--- a +++ b/clusters/3009knumclusters/clust_85.txt @@ -0,0 +1,624 @@ +Adequate organ function as defined per protocol +Adequate organ function +Adequate organ function +Adequate major organ function +Normal organ and marrow function: +Adequate hematologic and end-organ function +Have adequate organ function. +Subject has adequate organ and marrow function. +Adequate organ function +Demonstrate adequate organ function as defined below: +6. Adequate organ and marrow function; +Adequate hematologic and end organ function +Adequate hematologic and end-organ function +Demonstrated adequate organ function within 14 days of Cycle 1 Day 1 (C1D1). +Has adequate organ function +Adequate organ function +Demonstrate adequate organ function as evidenced by laboratory testing +Adequate bone marrow and organ function, as defined by the protocol +Adequate organ function as defined below: +Adequate organ function as indicated by laboratory values +Adequate organ function per protocol-defined criteria. +Adequate organ function defined as follows: +Adequate end-organ function +Has adequate organ function. +Adequate hematologic and end organ function based on laboratory results obtained within 14 days prior to initiation of study treatment; +Adequate organ function at baseline . +Adequate hematologic and end-organ function, defined by laboratory test results, obtained within 14 days before initiation of study treatment +Adequate hematologic and end-organ function +Patient must meet the organ function and system function requirements as stated in the protocol +Adequate organ and bone marrow function: +Adequate organ and marrow function +Adequate organ and marrow function +Adequate organ function as measured by various blood parameters +Subject must have adequate organ function as defined below. The following parameters must be evaluated within 28 days prior to Cycle 0 Day 1 (monotherapy run-in period): +Adequate hematologic and end organ function +Have adequate organ function. +Have adequate organ function, defined as: +Demonstrates adequate organ function +Must have adequate organ and marrow function +Adequate organ function. +Adequate organ function +Adequate hematologic and end-organ function +Adequate organ function +Have adequate organ function +Adequate hematological and organ function as confirmed by laboratory values +Adequate organ function (defined by the following parameters): +Adequate organ function +Have adequate organ function, including: +Patient with adequate organ functions +Adequate organ function defined as follows: +Have adequate organ function. +Have adequate organ function. +Adequate organ function as defined by and obtained within 28 days of starting treatment: +Adequate organ function +Adequate organ functions +Poor organ function. +Demonstrates adequate organ function. +Adequate organ function, defined as follows: +Adequate organ function. +Subjects with adequate organ and marrow function +Adequate hematologic and end-organ function Cancer-Related Inclusion Criteria: +Participant has adequate bone marrow and organ function as defined by the following laboratory values: +Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined below: +Adequate hematologic and end-organ function +Good organ function: +Adequate organ function within 14 days of study registration (30 days for pulmonary and cardiac) as defined in section 4.5 +Adequate hematologic and organ function +Must have adequate organ function. +Demonstrates adequate organ function. +Adequate hematologic and end-organ function +Adequate organ function as defined by the following laboratory values at screening: +Adequate organ function +Adequate organ function +Adequate bone marrow and organ function +Adequate hematologic and organ function within 28 days before the first study treatment +Has adequate organ function +Poor vital organ function defined as: +Adequate organ function defined as: +Adequate hematologic and end organ function +Adequate organ and marrow function as defined below: +Have adequate organ function. +Has adequate organ function. +Have adequate normal organ and marrow function, including the following: +Adequate organ function as determined by the following laboratory values: +The patient has adequate baseline organ function, as demonstrated by the following: +The patient has adequate organ and marrow function as follows: +Organ Function Requirements: +Adequate organ function within 14 days of study registration including:\r\n* Absolute lymphocyte count (ALC) >= 0.5 x 10^9/L +Adequate organ function within 14 days of study registration including:\r\n* Platelets >= 100 x 10^9/L +Adequate organ function within 14 days of study registration including:\r\n* Hemoglobin >= 8 g/dL +Organ function: +Subjects with adequate organ function as measured by: +Adequate hematologic and end organ function +adequate organ function +Adequate organ system function. +Patients must have adequate major organ function and meet the following criteria: +Inadequate performance status/organ function. +Demonstrate adequate organ function +Adequate organ function +Adequate organ function with the following laboratory results during screening (within 21 days) and immediately before study drug administration on Cycle 1 Day 1: +Adequate hematologic and end-organ function +Adequate baseline organ function within 14 days prior to the first dose of enzalutamide and/or CORT125281 +ORGAN FUNCTION AND PERFORMANCE STATUS CRITERIA: +Inadequate performance status/organ function. +Adequate organ function at screening +Adequate organ function defined as: Bone Marrow: +Subject has adequate bone marrow and