Platelets greater than or equal to ,/mm (greater than or equal to X /L)
ANC must be greater than or equal to /mm,
Platelets greater than or equal to ,/mm (greater than or equal to X /L)
Platelets greater than or equal to ,/ul
Third or greater relapse.
Platelets greater than or equal to ,/mcl
Subject in whom all visible vessels or suture holes greater than or equal to mm in diameter have been ligated;
Serum creatinine equal or greater than . mg/deciliter
PART I: Greater than or equal to week since standard or investigational treatment for metastatic disease
Platelets greater than or equal to , mcL
Platelets greater than or equal to x ^/L
Platelets greater than or equal to ,/mm^
Platelets greater than or equal to ,/uL
Previous treatment with ifosfamide and Grade greater than or equal to nephrotoxicity or encephalopathy (Cohorts A and B).
Serum creatinine less than or equal to . in males, or . in female
Inclusion Criteria:\n\n Participants must meet all of the following criteria to be included in the study:\n\n . Age greater than or equal to years.\n\n . 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 . CD assay-positive tumor, defined as detectable CD on greater than or equal to %\n of total lymphoid infiltrate in biopsied skin lesions by immunohistochemistry.\n\n . CTCL disease stage at study entry as follows, according to ISCL/EORTC (Olsen ).\n\n - Lead-In Phase: Stage IA - IV, except participants with CNS involvement.\n\n - Main Study: Stage IA - IVA including lymph node disease N and N\n\n . 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 . A minimum washout period of weeks after previous CTCL therapy is recommended before\n the first dose of E.\n\n Participants must have recovered from any adverse effects from any previous CTCL\n therapy to CTCAE Grade < before starting study drug. A shorter washout may be allowed\n if participant is experiencing progressive disease despite ongoing treatment\n\n . Eastern Cooperative Oncology Group (ECOG) performance status , , or in the Lead-In\n Phase and performance status of or in the Main Study.\n\n . Life expectancy greater than or equal to months in the Lead-In Phase and greater\n than or equal to months in the Main Study.\n\n . Adequate bone marrow reserves as evidenced by:\n\n - platelets greater than or equal to ,/mm ( x ^/L)\n\n - clinically stable hemoglobin greater than or equal to g/dL ( g/L) and\n hematocrit greater than or equal to % without transfusion support\n\n . Normal hepatic function as evidenced by:\n\n - bilirubin and alkaline phosphatase less than or equal to x the upper limit of\n normal (ULN).\n\n - aspartate aminotransferase (AST) less than or equal to U/L and alanine\n aminotransferase (ALT) less than or equal to U/L.\n\n - albumin greater than or equal to . g/dL ( g/L).\n\n . Adequate renal function as evidenced by serum creatinine less than or equal to .\n mg/dL ( umol/L) OR calculated creatinine clearance greater than or equal to \n mL/min (per the Cockcroft-Gault formula) with less than + protein OR - hour urine\n creatinine clearance greater than or equal to mL/minute with - hour urine protein\n less than g.\n\n . Provide written informed consent prior to any study-specific screening procedures.\n\n . Females may not be lactating or pregnant at Screening or Baseline\n\n . All females will be considered to be of childbearing potential unless they are\n postmenopausal or have been sterilized surgically\n\n . 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 . Prior denileukin diftitox therapy\n\n . Use of topical steroids within days of Day of initial therapy is not allowed\n\n . 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 months.\n\n . Serious intercurrent illness\n\n . 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 . Significant pulmonary symptoms or disease\n\n . History of uncontrolled seizure disorder or active central nervous system disease\n\n . Major surgery within weeks of study enrollment\n\n . Significant or uncontrolled infections requiring specific anti-infective therapy\n\n . Known human immunodeficiency virus (HIV) infection; known active hepatitis B or\n hepatitis C infection\n\n . Females who are pregnant (positive urine test) or breastfeeding\n\n . 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.
Creatinine less than or equal to . unless related to the disease
Bilirubin less than or equal to .
