Adequate bone marrow, cardiac, kidney and liver function
Adequate liver function, including:
Patients must have adequate renal function with serum creatinine level =< IULN within 21 days prior to registration
Adequate liver function must be demonstrated, defined as:
Subjects must have adequate renal function defined as a serum creatinine based on age/gender
Adequate bone marrow, kidney, and liver function
Adequate liver function must be demonstrated, defined as:
Liver function test must be obtained within 14 days prior to registration
Adequate hematological and biological function, confirmed by the following laboratory values within 96 hours prior to enrollment: Bone Marrow Function
Adequate bone marrow, renal, and liver function
Adequate bone marrow, kidney and liver function
Adequate bone marrow, kidney and liver function
Acceptable liver function:
Adequate bone marrow, liver and kidney function
Adequate renal function as evidenced by a serum/plasma creatinine < 1.5 x ULN
Acceptable liver function:
Adequate bone-marrow, renal and liver function.
Adequate renal function
Adequate blood coagulation function
Adequate liver function
Participants have adequate bone marrow, kidney and liver function.
Adequate performance status and hematological, liver, and kidney function
Adequate renal function
Adequate coagulation function
Acceptable hematological function:
Acceptable liver function:
Adequate bone marrow, kidney and liver function
Adequate renal function:
Adequate cardiovascular, hematological, liver and renal function
Good kidney and liver function
Adequate liver function:
Adequate Bone Marrow, Renal, and Liver Function.
Acceptable liver and renal function
Must have adequate bone marrow, liver, and renal function as described in protocol
Adequate renal function
Adequate liver function
Adequate bone marrow, cardiac, kidney and liver function
Adequate renal function
Acceptable liver function, as specified below:
Adequate liver function defined by:
Adequate liver and renal function
Inadequate liver function as evidenced by any of the following:
Adequate Bone Marrow, Liver, Renal, Pancreatic Function
Adequate Renal & Liver Function.
Adequate renal function within 28 days prior to study registration defined by either of the following criteria:
Combination Arm: adequate heart function
Adequate pulmonary and cardiac function
Adequate renal function.
Severe impairment of your kidney or liver function
Hematological function:
Acceptable liver function at Screening,
Have acceptable liver function defined as:
Patients must have adequate bone marrow, kidney, and liver function, (within 14 days prior to registration), defined as:
Acceptable liver function:
Acceptable liver function, serum creatinine and hematological status
Adequate organ function defined as absolute neutrophil count ?1,500×10^6/L, absolute lymphocyte count ?500/mm^3, and platelet count ?100,000×10^6/mm^3. Adequate liver function defined as aspartate aminotransferase and alanine aminotransferase ?2.5× the upper limit of institutional normal, bilirubin ?1.5 mg/dL or 25 µmol/L. Adequate renal function defined as blood urea nitrogen and serum creatinine of ?1.5 mg/dL or 130 µmol/L.
Subjects must have adequate liver function as defined by:
Subjects must have adequate renal function
Adequate bone marrow, liver, renal, and cardiac function at study entry, assessed as follows:
Adequate cardiac, hematological, liver and renal function
Adequate bone marrow, renal and liver function
Adequate liver function as demonstrated by:
Adequate bone marrow reserve, liver and renal function
Inadequate renal function as defined by serum creatinine > 3x normal for age
Acceptable liver function:
Adequate hematological function, defined as:
Adequate liver function, defined as:
Adequate renal function, defined as:
Adequate coagulation function
Adequate renal function
Adequate bone marrows, liver and renal function as assessed by the following laboratory requirements. Hemoglobin ?8.0 g/dL (may not be transfused or treated with erythropoietin in preceding week to maintain or exceed this level)
Must have adequate coagulation, hematology, kidney, and liver function, per protocol.
Liver function:
Adequate renal function.
Adequate renal function
Adequate liver function
Adequate hematological function
High screening liver function tests
Adequate renal function:
Adequate bone marrow, liver, and renal function.
