Within less than or equal to 14 days prior to registration: Platelets >= 100 x 10^9/L
Patients must have an estimated survival greater or equal to 3 months
Platelet greater than or equal to 100,000/mcl
Absolute neutrophil count (ANC) greater than or equal to 1500/mm3 (greater than or equal to 1.5 X 103/uL)
Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 X 109/L)
Hemoglobin greater than or equal to 9.0 g/dL
Platelet count equal to or greater than 150,000/mcl
Have a Karnofsky performance status greater than or equal to 50 for patients aged 16 years or older and a Lansky performance status greater than or equal to 50 for patients less than 16 years old
Platelets (Plts) greater than or equal to 75,000/mm^3 (transfusion independent)
Age greater than or equal to (>/=) 18 years
Pre-existing neuropathy greater than or equal to grade 2
ANC must be greater than or equal to 1500/mm3,
Hemoglobin must be greater than or equal to 9 g/dL.
Participant must not have a prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis while receiving immunotherapy.
Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis (or any other unresolved or symptomatic adverse event in the last 3 months) while receiving immunotherapy.
Within 30 days prior to enrollment: Platelet count equal to or greater than 150,000/mcl
Age greater than or equal to (>/=) 18 years
Age greater than or equal to 18 years
Absolute neutrophil count (ANC) greater than or equal to 1500/mm3 (greater than or equal to 1.5 X 103/ul)
Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 X 109/L)
Hemoglobin greater than or equal to 9.0 g/dL
Platelets greater than or equal to 75,000/ul
Granulocytes greater than or equal to 1500/ul
Men and women greater than or equal to 18 years of age.
Platelet (PLT) count greater than or equal to 100,000/µL
Immunotherapy less than or equal to 4 weeks prior to registration
Third or greater relapse.
Platelets greater than or equal to 100,000/mcl
Hemoglobin (Hb) greater than or equal to 9.0 g/dL
Patients must have a Karnofsky performance status of greater than or equal to 50 for patients older than 16 years of age or Lansky performance status of greater than or equal to 50 for patients less than or equal to 16 years of age.
Hemoglobin greater than or equal to 10 gram/deciliter
Platelet count greater than or equal to 100 x 10 to the ninth/Liter
Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or
Subjects must have measurable disease by RECIST 1.1 criteria including one target tumor for injection. Superficial tumors must have one tumor greater than or equal to 1.0 cm, deep tumors greater than or equal to 1.0 cm (as measured by caliper (for non-injected tumors only) or image guidance);
Platelets greater than or equal to 100,000/mcl, within 14 days prior to registration
Participants must have operable breast cancer, with tumors greater than or equal to 2 cm in size; participants must not have any evidence of metastatic disease
Subject in whom all visible vessels or suture holes greater than or equal to 2mm in diameter have been ligated;
Subject in whom the anatomic site is equal to or less than 25cm²;
Serum creatinine equal or greater than 2.5 mg/deciliter
PART I: Greater than or equal to 1 week since standard or investigational treatment for metastatic disease
PART II: Greater than or equal to 1 week since receipt of standard or investigational HER2-directed therapy for metastatic or recurrent disease
Normal prothrombin time (less than or equal to 15.2 seconds)
Patients who have had less than or equal to 5 metastases treated with SRS are eligible.
The time from the end of last induction, re-induction, or consolidation regimen should be greater than or equal to 14 days
Platelet count of greater than or equal to 100,000/mcL
Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
Karnofsky equal or greater than 70
REP ELIGIBILITY: Absolute neutrophil count greater than or equal to 1000/mcL
REP ELIGIBILITY: Platelet count greater than or equal to 100,000/mcL
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Platelet count greater than or equal to 100,000/mcL
Absolute neutrophil count greater than or equal to 1000/mm^3 without the support of filgrastim or other growth factors
Platelet count greater than or equal to 55,000/mm^3 without transfusion support
Normal cardiac ejection fraction (greater than or equal to 50% by echocardiography) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram within 4 weeks of the start of the treatment protocol
>= 1 tumor site must have demonstrated uptake equal to or greater than normal liver as documented by nuclear scan imaging
Subjects with hemoglobin values at the screening visit equal to or greater than 12.0 g/dL
Be greater than or equal to (>=) 16 years of age at the time of consent.
Age greater than or equal to 18 years old at the time of informed consent
Platelets greater than or equal to 50,000 mcL
Absolute neutrophil count greater than or equal to 1.5 x 10^9 cells/L
Hemoglobin greater than or equal to 8.0 g/dL
Platelets greater than or equal to 75 x 10^9/L
Age greater than or equal to 16 years old
The risk of disease recurrence with a five (5) year time period, as estimated by the treating physician, must be greater than or equal thirty percent (30%)
Absolute neutrophil count greater than or equal to 1000/mm^3 without the support of filgrastim or other growth factors
Platelet count greater than or equal to 45,000/mm^3 without transfusion support
Normal cardiac ejection fraction (greater than or equal to 55% by echocardiography) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram within 4 weeks of the start of the treatment protocol
Cardiac ejection fraction greater than or equal to 50% by echocardiogram
Creatinine of less than or equal to 1.7 gm/dL
Participants who are either refractory to or relapsed within 90 days of receiving a regimen containing a cumulative dose of greater than or equal to (>/=) 18 g/m^2 of cytarabine
Platelets greater than or equal to 100,000/mm^3
Hemoglobin greater than or equal to 8 g/dL
Platelet count greater than or equal to 100 x 10^9/L
Hemoglobin greater than or equal to 9 g/dL
Baseline albumin greater than or equal to Lower Limit of Normal
Must weigh greater than or equal to 20 kg.
Participants less than or equal to 16 years of age: Lansky greater than or equal to 50
Participants greater than 16 years of age: Karnofsky greater than or equal to 50 or Eastern Cooperative Oncology Group (ECOG) less than 3.
Platelets greater than or equal to 100,000/uL
Hemoglobin greater than or equal to 8.0 g/dL
Lansky play score greater than or equal to 50% or Karnofsky Performance Status score greater than or equal to 50%. Use Karnofsky for participants greater than or equal to 16 years of age and Lansky for participants less than 16 years of age.
absolute neutrophil count (ANC) greater than or equal to 1.0 x 10^9/L (for Cohorts 3A and 3B leucocyte count greater than or equal to 2 x 10^9/L; participants with bone marrow involvement should have ANC greater than or equal to 0.8 x 10^9/L and leucocyte count greater than or equal to 1 x 10^9/L).
platelet count greater than or equal to 75 x 10^9/L.
Previous treatment with ifosfamide and Grade greater than or equal to 3 nephrotoxicity or encephalopathy (Cohorts 3A and 3B).
