Measured creatinine clearance (CL) > 40 mL/min OR calculated creatinine clearance (CL) > 40 mL/min as determined by Cockcroft-Gault (using actual body weight)
Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault
Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)
Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault OR creatinine < 1.5 x ULN, within 2 weeks of randomization
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min within 30 days of day 1 of study
Must have creatinine ? 1.5 × institutional ULN or Creatinine Clearance > 50 ml/min (as calculated by the Cockcroft-Gault equation) within 14 days prior to randomization.
Creatinine =< 1.5 mg/dl or creatinine clearance >= 60 cc/min (can be calculated by 24 hour urine or by the Cockroft-Gault formula)
Creatinine =< 1.5 x upper normal institutional limits (UNL) OR creatinine clearance >= 40 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour)
Within 28 days prior to registration: Creatinine clearance (CrCl) >= 50 mL/min., as estimated by the Cockcroft and Gault formula; estimated creatinine clearance is based on actual body weight
Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula, must be obtained within 8 weeks prior to screening for protocol therapy
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula
Serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault Formula within 28 days prior to sub-study registration
Serum creatinine =< 1.5 x ULN or calculated creatinine clearance > 50 mL/min (using the Cockcroft-Gault formula) must be obtained =< 7 days prior to protocol registration
Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min\r\n* NOTE: creatinine clearance must be calculated using the Cockcroft-Gault equation
Within 2 weeks prior to registration: Creatinine =< 1.5 x ULN or calculated (Cockcroft-Gault formula) or measured creatinine clearance >= 50 mL/min/1.73 m^2 (normalized to body surface area [BSA]) for patients with creatinine levels greater than 1.5 times the institutional normal
Calculated creatinine clearance >= 45 mL/min by Cockcroft-Gault equation
Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula within 4 weeks prior to randomization
Within less than or equal to 14 days prior to registration: Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min\r\n* NOTE: Creatinine clearance must be calculated using the Cockcroft-Gault equation
Calculated (Calc.) creatinine clearance >= 30 mL/min; calculated utilizing the Cockcroft-Gault formula or 24-hour urine collection
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Calc. creatinine clearance >= 30 mL/min\r\n* Calculated utilizing the Cockcroft-Gault formula or 24-hour urine collection
Creatinine =< 2.0 mg/dL OR creatinine clearance (calculated clearance permitted) >= 40 mL/min by Cockcroft-Gault formula
Serum creatinine =< 1.5 mg/dl or calculated creatinine clearance (CC) >= 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula, within 21 days prior to registration
Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault
Creatinine clearance >= 51 mL/min/1.73 m^2 by Cockcroft-Gault
Calculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula)
Adequate renal function defined as creatinine less than or equal to 1.5 X ULN (upper limit of normal) or calculated creatinine clearance greater than or equal to 40 mL/min per the Cockcroft and Gault formula with creatinine levels greater than 1.5 X ULN
Creatinine clearance >= 25 ml/min (using the Cockcroft-Gault equation), documented within 14 days of registration
Serum creatinine =< 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min as determined by the Cockcroft-Gault equation
Estimated creatinine clearance of > 50 ml/min (0.84 mL/s) by the Cockcroft-Gault equation
Creatinine clearance (CrCl) ? 40 mL/min as estimated by the Cockcroft and Gault formula1 in subjects with creatinine > 2 X ULN
Calculated creatinine clearance using cockroft Gault formula >/= 50 mL/min (see Appendix 1)
Creatinine clearance > 50 mL/min (calculated according to institutional standards or using Cockcroft-Gault or Modification of Diet in Renal Disease [MDRD] formula)
Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula or by 24-hour urine collection for creatinine clearance or according to local institutional standard
Serum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance using Cockcroft-Gault formula >= 50 mL/min
Calculated creatinine clearance >= 50 mL/min (per the Cockcroft-Gault formula)
Serum creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min (calculated by Cockcroft Gault equation)
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR, for subjects with creatinine levels > 1.5 x ULN, an estimated creatinine clearance of >= 40 mL/min calculated using the Cockcroft and Gault formula must be met within 28 days of C1D1
Obtained =< 14 days prior to registration: Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula
Renal function: Estimated creatinine clearance by Cockcroft-Gault formula ? 45 mL/min.
Creatinine clearance >= 40 mL/min per 24 hour urine collection or the Cockcroft-Gault formula
Acceptable renal function with serum creatinine ? 1.5 x ULN or a calculated creatinine clearance ? 50 mL/min using the Cockcroft-Gault or Modification of Diet in Renal Disease formulas.
Adequate renal function within 4 weeks prior to study entry, defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than 40 mL/min by Cockcroft-Gault formula.
Participants must have creatinine clearance greater than or equal to 50 mL/min as measured by 24-hour urine or estimated by the Cockcroft-Gault formula.
Adequate renal function as demonstrated by serum creatinine ?1.5 x ULN or creatinine clearance>60 mL/min as calculated by the Cockroft and Gault formula
Serum creatinine =< 1.5 x institution's upper limit of normal (ULN), or creatinine clearance >= 30 ml/min (according to Cockroft-Gault formula, or local institutional standard method)
Subject has adequate renal function with an estimated creatinine clearance of ? 30 mL/min by the Cockcroft-Gault equation adjusted for body weight
Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault
Creatinine ?1.2 mg/dL or clearance ?50ml/min (Cockcroft-Gault)
Creatinine clearance >= 60 mL/min by the modified Cockcroft-Gault formula; timeline: within 3 weeks prior to enrollment
Calculated creatinine clearance (CrCl) >= 50 mL/min (based upon the Cockcroft-Gault equation)
Acceptable renal function with serum creatinine ? 1.5 x ULN or a calculated creatinine clearance ? 60 mL/min using the Cockcroft-Gault or Modification of Diet in Renal Disease formulas.
Calculated creatinine clearance >= 30 mL/min as determined by the Cockcroft-Gault equation
Creatinine ?1.5 mg/dL or calculated creatinine clearance using the Cockcroft-Gault formula ?60 mL/min or measured creatinine clearance
Creatinine =< 1.5 X ULN or calculated creatinine clearance (CrCl) > 60 mL/min using the Cockcroft-Gault formula less than eight days prior to start of treatment within 14 days of starting cycle 1 day 1 treatment
Creatinine clearance >= 50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour)
Adequate renal function defined as serum creatinine less than 1.5 X ULN (upper limit of normal) or use SI units or calculated creatinine clearance greater than or equal to 50 mL/min per the Cockcroft and Gault formula
Estimated creatinine clearance >= 70 cc/min (calculated by Cockcroft-Gault formula)
Creatinine clearance > 50 ml/min calculated by the Cockcroft-Gault formula
Creatinine clearance >= 30 mL/min (Cockcroft-Gault equation)
Creatinine =< 1.5 ULN or calculated creatinine clearance* >= 50 mL/min\r\n* Calculate creatinine clearance using standard Cockcroft-Gault formula; creatinine clearance must be >= 50 mL/min to be eligible
Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used, within 14 days before the first dose of cabozantinib
Creatinine clearance (CrCl) >= 30 mL/minute, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
Estimated creatinine clearance (using Cockcroft-Gault equation) must be > 50 mL/min
Creatinine < 1.5 x ULN or creatinine clearance > 60 ml/min according to Cockcroft-Gault formula
Renal function assessed by calculated creatinine clearance >= 60 ml/min by Cockcroft-Gault formula
Has adequate renal function, defined as: Creatinine clearance >= 60 mL/min, as calculated using the modified Cockcroft Gault equation, ([{140 - age in year
Calculated or measured creatinine clearance of >= 30 mL/minute calculated using the Cockcroft and Gault formula
Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min within 7 days before the first dose of cabozantinib. For creatinine clearance estimation, the Cockcroft and Gault equation should be used
Serum creatinine ? 1.5 X upper limit of normal (ULN) OR calculated clearance ? 50 mL/min/1.73 m^2; if using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockcroft-Gault formula); for subjects with a body mass index (BMI) > 30 kg/m^2, lean body weight should be used instead
Serum creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 by Cockcroft-Gault
Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 50 mL/min as determined by the Cockcroft-Gault formula
Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault
Calculated creatinine clearance (CrCl) of ? 50 mL/min by the Cockcroft-Gault formula.
Obtained within 14 days prior to C1D1: Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min calculated using the Cockcroft-Gault formula
Acceptable renal function, as specified below:: • Creatinine clearance (CrCl) calculated by Cockroft-Gault formula of ? 60 mL/min.
Creatinine clearance >= 60 mL/min/1.73 m^2 (as estimated by Cockcroft Gault equation) for subjects with creatinine levels above institutional normal
Calculated creatinine clearance ? 30 mL/min (Cockcroft-Gault formula)
Adequate renal function defined as calculated creatinine clearance ?30 milliliters per minute (mL/min) per the Cockcroft and Gault formula
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Calculated creatinine clearance (determined as per Cockcroft-Gault) >= 50 mL/min
EXPANDED ACCESS COHORT: Creatinine clearance >= 50 mL/min (determined by the Cockcroft-Gault method) for participants with creatinine levels above 1.5 x institutional ULN
Creatinine clearance of ? 60 mL/min as estimated by the Cockcroft-Gault equation or by 24 hour urine collection.