ANC must be greater than or equal to /mm
Greater than or equal to weeks since the receipt of chemotherapy or radiation therapy
Platelets less than or equal to ,
Bilirubin greater than or equal to . x ULN
EXCLUSION CRITERIA FOR TREATMENT: Creatinine greater than or equal to . x ULN
EXCLUSION CRITERIA FOR TREATMENT: AST/ALT greater than or equal to . x ULN
EXCLUSION CRITERIA FOR TREATMENT: Bilirubin greater than or equal to . x ULN
Inclusion Criteria\n\n . 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 . 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 . ? years of age\n\n . For solid tumors, measurable disease as defined by Response Evaluation Criteria in\n Solid Tumors (RECIST .)\n\n . For lymphoma, measurable disease as defined by the International Workshop to\n Standardize Response Criteria for Non-Hodgkin's Lymphoma\n\n . For multiple myeloma, measurable disease as defined by the International Uniform\n Response Criteria for Multiple Myeloma\n\n . Karnofsky performance status greater than or equal to %\n\n . Male or female patients of child-producing potential must agree to use contraception\n or avoidance of pregnancy measures during the study and for days after the last\n BBI dose\n\n . Females of childbearing potential must have a negative serum pregnancy test\n\n . Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to .\n upper limit of normal(ULN)\n\n . Hemoglobin (Hgb) greater than or equal to g/dl\n\n . Total bilirubin less than or equal to . ULN\n\n . Creatinine less than or equal to . x ULN or creatinine clearance greater than \n mL/min/. m for patients with creatinine levels above institutional normal.\n Creatinine < . x ULN for multiple myeloma patients.\n\n . Absolute neutrophil count greater than or equal to . x /L\n\n . Platelets greater than or equal to x /L\n\n . Life expectancy greater than or equal to months\n\n Exclusion Criteria\n\n . 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 Gray (equal to RAD) with palliative intent for pain control up to days\n before beginning the administration of BBI.\n\n . Surgery within weeks prior to first dose\n\n . Any known untreated brain metastases. Treated subjects must be stable for 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 weeks prior to protocol enrollment. Patients\n with known leptomeningeal metastases are excluded, even if treated.\n\n . Pregnant or breastfeeding\n\n . 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 . Unable or unwilling to swallow BBI capsules daily\n\n . 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 . 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 . 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 . ? years of age\n\n . For solid tumors, measurable disease as defined by Response Evaluation Criteria in\n Solid Tumors (RECIST .)\n\n . For lymphoma, measurable disease as defined by the International Workshop to\n Standardize Response Criteria for Non-Hodgkin's Lymphoma\n\n . For multiple myeloma, measurable disease as defined by the International Uniform\n Response Criteria for Multiple Myeloma\n\n . Karnofsky performance status greater than or equal to %\n\n . Male or female patients of child-producing potential must agree to use contraception\n or avoidance of pregnancy measures during the study and for days after the last\n BBI dose\n\n . Females of childbearing potential must have a negative serum pregnancy test\n\n . Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to .\n upper limit of normal(ULN)\n\n . Hemoglobin (Hgb) greater than or equal to g/dl\n\n . Total bilirubin less than or equal to . ULN\n\n . Creatinine less than or equal to . x ULN or creatinine clearance greater than \n mL/min/. m for patients with creatinine levels above institutional normal.\n Creatinine < . x ULN for multiple myeloma patients.\n\n . Absolute neutrophil count greater than or equal to . x /L\n\n . Platelets greater than or equal to x /L\n\n . Life expectancy greater than or equal to months\n\n Exclusion Criteria\n\n . 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 Gray (equal to RAD) with palliative intent for pain control up to days\n before beginning the administration of BBI.\n\n . Surgery within weeks prior to first dose\n\n . Any known untreated brain metastases. Treated subjects must be stable for 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 weeks prior to protocol enrollment. Patients\n with known leptomeningeal metastases are excluded, even if treated.\n\n . Pregnant or breastfeeding\n\n . 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 . Unable or unwilling to swallow BBI capsules daily\n\n . 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
Platelets greater than or equal to ,/mm^
Platelets greater than or equal to ,/ul
Platelets greater than or equal to ,/mm^ (CTCAE grade -)
Platelets greater than or equal to ,/mcl
Platelets greater than or equal to ,/mcl
ANC greater than or equal to , K/uL
Platelets greater than or equal to K/uL
Biochemical recurrence: defined as a cancer antigen (CA)- greater than or equal to two times the upper normal limit; patients whose CA is less than U/mL must undergo a second confirmatory value within a period of not more than weeks; patients with a level greater than or equal to U/mL may be entered without confirmatory measurement
Platelets greater than or equal to ,/mm (greater than or equal to X ^/L)