At the time of study enrollment patients must have a Karnofsky greater than or equal to 50% for patients > 16 years of age and Lansky greater than or equal to 50 for patients less than or equal to 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
Platelet count greater than or equal to 100,000/microL (transfusion independent)
Hemoglobin greater than or equal to 10.0 gm/dL (transfusion independent)
Platelets greater than or equal to 75,000/mm^3 (transfusion independent; no transfusion for >= 7 days prior to study enrollment)
Smoking 5 or more cigarettes, little cigars and/or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm) (if less than or equal to 5, then NicAlert Strip > 2)
hemoglobin must be greater than or equal to 9 g/dL. (Note: Patient must have discontinued growth factors greater than or equal to two weeks prior to entry labs.)
Persistent greater than or equal to grade 2 diarrhea regardless of etiology.
Karnofsky greater than or equal to 80%
Hemoglobin greater than or equal to 8.0
ANC greater than or equal to 500 (7 days after last dose of growth factor)
SGPT (ALT) and SGOT (AST) less than or equal to 3 x normal for age
Patients with untreated AML must meet at least one of the following conditions:\r\n* Age greater than or equal to 75 years;\r\n* Age greater or equal to 60 and less than 75 years with at least one of the following poor prognostic factors:\r\n** Secondary AML, as determined by known and documented exposure to chemotherapy or radiation therapy\r\n** Antecedent history of MDS or myeloproliferative disorder according to WHO criteria for at least 3 months prior to trial entry;\r\n** Unfavorable cytogenetic abnormalities including chromosome 5 and 7 as well as complex;\r\n** ECOG performance status 2
Absolute neutrophil count greater than or equal to 1000/mm^3 (Turnstile II)
Platelet count greater than or equal to 100,000/mm^3 (Turnstile II)
Hemoglobin greater than or equal to 8.0 g/dl (Turnstile II)
Karnofsky or Lansky performance scale (PS) greater or equal to 70
Serum creatinine less than or equal to 1.5 in males, or 1.4 in female
Absolute neutrophil count greater than or equal to 1000/mm^3 (Turnstile II)
Platelet count greater than or equal to 100,000/mm^3 (Turnstile II)
Hemoglobin greater than or equal to 8.0 g/dl (Turnstile II)
Direct bilirubin equal to or less than 1.5 x ULN; or equal to or less than 2 x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis related to MF)
Stable hemoglobin greater than or equal to 8.0 g/dl
Platelets more or equal to 50,000/mL
Inclusion Criteria:\n\n Participants must meet all of the following criteria to be included in the study:\n\n 1. Age greater than or equal to 18 years.\n\n 2. Histopathologic diagnosis of CTCL (mycosis fungoides [MF] or Sezary Syndrome [SS]),\n confirmed by skin biopsy, or lymph node, or blood assessment, of current disease.\n\n 3. CD25 assay-positive tumor, defined as detectable CD25 on greater than or equal to 20%\n of total lymphoid infiltrate in biopsied skin lesions by immunohistochemistry.\n\n 4. CTCL disease stage at study entry as follows, according to ISCL/EORTC (Olsen 2011).\n\n - Lead-In Phase: Stage IA - IV, except participants with CNS involvement.\n\n - Main Study: Stage IA - IVA2 including lymph node disease N2 and N3\n\n 5. History of prior therapies for CTCL as follows: must have had prior therapy, any\n number of prior therapies allowed.\n\n Topical treatments (except topical chemotherapy) and steroids are not considered as\n prior therapies.\n\n 6. A minimum washout period of 4 weeks after previous CTCL therapy is recommended before\n the first dose of E7777.\n\n Participants must have recovered from any adverse effects from any previous CTCL\n therapy to CTCAE Grade <2 before starting study drug. A shorter washout may be allowed\n if participant is experiencing progressive disease despite ongoing treatment\n\n 7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 in the Lead-In\n Phase and performance status of 0 or 1 in the Main Study.\n\n 8. Life expectancy greater than or equal to 3 months in the Lead-In Phase and greater\n than or equal to 12 months in the Main Study.\n\n 9. Adequate bone marrow reserves as evidenced by:\n\n - platelets greater than or equal to 100,000/mm3 (100 x 10^9/L)\n\n - clinically stable hemoglobin greater than or equal to 9 g/dL (90 g/L) and\n hematocrit greater than or equal to 27% without transfusion support\n\n 10. Normal hepatic function as evidenced by:\n\n - bilirubin and alkaline phosphatase less than or equal to 1 x the upper limit of\n normal (ULN).\n\n - aspartate aminotransferase (AST) less than or equal to 75 U/L and alanine\n aminotransferase (ALT) less than or equal to 100 U/L.\n\n - albumin greater than or equal to 3.0 g/dL (30 g/L).\n\n 11. Adequate renal function as evidenced by serum creatinine less than or equal to 1.8\n mg/dL (158 umol/L) OR calculated creatinine clearance greater than or equal to 50\n mL/min (per the Cockcroft-Gault formula) with less than 2+ protein OR 24- hour urine\n creatinine clearance greater than or equal to 50 mL/minute with 24- hour urine protein\n less than 1g.\n\n 12. Provide written informed consent prior to any study-specific screening procedures.\n\n 13. Females may not be lactating or pregnant at Screening or Baseline\n\n 14. All females will be considered to be of childbearing potential unless they are\n postmenopausal or have been sterilized surgically\n\n 15. Male participants must have had a successful vasectomy (confirmed azoospermia) or they\n and their female partner must meet the criteria above\n\n Exclusion Criteria\n\n Participants who meet any of the following criteria will be excluded from the study:\n\n 1. Prior denileukin diftitox therapy\n\n 2. Use of topical steroids within 14 days of Day 1 of initial therapy is not allowed\n\n 3. Active malignancy (except for CTCL, definitively treated basal or squamous cell\n carcinoma of the skin, and carcinoma in-situ of the cervix) within the past 24 months.\n\n 4. Serious intercurrent illness\n\n 5. Significant cardiac disease requiring ongoing treatment, including congestive heart\n failure (CHF), severe coronary artery disease (CAD), cardiomyopathy, uncontrolled\n cardiac arrhythmia, unstable angina pectoris, or myocardial infarction (MI)\n\n 6. Significant pulmonary symptoms or disease\n\n 7. History of uncontrolled seizure disorder or active central nervous system disease\n\n 8. Major surgery within 2 weeks of study enrollment\n\n 9. Significant or uncontrolled infections requiring specific anti-infective therapy\n\n 10. Known human immunodeficiency virus (HIV) infection; known active hepatitis B or\n hepatitis C infection\n\n 11. Females who are pregnant (positive urine test) or breastfeeding\n\n 12. Any history of a medical condition or a concomitant medical condition that, in the\n opinion of the investigator, would compromise the participant's ability to safely\n complete the study.