Serum creatinine =< 1.5 mg/dL or calculated creatinine clearance >= 40 mL/min as determined by the Cockcroft-Gault equation
Creatinine clearance of >= 60 mL/min per the Cockcroft-Gault formula
Obtained within 28 days prior to registration: Calculated creatinine clearance >= 60 cc/min (Cockcroft-Gault formula will be used to calculate creatinine clearance)
Serum creatinine clearance > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Creatinine clearance of >= 30 ml/min; creatinine clearance should be determined by the Cockcroft-Gault formula within 14 days of enrollment to trial
Creatinine clearance >= 60 mL/min by Cockcroft-Gault equation for participants with creatinine levels above institutional normal, completed within 14 days prior to the date of registration
Calculated creatinine clearance > 50 mL/min (per the Cockcroft-Gault formula)
Serum creatinine =< 1.5 mg/dL OR measured creatinine clearance (CrCl) >= 45 mL/min as calculated by the Cockcroft-Gault method OR 24-hour measured urine CrCl >= 45 mL/min
Estimated creatinine clearance greater than 40 mL/minute (using the Cockcroft-Gault formula and actual body weight)
Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula
Serum creatinine within normal limits or calculated clearance > 60 mL/min/1.73 m^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg. Using the Cockcroft-Gault formula). For patients with a Body Mass Index (BMI) > 30 kg/m^2, lean body weight should be used instead.
Estimated creatinine clearance (CrCl) >= 50 mL/min/1.73 m^2 according to the Cockcroft-Gault formula, within 14 days prior to registration
Creatinine clearance >= 45 ml/min (24 hour urine creatinine clearance or calculated by Cockcroft-Gault equation)
Serum creatinine within normal range, or if serum creatinine outside normal range, then GFR > 40 mL/min/1.73m2 as calculated with the Cockcroft-Gault equation with adjustment if total body weight is ? 125% of ideal body weight.
Renal status: Creatinine clearance ?50 mL/min based on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour);
Creatinine > 1.5 times the ULN concurrent with creatinine clearance < 50 mL/min (measured or calculated by the Cockcroft - Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5 times the ULN.
Creatinine =< 1.5 times upper limit of normal OR calculated creatinine clearance > 45 mL/min\r\n* Using the lean body mass formula only (Modified Cockcroft Gault)
Estimated creatinine clearance >= 50 ml/min (Cockcroft-Gault based on actual weight)
Creatinine clearance (by Cockcroft Gault formula) <40 mL/min
Creatinine clearance ? 50 mL/min; the serum creatinine value used in the calculation must have been obtained within 28 days prior to registration using the modified Cockcroft-Gault formula
Estimated creatinine clearance >= 30 ml/min (Cockcroft-Gault)
Acceptable renal function with serum creatinine ? 1.5 x ULN or a calculated creatinine clearance ? 60 mL/min using the Cockcroft-Gault or Modification of Diet in Renal Disease formulas.
Calculated creatinine clearance >= 50 ml/min using the Cockcroft-Gault formula
Calculated creatinine clearance (using Cockcroft-Gault formula) > 45 mL/min, at the screening visit
Calculated creatinine clearance >= 30 mL/min using Cockcroft-Gault formula
Calculated creatinine clearance (CrCL) ? 30 mL/minute (using Cockcroft-Gault formula).
Creatinine clearance > 30 mL/min by Cockcroft-Gault formula
Estimated creatinine clearance of >= 40 mL/min/1.73 m^2, calculated using the Cockcroft-Gault equation for adults and Schwartz formula for pediatric patients, for patients with creatinine levels above the institutional upper limit of normal
ARM 2 - A: Calculated GFR > 30 cc/min; creatinine clearance (CrCl) by Cockcroft Gault will be used to estimate GFR
Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min, obtained =< 14 days prior to registration
PHASE I: Calculated creatinine clearance (CrCl) >= 60 mL/min calculated by Cockcroft-Gault formula
PHASE IB: Calculated creatinine clearance (CrCl) >= 60 mL/min calculated by Cockcroft-Gault formula
Calculated creatinine clearance ? 30 mL/min (using the Cockcroft-Gault equation).
Creatinine clearance (as calculated by Cockroft Gault equation >= 30mL/min
Serum creatinine =< 1.5 x IULN OR creatinine clearance by Cockcroft-Gault >= 30 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x IULN
Calculated creatinine clearance (CrCl) >= 40 mL/min (based upon the Cockcroft-Gault equation)
Creatinine clearance >= 45 ml/min determined by 24-hour collection or estimated by the Cockroft-Gault formula
Creatinine (CR) within the institutional limits of normal or a calculated creatinine clearance of >= 30 mL/min according to the Cockcroft-Gault equation
Serum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 ml/min (by Cockroft-Gault formula)
Creatinine clearance >= 45 mL/min calculated by Cockcroft-Gault or 24 hour collection
Renal function: >= 60 ml/min (actual or calculated by the Cockcroft-Gault method) or a creatinine =< the upper limits of normal
Creatinine ?1.5 x ULN or creatinine clearance ?40 mL/min as calculated by the Cockcroft-Gault method
Calculated creatinine clearance >= 30 ml/min (by the Cockcroft-Gault equation)
Obtained =< 14 days prior to registration: Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min
Creatinine clearance (CrCl) >= 30 ml/min (Cockroft-Gault equation)
Creatinine clearance >= 60 mL/min by the Cockcroft Gault equation
CrCl of >= 60 (as calculated by Cockcroft-Gault formula)
Serum creatinine calculated creatinine clearance by the method of Cockcroft and Gault (< 50mL/min)
Estimated creatinine clearance greater than 60 mL/min determined by 24-hour urine sampling or by the Cockcroft- Gault formula
Serum creatinine < 1.5 x upper limit of normal (ULN) or calculated creatinine clearance of >= 45 cc/min using the Cockcroft-Gault formula
Creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above 1.5 x institutional normal (using the Cockcroft Gault formula)
Serum creatinine =< 1.5 times institutional upper limit of normal (ULN), or calculated creatinine clearance >= 40 mL/min (per the Cockcroft-Gault formula) within 14 days prior to first dose of protocol-indicated treatment.
Serum creatinine =< 1.5 x ULN or estimated creatinine clearance >= 50 mL/min as calculated using the Cockcroft-Gault (CG) equation.
Within 14 days of the first dose of study drug: Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula)
Creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula), =< 5 days prior to C1D1
Calculated creatinine clearance >= 40 mL/min using the Cockcroft-Gault formula obtained within 14 days prior to initiating study treatment.
Adequate renal function defined by an estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula or be measure for creatinine clearance from 24 hour urine collection.
Should be performed within 10 days of treatment initiation: serum creatinine clearance (CL) > 60 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Calculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula)
Obtained ? 14 days prior to registration: Calculated creatinine clearance (using Cockcroft-Gault equation below) ? 30 mL/min
Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula
Calculated creatinine clearance > 40 mL/min as determined by Cockcroft-Gault (using actual body weight).
Serum creatinine ? 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl ? 40 mL/min (if using the Cockcroft-Gault formula)
Renal function: Estimated creatinine clearance by Cockcroft-Gault formula ? 45 mL/min and serum creatinine ? 2 mg/dL
Serum creatinine < 1.5 x ULN or measured creatinine clearance (calculated using Cockcroft-Gault formula) > 40 ml/min
Creatinine clearance (CrCL) >= 60 mL/min/1.73 m^2 calculated by Cockcroft-Gault
Serum creatinine ? 1.5 x ULN or CrCl > 60 ml/min (Cockcroft-Gault formula)
Creatinine clearance >= 30 ml/min based on the Cockcroft-Gault equation.
Patients must have a serum creatinine of less than or equal to 1.3 mg/dL or creatinine clearance > 70 ml/min as calculated by the Cockcroft-Gault formula
Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ? 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula
Creatinine clearance ? 30 ml/min by Cockcroft-Gault formula
Estimated creatinine clearance (CrCL) using the Cockroft-Gault equation ? 50 mL/min
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (using the\r\nCockcroft-Gault formula).
Creatinine up to 1.5 upper institutional limits OR creatinine clearance (CrCl) > 50 mL/min/1.73 m^2 OR within normal as predicted by the Cockcroft-Gault formula
Cisplatin-ineligible as defined by at least one of the following:\r\n* Calculated creatinine clearance >= 30 but =< 60 mL/min (Cockcroft-Gault)\r\n* ECOG performance status of 2 or greater\r\n* CTCAE v4 grade >= 2 audiometric hearing loss
Obtained within 28 days prior to registration: Calculated creatinine clearance >= 30 but =< 60 mL/min (Cockcroft-Gault)
Within 7 days of enrollment and with 24 h of starting lymphodepleting chemotherapy: Calculated creatinine clearance (Cockcroft-Gault) >= 50.0 mL/min.
Within 28 days prior to registration: Calculated creatinine clearance >= 40 mL/min\r\n* Cockcroft-Gault formula will be used to calculate creatinine clearance
Creatinine clearance >= 50 mL/min for Cohort #1 (DLBCL) and >= 30 mL/min for Cohort #2 (MCL) per the Cockcroft-Gault formula, performed within 14 days prior to day 1 of protocol therapy
Creatinine clearance (by Cockcroft Gault formula) greater than or equal to 50 mL/min
An estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula or be measure for creatinine clearance from 24-hour urine collection.
Cockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN obtained =< 14 days prior to study initiation
Creatinine ? 1.5 x institutional ULN or estimated creatinine clearance of ? 45 mL/min by the Cockcroft-Gault equation or measured creatinine clearance > 45 mL/min
Creatinine clearance >=50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour).
Creatinine within normal institutional limits OR, creatinine clearance > 40 mL/min by Cockcroft-Gault or 24h urine collection.
Adequate renal function as defined by calculated creatinine clearance =< 60 mL/min (Cockcroft-Gault formula)
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min according to the Cockcroft-Gault formula
Creatinine clearance > 50mls/min (calculated with Cockroft-Gault formula);
Creatinine =< 3 X ULN or calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft- Gault formula
Creatinine clearance >= 40 ml/min as determined by 24-hour collection or estimated by the Cockcroft-Gault formula (measured within 28 days of registration)
Calculated creatinine clearance (CrCl) >= 40 mL/min (based upon the Cockcroft-Gault Equation)
Serum creatinine =< 1.5 X institutional ULN or creatinine clearance > 40 ml/min as calculated by the Cockcroft-Gault formula
Creatinine outside normal limits OR, if creatinine outside normal limits, a creatinine clearance <60 mL/min (measured by 24-hour urine collection or calculated by Cockcroft and Gault equation (Cockcroft and Gault 1976).