Adequate renal function including creatinine < 2 unless related to the disease
Adequate bone marrow, liver, and renal function
Good kidney and liver function
Adequate bone marrow, renal, and liver function
Participant must have adequate liver function as demonstrated by:
Adequate bone marrow, liver and renal function
Adequate bone marrow, renal and liver function.
Subject has adequate liver function defined as:
Subject has adequate pulmonary function defined as:
Normal liver, kidney and bone marrow function
Participants must have adequate renal function, defined as:
Participants must have adequate liver function, defined as:
Adequate organ function, hematologic status, coagulation status, kidney function, and liver function as follows:
Adequate liver function:
Adequate bone marrow reserve, cardiac, liver, renal and metabolic function:
Acceptable liver function within 7 days of day 1 of therapy defined as:
Adequate marrow, liver, and renal function:
Participant must have adequate liver function as demonstrated by:
Patients must have adequate bone marrow, liver, coagulation and renal function within 7 days prior to study registration, as defined below:
Inadequate liver function at screening as demonstrated by the following:
Adequate renal function
Renal Function as follows:
Adequate renal function defined as follows:
Inadequate liver, renal function as defined below for both cohorts:
Adequate renal function, as indicated by creatinine =< 1.5 x ULN
Adequate liver function:
Adequate renal function:
Adequate renal function with creatinine (Cr) =< 2.5 mg/dL
Hematological function:
Renal function:
Adequate renal function assessed by: serum creatinine ? 1.5 × ULN
Adequate renal function: creatinine ?1.5 x ULN
Impaired renal function
Reproductive function:
Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis)
Adequate bone marrow function, renal and liver functions
Renal Function:
Have adequate renal function as defined by the following criterion:
Adequate marrow function
Adequate bone marrow, liver and kidney function
Renal
Adequate organ function as defined below: • Liver function: a. Total bilirubin < 2.0 mg/dL (34 µmol/L) b. AST and/or ALT <3 x ULN
Adequate liver function as evidenced by:
Adequate renal function:
Adequate Renal Function:
Adequate Liver Function:
Evidence of inadequate renal function (creatinine > 2 g/dL)
Renal function: preservation of renal function, serum creatinine did NOT increase by more than 2 fold above the normal reference range
Renal function criteria: preservation of renal function, serum creatinine did NOT increase by more than 2 fold above the normal reference range
Subjects must have adequate liver function as defined by:
Subjects must have adequate renal function defined as: Serum creatinine based on age/gender.
Patients are required to have adequate renal function as indicated by a serum creatinine =< 2.5 mg/dL; this value must be obtained within four weeks before protocol entry
Adequate bone marrow, liver, renal and coagulation function
Impaired heart function
Acceptable liver function
Acceptable renal function
Patient must have adequate renal function as defined by serum creatinine < -2.5 mg/dl obtained within 28 days prior to registration
Liver function test must be obtained within 14 days prior to registration
Renal Function: Adequate renal function in the opinion of the Investigator with no clinically significant renal impairment or uncontrolled renal disease.
Immunological Function: Adequate immune system function in the opinion of the Investigator with no known immunodeficiency disease.
Adequate bone marrow, renal and liver function.
Adequate renal function, defined as:
Adequate liver function, defined as:
Adequate liver function at Cycle 1 Day 1 pre-dosing defined as:
Acceptable renal function
Acceptable liver function
Adequate hematological, liver and kidney function.
Adequate hematological, liver, and kidney function
Adequate liver and renal function
Acceptable liver function
Adequate renal, liver and bone marrow function:
Have adequate values, bone marrow, renal and liver functions at screening as defined below:
Adequate liver and renal function and hematology laboratory values
Adequate liver function
Adequate renal function
Adequate bone marrow, renal and liver function.
Adequate bone marrow, liver, and renal function, as documented by the following laboratory assessments conducted within 28 days prior to dosing:
Adequate bone marrow, liver and renal function.