Have a Karnofsky performance status greater than or equal to 50 for patients aged 16 years or older and a Lansky performance status greater than or equal to 50 for patients less than 16 years old
Platelets (Plts) greater than or equal to 75,000/mm^3 (transfusion independent)
Performance status Lansky for children =< 16 years equal to at least 60, or greater Karnofsky status for those > 16 years of age equal to at least 70 or greater
Creatinine less than or equal to 2.0 unless related to the disease
Bilirubin less than or equal to 3.0
Absolute neutrophil count greater than or equal to 750/mm^3 (Turnstile II - Chemotherapy/Cell\r\nInfusion- Inclusion Criteria)
Platelet count greater than or equal to 75,000/mm^3 (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria)
Hemoglobin greater than or equal to 8.0 g/dl (Turnstile II - Chemotherapy/Cell Infusion)
Performance status (Eastern Cooperative Oncology Group [ECOG]) must be less than or equal to 2 (Karnofsky greater than or equal to 50)
ANC must be greater than or equal to 1500/mm3
Hemoglobin must be greater than or equal to 9 g/dL.
Subjects previously treated with enzyme-induced antiepileptic drugs (EIAEDs) must have discontinued treatment with these agent(s) greater than or equal to 2 weeks prior to enrollment.
absolute neutrophil count greater than or equal to 1,500 cells/microliter
platelets greater than or equal to 100,000 cells/microliter
History of serious ventricular arrhythmia (ventricular tachycardia [VT] or ventricular fibrillation [VF], greater than or equal to 3 beats in a row); QTc greater than or equal to 450 msec for men and 470 msec for women; or left ventricular ejection fraction (LVEF) less than or equal to 40% by multi-gated acquisition scan (MUGA).
Age greater than or equal to 15 years
Greater than or equal to 6 weeks since the receipt of chemotherapy or radiation therapy
Inclusion Criteria:\n\n The tumor tissue must have been determined to be KRAS, NRAS, BRAF, PIK3CA (all RAS\n quadruple) wild-type by CLIA testing.\n\n The ECOG performance status must be 0, 1 or 2. Patients must have the ability to swallow\n and retain oral medication. There must be documentation by CT scan, or MRI, that the\n patient has evidence of measurable metastatic disease per RECIST 1.1 criteria.\n\n Patients must have an accessible metastatic lesion for pretreatment core biopsy\n procurement.\n\n Unless either drug is medically contraindicated, patients must have received oxaliplatin\n and irinotecan as part of standard chemotherapy regimens. (This includes adjuvant therapy.)\n\n Specific patient eligibility for quadruple WT and HER2 status:\n\n Arm 1:\n\n HER2 amplified confirmed by CLIA testing performed on blood samples, and prior treatment\n with cetuximab or panitumumab.\n\n HER2 mutation confirmed by CLIA testing of tumor, and with or without prior treatment with\n cetuximab or panitumumab.\n\n Arm 2:\n\n HER2 WT or HER2 amplified confirmed by CLIA testing of this tumor, and no prior therapy\n with cetuximab or panitumumab.\n\n Blood counts performed within 2 weeks prior to study entry must meet the following\n criteria:\n\n ANC must be greater than or equal to 1000/mm3. Platelet count must be greater than or equal\n to 75,000/mm3. Hemoglobin must be greater than or equal to 8 g/dL.\n\n Adequate hepatic function performed within 2 weeks prior to study entry must be met:\n\n - Total bilirubin must be less than or equal to 1.5 x ULN (upper limit of normal) for\n the lab unless the patient has a bilirubin elevation greater than 1.5 x ULN to 3 x ULN\n due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin;\n and\n\n - Alkaline phosphatase must be less than or equal to 3 x ULN for the lab with the\n following exception: for patients with documented liver metastases or bone involvement\n alkaline phosphatase must be less than or equal to 5 x ULN; and\n\n - AST and ALT must be less than or equal to 3 x ULN for the lab with the following\n exception: for patients with documented liver metastases, AST and ALT must be less\n than or equal to 5 x ULN.\n\n Serum creatinine performed within 2 weeks prior to study entry must be less than or equal\n to 1.5 x ULN for the lab.\n\n Patients eligible for Arm 1 (neratinib + trastuzumab): Left ventricular ejection fraction\n must be greater than or equal to 50% or within normal range for the institution (whichever\n is lowest).\n\n Female patients and male patients with female partners of reproductive potential must agree\n to use an effective method of contraception during therapy and for at least 7 months after\n the last dose of study therapy.\n\n Exclusion Criteria:\n\n Diagnosis of anal or small bowel carcinoma. Colorectal cancer histology other than\n adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid.\n\n Previous therapy with any HER2 targeting agents (such as trastuzumab, lapatinib, neratinib,\n etc.) for any malignancy.\n\n Symptomatic brain metastases or brain metastases requiring chronic steroids to control\n symptoms.\n\n Active hepatitis B or hepatitis C with abnormal liver function tests. Malabsorption\n syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small\n bowel, or other disease or condition significantly affecting gastrointestinal function.\n\n Persistent CTCAE v4.0 greater than or equal to grade 2 diarrhea regardless of etiology.\n\n CTCAE v4.0 grade 3 or 4 anorexia or nausea related to metastatic disease. CTCAE v4.0\n greater than or equal to grade 2 vomiting related to metastatic disease.\n\n Any of the following cardiac conditions: documented congestive heart failure; myocardial\n infarction within 6 months prior to study entry; unstable angina within 6 months prior to\n study entry; symptomatic arrhythmia.\n\n Serious or non-healing wound, skin ulcer, or bone fracture. History of bleeding diathesis.\n (Patients on stable anticoagulant therapy are eligible.) Symptomatic interstitial lung\n disease or definitive evidence of interstitial lung disease described on CT scan, MRI, or\n chest x-ray in asymptomatic patients; dyspnea at rest requiring current continuous oxygen\n therapy.\n\n Previous serious hypersensitivity reaction to monoclonal antibodies. (Determination of\n \serious\ hypersensitivity reaction is at the investigator's discretion.) Other\n malignancies unless the patient is considered to be disease-free and has completed therapy\n for the malignancy greater than or equal to 12 months prior to study entry. Patients with\n the following cancers are eligible if diagnosed and treated within the past 12 months:\n carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal\n cell and squamous cell carcinoma of the skin.\n\n Psychiatric or addictive disorders or other conditions that, in the opinion of the\n investigator, would preclude the patient from meeting the study requirements.\n\n Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be\n performed within 14 days prior to study entry according to institutional standards for\n women of childbearing potential.) Use of any investigational agent within 4 weeks prior to\n study entry. Note: Use of agents known to be strong cytochrome P450 (CYP) 3A4 inducers or\n inhibitors, and proton pump inhibitors (PPIs) should be avoided for the duration of study\n therapy.