Creatinine ? 1.5 x ULN or creatinine clearance (CrCl) ? 40 mL/min (if using the Cockcroft-Gault formula)
Estimated creatinine clearance (eClCR) >45 mL/min (with eCLCR to be calculated by the Cockcroft-Gault formula, or
Creatinine clearance < 50 mL/min/1.73 m2 by Cockcroft-Gault equation
Calculated creatinine clearance >= 60 ml/min (by the Cockcroft-Gault equation)
(** = calculated by Cockcroft and Gault's formula)
Obtained within 14 days prior to randomization/registration: serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 50 mL (if using the Cockcroft-Gault formula)
Adequate renal function defined by an estimated creatinine clearance >= 40 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
Within 28 days prior to administration of study treatment: Creatinine clearance >= 51 mL/min, calculated using Cockcroft-Gault formula
Renal function, as follows: Dose Escalation, NSCLC, Ovarian, and CPI Treated Expansion Cohorts: creatinine clearance of ? 30 mL/min by the Cockcroft-Gault equation or as measured by 24 hour urine collection. For the Renal Insufficiency Expansion Cohort: creatinine clearance estimate ?15 ml/min and <30 ml/min by Cockcroft-Gault equation or as measured by 24 hour urine collection.
Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault
Creatinine clearance (as estimated by Cockcroft Gault) ? 60 cc/min
Body surface area (BSA)-normalized creatinine clearance >= 60 mL/min/1.73 m^2 (using Cockcroft-Gault creatinine clearance [CrCl])
Participant must have adequate renal function as demonstrated by a creatinine >= 30 mL/min; calculated by the Cockroft Gault formula or measured by 24 hours urine collection.
Obtained within 28 days prior to registration: serum creatinine < 1.5 mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula
Serum creatinine clearance (CL) =< 1.5 x ULN or creatinine clearance > 45 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Obtained within 28 days prior to the first dose of cabozantinib: serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used.
Serum creatinine of =< 1.5 X ULN or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula)
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min according to the Cockcroft-Gault formula or local institutional standard method
Serum creatinine =< 1.5 x the upper limit of normal (ULN) or calculated creatinine clearance (by Cockcroft-Gault formula) >= 60 mL/min
Calculated creatinine clearance > 40 cc/min by the modified Cockcroft-Gault formula for adults or the Schwartz formula for pediatrics
Adequate renal function defined by an estimated creatinine clearance > 50 mL/min according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24 hour urine collection
Creatinine clearance (CrCl) > 30 mL/min, calculated using the Cockcroft-Gault formula
Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.)
Creatinine =< 1.5 x ULN and requires creatinine clearance (CrCl) >= 60ml/min (per 24-hour urine collection or calculated according to the Cockcroft-Gault formula)
Estimated creatinine clearance ? 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
Subjects must have adequate renal function with a creatinine clearance of >= 40 mL/min as determined by the Cockcroft-Gault calculation
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Obtained =< 14 days prior to registration: Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula
Creatinine clearance >= 50 ml/min by Cockcroft-Gault formula or 24 hour urinary clearance
Serum creatinine clearance (CL) > 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Within 14 days of the first dose of the study drugs: Serum creatinine =< 1.5 x ULN by gender (as long as patient does not require dialysis); May receive transfusion; Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days; If creatinine is not < 1.5 x ULN, then calculate by Cockcroft-Gault methods or local institutional standard and creatinine clearance (CrCl) must be > 30 mL/kg/1.73 m^2.
Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 40 mL/min (if using the Cockcroft-Gault formula) within 14 days of registration
Calculated creatinine clearance >= 30 mL/min using the Cockcroft-Gault formula for subjects with creatinine levels > 2.0 x institutional ULN (obtained within three days prior to study treatment)
Within 7 days prior to administration of study treatment: Calculated creatinine clearance (Cockcroft-Gault equation) >= 40 mL/min.
Serum creatinine =< 2 mg/dL, or calculated creatinine clearance > 50 mL/min (per the Cockcroft-Gault formula)
Calculated creatinine clearance of >= 60 cc/min using the Cockcroft-Gault formula
Creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Serum creatinine of =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) > 50 mL/minute (using Cockcroft/Gault formula) within 14 days of study registration.
Renal function: creatinine clearance by Cockcroft-Gault formula >= 30 mL/min must be met during screening (within 21 days) and also prior to study drug administration on cycle 1 day 1
Obtained within 21 days prior to randomization/registration: Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula).
Have adequate renal function within 15 days prior to study treatment, defined by the following criteria: Creatinine ? 1.5 x ULN and CrCl ? 30 ml/min per Cockcroft Gault formula:
Patients must be considered ineligible for cisplatin\r\n* Cisplatin ineligibility is defined as meeting at least one of the following criteria\r\n** Creatinine clearance (calculated or measured) < 60 mL/min (but >= 30 mL/min) calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection of creatinine for determination\r\n** Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 audiometric hearing loss\r\n** New York Heart Association class III/IV heart failure\r\n** Eastern Cooperative Oncology Group (ECOG) performance status of 2 as determined by treating investigator
Calculated or measured creatinine clearance < 60 mL/min (but >= 30 mL/min) calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection of creatinine for determination
Creatinine =< 2 mg/dL or creatinine clearance (as estimated by Cockcroft Gault equation) >= 60 mL/min
Creatinine clearance > 30 mL/min by Cockcroft-Gault formula
Creatinine clearance (CrCl) >= 40 mL/minute within 21 days prior to start of therapy either measured or calculated using a standard formula (e.g., Cockcroft and Gault)
Creatinine =< 1.5 mg/dl or creatinine clearance >= 60 mL/min/1.73 m^2 (calculated per Cockcroft & Gault formula) for subjects with creatinine levels above institutional normal
Serum creatinine =< 2 x upper limit of normal (ULN) or estimated creatinine clearance >/=30 ml/min as calculated using the Cockcroft-Gault formula.
Serum creatinine =< mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24 hour collection or estimated by Cockcroft-Gault formula
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Creatinine clearance >= 30 mL/min based on the Cockcroft-Gault equation
Within 7 days before the first dose of study treatment: Serum creatinine =< 1.5 x the ULN or creatinine clearance (CrCl) >= 40 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
Creatinine clearance >= 40 mL/min/1.73 m^2 by the Cockcroft-Gault formula
Alanine aminotransferase (ALT) =< 2.5 x ULN; and estimated creatinine clearance (CrCl) of > 30 mL/min, as calculated by the Cockcroft-Gault equation.
Either serum creatinine > 1.7 mg/dL, or creatinine clearance < 50 mL/min calculated by the Cockcroft Gault method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate [GFR] using plasma clearance methods)
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.
Obtained =< 14 days prior to registration: Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min
have adequate renal function, defined as having a serum creatinine ?1.5 × ULN and a creatinine clearance ?40mL/min (estimated using the Cockcroft-Gault formula);
Creatinine clearance (CrCl) >= 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula
Estimated creatinine clearance ? 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
No more than 14 days prior to registration: Serum creatinine clearance > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Creatinine clearance > 30 ml/min according to Cockcroft-Gault
Creatinine =< 1.5 x institutional ULN or estimated creatinine clearance of >= 45 mL/min by the Cockcroft-Gault equation or measured creatinine clearance > 45 mL/min
Creatinine ?1.5 times the ULN and calculated creatinine clearance >60 mL/min (by Cockcroft Gault formula; see Appendix B);
Serum creatinine ? 1.5 times the ULN or creatinine clearance > 30 mL/min by Cockcroft-Gault formula
Creatinine clearance (CrCL) > 40 mL/min as measured via Cockcroft-Gault
Serum creatinine =< 1.5 x ULN or estimated creatinine clearance >= 50 ml/min by Cockcroft-Gault equation
STUDY TREATMENT: Creatinine clearance of 20 ml/min or greater as measured by the Cockroft-Gault formula
Serum creatinine < 1.5 x ULN or creatinine clearance (CrCl) > 40 mL/min (measured or calculated using the Cockcroft-Gault formula)
Serum creatinine =< 1.5 mg/dL, or calculated (using the formula of Cockcroft and Gault) or measured creatinine clearance >= 30 mL/min
Serum creatinine clearance (CL) > 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Within 14 days of the first study treatment: Creatinine clearance >= 30 mL/min by Cockcroft-Gault formula (or local institutional standard method)
Creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 mL/min using Cockcroft-Gault formula for creatinine clearance calculation OR 24-hour urine creatinine clearance >= 50 mL/min
Adequate renal function defined as serum creatinine <1.5 × upper limit of normal (ULN) (or use System of Units [SI] units or calculated creatinine clearance ?50 milliliter per minute [mL/min] per the Cockcroft and Gault formula)
Within 14 days prior to registration: Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockcroft-Gault glomerular filtration rate estimation
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Estimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault at the time of screening
Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: serum creatinine of =< 3.0 X ULN (upper limit of normal) or creatinine clearance >= 30 mL/minute (using Cockcroft/Gault formula)
Creatinine clearance (calculated per Cockcroft-Gault equation) >= 60 mL/min for participants with creatinine levels above institutional normal
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula
Calculated creatinine clearance >= 50 ml/min (using Cockcroft-Gault method)
Within 14 days prior to cycle 1 day 1 of treatment: Serum creatinine < 2.0 or >= 30 cc/min using a direct method or the Cockcroft-Gault formula
Creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Patients must have an estimated creatinine clearance greater than 50/ml per minute by the following formula (Cockcroft-Gault); serum creatinine value must be within 28 days prior to registration
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula)
Serum creatinine =< 2 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
creatinine clearance ? 60 mL/min (Cockroft & Gault formula);
Calculated creatinine clearance < 30 ml/min according to Cockcroft-Gault equation Other exclusion criteria included in the protocol might apply.