Fasting (greater than or equal to [>=] hours) glucose less than or equal to (<=) milligrams per deciliter (mg/dL)
Platelets greater than or equal to , cells/mcl
Inclusion Criteria:\n\n . years of age or older . Able to provide written informed consent or have their legal\n representatives provide written informed consent . 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 . ECOG Performance Status of or\n . Undergone orchiectomy, or have ongoing LHRH analogue therapy prior to CD. Subjects\n on LHRH analogues should remain on these agents for the duration of the study . Castrate\n levels of testosterone less than or equal to ng/dl (or . nmol/L) and have progressive\n disease at Screening defined as PSA rise determined by a minimum of rising PSA values\n greater than or equal to week between each assessment. The PSA value at the Screening\n visit must be greater than or equal ng/mL with or without: Soft tissue disease progression\n defined by RECIST . at Screening or less than or equal to days of CD. Measurable\n disease is not required for entry.\n\n Lymph nodes greater than or equal to .cm (short axis) are considered measurable disease\n bone disease progression defined by greater than or equal new lesions on bone scan at\n Screening, or less than or equal days of CD . Have received abiraterone and/or\n enzalutamide. Subject must have received either abiraterone or enzalutamide for greater\n than or equal to weeks. Other second generation CYP inhibitors/androgen receptor\n antagonists including but not limited to TAK- (orteronel), TOK- (galeterone) may have\n been taken in place of abiraterone and ARN- (apalutamide) may have been taken in place\n of enzalutamide.\n\n . Adequate hematopoietic function as evidenced by:\n\n - WBC greater than or equal to ,/?l\n\n - ANC greater than or equal to ,/?l\n\n - Platelet count greater than or equal to ,/?l\n\n - HGB greater than or equal to g/dl and not transfusion dependent . Adequate liver\n function, including all the following:\n\n - Total serum bilirubin less than or equal to . x ULN unless the subject has\n documented Gilbert syndrome;\n\n - Aspartate and alanine aminotransferase (AST & ALT) less than or equal to . x ULN or\n less than or equal to . x ULN if subject has liver metastasis;\n\n - Alkaline phosphatase less than or equal to . x ULN or less than or equal to x ULN\n in case of bone metastasis and/or hepatic metastasis . Subjects must have adequate\n renal function as evidenced by a serum creatinine of less than or equal to . mg/dl\n . Potassium (K+) greater than or equal to . mEq/l . Subject and his female\n partner who is of childbearing potential must use 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 months\n after final study drug administration.\n\n - Two acceptable forms of birth control include:\n\n . Condom (barrier method of contraception), and\n\n . One of the following:\n\n . Oral, injected or implanted hormonal contraception\n\n . Placement of an intrauterine device (IUD) or intrauterine system (ISU)\n\n . Additional barrier methods of contraception: Occlusive cap (diaphragm or\n cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.\n\n . Vasectomy or surgical castration greater than or equal to months prior to\n Screening.\n\n . Able to swallow study medication . 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 . Received sipuleucel-T (Provenge ) treatment within days of CD\n\n . Received -alpha reductase inhibitors such as finasteride (PROSCAR, PROPECIA), or\n dutasteride (AVODART) within days of CD\n\n . Received any investigational agent less than or equal to days of CD\n\n . Received palliative radiotherapy less than or equal to weeks of CD\n\n . Symptomatic CNS metastases\n\n . History of another invasive malignancy less than or equal to years of CD\n\n . A QTcF interval of greater than msec; if the Screening ECG QTcF interval is\n greater than msec, it may be repeated, and if repeat less than or equal to \n msec, the subject may be enrolled\n\n . 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 . Started a bone modifying agent (e.g. bisphosphonates, denosumab) less than or equal to\n days of CD (note: ongoing bone modifying agents administered less than days\n are allowed)\n\n . 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 . Class III or IV Congestive Heart Failure (CHF) as defined by the New York Heart\n Association (NYHA) functional classification system within the previous months\n\n . A history of loss of consciousness or transient ischemic attack less than or equal to\n months of CD\n\n . Known active HIV, Hepatitis B, or Hepatitis C infections\n\n . Known or suspected hypersensitivity to seviteronel, or any components of the\n formulation\n\n . Any other condition which in the opinion of the investigator would preclude\n participation in the study
Patients must have an interval of greater than or equal to days from the completion of radiation therapy to study entry
Platelets greater than or equal to ,/microL
Platelets greater than or equal to x ^/L
Platelets greater than or equal to ,/mcl
greater than or equal to to 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 % or FEV less than or equal to %;
Baseline LVEF greater than or equal to (>/=) %
CTCAE v. greater than or equal to grade vomiting related to metastatic disease.