Hematocrit (Hct) less than or equal to 24%
Platelets less than or equal to 75,000
Bilirubin greater than or equal to 2.0 x ULN
EXCLUSION CRITERIA FOR TREATMENT: Creatinine greater than or equal to 1.5 x ULN
EXCLUSION CRITERIA FOR TREATMENT: AST/ALT greater than or equal to 2.5 x ULN
EXCLUSION CRITERIA FOR TREATMENT: Bilirubin greater than or equal to 2.0 x ULN
AST or ALT less than or equal to 2.5 X institutional ULN
KPS equal to or greater than 70
Absolute neutrophil count greater than or equal to 1000/mm^3 without the support of filgrastim or other growth factors
Platelet count greater than or equal to 45,000/mm^3 without transfusion support
Normal cardiac ejection fraction (greater than or equal to 50% by echocardiography) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram within 6 weeks of the start of the treatment protocol
Inclusion Criteria\n\n 1. Signed written informed consent must be obtained and documented according to\n International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the\n local regulatory requirements, and permission to use private health information in\n accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior\n to study-specific screening procedures\n\n 2. For solid tumors or lymphoma, a histologically or cytologically confirmed solid tumor\n that is metastatic, unresectable, or recurrent and for which standard curative or\n palliative therapies do not exist or are no longer effective.\n\n 3. ? 18 years of age\n\n 4. For solid tumors, measurable disease as defined by Response Evaluation Criteria in\n Solid Tumors (RECIST 1.1)\n\n 5. For lymphoma, measurable disease as defined by the International Workshop to\n Standardize Response Criteria for Non-Hodgkin's Lymphoma\n\n 6. For multiple myeloma, measurable disease as defined by the International Uniform\n Response Criteria for Multiple Myeloma\n\n 7. Karnofsky performance status greater than or equal to 70%\n\n 8. Male or female patients of child-producing potential must agree to use contraception\n or avoidance of pregnancy measures during the study and for 30 days after the last\n BBI608 dose\n\n 9. Females of childbearing potential must have a negative serum pregnancy test\n\n 10. Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 1.5\n × upper limit of normal(ULN)\n\n 11. Hemoglobin (Hgb) greater than or equal to 10 g/dl\n\n 12. Total bilirubin less than or equal to 1.5 × ULN\n\n 13. Creatinine less than or equal to 1.5 x ULN or creatinine clearance greater than 60\n mL/min/1.73 m2 for patients with creatinine levels above institutional normal.\n Creatinine < 2.5 x ULN for multiple myeloma patients.\n\n 14. Absolute neutrophil count greater than or equal to 1.5 x 109/L\n\n 15. Platelets greater than or equal to 100 x 109/L\n\n 16. Life expectancy greater than or equal to 3 months\n\n Exclusion Criteria\n\n 1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents\n within four weeks of first dose with the exception for a single dose radiation up to\n 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days\n before beginning the administration of BBI608.\n\n 2. Surgery within 4 weeks prior to first dose\n\n 3. Any known untreated brain metastases. Treated subjects must be stable for 4 weeks\n after completion of that treatment, with image documentation required. Patients must\n have no clinical symptoms from brain metastases and must be either off steroids or on\n a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients\n with known leptomeningeal metastases are excluded, even if treated.\n\n 4. Pregnant or breastfeeding\n\n 5. Significant gastrointestinal disorder(s), in the opinion of the Principal\n Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small\n intestine resection)\n\n 6. Unable or unwilling to swallow BBI608 capsules daily\n\n 7. Uncontrolled intercurrent illness including, but not limited to ongoing or active\n infection, clinically significant non-healing or healing wounds, symptomatic\n congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant\n pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled\n infection or psychiatric illness/social situations that would limit compliance with\n study requirements
Inclusion Criteria\n\n 1. Signed written informed consent must be obtained and documented according to\n International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the\n local regulatory requirements, and permission to use private health information in\n accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior\n to study-specific screening procedures\n\n 2. For solid tumors or lymphoma, a histologically or cytologically confirmed solid tumor\n that is metastatic, unresectable, or recurrent and for which standard curative or\n palliative therapies do not exist or are no longer effective.\n\n 3. ? 18 years of age\n\n 4. For solid tumors, measurable disease as defined by Response Evaluation Criteria in\n Solid Tumors (RECIST 1.1)\n\n 5. For lymphoma, measurable disease as defined by the International Workshop to\n Standardize Response Criteria for Non-Hodgkin's Lymphoma\n\n 6. For multiple myeloma, measurable disease as defined by the International Uniform\n Response Criteria for Multiple Myeloma\n\n 7. Karnofsky performance status greater than or equal to 70%\n\n 8. Male or female patients of child-producing potential must agree to use contraception\n or avoidance of pregnancy measures during the study and for 30 days after the last\n BBI608 dose\n\n 9. Females of childbearing potential must have a negative serum pregnancy test\n\n 10. Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 1.5\n × upper limit of normal(ULN)\n\n 11. Hemoglobin (Hgb) greater than or equal to 10 g/dl\n\n 12. Total bilirubin less than or equal to 1.5 × ULN\n\n 13. Creatinine less than or equal to 1.5 x ULN or creatinine clearance greater than 60\n mL/min/1.73 m2 for patients with creatinine levels above institutional normal.\n Creatinine < 2.5 x ULN for multiple myeloma patients.\n\n 14. Absolute neutrophil count greater than or equal to 1.5 x 109/L\n\n 15. Platelets greater than or equal to 100 x 109/L\n\n 16. Life expectancy greater than or equal to 3 months\n\n Exclusion Criteria\n\n 1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents\n within four weeks of first dose with the exception for a single dose radiation up to\n 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days\n before beginning the administration of BBI608.\n\n 2. Surgery within 4 weeks prior to first dose\n\n 3. Any known untreated brain metastases. Treated subjects must be stable for 4 weeks\n after completion of that treatment, with image documentation required. Patients must\n have no clinical symptoms from brain metastases and must be either off steroids or on\n a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients\n with known leptomeningeal metastases are excluded, even if treated.\n\n 4. Pregnant or breastfeeding\n\n 5. Significant gastrointestinal disorder(s), in the opinion of the Principal\n Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small\n intestine resection)\n\n 6. Unable or unwilling to swallow BBI608 capsules daily\n\n 7. Uncontrolled intercurrent illness including, but not limited to ongoing or active\n infection, clinically significant non-healing or healing wounds, symptomatic\n congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant\n pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled\n infection or psychiatric illness/social situations that would limit compliance with\n study requirements
Creatinine of less than or equal to 1.7 gm/dL
Creatinine of less than or equal to 1.7 gm/dL
Platelet count greater than or equal to 100,000/mcL
Hemoglobin greater than or equal to 8.0 g/dL
Criteria for cohort A (recently diagnosed subjects to receive AHCT)\r\n* Must have presence of clonal plasma cells in the bone marrow greater or equal to 10% or biopsy proven plasmacytoma\r\n* Must have either (a) presence of myeloma protein (M-component) (immunoglobulin [Ig]G or IgA) in serum greater or equal to 1 g/dl or in urine greater or equal to 200 mg/24 hours (h); or (b) presence of an abnormal serum free light chain (FLC) ratio on the serum FLC assay
Bilirubin less than or equal to 1.5 (except if due to Gilbert's disease)
Platelets greater than or equal to 100,000/mm^3
Albumin greater than or equal to 3.0 g/dL
Platelets greater than or equal to 75,000/ul
Granulocytes greater than or equal to 1500/ul
Platelets greater than or equal to 100,000/mm^3 (CTCAE grade 0-1)
Platelets greater than or equal to 100,000/mcl
Male or female subjects aged greater than or equal to (>=) 18 years
Subjects must have Eastern Cooperative Oncology Group (ECOG) Performance Status of ) to 2 for subjects greater than or equal to 75 years of age, or 0 to 3 for subjects greater than or equal to 60 to 74 years of age
Platelets greater than or equal to 100,000/mcl
Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
Age greater than or equal to (>=)18 years
IHC greater than or equal to 20 percent of tumor on tissue sections must stain with NPC-1C.