Serum creatinine =< 2 x upper limit of normal (ULN) or creatinine clearance (calculated with the Cockcroft-Gault formula) >= 30 mL/min, within 30 days before study registration
Serum creatinine =< 1.5 x ULN or creatinine clearance (calculated with the Cockcroft-Gault formula) >= 40 mL/min, within 30 days before study registration
Creatinine clearance > 45 mL/min (or serum creatinine [SCr] =< 1.5 mg/dL), normal within 2 weeks prior to start of treatment; the standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate creatinine clearance (CrCl) for enrollment or dosing
Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >=30 mL/min (using the Cockcroft-Gault formula) within 14 days prior to first dose
Serum creatinine =< 1.5 x age-adjusted upper limit of normal (ULN) or calculated creatinine clearance (Cockcroft and Gault) > 30 mL/min/1.73 m^2
Acceptable renal function within 7 days defined as serum creatinine ? 2.0 times the institutional upper limit of normal (ULN) or calculated creatinine clearance ? 50 mL/min (by the Cockcroft Gault formula).
Calculated creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula) using actual weight (ideal or adjusted weights are unacceptable)
Serum creatinine =< 1.5 mg/dL and /or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/min
Creatinine clearance >= 60 mL/min/1.73 m^2 by Cockcoft-Gault
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula obtained =< 7 days prior to registration
Creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula
Obtained within 14 days of randomization: Creatinine serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula)
Participant must have adequate renal function as demonstrated by a creatinine clearance ? 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection.
Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 by Cockcroft-Gault formula
Creatinine clearance > 50 mL/min/1.73 m^2 by Cockcroft-Gault equation
Creatinine clearance (as estimated by Cockcroft Gault) >= 60 cc/min
Creatinine clearance (Cockroft-Gault calculated or 24-hour urine) >= 30 mL/min
Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
Creatinine clearance > 30 mL/min based on the Cockcroft-Gault equation
Participants must have creatinine clearance estimated using the Cockcroft-Gault equation of >= 51 mL/min, measured within 28 days prior to administration of study treatment\r\n* Note: patients with creatinine clearance between 51- 80 mL/min either at trial enrollment or during the course of the trial should be monitored every 2 weeks for laboratory assessment and toxicity evaluation
Creatinine clearance of >= 30 mL/min; creatinine clearance (CrCl) should be calculated suing the Cockcroft-Gault formula
Calculated creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)
Adequate renal function: serum creatinine =< 2.0 x ULN or creatinine clearance (CrCl) >= 30mL/min obtained within 28 days prior to registration; a calculated creatinine clearance by Cockcroft-Gault formula is acceptable in lieu of a measured value
Serum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 60 mL/min (Cockcroft Gault equation)
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.
Serum creatinine =< 1.5 X upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40mL/min (if using the Cockcroft-Gault formula)
Creatinine =< 1.5 X ULN and creatinine clearance (CrCL) >= 30 ml/min per Cockcroft Gault formula (obtained =< 14 days prior to registration)
Creatinine =< 1.5 mg/dL or creatinine clearance >= 40 mL/min using Cockcroft-Gault formula, within 14 days of study registration (within 30 days for pulmonary and cardiac assessments)
Creatinine clearance (Cockcroft Gault) ? 60 mL/min
Creatinine </=2.0 milligrams per deciliter (mg/dL), with creatinine clearance (CrCl) using the Cockcroft-Gault formula >/=40 milliliters per minute (mL/min) or 60 mL/min for those who receive lenalidomide
Serum creatinine ?1.5 x ULN or creatinine clearance ?50 mL/min based on either urine collection or Cockcroft Gault estimation.
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance >= 40 mL/min (obtained within 28 days prior to first study treatment)\r\n* Cockcroft-Gault formula will be used to calculate creatinine clearance
Within 14 days of registration: Creatinine >= 51 mL/min estimated using the Cockcroft-Gault equation
Creatinine clearance >= 50 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) based either on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection.
Serum creatinine level =< 1.5 x ULN and clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance within 28 days prior to study registration
Creatinine clearance >= 50 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour)
Serum creatinine =< 1.5 x ULN (as long as patient does not require dialysis); a) may receive transfusion b) if creatinine is not < 1.5 x ULN, then calculate by Cockcroft-Gault methods or local institutional standard and creatinine clearance (CrCl) must be >= 40 mL/kg/1.73 m^2 within 14 days prior to study entry
To be performed within 10 business days prior to day 1: Creatinine clearance of >= 50 mL/min per the Cockcroft-Gault formula and/or 24 hour (hr) urine analysis as needed
Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min, obtained =< 14 days prior to registration
Within 14 days prior to planned start of treatment: Creatinine clearance of >= 60 mL/min per the Cockcroft-Gault formula
Estimated creatinine clearance (CrCL) using the Cockcroft-Gault equation >= 50 mL/min
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Serum creatinine =< 1.5 x ULN or estimated creatinine clearance >= 30 mL/min as calculated using the Cockcroft-Gault (CG) equation
Estimated creatinine clearance greater than or equal to 30 ml/min (Cockcroft-Gault) or serum creatinine less than or equal to 2 x ULN
Creatinine clearance >= 50 ml/min using a 24 hour creatinine clearance or estimated creatinine clearance using the Cockcroft-Gault equation
Creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min calculated using the formula of Cockcroft and Gault
Creatinine clearance >= 50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour)
Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula), within 14 days prior to treatment
Creatinine within normal limits OR, for patients with levels above institutional normal: creatinine clearance measured by 24-hour urine collection >= 60 mL/min, OR calculated corrected creatinine clearance >= 60 mL/min/1.73 m^2 using the Cockcroft-Gault formula (Cockcroft and Gault 1976) corrected for the body surface area
Adequate renal function as demonstrated by serum creatinine ?1.5 x ULN or creatinine clearance calculation ?60 mL/min as calculated by the Cockcroft and Gault formula
Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min should be obtained within 21 days prior to enrollment\r\n* Use the Cockcroft-Gault formula \r\n* Alternatively to Cockcroft-Gault formula of CrCl, 24 hour (hr) urine CrCl can be used
Creatinine clearance greater than or equal to 50 mL/min (Cockcroft-Gault)
Serum creatinine clearance >= 50 ml/min (calculated with Cockcroft-Gault formula)
Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
Creatinine =< 1.5 x ULN, serum creatinine clearance (CL) > 51 ml/min (by the Cockcroft- Gault equation)
Renal function: >= 60 ml/min (actual or calculated by the Cockcroft-Gault method) or a creatinine =< the upper limits of normal at cycle 1 day 1 of TPF
Estimated creatinine clearance >= 30 ml/min (Cockcroft-Gault)
Serum creatinine =< 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault equation
Creatinine clearance >= 30 mL/min/1.73 m^2 (as determined by Cockcroft-Gault equation) obtained =< 14 days prior to registration
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)
Creatinine clearance < 50 cc/min measured or calculated by Cockroft-Gault equation
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Estimated creatinine clearance >= 30 ml/min (Cockcroft-Gault)
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
The patient has serum creatinine clearance ?50 mL/min by the Cockcroft-Gault formula.
Creatinine clearance >= 40 mL/min for patients with creatinine\r\n* Levels above institutional normal (calculated using the Cockcroft-Gault formula)
Creatinine clearance (calculated creatinine clearance by Cockroft-Gault using adjusted body weight if actual body weight is 20% greater than ideal is permitted) should be > 50 ml/min
Obtained =< 14 days prior to randomization: Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula
Calculated creatinine clearance (CCr) >= 50 mL/min/1.73^2 using the Cockcroft-Gault equation
Creatinine =< 1.5 x ULN or creatinine clearance > 50 mL/min (calculated by Cockcroft-Gault method)
Serum creatinine clearance (CrCl) ? 30 mL/min using the Cockcroft- Gault equation
Serum creatinine >= 1.5 x upper limit of normal (ULN) and creatinine clearance (by Cockcroft-Gault formula) < 60 mL/min
Completed within 60 days of surgery: Calculated creatinine clearance ? 60 mL/min; the creatinine clearance CrCl is determined by the Cockcroft-Gault formula
Calculated creatinine clearance (CrCl) or 24-hour urine CrCl > 50 mL/min (Cockcroft-Gault formula will be used to calculate CrCl) (within 14 days prior to registration)
For patients >= 13.0 years of age at the time of enrollment: estimated creatinine clearance > 50 mL/minute (using the Cockcroft-Gault formula and actual body weight)
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Calculated creatinine clearance (CrCl) or 24-hour urine CrCl > 50 mL/min Cockcroft-Gault formula (using actual body weight) will be used to calculate CrCl, except for patients (pts) with osteosarcoma who will be allowed to participate with an estimated creatinine clearance (CrCl) of > 40 mL/min, as calculated by the Cockcroft-Gault equation
Creatinine > 1.5 x ULN, or a creatinine clearance of < 60 ml/min as calculated by Cockcroft-Gault or by 24-hour urine collection
Creatinine clearance (by Cockcroft Gault formula or measured) >= 50 mL/min
Creatinine < 1.5 mg/dL OR creatinine clearance (by Cockcroft Gault formula) >= 50 mL/min
Within 14 days prior to registration: Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Estimated (by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] or Cockgroft-Gault equations) or calculated creatinine clearance (CrCl) >= 40 ml/min
Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 by Cockcroft-Gault formula
PHASE I: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normal
PHASE II SCLC: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normal
UROTHELIAL CARCINOMA EXPANSION COHORT: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normal
mCRPC EXPANSION COHORT: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normal
Or creatinine clearance ? 60 mL/minute for subjects with serum creatinine outside the normal range (calculated using the Cockcroft-Gault equation).