Greater than or equal to mm of cervical stromal invasion
Platelets greater than or equal to ,/ul, CTCAE grade -
Adequate organ function, defined as follows: .. Electrocardiogram (ECG) without significant anomalies, performed in the days preceding entry .. Haemoglobin greater than or equal to g/L .. Total white blood cell count (WBC) greater than or equal to . x ^/L .. Absolute neutrophil count (ANC) greater than or equal to . x ^/L .. Platelet count greater than x ^/L .. Total bilirubin less than or equal to . fold the maximum normal value at the place of evaluation or . fold the maximum normal value in case of liver metastases .. Glutamic-oxaloacetic transaminase/aspartate aminotransferase (GOT/AST), and glutamic-pyruvic transaminase/alanine aminotransferase (GPT/ALT), less than or equal to . fold the maximum normal value at the place of evaluation (in case of liver metastasis, less than fold the maximum normal value) .. Creatinine less than or equal to mg/dL (less than or equal to mol/L)
Serum albumin greater or equal to g/dl (CTCAE . grade abnormality is acceptable)
A discrete hepatic artery feeding the tumor with diameter of the vessels equal to or greater than . mm.
Platelets greater than or equal to ,/mcl
For Post-allo Part B: Transplant must have been performed with active AML (greater than % blasts) using a conventional conditioning regimen and have achieved CR or CRi post-alloSCT (with ANC greater than or equal to , and platelet greater than or equal to ,)
Platelets greater than or equal to ,/ul
Grade greater than equal to (>=) hypertriglyceridemia
Bone marrow blasts greater than or equal to % for relapsed patients, or greater than or equal to % for untreated patients
Participants with evidence of electrolyte imbalance greater than or equal to (>/=) Grade which cannot be corrected prior to study initiation
A minimum of any one of the following disease-related symptoms must be present: a. Unintentional weight loss greater than or equal to % within the previous six months; b. Fevers greater than .F (.C) for greater than or equal to Weeks without evidence of infection; Or c. Night sweats for more than month without evidence of infection.
Platelets greater than or equal to ,/microL
Hematologic: Absolute neutrophil count (ANC) greater than or equal to . x /L, platelets greater than or equal to x /L, and hemoglobin greater than or equal to g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin until days after the erythrocyte transfusion.
Platelets greater than or equal to ,/ul (CTCAE grade -)
Platelets greater than or equal to ,/mcl
There must be a minimum of days (i.e., an interval equal to or greater than days) since last treatment with bevacizumab and registration
Greater or equal to months from last chemotherapy treatment
Patients with BMI greater than or equal to kg/m^ who are undergoing hormonal treatment of endometrial cancer
Greater than or equal to grade dry mouth prior to chemoradiotherapy or greater than or equal to grade mucositis
Adequate serum folate (greater than or equal to ng/mL) and vitamin B (greater than or equal to pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
Patient has grade or greater hypo-albuminemia, serum sodium greater than meq/L, serum osmolality greater than mOsm/kg or blood urea nitrate/serum creatinine ratio greater than , within days of screening
Requiring greater than or equal to mg of morphine per day
African-American postmenopausal women with waist circumference greater than inches ( cm), -year invasive breast cancer risk is greater than .% 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 mg/dL\r\n* Elevated blood pressure is greater than or equal to / mm/Hg
Have a Khorana thromboembolic risk Score greater than or equal to (>=)
Patients with an existing local or systemic infection as defined by evidence of fever (a body temperature greater than or equal to . Celsius (C) with two readings taken at least minutes apart or one body temperature greater than or equal to .) and any of the following within hours of enrollment: (a) pulse rate greater than or equal to beats/min; (b) respiratory rate greater than or equal to /min; (c) white blood cell (WBC) count greater than or equal to ,/mm, less than or equal to ,/mm or differential count showing greater than % band forms; (d) systolic blood pressure less than or equal to mm Hg
T post contrast lesion size greater than or equal to mm