Hemoglobin greater than or equal to 8.5 g/dL (may be receiving supportive therapy)
ANC greater than or equal to 1,500 K/uL
Platelets greater than or equal to 100 K/uL
ALT/AST less than or equal to 3 times ULN or less than or equal to 5 times ULN in the setting of liver metastases.
Biochemical recurrence: defined as a cancer antigen (CA)-125 greater than or equal to two times the upper normal limit; patients whose CA125 is less than 100 U/mL must undergo a second confirmatory value within a period of not more than 4 weeks; patients with a level greater than or equal to 100 U/mL may be entered without confirmatory measurement
Radiotherapy less than or equal to (<=) 7 days prior to Day 1
hemoglobin must be greater than or equal to 9 g/dL.
Persistent CTCAE v4.0 greater than or equal to grade 2 diarrhea regardless of etiology.
Any significant bleeding (greater than or equal to grade 3, hemorrhage) that is not related to the primary colon tumor within 6 months before randomization.
KPS 70% or greater
Participant has measurable disease at Screening, defined as at least one of the following: Serum M-protein greater than or equal to 0.5 g/dL, OR Urine M-protein greater than or equal to 200 mg in 24-hours, OR serum immunoglobulin free light chain (FLC) greater than or equal to 10 mg/dL provided serum FLC ratio is abnormal.
Age greater than or equal to 18 years at the time of informed consent.
Absolute neutrophil count (ANC) greater than or equal to 750/mm3 (greater than or equal to 0.75 X 10^9/L)
Platelets greater than or equal to 75,000/mm3 (greater than or equal to 75 X 10^9/L)
Hemoglobin greater than or equal to 9.0 g/dL
Fasting (greater than or equal to [>=] 8 hours) glucose less than or equal to (<=) 160 milligrams per deciliter (mg/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
Hemoglobin greater than or equal to 9 g/dL
Platelets greater than or equal to 100,000 cells/mcl
Hemoglobin greater than or equal to 9 g/dL
ALT and AST less than or equal to 3 x ULN
Albumin greater than or equal to 2.8 g/dL
Male patient aged, equal to, or more than,18 years old.
Inclusion Criteria:\n\n 1.18 years of age or older 2. Able to provide written informed consent or have their legal\n representatives provide written informed consent 3. Documented histological or cytological\n evidence of adenocarcinoma of the prostate. Subjects whose pathology reports are no longer\n available may be enrolled if, in the opinion of the investigator, the subject has a\n clinical course consistent with prostatic adenocarcinoma 4. ECOG Performance Status of 0 or\n 1 5. Undergone orchiectomy, or have ongoing LHRH analogue therapy prior to C1D1. Subjects\n on LHRH analogues should remain on these agents for the duration of the study 6. Castrate\n levels of testosterone less than or equal to 50 ng/dl (or 1.7 nmol/L) and have progressive\n disease at Screening defined as PSA rise determined by a minimum of 2 rising PSA values\n greater than or equal to 1 week between each assessment. The PSA value at the Screening\n visit must be greater than or equal 2ng/mL with or without: Soft tissue disease progression\n defined by RECIST 1.1 at Screening or less than or equal to 28 days of C1D1. Measurable\n disease is not required for entry.\n\n Lymph nodes greater than or equal to 1.5cm (short axis) are considered measurable disease\n bone disease progression defined by greater than or equal 2 new lesions on bone scan at\n Screening, or less than or equal 28 days of C1D1 7. Have received abiraterone and/or\n enzalutamide. Subject must have received either abiraterone or enzalutamide for greater\n than or equal to 12 weeks. Other second generation CYP17 inhibitors/androgen receptor\n antagonists including but not limited to TAK-700 (orteronel), TOK-001 (galeterone) may have\n been taken in place of abiraterone and ARN-509 (apalutamide) may have been taken in place\n of enzalutamide.\n\n 8. Adequate hematopoietic function as evidenced by:\n\n - WBC greater than or equal to 3,000/?l\n\n - ANC greater than or equal to 1,500/?l\n\n - Platelet count greater than or equal to 100,000/?l\n\n - HGB greater than or equal to 10 g/dl and not transfusion dependent 9. Adequate liver\n function, including all the following:\n\n - Total serum bilirubin less than or equal to 2.0 x ULN unless the subject has\n documented Gilbert syndrome;\n\n - Aspartate and alanine aminotransferase (AST & ALT) less than or equal to 3.0 x ULN or\n less than or equal to 5.0 x ULN if subject has liver metastasis;\n\n - Alkaline phosphatase less than or equal to 3.0 x ULN or less than or equal to 5 x ULN\n in case of bone metastasis and/or hepatic metastasis 10. Subjects must have adequate\n renal function as evidenced by a serum creatinine of less than or equal to 2.0 mg/dl\n 11. Potassium (K+) greater than or equal to 3.5 mEq/l 12. Subject and his female\n partner who is of childbearing potential must use 2 acceptable methods of birth\n control (one of which must include a condom as a barrier method of contraception)\n starting at Screening and continuing throughout the study period and for 3 months\n after final study drug administration.\n\n - Two acceptable forms of birth control include:\n\n 1. Condom (barrier method of contraception), and\n\n 2. One of the following:\n\n 1. Oral, injected or implanted hormonal contraception\n\n 2. Placement of an intrauterine device (IUD) or intrauterine system (ISU)\n\n 3. Additional barrier methods of contraception: Occlusive cap (diaphragm or\n cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.\n\n 4. Vasectomy or surgical castration greater than or equal to 6 months prior to\n Screening.\n\n 13. Able to swallow study medication 14. Able to comply with study requirements\n\n Exclusion Criteria\n\n Each subject eligible to participate in this study must not have any of the following:\n\n 1. Received sipuleucel-T (Provenge ®) treatment within 28 days of C1D1\n\n 2. Received 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or\n dutasteride (AVODART®) within 28 days of C1D1\n\n 3. Received any investigational agent less than or equal to 28 days of C1D1\n\n 4. Received palliative radiotherapy less than or equal to 2 weeks of C1D1\n\n 5. Symptomatic CNS metastases\n\n 6. History of another invasive malignancy less than or equal to 3 years of C1D1\n\n 7. A QTcF interval of greater than 470 msec; if the Screening ECG QTcF interval is\n greater than 470 msec, it may be repeated, and if repeat less than or equal to 470\n msec, the subject may be enrolled\n\n 8. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular\n fibrillation, torsades de pointes, second degree or third degree atrioventricular\n heart block without a permanent pacemaker in place)\n\n 9. Started a bone modifying agent (e.g. bisphosphonates, denosumab) less than or equal to\n 28 days of C1D1 (note: ongoing bone modifying agents administered less than 28 days\n are allowed)\n\n 10. Any medical condition that could preclude subject participation in the study, pose an\n undue medical hazard, or which could interfere with study results\n\n 11. Class III or IV Congestive Heart Failure (CHF) as defined by the New York Heart\n Association (NYHA) functional classification system within the previous 6 months\n\n 12. A history of loss of consciousness or transient ischemic attack less than or equal to\n 12 months of C1D1\n\n 13. Known active HIV, Hepatitis B, or Hepatitis C infections\n\n 14. Known or suspected hypersensitivity to seviteronel, or any components of the\n formulation\n\n 15. Any other condition which in the opinion of the investigator would preclude\n participation in the study
Nonhepatic lesion c. Lymph node (LN) lesion that measures at least one dimension as greater than or equal to 1.5 cm in the short axis, except for porta hepatis LN that measures greater than or equal to 2.0 cm in the short axis d. Non-nodal lesion that measures greater than or equal to 1.0 cm in the longest diameter Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion.
Hemoglobin (Hb) greater than or equal to 8.5 g/dL
Platelet count greater than or equal to 75 X 10^9/L
Albumin greater than or equal to 2.8 g/dL
HCC with greater than or equal to 50 percent liver occupation
Patients must have an interval of greater than or equal to 60 days from the completion of radiation therapy to study entry
Age greater than or equal to 18 years.
Man or woman greater than or equal to (>=) 18 years of age
Male or female subjects aged greater than or equal to (>=) 18 years
Hematocrit of greater than 30%
Zubrod performance status equal to or less than 2 (Karnofsky equal to or greater than 50%)
Absolute neutrophil count greater than or equal to 1,500/microL
Platelets greater than or equal to 100,000/microL
Patients must have adequate: i. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl. ii. Renal function: Creatinine ? 1.5 x institutional upper limit normal (ULN). iii. Hepatic function: Bilirubin ? 1.5 x ULN. SGOT (AST) and SGPT (ALT) ? 3.0 x ULN and alkaline phosphatase ? 2.5 x ULN. iv. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.
Platelets greater than or equal to 100 x 10^9/L
Serum creatinine less than or equal to 1.5 x ULN or 24-hour clearance greater than or equal to 50 mL/min
Patient who has received radiotherapy within less than or equal to 4 weeks or limited field radiation for palliation within less than or equal to 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 greater than or equal to 30% of the bone marrow was irradiated
The Gleason score should be less than or equal to 7
Adequate bone marrow, liver, and renal function defined as: 1) Absolute neutrophil count (ANC) greater than equal to (>=) 1.5* 10^9cells/litre (L); 2) Platelets >=75 x 109cells/L without transfusion support within 7 days prior to test; 3) Hemoglobin >= 8 gram/deciliter (g/dL) without transfusion support within 7 days prior to test 4) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than equal to (<=) 2.5 * upper limit of normal (ULN) 5) Total bilirubin less than (<) 2 milligram/deciliter (mg/dL) 6) Creatinine determined by serum creatinine levels <=1.5 * ULN or a calculated creatinine clearance of >= 50 mL/min/1.73 m^2
Platelets greater than or equal to 100,000/mcl
At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL.
Subject must be greater than or equal to 65 years of age in Phase 1 and 2. Subjects enrolled in Cohort C must be either:
greater than or equal to 75 years of age; OR
greater than or equal to 60 to 74 years will be eligible if the subjects has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy:
DLCO less than or equal to 65% or FEV1 less than or equal to 65%;
Moderate hepatic impairment with total bilirubin greater than 1.5 to less than or equal to 3.0 × ULN
of 0 to 2 for subjects greater than equal to 75 years of age
of 0 to 3 for subjects greater than equal to 60 to 74 years of age, if 0 - 1 another co-morbidity is required to make subject eligible.
Gleason score sum of less than or equal to 7
Tumor size greater than or equal to 1.0 cm in two perpendicular diameters
Serum creatinine less than or equal to 1.5 x ULN or 24-hour clearance greater than or equal to 50 ml/min
Baseline LVEF greater than or equal to (>/=) 55%
Adult participants greater than or equal to 18 years of age
At the time of study entry, blood counts performed within 4 weeks prior to study entry must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1000/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 9 g/dL
The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to study entry must be met: Total bilirubin must be less than or equal to 1.5 x upper limit of normal (ULN); aspartate aminotransferase (AST) and ALT must be less than or equal to 2.5 x ULN for the lab or less than or equal to 5 x ULN if liver metastasis;
CTCAE v4.0 greater than or equal to grade 2 vomiting related to metastatic disease.
Greater than or equal to 10 mm of cervical stromal invasion
Male or female subjects aged greater than or equal to (>=) 20 years
Subject must be greater than or equal to 18 years of age.
Untreated AML, greater than or equal to 60 years of age and are not candidates for standard therapy due to age, performance status, and/or adverse risk factors, according to the treating physician and with approval of the Medical Monitor;
Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L (greater than or equal to 1500/mm^3)
Hemoglobin (Hb) greater than or equal 8.5 g/dL
Platelet count greater than or equal 75 x 10^9/L (greater than or equal 75,000/mm^3)
Corrected pulmonary diffusion capacity of greater than or equal to 50%
Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by PCR reported on the International scale. This will be confirmed during screening
Patients 18 years old or greater
Shortening fraction greater than or equal to 25%
Platelets greater than or equal to 100,000/ul, CTCAE grade 0-1
Patients must have an estimated survival greater than or equal to 3 months
Age greater than or equal to 18 years, either sex.