Creatinine > 1.5 times ULN concurrent with creatinine clearance < 30 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5 times ULN
Creatinine clearance > 50 mL/min (calculated according to institutional standards or using Cockcroft-Gault, Modification of Diet in Renal Disease [MDRD], or Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
Serum creatinine =< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance >= 60 ml/min per modified Cockcroft-Gault formula
Serum creatinine =< 1.5 times the ULN, or calculated creatinine clearance >= 50 mL/minute (per the Cockcroft-Gault formula)
Serum creatinine =< 1.5 x mg/dL and/or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/min
Creatinine clearance >= 50 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour)
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine
Renal: creatinine < 1.5 X ULN or creatinine clearance >= 50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour)
Serum creatinine < 1.5 x ULN or creatinine clearance > 50 mL/min (by Cockcroft- Gault)
Creatinine clearance >= 50 mL/min (calculated using the Cockroft-Gault formula or measured with 24 hour urine collection)
Calculated creatinine clearance (Cockcroft-Gault equation) >= 40 mL/min
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Calculated creatinine clearance (using Cockcroft-Gault equation) >= 60 mL/min
Normal serum creatinine, or a creatinine clearance >= 40 ml/min (either measured using a 24 hour urine, calculated using Cockroft-Gault, or estimated using the Modification of Diet in Renal Disease [MDRD] method from the National Kidney Disease Education Program [NKDEP] [the method reported by M D Anderson Cancer Center (MDACC) laboratories])
Serum creatinine =< 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault equation
Serum creatinine =< 1.5 mg/dL or creatinine clearance >= 60 mL/min as estimated by the Cockcroft-Gault equation
Creatinine ? 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ? 60 mL/minute x 1.73 m2 per the Cockcroft-Gault formula
Creatinine clearance (CrCl) < 60 ml/min by Cockcroft-Gault formula
Creatinine clearance (based on modified Cockcroft-Gault formula) ? 45 ml/min.
Serum creatinine less than or equal to 1.3 mg/dL; if creatinine is > 1 mg/dL the creatinine clearance should be > 40 mL/min as calculated using the Cockcroft-Gault formula
plasma creatinine ? 1.5 x upper limit of normal (ULN) for the institution or calculated clearance ? 60 mL/min (Cockcroft-Gault formula)
Serum creatinine =< 1.5 x IULN OR creatinine clearance by Cockcroft-Gault >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x IULN
Renal function assessed by calculated creatinine clearance: \r\n* Calculated creatinine clearance >=30 ml/min by Cockcroft-Gault formula
Serum creatinine =< 1.5 x IULN OR creatinine clearance by Cockcroft-Gault >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x IULN
Creatinine clearance >= 50 mL/min based either on Cockcroft-Gault estimate from serum creatinine or based on urine collection (12 or 24 hour)
Creatinine =< 1.5 mg/dL × ULN, or calculated creatinine clearance (determined as per Cockcroft-Gault)
Creatinine < 1.5 mg/dl and/or creatinine clearance > 60 mL/min using the Cockcroft-Gault formula
Creatinine within normal institutional limits OR creatinine clearance >= 50 mL/min based on the standard Cockcroft and Gault formula obtained within 14 days of first treatment
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft?Gault formula) obtained within 14 days prior to randomization/registration
Creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)
Creatinine clearance (CrCl) >= 50 mL/min calculated by the Cockcroft-Gault method
Serum creatinine clearance (CL) > 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Serum creatinine within the institutional normal limits, OR if the creatinine is elevated: creatinine clearance (CrCl) >= 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula
Within 14 days of first dose of study drug administration: Serum creatinine: creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Adequate renal function, estimated or calculated creatinine clearance of > 50 mL/min (calculated using the formula of Cockcroft and Gault) -or- serum creatinine ? 2.0 mg/dL.
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (using the Cockcroft-Gault formula)
Serum creatinine < 1.5 mg/dL and/or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/min
Estimated serum creatinine clearance >= 50 ml/min (using the Cockcroft-Gault formula) and/or serum creatinine =< 1.6 mg/dL; renal function will be calculated using ideal body weight (IBW), unless a patient weighs > 40% of their IBW, then adjusted body weight will be utilized
Calculated creatinine clearance >= 30 mL/min; Cockcroft-Gault formula will be used to calculate\r\ncreatinine clearance
Creatinine > 1.5 times ULN or an estimated creatinine clearance < 50 mL/minute calculated using the Cockcroft-Gault equation
PHASE I: Subjects must have calculated creatinine clearance >= 60 ml/min by Cockcroft-Gault formula, obtained =< 7 days prior to registration
PHASE II: Subjects must have calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula, obtained =< 7 days prior to registration
Estimated creatinine clearance ? 30mL/min (Cockcroft-Gault formula)
Serum creatinine =< 1.5 mg/dL (=< 133 umol/L) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Within 14 days prior to study entry: Calculated creatinine clearance >= 40 mL/min using Cockcroft-Gault formula
Calculated creatinine clearance (CrCl) >= 50 mL/min per 24 hour urine collection or the Cockcroft-Gault formula
Calculated creatinine clearance (CrCl) >= 30 mL/min per 24-hour urine collection or the Cockcroft-Gault formula
Creatinine =< 1.5 x ULN OR calculated creatinine clearance >= 60 mL/min calculated by the Cockcroft-Gault formula
Adequate renal function as defined by one of the following: \r\n• Serum Creatinine ?1.5 mg/dl OR \r\n• Serum Creatinine clearance > 50ml/min (calculated by Cockcroft-Gault formula)
ARM A COHORT 1: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula)
ARM B COHORT 2: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula)
ARM B COHORT 3: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula)
ARM C COHORT 4: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula)
Creatinine clearance (CrCl) >= 30 mL/min (as calculated by Cockcroft-Gault equation)
Creatinine =< 1.5 mg/dL or creatinine clearance by Cockcroft-Gault formula >= 60 mL/min
Either an estimated creatinine clearance value of >= 50 mL/min as determined by the Cockcroft-Gault formula or a creatinine clearance value of >= 50 mL/min based on a 24 hour urine collection
Creatinine clearance >= 50 mL/min (by Cockcroft?Gault equation)
Creatinine ? 1.5x the upper limit of normal (ULN), or calculated creatinine clearance ? 60 mL/minute x 1.73 m^2 per the Cockcroft-Gault formula
Creatinine =< 2.0 x ULN (for patients with > 1.5 x ULN, calculated or measured creatinine clearance must be = 40 mL/minute [Cockcroft-Gault]).
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)
Adequate renal function: calculated creatinine clearance > 30 ml/min (Cockcroft-Gault)
Serum creatinine clearance >= 50 ml/min (calculated by Cockroft-Gault formula)
Serum creatinine =< 1.5 times the upper limit of normal or creatinine clearance > 30 mL/min by Cockcroft-Gault formula
Creatinine clearance (CrCl) ? 60 mL/minute (Cockcroft-Gault).
Calculated creatinine clearance of < 30 mL/min using Cockcroft Gault or measured by 24 hour urine
Creatinine clearance >= 30 mL/min by Cockcroft-Gault formula
Creatinine =< 1.5 mg/dL or creatinine clearance > 30 ml/min (estimated as calculated with Cockcroft-Gault equation)
Creatinine clearance of < 50 ml/minute by Cockcroft Gault equation
Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula
24 hour creatinine clearance or calculated (using the Cockcroft-Gault formula) creatinine clearance > 60 mL/min/1.73 m^2 (induction phase only)
RESEARCH PHASE INCLUSION CRITERIA: 24 hour creatinine clearance or calculated (using the Cockcroft-Gault formula) creatinine clearance > 60 mL/min/1.73 m^2 (induction phase only)
Must be met within 28 days of C1D1: Serum creatinine =< 1.5 x ULN or estimated creatinine clearance of >= 40 mL/min calculated using the formula of Cockcroft and Gault
Creatinine clearance >= 45 mL/min as calculated by the standard Cockcroft-Gault equation using age, actual weight, creatinine and gender
Adequate renal function, as defined by creatinine clearance of ? 50 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection).
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)
Creatinine =< 1.5 mg/dl OR creatinine clearance >= 55 mL/min using the Cockcroft-Gault equation for patients with creatinine levels above 1.5 mg/dl
Creatinine clearance greater than or equal to (>=) 60 milliliter per minute (mL/min) either as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours).