The patient has adequate pulmonary function
Adequate renal functions
Patients must have adequate renal function defined as age-adjusted serum creatinine =< 1.5 x normal for age
Have adequate renal function
Patient has adequate bone marrow, coagulation, liver and renal function
Acceptable renal function
Acceptable liver function
Adequate performance status and hematological, liver and kidney functions
Adequate liver and renal function
Adequate bone marrow function (absolute neutrophil count > 1,500/mm3 and platelet count of > 100,000/mm3), adequate liver function [ALT and AST <3 x upper limit normal (ULN), alkaline phosphatase <2 x ULN, and total bilirubin <1.5 mg/dL], & adequate renal function (BUN and creatinine <1.5 x ULN)
Adequate bone marrow, liver, kidney function
Liver function < 3 x normal
Renal function: CrCl < 15 ml/min.
Adequate renal function: serum creatinine =< 1.5 x ULN
Inadequate lung function
Inadequate renal function
Subject has adequate renal function, which is defined as:
Subjects must have adequate hematopoietic function as evidenced by:
Subjects must have adequate liver function, including all of the following:
Adequate bone marrow, kidney and liver function
Patients must have adequate heart, kidney, liver and bone marrow function.
Adequate Bone Marrow, Pancreatic Function, Renal Function and Liver Function.
Adequate hematological, renal, and liver function
Subject must have adequate kidney and liver function as described in the protocol
Renal function defined as:
Liver function defined as:
Have adequate coagulation function.
Have adequate renal function as defined by creatinine clearance >30 milliliters/minute.
Adequate hematological, liver, and renal function
Adequate renal function, defined as serum creatinine ?1.5x ULN or GFR >50 mL/min
Acceptable liver and renal function:
Adequate liver function:
Adequate blood clotting function
Bone marrow impairment, renal impairment, liver function abnormality and impaired cardiac function as defined in the protocol
Adequate liver function
Abnormal liver function test results
Adequate major organ function (normal or minimal alteration in liver, kidney, hematological, metabolic and cardiac function)
Adequate hematological, liver and kidney function.
Adequate cardiovascular function
Adequate renal, liver, and bone marrow function according to the following criteria:
Inclusion Criteria:\n\n        Patients with histologically or cytologically confirmed advanced solid malignancy or\n        Lymphoma\n\n        Relapsed or refractory disease after at least 1 prior systemic treatment for the primary\n        malignancy and not a candidate for other curative treatment.\n\n        Adequate hematologic status\n\n        Adequate coagulation function\n\n        Adequate hepatic function\n\n        Adequate renal function\n\n        Exclusion Criteria:\n\n        Known primary tumors of central nervous system disease\n\n        Known active brain metastases\n\n        Known cardiopulmonary disease
Adequate liver, bone marrow and renal function
Adequate liver function:
Participants with Hepatitis B or C are eligible on the condition that they have adequate liver function as defined by Inclusion Criterion 9.
Adequate bone marrow, renal, liver and pancreatic function
Adequate liver and renal function
Have adequate organ function including hematology, renal, and liver.
Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements:
Abnormal hematological, renal, or liver function
Adequate liver function
Adequate renal function
Renal function: • Creatinine less than or equal to 1.5 x ULN
Inadequate renal or liver function
Acceptable renal function
Acceptable liver function
Adequate bone marrow, kidney and liver function
Adequate liver function, defined as:
Adequate cardiac function as assessed clinically
Adequate cardiac function as measured by echocardiogram
Inadequate hematological, liver, renal, cardiac function
Adequate coagulation function
Adequate renal function
Eligible study subjects must exhibit acceptable liver, renal, and coagulation function as assessed by laboratory tests.
Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
Inadequate hematologic function, renal function, and liver function
Adequate bone marrow, liver and renal function
Adequate renal function (defined as serum creatinine =< 1.5 X ULN)
Adequate bone marrow function, renal and liver functions
Adequate hematological and biological function
Adequate liver, kidney, and bone marrow function
Adequate bone marrow, liver and renal function
Adequate bone marrow, liver, and renal functions.
