Bone marrow, liver and renal functions as assessed by adequate laboratory methods to be conducted within 7 days prior to starting study Treatment
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)
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 as assessed by the following laboratory requirements:
Adequate bone marrow, liver and renal function as assessed by the following laboratory tests conducted within 7 days before randomization.
Adequate bone marrow, liver and renal function as assessed within 7 days before starting study treatment
Adequate hematologic, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
Adequate liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to starting study treatment:
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 liver and renal functions as assessed by the following laboratory requirements to be conducted within 14 days before the first dose of study drug:
Inadequate bone marrow, liver, and renal function, as assessed by the following laboratory parameters:
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment:
Adequate bone marrow, liver, and renal functions as assessed by laboratory analysis to be conducted within 7 days prior to the first dose of study drug
Bone marrow, liver and renal functions as assessed by adequate laboratory methods to be conducted within 7 days prior to starting study treatment
Adequate bone marrow, and liver function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment
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 as assessed by the following laboratory requirements to be conducted within 7 days prior to the first dose of study drug:
Adequate bone marrow, cardiac, kidney and liver function
Adequate bone marrow, kidney, and liver function
Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these
Adequate bone marrow, kidney and liver function
Adequate bone marrow, kidney and liver function
Adequate bone marrow, liver and kidney function
Participants have adequate bone marrow, kidney and liver function.
Adequate performance status and hematological, liver, and kidney function
Adequate bone marrow, kidney and liver function
Good kidney and liver function
Adequate bone marrow, cardiac, kidney and liver function
Severe impairment of your kidney or liver function
Patients must have adequate bone marrow, kidney, and liver function, (within 14 days prior to registration), defined as:
Must have adequate coagulation, hematology, kidney, and liver function, per protocol.
Patient with bilateral LG UTUC may be enrolled if at least one side meets the inclusion criteria for the trial and if the other kidney does not require further treatments (The other kidney can be treated prior to the beginning of the study).
Good kidney and liver function
Normal liver, kidney and bone marrow function
Must have adequate hepatic and kidney function.
Adequate bone marrow, liver and kidney function
Kidney function: creatinine < 2.5 x ULN.
History of severe kidney disease (e.g chronic or acute kidney failure) with creatinine clearance below 30 and/or severe liver disease with liver tests over 4 times the upper normal level
Patient with only 1 kidney
History of kidney stones
In cases of concern about decreased renal function and potential high radiation dose to the kidneys, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney
Significant liver, lung, heart, or kidney dysfunction
Adequate hematological, liver and kidney function.
Adequate hematological, liver, and kidney function
Chronic kidney disease > stage 3.
Adequate bone marrow, liver, kidney function
Adequate bone marrow, kidney, and hepatic function (no laboratory value > 2 times the normal limit)
Adequate bone marrow, kidney and liver function
Patients must have adequate heart, kidney, liver and bone marrow function.
Subject must have adequate kidney and liver function as described in the protocol
Abnormal kidney 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 hematologic, liver, coagulation and kidney function
Adequate bone marrow, kidney and liver function
Adequate liver, kidney, and bone marrow function
Adequate bone marrow, kidney and liver function.
Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function
Active severe kidney or liver disease
Adequate organ function (bone marrow, kidney and liver)
Adequate kidney function
Adequate liver, kidney, and bone marrow function
Participants must have adequate liver, kidney, and bone morrow function
Adequate hematological, liver and kidney function.
Adequate glucose control, bone marrow, kidney, liver, and heart function.
Patients with a solitary kidney
Adequate bone marrow, kidney and liver function
Severe impairment of your kidney or liver function
Adequate bone marrow, kidney, liver, and heart function.
Adequate blood, liver, and kidney function as defined by laboratory tests.
Subjects must have adequate kidney function
Adequate hematologic, kidney and liver function
Adequate bone morrow and kidney function
Adequate bone marrow, kidney and liver function
Acceptable bone marrow, liver and kidney function.
Adequate bone marrow, kidney, and liver function
Inadequate functions of bone marrow, liver, and kidney.