Has adequate renal function, defined as: Creatinine clearance >=60 mL/min, as calculated using the modified Cockcroft Gault equation, ([{140 - age in year
Within 4 days prior to the first dose of cabozantinib: Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min (for creatinine clearance estimation, the Cockcroft and Gault equation should be used)
Creatinine clearance (CrCl) >= 45 mL/minute within 7 days prior to enrollment either measured or calculated using a standard formula (eg, Cockcroft and Gault); in cases that creatinine clearance cannot be measured accurately, 24 hour urine can be used
Creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min calculated using the formula of Cockcroft and Gault
Serum creatinine < 1.5 mg/dL and/or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/min
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 60 mL/min OR 24-hour urine creatinine clearance >= 60 mL/min
Calculated creatinine clearance >= 50 mL/min (calculated by the Cockcroft-Gault formula), obtained within 30 days of study registration, or
Creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft?Gault formula)
PART 2: Calculated creatinine clearance using the Cockcroft-Gault formula or 24 hr urine creatinine clearance must be > 60 ml/min
Within 21 days prior to C1D1: Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault
Calculated or measured creatinine clearance (CrCL) >= 60 mL/min using modified Cockcroft and Gault formula
Creatinine clearance (CC) >= 50 ml/min within 4 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula
Serum creatinine level to be < 2 mg/dl or estimated creatinine clearance (CrCl) must be equal or greater than 40 mL/min/1.73 m^2 as calculated by the Cockcroft-Gault formula
Adequate renal function as defined by: calculated creatinine clearance must be >= 40 mL/minute (Cockcroft-Gault)
A pretreatment creatinine clearance (CrCl) of >= 60 mL/minute (min), calculated by Cockcroft Gault
Creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Serum creatinine =< 1.5 x ULN or calculated creatinine clearance (CrCl) >= 50 ml/min based upon the Cockcroft-Gault equation
Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 40 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
Creatinine clearance (calculated by the Cockroft-Gault formula) >= 30 ml/min
Creatinine clearance of >= 50 mL/min (estimated by the Cockcroft-Gault [C-G] formula)
Serum creatinine > 1.5 x ULN and/or creatinine clearance (CrCl) < 30 mL/min at screening (calculation according to Cockcroft & Gault formula)
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
Creatinine clearance (CrCl) >= 30 mL/minute, either measured or calculated using a standard formula (e.g., Cockcroft and Gault)
Creatinine > 1.5 times the upper limit of normal (ULN) (unless creatinine clearance normal), or calculated creatinine clearance < 40 mL/min (using Cockcroft-Gault formula)
The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m^2 as calculated by the Cockcroft-Gault Formula
Serum creatinine of =< 1.5 mg/dL; if creatinine > 1.5 mg/dL creatinine clearance must be > 60 mL/min within 7 days prior to treatment either measured or calculated using a standard Cockcroft and Gault formula
Creatinine clearance < 60 mL/min (calculated by Cockcroft-Gault formula)
Patients must have a serum creatinine ? the institutional upper limit of normal OR a creatinine clearance ? 60 cc/min, measured or calculated (Cockcroft-Gault formula), obtained within 14 days prior to registration.
Serum creatinine =< 1.6 mg/dL and creatinine clearance >= 30 ml/min; creatinine clearance will be calculated using the Cockcroft-Gault equation
Known chronic liver disease, end stage renal disease, or creatinine clearance < 30 mL/min as defined by Cockcroft-Gault equation
Serum creatinine clearance equal or more than 50 ml/min (calculated with Cockcroft-Gault formula)
Creatinine within normal institutional limits OR creatinine clearance >= 50 mL/min/1.73 m^2 by Cockcroft-Gault formula
Calculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Calculated creatinine clearance by Cockroft-Gault formula >= 30 ml/min, obtained within 2 weeks prior to registration
Serum creatinine =< 1.5 x ULN or estimated creatinine clearance >= 50 ml/min by Cockcroft-Gault equation
Calculated creatinine clearance according to the formula of Cockroft and Gault >= 50 mL/min
Creatinine clearance (CrCL) >= 30 mL/min as calculated by the standard Cockcroft-Gault equation
Subjects must have adequate renal function with a creatinine clearance of >= 40 mL/min as determined by the Cockcroft-Gault calculation
Estimated serum creatinine clearance >= 60 ml/min (using the Cockroft-Gault formula and/or serum creatinine =< 1.6 mg/dL
Estimated serum creatinine clearance >= 50 ml/min (using the Cockcroft-Gault formula)
Creatinine < 1.5 x ULN or creatinine clearance > 60 ml/min according to Cockroft-Gault formula
Serum creatinine =< 2 mg/dl or creatinine clearance >= 40 ml/min (creatinine clearance calculated per Cockroft-Gault formula or by 24-hour urine collection), within 14 days prior to study entry
Creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) > 40 mL/min (using the Cockcroft-Gault formula)
Serum creatinine > 1.5 times ULN concurrent with creatinine clearance < 50 mL/min (measured or calculated by Cockcroft and Gault equation)—confirmation of creatinine clearance is only required when creatinine is > 1.5 times ULN
Patients enrolled in the dose escalation phase who are not enrolled on the expansion cohorts must have calculated creatinine clearance >= 50 ml/min by Cockcroft-Gault formula; patients enrolled in the dose expansion phase must have calculated creatinine clearance >= 40 ml/min by Cockcroft-Gault formula, without use of growth factor support for 1 week
Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min obtained =< 14 days prior to registration
Serum creatinine ? 1.5 x ULN and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/min
Obtained =< 28 days prior to randomization:\r\nCreatinine =< 1.5 mg/dL OR calculated creatinine clearance of >= 50 ml/min by either the Cockcroft-Gault formula or 24-hours urine collection analysis
Serum creatinine clearance of < 30 mL/min as estimated by the Cockcroft-Gault method
Creatinine clearance >= 40 mL/min/m^2 by Cockroft-Gault or Modification of Diet in Renal Disease (MDRD) equation
Serum creatinine < 2x normal, or creatinine clearance (as determined by the Schwartz formula Cockcroft and Gault) > 40ml/min/m^2 or 70ml/min
Serum creatinine > 2.0 mg/dL or 177 ?mol/L or creatinine clearance < 40 mL/min (using the Cockcroft-Gault formula)
Creatinine =< 1.6 mg/dL; if over 1.6 then the calculated creatinine clearance must be >= 55 ml/min using the Cockcroft-Gault formula, obtained =< 7 days prior to registration
Obtained =< 14 days prior to registration: Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min
Creatinine clearance < 40 mL/min calculated by Cockcroft-Gault equation.
Creatinine within normal institutional limits OR creatinine clearance > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula
Calculated creatinine clearance of >= 50 cc/min using the Cockcroft-Gault formula
Adequate renal function within 4 weeks of study entry, defined as serum creatinine less than or equal to 1.5 x ULN for the lab. (If creatinine is 1.0-1.5 x ULN, the creatinine clearance should be greater than 40 mL/min per Cockcroft-Gault formula (Cockcroft-Gault 1976), or by 24-hour urine collection for determination of creatinine clearance.)
creatinine clearance < 30 ml /min based on the Cockcroft Gault equation;
Cockcroft-Gault equation: creatinine clearance = (140 - age in years) x (wt in kg)) x 1.23) / (serum creatinine in micromol/l) [For women multiply the result of calculation by 0.85].
Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 45 mL/min
Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault
Calculated creatinine clearance of >= 55 cc/min using the Cockcroft-Gault formula
Renal function: >= 60 ml/min (actual or calculated by the Cockcroft-Gault method)
Creatinine clearance ? 30 mL/min/1.73 m^2 by Cockcroft-Gault\r\n* At the discretion of the treating physician, a 24-hour urine creatinine clearance could be obtained and utilized as the gold standard if creatinine clearance by Cockcroft-Gault is < 30, and prevents patient enrollment on the trial
Serum creatinine ? 2.0 mg/dL OR calculated creatinine clearance (crcl) ? 45 mL/min (if using the Cockcroft-Gault formula)
Renal: serum creatinine within normal limits; for patients with levels above the institutional normal value, the calculated corrected creatinine clearance must be ? 60 mL/min/1.73 m^2 using the Cockcroft-Gault formula corrected for the body surface area.
Serum creatinine =< 1.5 x ULN, or measured creatinine clearance (CrCl) >= 45 mL/min as calculated by the Cockcroft-Gault method or 24-hour measured urine CrCl >= 45 mL/min
Within 14 days prior to randomization: Serum creatinine =< 1.5 x ULN or measured or calculated creatinine clearance >= 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab
Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of >= 51 mL/min within 28 days prior to administration of study treatment.
Serum creatinine =< 2 mg/dL. The Cockcroft-Gault formula will be used to calculate creatinine clearance in all subjects.
To be performed within 14 days prior to day 1 of protocol therapy: creatinine clearance of >= 50 mL/min per 24 hour urine or the Cockcroft-Gault formula
Within 28 days prior to administration of study treatment: Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of ? 51 mL/min
Creatinine clearance ? 40 mL/min/1.73m^2\r\n* Using 24-hour creatinine clearance or modified Cockcroft-Gault equation
Creatinine ? 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ? 50 mL/minute x 1.73 m2 per the Cockcroft-Gault formula
Creatinine clearance >60 mL/min (calculated using the Cockcroft-Gault formula) or by 24-hours urine collection
Adequate renal function, defined as an estimated creatinine clearance ?30 mL/min using the Cockcroft-Gault equation
Creatinine clearance (as estimated by Cockcroft Gault) >= 60 cc/min
Creatinine clearance (as estimated by Cockcroft Gault) >= 50 cc/min.
Creatinine clearance >= 50 mL/min (using Cockcroft-Gault)
Obtained ? 14 days prior to registration: calculated creatinine clearance must be ? 30 ml/min using the Cockcroft Gault formula
Measured creatinine clearance (CL) >= 50 mL/min or calculated creatinine CL ? 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Severely impaired renal function, defined as creatinine clearance (CrCl) ? 30 mL/min estimated by the Cockcroft-Gault formula
Estimated creatinine clearance (CrCL) using the Cockcroft-Gault equation >= 50 mL/min
RENAL COHORT: Laboratory values as follows within 4 days before the first dose of daratumumab: serum creatinine clearance (CrCl) ? 20 mL/min; dialysis patients will be excluded; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
BLADDER: Clinical laboratory values at screening: serum creatinine clearance (CrCl) ? 20 mL/min; dialysis patients will be excluded; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
Within 7 days before the first dose of cabozantinib: Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
Serum creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min (calculated by Cockcroft Gault equation) =< 14 days prior to registration
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance within 3 weeks prior to initial treatment
Creatinine ? 1.5 x upper limits of normal (ULN) OR calculated creatinine clearance ? 60 mL/min by Cockcroft-Gault formula
Serum creatinine =< 2.0 mg/dL or creatinine clearance >= 40 mL/min (measured or calculated according to the method of Cockcroft and Gault), within 28 days of day 0.