organ function as shown by: +Has adequate organ function +Has adequate organ function within 7 days before enrollment +Subject has adequate organ function as determined by the following laboratory values: +Adequate organ function +Adequate hematologic and organ function as confirmed by laboratory values +Adequate hematologic and end-organ function +- Has adequate organ function. +Demonstrate adequate organ function obtained within 14 days prior to randomization and analyzed by the central laboratory. +Demonstrate adequate organ function +The participant has adequate hematologic, organ, and coagulation function ?2 weeks (14 days) prior to first dose of study drug: +Adequate organ function as defined by the following criteria: +Adequate hematologic and organ function as confirmed by laboratory values +Adequate organ system function. +Must have adequate organ function defined as: +Adequate haematologic and end-organ function +Have adequate organ function. +Adequate hematologic and end-organ function +Adequate organ function per protocol-defined criteria. +Evidence of insufficient organ function as determined by the protocol. +Adequate organ function as appropriate for the disease under study. All screening laboratory tests should be performed within 10 days of treatment initiation. +Adequate organ and marrow function +Have adequate hematologic, organ and coagulation function within 2 weeks (14 days) prior to enrollment. +Candidate for pembrolizumab (as determined by physician, and adequate organ function) +Adequate organ function and blood cell counts. +Adequate organ function. +Have adequate organ function (all screening labs should be performed within 15 days prior to study treatment): +HEALTHY SUBJECT: Have adequate organ function +Demonstrate adequate organ function, all screening labs should be performed within 14 days prior to registration +Adequate organ function. +Adequate organ function confirmed at Screening and within 10 days of initiating treatment, as evidenced by: +Adequate organ function as defined by the following criteria: +Adequate organ function within 14 days of study registration +Adequate hematologic and organ function +Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: leukocytes >= 2,000/mcL +Subjects with adequate organ and bone marrow function as defined below: +Patients must have adequate organ and marrow function as determined by the treating oncologist +Must have adequate organ function, as defined by the following: +Adequate organ function. +Patient has adequate organ function at Baseline +Adequate organ function as defined by: +Adequate organ and bone marrow function +Adequate organ and neurologic function +Has adequate organ function including: +Adequate organ function +Adequate organ function within 28 days prior to enrollment, as defined by the following criteria: +Subjects must have adequate organ and marrow at screening as defined below: +Have adequate organ function. +Demonstrate adequate organ function; all screening laboratory tests should be performed within 7 days of treatment initiation +Patients must have adequate organ and bone marrow function =< 14 days prior to registration, as defined below: +Persons who do not meet the age and organ function criteria specified above +The patient has adequate organ and marrow function per protocol +Adequate organ function +Adequate organ function as defined below: +Adequate organ function as defined below: +Have adequate organ function. +Potentially eligible for reduced intensity conditioning based on known organ function (formal organ function testing may occur after consent) +Have adequate organ function. +Adequate organ and marrow function +Demonstrate adequate organ function, all screening labs should be performed within 10 days of study drug administration +Patients must have adequate bone marrow and organ function. +Adequate organ function as defined by all the following criteria: +Patients must have adequate organ function at baseline as defined below: • Adequate liver function (within 7 days of crenolanib commencement), as determined by: +Adequate hematologic and end organ function obtained within 2 weeks prior to first dose of study drug +Patient has adequate organ function, as indicated by the following laboratory values +Adequate organ function +Adequate organ functions +Adequate organ function as defined by the following criteria: +Organ function: +Patients must have adequate organ function +Adequate organ function within 14 days of registration +Adequate organ function +Adequate organ function as determined by the following laboratory values: +Adequate other organ functions +Acceptable end-organ function, except for documented exclusions for organ function compromise due to ALL itself +Adequate organ function +Adequate normal organ and marrow function +Adequate organ and bone marrow function defined by routine testing +Adequate organ and marrow function as determined by medical oncology evaluation +All patients must have adequate organ function defined as: +Organ Function Requirements: +Adequate organ function as outlined below (unless due to leukemia) +Adequate organ function +Adequate organ function including: +Adequate organ function +All organ function testing should be done within 28 days of study registration +Adequate bone marrow and organ function defined by laboratory values +Adequate bone marrow and organ function +Adequate organ and marrow function +Have adequate organ function. +Inadequate performance status/ organ function +Adequate organ and bone marrow function +Adequate organ function. +Adequate End organ function +Has adequate