Adequate renal function within 28 days prior to registration for protocol therapy defined by either of the following criteria:
Inadequate liver, renal or bone marrow function within 2 weeks of first dose
Patient has adequate renal function defined as: Serum creatinine ?1.5 the institutional ULN
Inadequate renal function
Subject must have adequate liver function as demonstrated by:
Adequate liver function
Inadequate renal function
Renal
Inadequate bone marrow, renal, or liver function
Adequate hematological function defined as:
Adequate liver function defined as:
Acceptable liver function defined as:
Adequate bone marrow, kidney and liver function.
Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function
Adequate liver function, defined as both of the following:
Adequate bone marrow, renal, and liver function.
Adequate renal function
Adequate liver function
Adequate cardiac function
Adequate neurologic function
Adequate pancreatic function
Adequate liver function, defined as:
Adequate bone marrow, liver and renal function renal function
Adequate cardiac function
Adequate bone marrow, liver and renal function as assessed by the following laboratory tests conducted within 7 days before randomization.
Abnormal heart function
Adequate bone marrow, liver and renal function as assessed within 7 days before starting study treatment
Adequate renal function, defined as serum creatinine ?1.5x ULN
Adequate renal function
Adequate organ function (bone marrow, kidney and liver)
Adequate kidney function
Adequate liver function
Normal pancreatic function
Patients must have adequate renal function (creatinine < 1.5 mg/dL) before starting therapy and the test must be performed within 14 days prior to registration
Renal
Inadequate liver function at screening and Day 1 (before drug administration) as demonstrated by:
Adequate haematological, renal (creatinine < 2xULN), cardiac and liver functions
Abnormal/inadequate blood values, liver and kidney function
Adequate cardiac and renal function
abnormal/inadequate blood values, liver, and kidney function
Adequate liver function (bilirubin less than or equal to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine less than or equal to 3.0 mg/dl, unless considered due to tumor)
Adequate cardiac function as assessed clinically.
Adequate Bone Marrow, Renal and liver Functions.
Adequate liver, kidney, and bone marrow function
Participants must have adequate liver, kidney, and bone morrow function
Adequate bone marrow, renal and liver function.
Adequate hematological, liver and kidney function.
Adequate renal function.
Adequate glucose control, bone marrow, kidney, liver, and heart function.
Inadequate heart function
Inadequate lung function
Adequate hematological function, defined as:
Adequate liver function, defined as:
Adequate bone marrow, liver and renal function
Adequate hematological function, defined as:
Adequate liver function, defined as:
Adequate hematological, liver, and renal function
Adequate bone marrow, liver and renal function
Adequate renal and liver function
Must have adequate hematological function
Must have adequate renal function
Patients must be suitable candidates for treatment with standard regimens; this includes having adequate hematologic parameters, liver function and renal function based on labs that are deemed acceptable for treatment by the investigators
Adequate bone marrow, kidney and liver function
Severe impairment of your kidney or liver function
Adequate white blood cell counts (with low blast counts), liver function, and renal function
Acceptable hematological status, liver and renal function as defined in the protocol
Adequate bone marrow function [absolute neutrophil count (ANC) > 1,500/mm3 & platelet count of > 100,000/mm3], adequate liver function [alanine aminotransferase (ALT) & aspartate aminotransferase (AST) <3 x upper limit normal (ULN), alkaline phosphatase <2 x ULN, & total bilirubin <1.5 mg/dL], & adequate renal function (BUN & creatinine <1.5 x ULN)
Adequate bone marrow, renal, liver, cardiac and pulmonary function.
Inadequate renal function (Blood creatinine > 1.5 times the institutional ULN)
Adequate renal function
Have adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:
Adequate bone marrow, kidney, liver, and heart function.
Acceptable liver function
Acceptable renal function
Adequate renal function
Acceptable liver function:
Adequate bone marrow, liver and renal function
Adequate renal function, defined by serum creatinine ? 1.5 x ULN.
Adequate hematological, renal and liver function
Patients must have adequate liver function
Patients must have adequate renal function as defined by a serum creatinine =< 1.5 times ULN within one week prior to treatment
Adequate bone marrow, liver and renal function
Adequate coagulation function as defined by the following criteria:
Adequate blood, liver, and kidney function as defined by laboratory tests.