Creatinine clearance of >= 40 mL/min, estimated or calculated using the Cockcroft-Gault equation.
Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Estimated creatinine clearance > 50 mL/min by Cockcroft-Gault equation
Estimated creatinine clearance greater than or equal to 60 ml/min (Cockcroft-Gault)
Obtained =< 21 days prior to registration: Creatinine =< 1.0 mg/dL or creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 30 mL/min based on the Cockroft-Gault equation
Serum creatinine clearance (CL) >40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.
Creatinine clearance estimated using the Cockcroft-Gault equation of >= 51 mL/min.
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Creatinine (Cr) Clearance >= 25 mL/min (per Cockcroft-Gault equation).
Creatinine clearance >= 50 mL/min (calculated by the Cockcroft-Gault or via 24-hour urine collection)
Serum creatinine performed within 3 weeks prior to starting study therapy must be =< 1.5 x ULN, or have calculated creatinine clearance (using Cockcroft-Gault formula) of >= 50 mL/minute
Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula
Estimated creatinine clearance > 40 mL/min by the Cockcroft-Gault formula
Creatinine clearance >= 50 ml/mm (can be calculated utilizing the Cockcroft & Gault equation)
Serum creatinine value < upper limit of normal (ULN) or creatinine clearance of >= 60 mL/min according to Cockgroft?Gault formula
Creatinine Clearance >= 60 mg/mL as calculated by the modified Cockraft-Gault formula
To be performed within 28 days prior to day 1 of protocol therapy: Creatinine < 1.5 x ULN or creatinine clearance of >= 60 mL/min per the Cockcroft-Gault formula
Estimated (Cockcroft-Gault formula) or measured creatinine clearance <40 mL/min.
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Calculated creatinine clearance of >= 30 mL/min according to Cockcroft-Gault equation
Calculated creatinine clearance according to the Cockcroft and Gault equation >= 50 mL/min
Within 14 days prior to step 1 registration: Measured creatinine clearance (CL) > 30 mL/min or calculated creatinine CL > 30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault
Creatinine within normal institutional limits OR creatinine clearance >= 30 Ml/min (Cockcroft-Gault formula or measured with 24 hour [h] urine)
Creatinine clearance (CrCl) >= 50 ml/min within 14 days prior to registration as determined by 24-hour collection or estimated by Cockcroft-Gault formula
Subject has adequate renal function: serum creatinine ? 2.0 mg/dL and estimated creatinine clearance of ? 30 mL/min by the Cockcroft-Gault equation
Serum creatinine levels =< 1.5 mg/dl and calculated (by Cockcroft-Gault formula) or measured creatinine clearance >= 50 mL/min, obtained within 14 days prior to registration for protocol therapy
Creatinine clearance >= 50; creatinine clearance must be calculated using Cockroft-Gault formula
Serum creatinine institutional ULN within 14 days prior to registration or; creatinine clearance (CC) >= 50 ml/min within 14 days prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)
Measured within 28 days prior to administration of study treatment: Creatinine clearance estimated using the Cockcroft-Gault equation of >= 51 mL/min
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)
Obtained within 14 days (or as stipulated) prior to study drug (treatment) administration: creatinine clearance ? 30 ml/min (calculated by the Cockcroft-Gault Equation or per 24-hour urine collection)
Creatinine clearance >= 50 ml/min measured by Cockcroft-Gault
Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula, obtained =< 14 days prior to registration
Creatinine clearance (CrCL) >=60 calculated by Cockroft-Gault
Obtained within 30 days prior to registration: Estimated creatinine clearance 40 cc/min OR serum creatinine =< 1.5 x upper limit of normal (ULN)\r\n* Cockcroft-Gault formula will be used to calculate creatinine clearance
Creatinine clearance > 60 mL/min/1.73 m^2 by either Cockcroft-Gault formula or 24-hour urine collection analysis
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Serum creatinine =< 1.5 x institutional ULN (Cockcroft and Gault formula)
Creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal (derived by the Cockcroft-Gault formula)
Obtained =< 7 days prior to registration: Creatinine clearance >= 30 mL/min (as determined by Cockcroft-Gault equation)
Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)
Creatinine (Cr) clearance > 50 mL/min by Cockcroft-Gault calculation
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min
Serum creatinine < 2 x institutional ULN or creatinine clearance > 50 ml/min as determined by 24 hour collection or estimated by Cockcroft-Gault formula
Creatinine ?1.5 mg/dL OR estimated creatinine clearance ?60 mL/min calculated using Cockcroft-Gault equation
Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
Serum creatinine =< ULN or calculated creatinine clearance >= 35 mL/min using Cockcroft-Gault formula
Creatinine clearance >= 60 mL/min by the Cockcroft-Gault equation
Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min
Creatinine clearance of >= 45 mL/min per 24 hour urine collection or the Cockcroft-Gault formula
Creatinine =< 1.5 x ULN OR calculated creatinine clearance >= 50 ml/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration)
Patients must have a serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the Cockroft-Gault formula
Creatinine clearance >= 60 mL/min, as calculated by Cockcroft-Gault equation
Calculated creatinine clearance (CrCl) >= 30 mL/min (Cockcroft-Gault method)
Creatinine clearance > 30 cc/min calculated using the Cockcroft and Gault (1976) formula or measured
Creatinine clearance >= 30 by Cockcroft-Gault formula
Serum creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min (calculated by Cockcroft Gault equation)
Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault
Serum creatinine =< 1.5 mg/dL (=< 120 umol/L) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Creatinine clearance >= 45 ml/min determined by 24-hour collection or estimated by the Cockroft-Gault formula
Creatinine =< 1.5 x institutional upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min using Cockcroft-Gault formula
Serum creatinine =< 1.5 mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula, within 14 days prior to registration
Creatinine clearance >= 50 mL/min by either Cockcroft-Gault formulate or 24 hour (hr) urine collection analysis
Creatinine clearance >= 30 mL/min according to Cockcroft-Gault formula
Creatinine =< 1.5 ULN or calculated creatinine clearance >= 50 mL/min or 24-hour urine creatinine clearance >= 50 mL/min; calculated by the Cockcroft-Gault formula
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min
Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 ml/min OR 24-hour urine creatinine clearance >= 50 ml/min
Serum creatinine =< 1.5 × ULN, OR calculated creatinine clearance >= 30 mL/minute (modified Cockcroft and Gault formula)
Creatinine clearance (CrCl) ? 15 mL/minute within 7 days prior to randomization,\n             either measured or calculated using a standard formula (e.g., Cockcroft and Gault)
Creatinine =< 1.5 times the upper limit of normal with creatinine clearance >= 50 mL/min using the modified Cockcroft-Gault method
Creatinine clearance >= 50 ml/min within 2 weeks prior to registration as determined by 24-hour collection or estimated by Cockcroft-Gault formula
Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above ULN as calculated by Cockcroft-Gault
For patients receiving chemotherapy:\r\n* Within 14 days prior to registration, serum creatinine =< 1.5 mg/dL and calculated creatinine clearance >= 50 cc/min; both tests must be within these limits; the creatinine clearance should be calculated using the Cockcroft-Gault formula\r\n* Aspartate aminotransferase (AST) =< 2 times upper limit of normal (ULN)\r\n* Bilirubin =< 2 times ULN\r\n* Alkaline phosphatase, magnesium, blood urea nitrogen (BUN), and electrolytes must be obtained and recorded
Creatinine =< grade 1 OR creatinine clearance >= 40 mL/min/1.73 m^2 for patients with creatinine (Cr) above normal institutional limits; a calculated creatinine clearance by Cockcroft-Gault Formula is acceptable in lieu of a measured value
Calculated creatinine clearance (CrCl) > 50 cc/min/1.73 m^2, using the Cockcroft-Gault equation; note: a measured CrCl from a 24 hour urine collection may also be used
Creatinine < 1.5 mg/dL or within normal institutional limits within 10 days prior to registration; Note: if neither criteria is met, the creatinine clearance must be > 50 mL/min/1.73 m^2 per either the Cockcroft-Gault equation, Jeliffe method, or 12- or 24-hour urine collection
Renal insufficiency at the time of screening, defined as serum creatinine > 2.0 mg/dL or creatinine clearance < 50 mL/min (either actual or calculated value may be used), within 7 days of initiation of protocol therapy; creatinine clearance will be the primary eligibility criteria in determining renal insufficiency; the Cockcroft-Gault formula should be used for calculating creatinine clearance values
Creatinine clearance (calculated creatinine clearance is permitted) < 60 mL/min based on Traditional Cockcroft-Gault formula\r\n* For patients < 18 years: creatinine clearance (CrCl) will be estimated by the Schwartz formula; a measured CrCl or a glomerular filtration rate (GFR) may be substituted to determine the subject’s CrCl
Calculated creatinine clearance >= 60 mL/min; the serum creatinine value used in the calculation must have been obtained within 28 days prior to registration; use the modified Cockcroft-Gault formula
Serum creatinine < 1.5 times the ULN, or creatinine clearance > 60 mL/minute as calculated by the standard Cockcroft-Gault formula
Creatinine clearance < 30 ml/min within 21 days of initiation of protocol therapy; creatinine clearance will be the primary eligibility criteria in determining renal insufficiency; the Cockcroft-Gault formula should be used for calculating creatinine clearance values
Creatinine clearance >= 50 mls/min by Cockcroft-Gault
Creatinine =< ULN (Common Toxicity Criteria [CTC] grade 0) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 60 mL/min OR >= 50 mL/min by ethylenediaminetetraacetic acid (EDTA) creatinine clearance
Serum creatinine levels <= 1.5 * ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) or measure creatinine clearance >=50 mL/min.