organ function as defined by: +Adequate organ function +Patient has adequate organ function +Patients must have adequate organ function +Adequate normal organ and marrow function as defined below (must be done within 30 days prior to enrolment): +Adequate organ system function within 14 days of baseline: +Poor organ function. +Adequate organ and marrow function +Has adequate organ function +Adequate organ function +Adequate organ function as defined in the protocol +Patients must have normal organ function as defined below: +Adequate organ function +Other serious co-morbid illness or compromised organ function +Organ function characterized by ? Grade 1 +Has adequate organ function as defined by the following criteria: +Have adequate organ function +Patients must have normal organ function as defined below: +Adequate non-hematologic organ system function, defined by: +Patients must have adequate organ and system function. +Subjects who have adequate organ functions +Organ function must be adequate as follows: +Adequate bone marrow and organ function as assessed by the laboratory tests performed within 7 days before of treatment initiation. +have inadequate organ function per protocol +Has adequate organ function +Adequate organ function. +Adequate organ function +Adequate organ and marrow function, defined per protocol +Patient must meet the organ function and system function requirements as stated in the protocol +Have adequate organ function defined by the protocol.: +Adequate organ function as evidenced by: +Adequate hematologic and end organ function +Adequate organ function as determined by following laboratory parameters: +Adequate end-organ function +Adequate end-organ function, as determined by laboratory tests obtained within 28 days prior to the first dose of study drug +Patients must have organ function as defined below: +Acceptable organ and marrow function during the Screening Period as defined by the\n protocol. +Demonstrate adequate organ function per institutional guidelines for high-dose melphalan and autologous transplant at the time of enrollment +Adequate organ function +Adequate hematologic and end-organ function +Adequate hematologic and organ function as confirmed by laboratory values +- The participant has adequate organ function: +Adequate organ function as defined by study-specific laboratory tests +Demonstrates adequate organ function. +Adequate organ function, as defined by the following criteria: +Adequate bone marrow and organ function +Adequate organ function. +Adequate organ function +Adequate hematological and organ function, confirmed by lab values +Adequate organ function per protocol-defined criteria. +Demonstrates adequate organ function. +adequate organ function +Adequate organ function +Adequate organ function +Adequate organ function defined as: +Adequate hematologic and end-organ function. +Adequate hematological and organ function as confirmed by laboratory values +Adequate organ function: +Inadequate organ function including: +Adequate hematologic and end organ function +Adequate organ function prior to registration +Adequate hematologic and organ function within 28 days prior to initiation of study treatment +Adequate hematologic and end-organ function test results +Adequate organ function +Adequate organ function +Adequate organ function +Demonstrates adequate organ function +Demonstrates adequate organ function. +Adequate organ function defined as follows: +Adequate organ function +Has adequate organ function +Adequate organ and marrow function +Have adequate organ function. +Has adequate organ function as defined by protocol defined labs. +Adequate organ function as shown by: +Adequate organ function defined as: +Adequate hematologic and end organ function +Hemodynamically stable and adequate organ function +Poor organ function. +Adequate organ function +Inadequate organ function including: +Adequate organ and marrow function +Adequate organ function. +Demonstrates adequate organ function. +Adequate organ function +Adequate hematologic and end organ function, confirmed by laboratory results obtained within 28 days prior to initiation of study drug +Inadequate organ function including: +Adequate organ function +Adequate hematologic and end-organ function +Adequate organ function as defined in the protocol +Adequate organ function +Chemistry panel obtained 30 days prior to registration on study, with adequate organ function +Have adequate organ function. +Adequate hematologic and end organ function +Adequate hematologic and end organ function +Adequate organ and bone marrow function determined within 14 days prior to enrollment defined as: +Adequate organ function +Adequate hematologic and organ function as confirmed by laboratory values +Adequate organ function at baseline as defined below. All laboratory assessments should be performed within 10 days of treatment initiation. +Adequate hematologic and end organ function +Have adequate organ function, as defined by the study protocol. +Subject must have adequate organ function as indicated by the following laboratory values in the table below: +Adequate organ function +Has adequate organ function. +Adequate hematologic and end-organ function within 28 days prior to treatment initiation +Subjects must have adequate organ and marrow function as defined below: +Have organ and marrow function at the screening and pre-dose visits as defined by: +Patients must have adequate organ function: +Must have adequate organ function as demonstrated by the following: +Adequate organ function as defined by the following criteria: +Patients must have normal organ and marrow function as defined below: +Adequate Organ Function +Adequate organ function per protocol-defined criteria. +Adequate organ function per protocol-defined criteria. +Adequate organ function per protocol-defined criteria. +Adequate organ and marrow function +Adequate organ function defined as follows: +Adequate hematologic and end-organ function +have adequate organ function +Adequate organ function +Have adequate organ function. +Demonstrates adequate organ function +Has adequate organ function +Adequate organ function as defined below: +Organ Function +Patients must have normal organ and marrow function documented within 7 days of study enrollment as defined below: +Inadequate organ function +Demonstrate adequate organ function as detailed above +Adequate hematologic and end organ function +Patient has adequate bone marrow and organ function +Subjects must have adequate organ function as indicated by the following laboratory values. +Have adequate organ functions. +Adequate hematologic and end organ function +Have adequate organ function. +Adequate organ and marrow function +Patient has adequate bone marrow and organ function +Adequate organ function +Have adequate organ function +Adequate baseline organ function. +Adequate hematologic and organ function within 14 days before the first study treatment +Adequate organ function +Adequate organ function +Have adequate organ function including: +Have adequate organ function +Has adequate organ function as defined by protocol +Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures +Adequate organ and marrow function +Organ Function Requirements - Subjects must have adequate organ functions as defined below: +Organ function requirements are not required for enrolled patients who are stage I, PFH and will not be receiving chemotherapy +Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1): +Subject has adequate organ function as determined by the following laboratory values: +Adequate baseline organ function, as demonstrated by the following: +Patients must have adequate organ and bone marrow function +Adequate organ function defined as: +Adequate organ function +Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined below: +Demonstrated adequate organ function within 14 days of treatment initiation. +Have adequate organ function, with all screening labs performed within 7 days of treatment initiation. +Have adequate organ function. +Adequate organ function defined as follows: System and Laboratory Values: Hematologic +Life expectancy ? 12 weeks. 7. ECOG PS of 0 or 1 8. Adequate organ and bone marrow function 9. Ability to undergo during screening a tumor biopsy that is adequate for biomarker analysis. +Has adequate organ function +Adequate organ function +Adequate organ function including: +Adequate organ function +Demonstrate adequate organ function, all screening labs should be performed within 14 days of treatment initiation +Adequate organ function. +Adequate organ function +The participant has adequate organ function. +The participant has adequate organ function, including: +Demonstrate adequate organ function, all screening labs should be performed within 6 weeks of treatment initiation +Adequate organ and bone marrow function within the 21 days prior to randomization defined by: +Subject has adequate organ function. +Adequate organ function +Adequate organ function +Adequate organ function +Adequate organ function +Adequate organ function +Adequate organ and marrow function; Evidence of post-menopausal status or negative urinary or serum pregnancy test. +Adequate hematologic and end organ function +Adequate organ function +Adequate organ function +Adequate organ function +Adequate baseline organ function as defined below +Adequate organ and marrow function +Adequate bone marrow and organ function +Adequate hematologic and end organ function Cohort 2-Specific Inclusion Criteria +Adequate organ function +Have adequate organ and hematologic function, as determined by: +Adequate organ function +Adequate organ function including: +Adequate organ function +Adequate hematologic and end organ function +Adequate organ and marrow function , as defined below: +Adequate organ function within 14 days of dosing +Adequate organ function +Adequate hematologic and end-organ function +Has adequate organ function +Adequate organ functions +Adequate organ function, defined as: +Adequate organ function according to protocol-defined criteria +Inadequate organ function as described +Adequate bone marrow, organ function, cardiac and laboratory parameters +Adequate major organ system function +Adequate organ function including: +Adequate organ function including: +Adequate bone marrow, organ function, cardiac and laboratory parameters +Have adequate organ function; +Adequate end organ function as defined by: +Adequate organ and marrow function. +Have adequate organ function as defined by specified laboratory values +Adequate organ function +Patients must have normal organ and marrow function as defined below: +Patients must have adequate hematologic and organ function. +Adequate baseline organ function +Have adequate organ system function +Adequate organ function as defined by the following criteria: +Patients with adequate organ function as measured by: +Adequate hematologic and end organ function +Adequate organ function +Have adequate organ and bone marrow function. +Has adequate organ function +Adequate organ and marrow function. +The participant has adequate organ function. +Adequate organ function as evidenced by the following laboratory findings: +Adequate organ function within 10 days