Subjects must have adequate liver function
Subjects must have adequate kidney function
Adequate bone marrow, liver, and renal function
Adequate liver function, defined as:
Patients must have adequate bone marrow function (ANC >/= 1,500/mm3 and platelet count of >/= 100,000/mm3), adequate liver function (SGPT and serum glutamate oxaloacetate transaminase (SGOT) </= 2.5 times normal, bilirubin </= 2 mg/dl), and adequate renal function (BUN and creatinine </=1.5 times institutional normal) prior to starting therapy.
Adequate bone marrow, liver, and renal functions
Adequate bone marrow, liver, and renal functions, defined as:
Inadequate hematopoietic, liver, endocrine or renal function
Inadequate lung function
Inadequate heart function
Adequate bone morrow and kidney function
Adequate bone marrow, liver, cardiac, and renal function
Adequate haematological, liver and renal function
Adequate renal function
Adequate liver, renal and cardiac function
Adequate bone marrow, kidney and liver function
Patient must have adequate renal function documented by a serum creatinine of ? 1.5 times the ULN for the reference lab.
Adequate hematological, renal and liver function For solid tumors only:
Impaired bone marrow, liver or renal function (as defined by protocol)
Reproductive Function
Adequate renal function
Adequate liver function
Adequate cardiac function
normal immune function
Acceptable bone marrow, liver and kidney function.
Adequate renal function
Adequate liver function within 72 hours of enrollment, defined as:
Adequate renal function, defined as serum creatinine ? 1.5x ULN
Adequate hematological and biological function; LVEF ?50%
Acceptable renal function
Acceptable liver function
Adequate cardiac function:
Inadequate bone marrow, liver, and renal function, as assessed by the following laboratory parameters:
Impaired heart function
Adequate bone marrow, renal and liver functioning
Chemistry, liver function tests, renal function, total CPK and hematology lab results must be ? Grade 1 at the time of screening;
Adequate bone marrow and renal function
Adequate bone marrow, renal and liver function
Adequate bone marrow, kidney, and liver function
Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment:
Adequate liver function as demonstrated by
Have adequate complete blood counts and liver function tests
Have adequate cardiac function
Has adequate organ function (bone marrow, kidney and liver)
Inadequate lung function
Adequate bone marrow, and liver function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment
For subjects with SEVERELY IMPAIRED renal function:
Protocol-defined renal , liver and bone marrow function
Adequate hematological function (as defined in the study protocol)
Adequate renal function (as defined in the study protocol)
Adequate liver function (as defined in the study protocol)
Have adequate cardiac, bone marrow, liver and kidney function
Abnormal heart function
Renal:
Adequate bone marrow, liver, and renal function within the 14 days prior to Day 1 of Cycle 1 of study drug up until pre-dose of Cycle 1
Renal function, as follows:
Liver function:
Renal function:
Adequate hematological function unless inadequate function is due to underlying disease
Adequate bone marrow, liver, and renal function
Adequate hematological and biological function
Abnormal renal function tests (creatinine > 1.5)
Inclusion Criteria:\n\n          -  Life expectancy of at least 3 months\n\n          -  Histological or cytological documentation of advanced solid tumors\n\n          -  ECOG Performance Status of ? 1 (ECOG: Eastern Cooperative Oncology Group)\n\n          -  Adequate bone marrow, liver and renal function\n\n          -  Women of childbearing potential and men must agree to use adequate contraception
Adequate liver and renal functions
Hematological function, as follows:
Adequate hematological, renal and liver function
Adequate hematological function
Adequate renal function:
Normal renal function: estimated CrCl ?90 ml/min
Participants with adequate hematological, liver, and renal function
Adequate liver function, defined as:
Adequate bone marrow, renal and liver function as defined in the protocol.
Renal Function Creatinine >1.5 mg%
Adequate bone marrow, liver and renal function
Adequate liver function, as indicated by bilirubin =< 1.5 x ULN
Adequate Renal function
Inadequate kidney, liver, blood clotting function
Adequate renal function.
Adequate cardiac function.
Adequate renal function.
Adequate pulmonary function
Patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function.