Adequate organ function, defined as follows: 8.1. Electrocardiogram (ECG) without significant anomalies, performed in the 7 days preceding entry 8.2. Haemoglobin greater than or equal to 90 g/L 8.3. Total white blood cell count (WBC) greater than or equal to 3.0 x 10^9/L 8.4. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L 8.5. Platelet count greater than 100 x 10^9/L 8.6. Total bilirubin less than or equal to 1.5 fold the maximum normal value at the place of evaluation or 2.5 fold the maximum normal value in case of liver metastases 8.7. Glutamic-oxaloacetic transaminase/aspartate aminotransferase (GOT/AST), and glutamic-pyruvic transaminase/alanine aminotransferase (GPT/ALT), less than or equal to 2.5 fold the maximum normal value at the place of evaluation (in case of liver metastasis, less than 5 fold the maximum normal value) 8.8. Creatinine less than or equal to 2 mg/dL (less than or equal to 176 µmol/L)
Have a performance status less than or equal to 1 for Dose Escalation (Part A) and less than or equal to 2 for Dose Confirmation (Parts B, C, D, E, F and G) on the Eastern Cooperative Oncology Group (ECOG) scale
Serum albumin greater or equal to 3 g/dl (CTCAE 4.0 grade 1 abnormality is acceptable)
Adequate bone marrow function as evidenced by ANC greater than 1.5 x 10^9/L, hemoglobin greater than 10.0 g/dL, and platelet count greater than 100 x 10^9/L.
Serum magnesium greater than or equal to 1.8 mg/dL
Lost greater than or equal to 10% of body weight in the 3 months proceeding signing the ICF
Platelet count greater than or equal to 75,000/mcL
Lymphocyte count greater than or equal to 700/mcL
Normal creatinine for age:\r\n* 0.8 mg/dL for less than or equal to 5 years\r\n* 1 mg/dL for 6 to less than or equal to 10 years\r\n* 1.2 mg/dL for 11 to less than or equal to 15 years\r\n* 1.5 mg/dL for greater than or equal to 16 years OR
Shortening fraction greater than or equal to 28% by echocardiogram OR
Absolute neutrophil count greater than or equal to 1000/mm^3 without the support of filgrastim
Lymphocyte count less than or equal to 4,000/mm^3
DONOR: Children greater than or equal to 12 years of age who have not provided informed assent in the presence of a parent and an attending physician who is not a member of the recipient’s care team
DONOR: Children greater than or equal to 12 years of age who have inadequate peripheral vein access to safely undergo apheresis
Must be greater than or equal to 18 years at the time of signing the informed consent form.
Greater than or equal to Grade-2 neuropathy
Age greater than or equal to 1 year but less than or equal to 55 years (myeloablative regimen 4); eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician; patients > 55 but < 65 years who have a performance status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s)
Age greater than 55 years and less than or equal to 80 years (nonmyeloablative regimen 2)
Age greater than or equal to 1 but less than or equal to 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive total body irradiation (TBI) may receive reduced intensity regimen 3
Age greater than or equal to 18 years
Patients must have a shortening fraction greater than or equal to 27% by echocardiogram, OR ejection fraction greater than or equal to 50% by radionuclide angiogram (multigated acquisition [MUGA])
Meets UCSF criteria: a single lesion less than or equal to 6.5 cm in diameter or 2-3 lesions less than or equal to 4.5 cm with total tumor diameter less than or equal to 8 cm.
A discrete hepatic artery feeding the tumor with diameter of the vessels equal to or greater than 1.5 mm.
Evidence of myeloid engraftment defined by absolute neutrophil count greater than or equal to (>=) 0.5*109/liter (L) on 3 consecutive days.
Group 5: Diffuse scleroderma with disease duration less than or equal to 2 years since development of first sign of skin thickening plus modified Rodnan skin score greater than or equal to 25 plus erythrocyte sedimentation rate (ESR) > 25 mm/1st hour and/or hemoglobin (Hb) < 11 g/dL, not explained by causes other than active scleroderma
Platelets greater than or equal to 100,000/mcl
For Post-allo Part B: Transplant must have been performed with active AML (greater than 5% blasts) using a conventional conditioning regimen and have achieved CR or CRi post-alloSCT (with ANC greater than or equal to 1,000 and platelet greater than or equal to 50,000)
Hemoglobin greater than or equal to 9 gm/dl
Platelets greater than or equal to 100,000/ul
Must be greater or equal to 20 years of age
KPS equal to or greater than 70
male or female greater than or equal to 18 years of age
International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age
Severe neuropathy greater than or equal to grade 2
Severe sensorineural hearing loss greater or equal to grade 2
Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of greater than 1,000/Fl, a hemoglobin level of greater than or equal to 9.0 gm/dL and a platelet count of greater than 75,000/dL.
Hemoglobin greater than or equal to 9.0 g/dL
Shortening fraction greater than or equal to 25%
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
Hemoglobin greater than or equal to (>=) 9 gram per deciliter (g/dL)
Previously treated with sorafenib for greater than or equal to 4 weeks and discontinued sorafenib treatment at least 14 days prior to Day 1 due to either intolerance or radiographic progression
Patients must have at least one lesion suitable for perfusion CT; the lesion should be greater than or equal to 3 cm in size in the cranial caudal direction
Grade greater than equal to (>=) 3 hypertriglyceridemia
Has unresolved toxicity of greater than or equal to CTCAE Grade 1 attributed to any prior therapies
Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients
Uncontrolled hypertension (diastolic greater to or equal to 100 mmHg) or hypotension (systolic less than or equal to 90 mmHg)
Greater than or equal to 75 years of age
Participants with evidence of electrolyte imbalance greater than or equal to (>/=) Grade 2 which cannot be corrected prior to study initiation
For solid tumor-History or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years
Ambulatory patients greater than or equal to (?) 30 years of age
Shortening fraction greater than or equal to 28% by echocardiogram OR
Participants less than or equal to 16 years of age must have performance status of Lansky greater than or equal to 50% and participants greater than 16 years of age must have performance status of Karnofsky greater than 50%.
Bilirubin needs to be less than or equal to 1.3 x ULN
In patients > 60 years old, documented LVEF of less than or equal to 45%
A minimum of any one of the following disease-related symptoms must be present: a. Unintentional weight loss greater than or equal to 10% within the previous six months; b. Fevers greater than 100.5°F (38.0°C) for greater than or equal to 2 Weeks without evidence of infection; Or c. Night sweats for more than 1 month without evidence of infection.