Has adequate organ function (bone marrow, kidney and liver)
Have adequate cardiac, bone marrow, liver and kidney function
Participants must have adequate hepatic and kidney function.
Patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function.
Patients with recent history of kidney stones.
Kidney tumor has been removed
Adequate hematologic and organ function, including blood counts, liver and kidney function Stage I Arm A (GDC-0077):
Normal kidney and liver function (lab results must be within 45 days prior enrollment)
Solitary kidney
No active kidney stones
Chronic kidney disease or in participants without known kidney disease, estimated creatinine clearance of =< 30 ml/min, even after rehydration
Any history of cardiovascular, kidney, or liver disease
acute kidney injury
Adequate bone marrow, liver and kidney function
History of severe kidney disease (e.g. chronic or acute kidney failure) with creatinine clearance below 30 and/or severe liver disease with liver tests over 4 times the upper normal level
Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
Known chronic kidney disease (creatinine >= 3.0)
Adequate hematological, liver and kidney function.
Adequate bone marrow reserves and liver and kidney function, as assessed by the following laboratory requirements:
Have adequate bone marrow reserves and liver and kidney function, as assessed by the following laboratory requirements:
Have known history of kidney diseases
Patients who have chronic kidney disease
Renal (kidney) disease, or solitary kidney
or have a history of kidney disease.
Adequate performance status and hematological, liver, and kidney function
Good kidney and liver function
Adequate bone marrow, liver, and kidney function within 2 weeks prior to first dose
Adequate function of kidney:
Adequate bone marrow, kidney and liver function
Adequate renal, bone marrow, hepatic, pulmonary, and cardiac function
Adequate bone marrow, renal, and liver function
Has adequate bone marrow, renal and hepatic function based upon laboratory tests as follows:
Participant has adequate bone marrow, renal, and hepatic function.
Adequate bone-marrow, renal and liver function.
Participants have adequate bone marrow, renal, hepatic and coagulation function.
Adequate hepatic, renal, and bone marrow function:
Adequate Bone Marrow, Renal, and Liver Function.
Must have adequate bone marrow, liver, and renal function as described in protocol
Patients must have adequate bone marrow, hepatic and renal function as defined below:
Adequate bone marrow function, hepatic function, and renal function
Participant has adequate bone marrow, renal and hepatic function.
Severe bone marrow, renal or liver impairment.
Adequate Bone Marrow, Liver, Renal, Pancreatic Function
Adequate bone marrow, renal, hepatic, and metabolic function (assessed ? 7 days before inclusion in the study):
Adequate bone marrow, liver, renal, and cardiac function at study entry, assessed as follows:
Adequate bone marrow, renal and liver function
Adequate bone marrow reserve, liver and renal function
Adequate bone marrow, liver, and renal function.
Adequate bone marrow, liver, and renal function
Adequate bone marrow, renal, and liver function
Adequate bone marrow, liver and renal function
Adequate bone marrow, renal and liver function.
Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the subject must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment)
Adequate bone marrow (BM), renal, hepatic and metabolic function.
Adequate bone marrow reserve, cardiac, liver, renal and metabolic function:
Adequate marrow, liver, and renal function:
Patients must have adequate bone marrow, liver, coagulation and renal function within 7 days prior to study registration, as defined below:
Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function
Participants have adequate bone marrow, renal, hepatic and coagulation function.
Bone marrow, hepatic, and renal function as follows:
Hepatic function, renal function, bone marrow function in defined lab-value-ranges
Subject has adequate bone marrow, renal, and hepatic function.
Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
Adequate bone marrow reserves, hepatic function, and renal function
Adequate bone marrow, liver, renal and coagulation function
Must have adequate bone marrow and renal/hepatic function at the screening and baseline visits, defined as:
Adequate bone marrow, renal and liver function.
Adequate renal, liver and bone marrow function:
Adequate bone marrow, hepatic, and renal function
Adequate bone marrow, hepatic, and renal function, as specified in the protocol
Participants must have adequate bone marrow, hepatic and renal function
Adequate bone marrow, hepatic, and renal function, as specified in the protocol
Adequate bone marrow (BM), renal, hepatic and metabolic function;
Adequate bone marrow, renal and liver function.