Inadequate liver function as evidenced by any of the following:
Hepatic and renal function meeting the strata as outlined below; nota bene (NB): patients must fulfill both total bilirubin and serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) criteria and creatinine function to be included in a group; however, if a patient’s total bilirubin and SGOT/AST and creatinine levels indicate different groups, the patient may be enrolled in the indicated group with the greatest degree of liver dysfunction; all liver and renal function tests must be completed within 24 hours prior to the start of treatment; Note: patients on dialysis will not be eligible\r\n* Group A: hepatic function: normal function (bilirubin =< upper limit of normal [ULN]; AST =< ULN); renal function: normal function (creatinine clearance [CrCl] >= 60 mL/min) \r\n* Group B: hepatic function: normal function (bilirubin =< ULN; AST =< ULN); renal function: moderate dysfunction (CrCl >= 30 and < 60 ml/min)\r\n* Group C: hepatic function: normal function (bilirubin =< ULN; AST =< ULN); renal function: severe dysfunction (CrCl >= 15 and < 30 ml/min)\r\n* Group D: hepatic function: mild dysfunction D1: bilirubin =< ULN; AST > ULN, D2: bilirubin > ULN and =< 1.5 x ULN; any AST; renal function: normal function (creatinine clearance [CrCl] >= 60 mL/min)\r\n* Group E: hepatic function: mooderate dysfunction (bilirubin 1.5 x > ULN and =< 3 x ULN; any AST); renal function: normal function (creatinine clearance [CrCl] >= 60 mL/min)\r\n* Group F: hepatic function: severe dysfunction (bilirubin > 3 x ULN and up to investigator’s discretion; any AST); renal function: normal function (creatinine clearance [CrCl] >= 60 mL/min)
Patients with solitary kidneys, bilateral renal tumors, compromised renal function (baseline creatinine > 1.4)
Have adequate liver function defined as:
Have adequate heart function defined as:
Adequate hematologic and organ function, including blood counts, liver and kidney function Stage I Arm A (GDC-0077):
Renal function at screening and enrollment as defined by the Modification of Diet in Renal Disease (MDRD) equation.
Adequate liver function:
Impaired heart function
Normal kidney and liver function (lab results must be within 45 days prior enrollment)
Adequate renal and liver function as indicated by:
Adequate bone marrow, liver, and renal function, as assessed by the following requirements conducted within 21 days prior to dosing:
Adequate bone marrow, liver, and renal functions
Adequate bone marrow, liver, cardiac, and renal function
Patients must have normal renal function test and no prior renal disease; the screening cut off for serum creatinine is < 1.5 mg/dL
Patients with normal renal function according to MD Anderson testing standards and no prior renal disease
Adequate bone marrow, liver, and renal function
Adequate bone marrow, liver and kidney function
Participants with renal insufficiency or failure, as determined by a point of care renal function blood test.
Liver: Subjects must have adequate liver function
Renal: Adequate renal function
Cardiac and pulmonary function that is adequate for ASCT
Adequate renal function
Adequate hematological, liver and kidney function.
Adequate bone marrow reserves and liver and kidney function, as assessed by the following laboratory requirements:
Compromised renal function
Patients must have adequate liver function as defined by AST or ALT <10x normal
Have adequate bone marrow reserves and liver and kidney function, as assessed by the following laboratory requirements:
Inadequate renal function
Adequate renal function: serum creatinine ? 1.5x ULN;
Adequate bone marrow, liver and renal function
Participants with renal insufficiency or failure, as determined by a point of care renal function blood test
Adequate performance status and hematological, liver, and kidney function
Good kidney and liver function
Adequate renal function within 28 days prior to C1D1
Adequate hematopoietic function within 7 days prior to C1D1
Adequate bone marrow, liver, and kidney function within 2 weeks prior to first dose
Adequate liver function:
Adequate hematological, liver, and renal functions
Adequate renal function defined as:
Adequate liver function defined as:
Adequate function of kidney:
Adequate function of liver:
Adequate liver function:
Adequate bone marrow, kidney and liver function
Adequate bone marrow, liver, and renal function