deemed appropriate by the treating physician. * (Continuation of # 20) Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study. * Core biopsy, fine needle aspiration, or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1. * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1. * Serious, non-healing wound, active ulcer, or untreated bone fracture. * 0ngoing or active infection requiring parenteral therapy. * Known HIV disease. * Uncontrolled psychiatric illness. * Known hypersensitivity to any component of bevacizumab and erlotinib. * Pregnancy (positive pregnancy test) or lactation. * Inability to comply with study and/or follow-up procedures.

Study Objectives Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals' HPV vaccine GSK580299 in healthy female subjects. Conditions: Infections, Papillomavirus, Papillomavirus Vaccines Intervention / Treatment: BIOLOGICAL: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™), BIOLOGICAL: Engerix™ Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 20 and 25 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Healthy subjects as established by medical history and history directed clinical examination before entering into the study. * Subjects must not be pregnant. * Subjects must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. Exclusion Criteria: * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. Administration of routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine is allowed. * Concurrently participating in another clinical study, at any time during the study period (up to Month 13), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose. * Pregnant or breastfeeding women. * Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period * Previous administration of components of the investigational vaccine. * Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period. * History of hepatitis B infection. * Known exposure to hepatitis B within the previous 6 weeks. * Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * Cancer or autoimmune disease under treatment. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Study Objectives Agnostos Trial is a multicentric phase 2 randomized trial with a 'pick-the-winner design' in chemonaive patients with cancer of unknown primary. It will assess the efficacy of the two best active single agent - carboplatin or gemcitabine - added to an innovative taxane back bone (nab-Paclitaxel). Agnostos trial is a part of a larger clinical and translational initiative to improve the outlook of patients with cancer of unknown primary through evaluation of novel chemotherapeutic regimens. Conditions: Unknown Primary Tumors Intervention / Treatment: DRUG: nab-paclitaxel, DRUG: Carboplatin, DRUG: Gemcitabine Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Provision of written informed consent. * Patients must be ≥ 18 years of age. * Diagnosis of CUP according to CUP Diagnostic Guidelines derived from ESMO 2011 and NCCN 2015 guidelines. * Sufficient archived biopsy tissue from a surgical or core needle biopsy required to perform the CUP multiplex assay. * Eastern Cooperative Oncology Group performance status ≤ 2. * No previous systemic therapy. * At least one measurable lesion by RECIST Criteria. * Good liver, cardiac, lung and marrow bone function. * Evidence of non-childbearing status for female patients: negative urine or serum pregnancy test within 21 days of study treatment for women of childbearing potential, or postmenopausal status. * Patients of child bearing potential and their partners, who are sexually active, must agree to the use of highly effective forms of contraception throughout their participation in the study. * Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations. Exclusion Criteria: * Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, breast Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma. * Specific treatable CUP syndromes including: extragonadal germ cell syndrome; neuroendocrine carcinoma; adenocarcinoma isolated to axillary lymph nodes (women cancer); peritoneal carcinomatosis (women - ovarian cancer); squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes; single resectable metastasis. * Patients receiving any radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry. * Patients with symptomatic uncontrolled brain metastases. * Major surgery within 2 weeks of starting the study and patients must have recovered from any effects of any major surgery. * Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. * Pregnant or breast feeding women. * Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV). * Patients with known hepatic disease (eg, Hepatitis B or C). * Previous cancer treatment. * Patients currently enrolled in another clinical tria, except AGNOSTOS PROFILING. * Patients that are receiving chemotherapy, hormonal therapy (HRT is acceptable) or other novel agents. * Patients receiving live virus and bacterial vaccines.