Participant has adequate bone marrow, renal, and hepatic function.
Adequate bone marrow, liver and renal function.
Adequate bone marrow, hepatic, and renal function
Adequate bone marrow, renal and hepatic function:
Patient has adequate bone marrow, coagulation, liver and renal function
Adequate Bone Marrow, Pancreatic Function, Renal Function and Liver Function.
Participant must have adequate bone marrow, renal, and hepatic function.
Adequate renal, liver, and bone marrow function according to the following criteria:
Adequate liver, bone marrow and renal function
Subject has adequate bone marrow, renal, hepatic and coagulation function.
Adequate bone marrow (BM), renal, hepatic, and metabolic function (assessed ? 14 days before inclusion in the study):
Subjects must have adequate bone marrow, renal and hepatic function and coagulation
Adequate hepatic, renal and bone marrow function.
Adequate bone marrow, renal, liver and pancreatic function
Participants must have adequate bone marrow, renal and hepatic function
Adequate bone marrow, liver and renal function
Adequate bone marrow, liver and renal function
Adequate bone marrow, renal, and liver function.
Acceptable bone marrow, renal, and hepatic function based upon screening lab tests
Adequate bone marrow, liver and renal function renal function
Subject must have adequate bone marrow, renal and hepatic function.
Adequate bone marrow, hepatic, renal and cardiac function
Adequate hepatic, renal, and bone marrow function
Patients with adequate bone marrow, renal and hepatic function:
Adequate bone marrow reserve, hepatic and renal function
Adequate bone marrow, renal and liver function.
Adequate bone marrow, liver and renal function
Adequate bone marrow, renal, and hepatic function.
Adequate bone marrow, liver and renal function
Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.
Adequate bone marrow, hepatic and renal function as evidenced by:
Adequate bone marrow, renal, liver, cardiac and pulmonary function.
Adequate bone marrow, liver and renal function
Adequate bone marrow, renal capacity and hepatic function
Adequate bone marrow, liver and renal function
Adequate bone marrow, liver, and renal function
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, cardiac, and renal function
Adequate bone marrow, renal, hepatic, and metabolic function
Impaired bone marrow, liver or renal function (as defined by protocol)
Adequate bone marrow, hepatic, and renal function tests within 30 days prior to enrollment:
Subject has adequate bone marrow, renal and hepatic function at baseline, as demonstrated by the following:
Adequate bone marrow, renal and liver functioning
Adequate bone marrow and renal function
Adequate bone marrow, renal and liver function
Planned biopsy or resection of recurrent tumor for therapeutic and/or diagnostic purpose, and with adequate bone marrow, hepatic, cardiac, and renal function to undergo this planned procedure
Adequate bone marrow, hepatic and renal function as evidenced by:
Protocol-defined renal , liver and bone marrow function
Adequate bone marrow, hepatic, renal and cardiac function
Adequate bone marrow, liver, and renal function
Adequate bone marrow, renal and liver function as defined in the protocol.
The participant has adequate bone marrow reserve, and renal and hepatic function
Adequate bone marrow, liver and renal function
Participant has adequate bone marrow, renal, hepatic and cardiac function.
Adequate bone marrow, renal, and hepatic function.
Adequate bone marrow, liver, cardiac, and renal function
Adequate bone marrow, liver, and renal function
Patients must have adequate bone marrow, renal, hepatic, and sensory neurologic function to be eligible to receive platinum/taxane-based chemotherapy
Adequate bone marrow, liver and renal function
Adequate bone marrow, renal, hepatic, and blood clotting function
Adequate bone marrow, renal, hepatic, and metabolic function (assessed ? 7 days before inclusion in the study):
Adequate bone marrow, liver, and renal function
Adequate hematological, renal, metabolic and hepatic function within 7-10 days prior to randomization
Adequate organ function as demonstrated by hematological, renal, hepatic laboratory assessments;
Adequate cardiovascular, hematological, liver and renal function
Adequate cardiac, hematological, liver and renal function
Demonstrate adequate hematological, renal, hepatic, and coagulation function;
Adequate hematological, hepatic and renal function prior to first dose
Adequate hematological, hepatic and renal function
Adequate hematological, renal, hepatic and coagulation function is required.