Age greater than or equal to 18 years.
Patients must be greater than or equal to 18 years old.
Adult participants, greater than or equal to (>/=) 18 years of age
History of hemoptysis greater than or equal to (>/=) grade 2 within 3 months of randomization
Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3 or greater than or equal to 1.5 x 10^9/L.
Platelet count greater than or equal to 100,000/mm3 or greater than or equal to 100 x 10^9/L.
Absolute neutrophil count greater than or equal to 1,500/microL
Platelets greater than or equal to 100,000/microL
Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 9 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin until 5 days after the erythrocyte transfusion.
Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), ALT, and aspartate transferase (AST) less than or equal to 2.0 times ULN. If the liver has tumor involvement AST and ALT equaling less than or equal to 5 times ULN are acceptable.
Platelets greater than or equal to 100,000/ul (CTCAE grade 0-1)
QTc interval greater than or equal to 480msecs.
At US sites, patients greater than or equal to 12 years of age may be enrolled. At non-US sites, patients must be greater than or equal to 18 years of age.
Male or female greater than or equal to 18 years of age.
Serum bicarbonate greater than or equal to 20 mEq/L
Hemoglobin greater than or equal to 500/uL
Shortening fraction greater than or equal to 27% by echocardiogram; corrected QT interval =< 450 milliseconds
Be diagnosed with PHPT (inappropriate PTH level in the setting of a high or high-normal serum calcium level greater than or equal to 10.0 mg/dL).
Platelets greater than or equal to 100,000/mcl
Hemoglobin greater than or equal to 9 g/dL
Gleason score equal to or less than 7
PATIENT INCLUSION: Worst pain in the past 2 weeks greater than or equal to 4 on the 0-10 pain scale
There must be a minimum of 14 days (i.e., an interval equal to or greater than 14 days) since last treatment with bevacizumab and registration
The minimum age from greater than 65, to greater than 55
The minimum age from greater than 55, to greater than 18
Patient must be opioid-tolerant (greater than or equal to 60 mg morphine or equivalent) and on a stable dose of oral opioids for greater than or equal to 1 week; stable baseline opioid dosage defined as a dosage that does not fluctuate by more than 50% from the average dosage over one week prior to screening
Corrected serum calcium level less than or equal to 10.5 mg/dL
Low lean mass defined as either\r\n* Age- and sex- specific relative lean muscle mass standard deviation scores =< -1.0 OR\r\n* Body fat content greater than or equal to 25% in males or greater than or equal to 35% in females
Greater or equal to 6 months from last chemotherapy treatment
Patient who eats yogurt equal or more than once a day in the last 3 days
Australian Karnofsky performance status greater than or equal to 70 as reported by the patient
Subjects with hemoglobin values at the screening visit equal to or greater than 12.0 g/dL
Patients with BMI greater than or equal to 30 kg/m^2 who are undergoing hormonal treatment of endometrial cancer
Greater than or equal to grade 2 dry mouth prior to chemoradiotherapy or greater than or equal to grade 2 mucositis
Adequate serum folate (greater than or equal to 2 ng/mL) and vitamin B12 (greater than or equal to 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
Patient has grade 2 or greater hypo-albuminemia, serum sodium greater than 150 meq/L, serum osmolality greater than 300 mOsm/kg or blood urea nitrate/serum creatinine ratio greater than 25, within 7 days of screening
Mini Mental State Exam score greater than or equal to 19
Requiring greater than or equal to 180 mg of morphine per day
Receiving a dose of radiation therapy greater than or equal to 6000 centigray (cGy) to one third of the oral cavity
Heart rate greater than or equal to -105 beats per minute (bpm), or below 45 bpm (one re-screen allowed)
Current heavy alcohol consumption (greater than or equal to 6 drinks/day, 6 days/week)
African-American postmenopausal women with waist circumference greater than 35 inches (88 cm), 5-year invasive breast cancer risk is greater than 1.40% using the Contraceptive and Reproductive Experience (CARE) model, and have at least one of the following:\r\n* Elevated fasting glucose is greater than or equal to 100 mg/dL\r\n* Elevated blood pressure is greater than or equal to 130/85 mm/Hg
Current moderate-to-heavy smoker as determined by:\r\n* Has smoked greater than or equal to 10 cigarettes per day regularly for the past year (by history) (greater than or equal to 5 cigarettes per day for study 2) and,\r\n* Has an expired carbon monoxide (CO) at screening visit of 8 ppm or more (6 ppm or more for study 2)
Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2
Patients with an existing local or systemic infection as defined by evidence of fever (a body temperature greater than or equal to 38.0° Celsius (C) with two readings taken at least 10 minutes apart or one body temperature greater than or equal to 38.3°) and any of the following within 24 hours of enrollment: (a) pulse rate greater than or equal to 100 beats/min; (b) respiratory rate greater than or equal to 20/min; (c) white blood cell (WBC) count greater than or equal to 12,000/mm, less than or equal to 4,000/mm or differential count showing greater than 10% band forms; (d) systolic blood pressure less than or equal to 90 mm Hg
Individuals greater than or equal to 18 years of age
T1 post contrast lesion size greater than or equal to 10 mm
HEALTHY VOLUNTEERS: Age greater than or equal to 18
Life expectancy (in the opinion of the investigator) of greater than or equal to (>=) 12 weeks and LDH levels less than or equal to (<=) 2.5 ULN
greater than or equal to 18 years of age
Clinically or radiologically measurable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 2.0 cm
Radiographically or clinically measurable disease with greater than or equal to (>=) 1 target lesion per IWG criteria for malignant lymphoma.
Criteria 4, Participants have measurable disease which is equal to one or more metastatic liver lesions that can be accurately and serially measured that are greater than or equal to 1 cm dimension and for which the longest diameter is greater or equal to 1 cm as measured by CT (Computed Tomography) scan or magnetic resonance imaging. The metastatic liver lesion(s) must not be in an area that received prior localized therapies.
Age greater than or equal to 18 years, and
The participant has adequate hematologic function as defined by absolute neutrophil count greater than or equal to 1500/microliter (?L), hemoglobin greater than or equal to 9 grams/deciliter (g/dL), and platelet count greater than or equal to 100,000/?L.
The participant has adequate hepatic function as defined by a total bilirubin less than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less than or equal to 5 x the ULN in the presence of known liver metastases).
The participant has adequate hematologic function as defined by absolute neutrophil count greater than or equal to 1500/microliter (?L), hemoglobin greater than or equal to 9 grams/deciliter (g/dL), and platelet count greater than or equal to 100,000/?L.
The participant has adequate hepatic function as defined by a total bilirubin less than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less than or equal to 5 x the ULN in the presence of known liver metastases).