of Day 1 +Has adequate organ function +Demonstrates adequate organ function. +Adequate baseline organ function. +Have adequate organ function (all screening labs should be performed within 15 days prior to treatment initiation): +Adequate organ function within 3 weeks prior to first study drug administration as evidenced by: +Adequate organ function per blood work +Adequate organ function +Patients must have adequate organ function as indicated by the following laboratory values: +End-organ function not appropriate for transplantation +Adequate organ function defined as follows: +Other serious co-morbid illness or compromised organ function +Patient must meet the organ function requirements as stated in the protocol. +Adequate organ function as shown by: +Adequate organ function, demonstrated by the following laboratory values: +Adequate baseline organ function +Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1) +Have adequate organ function +Patients must have adequate organ and marrow function as defined below +Adequate organ function and baseline laboratory values +Subject has adequate organ function. +Adequate organ function +Adequate organ function defined as follows: +Adequate organ function. +Adequate organ function including: +Has adequate organ function, before the first dose of study drug. +Adequate organ function. +Adequate organ function including the following: +Adequate organ function defined as follows: +Adequate organ function defined as: +Adequate organ function defined as follows: +Adequate organ and marrow function +Adequate organ and hematological function as evidenced by the following laboratory values within 14 days before enrollment: +Adequate organ and hematological function as evidenced by the following laboratory values within 14 days before enrollment: +Adequate organ function defined as follows: +Adequate bone marrow function and organ function +Adequate organ system function. +Patients must have normal organ and marrow function as defined below: +Adequate organ function +Adequate organ function +Adequate hematologic and end-organ function +Patient has adequate bone marrow and organ function. +Demonstrate adequate organ function. +Adequate organ and marrow function +Adequate organ function +Acceptable organ and marrow function ?21 days prior to registration: +Adequate hematologic and end-organ function +Acceptable organ function as evidenced by the following: +Adequate organ function. +Adequate hematologic and organ function within 14 days before the first study treatment +Adequate organ and marrow function +Have adequate organ function. +Have adequate organ function. +Adequate hematologic and end organ function +Have adequate organ function. +Adequate hematologic and end-organ function +Adequate organ function as defined below: +Adequate hematologic and end-organ function +Adequate hematologic and end-organ function +Adequate organ function as determined by the following laboratory results, within 28\n days prior to randomization +Adequate hematologic and organ function as confirmed by laboratory values at Screening: +Adequate hematologic and end-organ function +Adequate organ and marrow function +Patients must have normal organ and marrow function as defined below: +Adequate organ function defined as follows: +Adequate organ function defined as below: +Adequate organ function within 14 days of study entry +Adequate organ and marrow function +Adequate organ function +Adequate organ function at baseline: +Have adequate organ function. +Adequate organ function +Must have normal organ and marrow function reported within 14 days prior to randomization +Adequate organ function, including the following: +Adequate hematologic and end-organ function +Adequate baseline organ function as defined in the protocol. +Have adequate bone marrow reserve and organ function at screening as follows: +Adequate organ and marrow function +Adequate organ function as defined below: +For all tumor types, adequate organ and marrow function, as defined below: +Have adequate organ function as defined by specified laboratory values +Inadequate organ function as defined on laboratory tests +Must have adequate organ function as defined by the following screening values (Retesting of borderline screening organ function and treatment with blood transfusions, growth factors etc. will be allowed): +Adequate bone morrow and organ function +Adequate hematologic and end-organ function +Adequate hematologic and end-organ function +The subject has poor organ and marrow function as defined in the protocol. +Adequate bone marrow and organ function +Adequate hematologic and end organ function +Adequate organ function: +Previously treated; NOTE: no limit to prior therapy provided there is adequate residual organ function +Patients must have adequate organ function, as defined by the following parameter +Subject must have normal organ and marrow function as defined below: +Adequate organ function including: +Patients must have normal organ and marrow function as defined below: +Patient has adequate bone marrow and organ function. +Patients must have normal organ and marrow function +Adequate baseline organ function. +Adequate organ function +Adequate hematologic and organ function within 14 days prior to treatment initiation +Adequate hematologic and end-organ function +Adequate organ or bone marrow function +Adequate bone marrow and organ function +Adequate organ function as defined by: +Adequate organ and marrow function: +Adequate organ function +Organ function </= grade 1. +Adequate organ function +Adequate hematologic and end organ function +Patient has adequate bone marrow and organ function +Adequate organ and marrow function +Inadequate hematological, biochemical or organ function +Adequate organ function; +Adequate hematologic and end-organ function +Have adequate organ function as defined by specified laboratory values +Adequate organ function +Adequate organ system function determined within 14 days prior to first dose of study treatment. +Adequate organ and bone marrow function +Adequate organ function. +At the time of the CMV specific T cell infusion, the recipient must have adequate organ function as indicated by < grade 3 across all organ systems except for hematologic toxicity +Adequate organ and marrow function +Patients must have adequate organ function, as defined by the following parameters: +Have adequate organ function, including: +Adequate organ function. +Adequate organ system function. +Adequate organ and bone marrow function as assessed by laboratory tests +Normal organ function tests including Creatinine +Normal organ function tests including Bilirubin +Normal organ and marrow function. +Other serious co-morbid illness or compromised organ function. +Patients with adequate organ function as measured by: +Adequate hematologic and end-organ function +Adequate bone marrow and organ function +Patients must have adequate organ function within 14 days prior to registration, as defined below: +Adequate hematologic and end organ function +Has adequate organ function as determined by laboratory tests +adequate organ function +Adequate organ function, including the following: +Adequate other organ function at screening and enrollment. +Adequate other organ function at screening and enrollment. +Subject must have adequate organ function as indicated by the laboratory values below: +Participants must have adequate organ function, including the following: +Adequate bone marrow and organ function +Life expectancy of at least 12 weeks. - Adequate organ function +Patients are eligible regardless of organ/marrow function +All organ function testing should be done within 28 days of study registration +Participants must have adequate organ and marrow function to proceed to transplant +Regarding non-hematologic organ function, no specific criteria for non-hematologic organ function are specified; however, if moderate-to-severe (major) organ function is present, such should be discussed with the PI, as various degrees of non-hematologic organ dysfunction may compromise either (or both) toxicity and response evaluations; also, if there is concern regarding potential reversibility of any specific organ dysfunction, this issue should also be addressed by consultation with an appropriate sub-specialist +Adequate bone marrow and organ function as determined by the consenting/enrolling investigator +Adequate hematologic and end organ function +Adequate hematologic, cardiac, and end-organ function +Adequate organ and marrow function. +Adequate hematologic and end-organ function +No organ and marrow function requirements +Adequate organ function, as defined by the following criteria (per central or local laboratory values): +No restrictions will be made based on organ or marrow function +Patients must have adequate organ functions at the time of registration: +Adequate organ function as determined by the following laboratory values: +Organ Function Requirements: Subjects must have adequate liver function as defined by: +Normal organ and marrow function +Organ Function Requirements: Subjects must have adequate liver function as defined by: +Adequate hematologic and end-organ function +Acceptable pre-study organ function during screening defined as: +Adequate organ function +Adequate organ function including: +Requirements for organ and marrow function are not applicable to this study, but function will need to be sufficient to undergo planned therapy +No requirements for organ and marrow function +Has adequate organ function. +Subject must have adequate organ function as defined in the protocol. +Patients must have adequate organ and bone marrow function 10 days prior to registration, as defined below: +Adequate bone marrow and organ function as defined as: +Has adequate organ function +Adequate organ function including: +Adequate baseline organ function: +Have adequate organ function +Adequate organ function +Adequate organ function for patients receiving crizotinib therapy as defined by the following criteria: Bone marrow function +Normal organ and marrow function within limits as defined below: +Organ function requirements: +Adequate organ function determined within 14 days prior to enrollment +The patient has adequate organ and marrow function as follows: +Adequate end organ function as defined by: +Adequate organ function. +Subjects must have normal organ and marrow function as defined below: +Adequate organ and bone marrow function +Adequate hematologic and end organ function +Must have adequate organ function, including the following: +Adequate organ function as determined by the investigator +Subjects must have normal organ and marrow function as defined below: +Adequate organ and bone marrow function +Adequate organ and marrow function +Adequate organ function within 7 days prior to enrollment, as defined by the following criteria: +Demonstrates adequate organ function, within 10 days prior to the start of study drug. +Adequate hematologic and end-organ function +Adequate organ system function, defined as follows: +Adequate organ function as per protocol. +Has adequate organ function +Adequate organ function +Evidence of adequate organ function by standard laboratory tests.