Adequate hematological, hepatic, and renal function:
Adequate hematological, renal, and liver function
Adequate hematological, liver, and renal function
Adequate hematological, hepatic and renal function (renal function considered adequate as per protocol definition)
Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Abnormal hematological, renal, or liver function
Adequate hematological, hepatic and renal function as defined in the protocol
Adequate hematological, renal, metabolic and hepatic function
Adequate hematological, renal, hepatic and coagulation laboratory test results.
Other serious diseases (hematological, hepatic, renal, respiratory, central nervous system, autoimmune or psychiatric)
Adequate hematological, hepatic and renal function as defined in the protocol
Adequate hematological, renal and hepatic function
Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Adequate hematological, liver, and renal function
Adequate hematological, renal and liver function
Adequate hematological, hepatic, and renal function:
Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Adequate hematological, renal, hepatic and coagulation laboratory test results
Adequate hematological, renal, and hepatic function
Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Adequate hematological, renal and liver function For solid tumors only:
Adequate hepatic, renal, cardiac and hematological function
Adequate hematological, renal, metabolic and hepatic function
Inadequate hematological, hepatic, or renal function
Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Adequate hematological, renal and liver function
Participants with adequate hematological, liver, and renal function
Adequate hematological, renal and hepatic function.
Adequate hematological, hepatic, renal and cardiac function
Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Adequate organ functions (hematological, hepatic, renal function)
Adequate hematological, renal, and hepatic function
International normalized ratio (INR) =< 2\r\n* If a patient’s bone marrow function falls below the indicated values and it is not thought to be related to prior treatments a hematology consult will be ordered; if hematology deems the patients safe to proceed with treatment they will be allowed to enroll on study; in such cases, the patient’s absolute neutrophil count must be > 1,000/mcl, hemoglobin must be > 7.5 g/dL and the platelet count must be > 75,000 mcL; each patient will also be seen by a medical oncologist at follow-up visits if possible
Hematology: . Absolute neutrophil count ? 1.5 x 109/L or ? 1,500/µl Platelets ? 100 x 109/L or ? 100,000/µl
Hematologic, renal, and liver function as determined by hematology and clinical chemistry tests will be acceptable if within +/- 2x of “normal” reference range as defined by the local hospital clinical laboratory; final decision on inclusion will be made by physician, concerning suitability of patient for surgery
Evidence of other significant disease including hematologic, renal or liver disease that is not explained by the patient’s current medical condition or concomitant disease, (i.e. levels of absolute neutrophil count [ANC], hemoglobin, platelets, clotting time, serum creatinine, etc); lab values, as determined by hematology and clinical chemistry tests, will be unacceptable if greater than +/- 2x of “normal” reference range as defined by the local hospital clinical laboratory; final decision on inclusion will be made by physician, concerning suitability of patient for surgery
Baseline hematology laboratories will be performed prior to registration, the patient can be enrolled in the trial if laboratory values are deemed clinically acceptable by treating physician
Screening hematology values of the following:
Adequate hematology laboratory values at Cycle 1 Day 1 pre-dosing defined as follows:
Adequate liver and renal function and hematology laboratory values
Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
Screening hematology values of the following: absolute neutrophil count ? 1000/?L, platelets ? 100,000/?L, hemoglobin ? 10 g/dL (without transfusion support);
Participants must meet protocol specified hematology and chemistry lab parameters criteria
Have adequate organ function including hematology, renal, and liver.
Hematology and biochemical values within protocol-defined limits
Hematology and biochemical laboratory values within protocol-defined parameters prior to random assignment and at baseline
Hematology and biochemical values within protocol-defined limits
Presence of specific hematology and/or chemistry abnormalities
Lab values (hematology and chemistry) within institution's normal laboratory limits
Chemistry, liver function tests, renal function, total CPK and hematology lab results must be ? Grade 1 at the time of screening;
Adequate hematology, hepatic and renal function laboratory values within 14 days prior to first dose of study drug.
Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.
In the investigator's opinion and in compliance with the Institution Hematology Tumor Board's guidances, the patient should not be eligible for any additional chemotherapy treatment before the ASCI treatment.
Abnormal serum chemistry or hematology laboratory values
Hematology: ANC ? 1.5X109/L; Platelets >100x109/L.
Hematology and biochemistry laboratory results within the limits normally expected for the patient population, without evidence of major organ failure
Consent for sample collection for urine, hematology, histopathology and microbial profiling
Has adequate hematological and physiological functions.
Patient with adequate organ functions
Adequate organ functions
Patient with adequate bone marrow reserve, hepatic and renal functions
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): The patient must have completed radiation therapy and be at least 1 week from the last systemic therapy administration, with adequate recovery of bone marrow and organ functions, before starting neratinib
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): The patient must have completed radiation therapy and be at least 1 week from the last systemic therapy administration, with adequate recovery of bone marrow and organ functions, before starting neratinib
Adequate organ and bone marrow functions evaluated during the 14 days prior to enrollment as follows:
Adequate bone marrow and renal functions
Patients need to have adequate kidney, bone marrow, and liver functions =< 14 days of registration as specified below:
Acceptable liver and renal functions defined as:
Adequate hepatic and renal functions as defined by:
Adequate hepatic and renal functions as defined by:
Adequate organ functions
Poor vital organ functions defined as:
Adequate bone marrow function, renal and liver functions
Adequate other organ functions
Have adequate values, bone marrow, renal and liver functions at screening as defined below:
Adequate bone marrow, liver and renal functions (tests must be performed within 14 days prior to enrollment).
Subjects who have adequate organ functions
Adequate organ system functions as defined by the laboratory assessments.
Adequate renal functions within 48 hours prior to induction chemotherapy
Adequate renal functions
Adequate hematopoietic, renal, and hepatic functions defined as:
Adequate performance status and hematological, liver and kidney functions
Adequate haematological, hepatic and renal functions defined by the protocol
Subjects who have adequate hematological, renal, hepatic and respiratory functions defined.
Adequate organ and bone marrow functions
Patients must have adequate bone marrow, renal, hepatic, and neurologic functions
Have adequate organ functions.
Adequate hematological, hepatic and renal functions.
Adequate hematologic, hepatic, renal, and coagulation functions
Patient must have completed radiation therapy with adequate recovery of bone marrow and organ functions, before starting neratinib
Subjects must have adequate bone marrow, liver, kidney, and coagulation functions.
Participant has adequate organ functions, evidenced by the following:
Adequate bone marrow function, renal and liver functions
Adequate bone marrow, liver, and renal functions.
Adequate organ functions
Have clinically adequate hepatic and renal functions as defined by:
Adequate haematological, renal (creatinine < 2xULN), cardiac and liver functions
Adequate Bone Marrow, Renal and liver Functions.
Eligible study subjects must exhibit acceptable liver, bone marrow, renal and cardiac functions as assessed by laboratory tests, ECG and ECHO or MUGA scan.
Adequate organ and bone marrow functions
Adequate bone marrow, liver, and renal functions
Adequate bone marrow, liver, and renal functions, defined as:
Adequate organ and bone marrow functions.
Patient has adequate organ and bone marrow functions:
Adequate baseline functions:
Adequate liver and renal functions
Adequate hematologic, renal, and liver functions
Adequate Hepatic functions
Adequate bone marrow, liver, and renal functions
Patients must have adequate organ functions at the time of registration:
Adequate cardiac, renal, and hepatic functions.
Adequate hematological, liver, and renal functions
Criteria 8, Adequate organ function within 4 wks prior to enrollment. This includes hematology, renal, hepatic and blood-clotting functions as defined by protocol.
Adequate organ functions (kidney, liver, cardiac, bone marrow).
Patient has adequate hematologic, hepatic, and renal functions