Screening laboratory assessments outside the following limits: Absolute neutrophil count (ANC) <1,000/?l (<1.0 x 109/L) Platelet count <100,000/?l (<100 x 109/L) Hemoglobin <9 g/dL Total bilirubin >1.5 x institutional upper limit of normal (ULN) (i n case of known Gilbert's syndrome, <2 x ULN is allowed) Creatinine Creatinine clearance <30 mL/min (as calculated by Cockcroft-Gault formula or Modification of Diet in Renal Disease [MDRD] formula)
Creatinine clearance (CrCl) >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
Creatinine clearance (CrCl) >= 60 mL/min as calculated by the Cockcroft-Gault method
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Patients must have a serum creatinine =< the IULN AND measured or calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formula
REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have a serum creatinine =< (IULN) AND measured of calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formula
Patients must have a serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula
Adequate renal function as evidenced by calculated creatinine clearance ? 30 millimeter/ minute (mL/min) according to the Cockcroft and Gault formula.
Estimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault (140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female.
Part B: Renal function, as follows: creatinine clearance estimate ? 15 mL/min and <60 mL/min by cockroft gault equation adjusted for body weight
Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than 40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, as calculated by the Cockcroft Gault formula.
Serum creatinine < 2 x institutional ULN or; creatinine clearance (CC) >= 50 mL/min determined by 24-hour collection or estimated by Cockcroft-Gault formula
Creatinine =< 1.5 upper limit of normal (ULN) AND creatinine clearance (CrCl) > 50 mL/min by Cockcroft-Gault equation
Serum creatinine =< 2.0 g/dL or calculated creatinine clearance >= 60 mL/min (Cockcroft-Gault method)
Adequate renal function, with creatinine =< 1.3 mg/dl or calculated creatinine clearance >= 60 ml/min by Cockcroft and Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)
Serum creatinine level ? ULN or creatinine clearance ? 50 ml/min for patients with creatinine levels above normal limits (creatinine clearance calculated by the Cockcroft-Gault formula, see Appendix II),
Any of the following laboratory abnormalities: Absolute neutrophil count(ANC) < 1,000/µL, Platelet count < 75,000/µL or < 50,000/µL for patients in whom ? 50% of bone marrow nucleated cells are plasma cells, Hemoglobin < 8 g/dL, Creatinine clearance < 45 mL/min according to Cockcroft-Gault formula. If creatinine clearance calculated from the 24 hour urine sample is ? 45 mL/min, patient will qualify for the trial, Aspartate transaminase (AST) or Alanine transaminase (ALT) > 3.0 × Upper Limited Normal (ULN), Serum total bilirubin > 2.0 mg/dL or > 3.0 × ULN for patients with hereditary benign hyperbilirubinaemia.
Creatinine clearance >= 60 mL/min/1.73 m^2 as calculated by Cockcroft-Gault
Calculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula)
Creatinine clearance >= 30 mL/minute (calculated by Cockcroft-Gault formula)
Creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula)
Creatinine clearance (CrCL) >= 30 mL/min, measured by a 24-hour urine collection or estimated by the Cockcroft and Gault formula within 14 days prior to registration
Renal function assessed by calculated creatinine clearance (CrCl) must be >= 60 ml/min by Cockcroft-Gault formula
Serum creatinine ? ULN (with value applied to Cockcroft-Gault equation) or 24 hour clearance ? 50mL/min.
Subjects must have calculated creatinine clearance >= 30ml/min by Cockcroft-Gault formula
Calculated creatinine clearance (CrCL) ? 30 mL/minute (Cockcroft-Gault formula).
Creatinine clearance > 30 ml/min calculated by modified Cockcroft-Gault formula
Estimated creatinine clearance by Cockcroft-Gault >=40 milliliter per minute (mL/min) / 1.73 square meter (m^2);
Adequate renal function defined as calculated creatinine clearance greater than or equal to 30 mL/min per the Cockcroft and Gault formula.
Creatinine clearance >= 40 mL/min/1.73 m^2 by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Serum creatinine ?1.5 x the ULN and a calculated creatinine clearance (CrCl) ?45 mL/min by the Cockcroft-Gault method.
Estimated creatinine clearance >= 30 ml/min (Cockcroft-Gault)
Have a calculated serum creatinine clearance greater than or equal to 45 mL/min using the Cockcroft-Gault equation
Calculated creatinine clearance < 45mL/min (0.75 mL/sec)using Cockroft-Gault formula
Creatinine clearance (CrCl) < 50 mL/min (Cockcroft-Gault formula) at screening
Creatinine > 1.5 x the upper limit of normal; patients with creatinine > 1.5 x the upper limit of normal who have creatinine clearance >= 60 cc/min (calculated using the Cockcroft and Gault equation) are eligible
Creatinine =< 1.5 x upper limit of normal (ULN), or creatinine clearance >= 50 mL/min (estimated by Cockcroft-Gault or measured)
Creatinine clearance (estimated) >= 50 cc/min by Cockcroft Gault or 24 hour urine
Creatinine =< 2.0 x IULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault formula
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula)
Estimated creatinine clearance (CrCl) of > 30 mL/min, as calculated by the Cockcroft-Gault equation unless disease related
Creatinine clearance >= 40 mL/min\r\n* To be calculated by modified Cockcroft-Gault formula
Calculated creatinine clearance (eGFR) < 60 ml/min; EGFR values can be determined by either MDRD or Cockcroft-Gault equation based on the investigator’s discretion
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault method) >= 50 mL/minute within 14 days prior to treatment
Adequate renal function defined as creatinine clearance greater than 40 mL/min calculated per the Cockcroft and Gault formula
Calculated creatinine clearance by Cockroft-Gault formula >= 30 mL/min obtained within 4 weeks prior to registration
Calculated creatinine clearance by Cockroft-Gault formula >= 30 ml/min
Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)
Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula obtained =< 7 days prior to registration
Body surface area (BSA)-normalized creatinine clearance >= 30 mL/min/1.73 m^2 (using Cockcroft-Gault creatinine clearance [CrCl])
(** = calculated by Cockcroft and Gault's formula)
Creatinine clearance >= 30 mL/min as calculated by Cockcroft-Gault formula within 4 weeks of pre-registration
Have a calculated creatinine clearance (Cockroft-Gault equation) > 50 mL/min
Serum creatinine > 1.5 x upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/min
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)
Serum creatinine ?1.5 x upper limit of normal or creatinine clearance >60 mL/min (measured or calculated by the Cockcroft-Gault formula) (Cockcroft DW et al, 1976).
Patients must have a calculated serum creatinine clearance > 50 mL/min using Cockcroft-Gault calculation or based on 24-hour urine collection performed within 7 days prior to treatment
Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula or a 24 hour urine obtained =< 7 days prior to randomization
Calculated creatinine clearance (CrCl) >= 40 mL/min (based upon the Cockcroft-Gault equation)
Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) > 30 mL/min (measured or calculated using the Cockcroft-Gault formula)
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance, obtained within 14 days prior to first treatment
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance >= 25 ml/min as determined by Cockroft-Gault equation or a 24 hour urine collection
Serum creatinine of < 3.0 x ULN (upper limit of normal) or creatinine clearance (CrCl) > 30 mL/minute (using Cockcroft/Gault formula below)
Creatinine clearance >= 50 ml/min; creatinine clearance (CrCl) will be calculated by Cockcroft-Gault method
Serum creatinine < 2.0 mg/dL or calculated creatinine clearance (CrCl) > 45 mL/min (Cockcroft-Gault)
Creatinine clearance > 30 ml/min calculated by modified Cockcroft-Gault formula
Creatinine clearance > 50 mL/min (assessed by Cockcroft Gault estimation)
Creatinine clearance > 30 mL/min (calculated according to Cockcroft - Gault formula) unless due to lymphoma with documentation of normal function prior to onset of lymphoma
Creatinine must be < 1.5 ULN or creatinine clearance must be > 50 mL/min (calculated by Cockcroft and Gault equation)
Serum creatinine (sCr) =< 1.5 x ULN, or creatinine clearance (Ccr) >= 40 mL/min as calculated by the modified Cockcroft-Gault formula
Creatinine clearance > 30 cc/min calculated using the Cockcroft and Gault (1976) formula or measured
Adequate renal function: calculated creatinine clearance > 30 ml/min (Cockcroft-Gault)
Serum creatinine 1.5 × ULN or calculated creatinine clearance (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection) 60 milliliters/minute (mL/min).
Renal insufficiency (serum creatinine levels > 2.5 mg/dL, calculated creatinine clearance [Crcl] with Cockcroft-Gault formula, < 45 ml/min)
Serum creatinine, ? 1.5x Institutional Upper Limit of Normal (ULN), or Creatinine Clearance ? 50 mL/min (by Cockcroft-Gault formula)
Serum creatinine of =< 1.5 X upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula)
Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault equation for adult patients 18 to 70 years old based on ideal body weight, and the Schwartz equation for pediatric patients 6 months to 17 years old
Creatinine clearance > 50 ml/min, calculated using the formula of Cockcroft and Gault
Calculated creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation
Estimated creatinine clearance (Cockcroft-Gault) >40 mL/min
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Renal insufficiency, defined as creatinine clearance < 30 mL/min (either actual or calculated value), within 21 days of initiation of protocol therapy; the Cockcroft-Gault formula should be used for calculating creatinine clearance values
Known dihydropyrimidine dehydrogenase (DPD) deficiency or severe renal impairment (creatinine clearance < 30 mL/min by Cockcroft-Gault formula)
Phase Ib subjects must have calculated creatinine clearance >= 50 ml/min by Cockcroft-Gault formula, phase IIa subjects must have calculated creatinine clearance >= 40 ml4/min by Cockcroft-Gault formula
Serum creatinine ? 1.5 x ULN or calculated creatinine clearance (using Cockcroft and Gault method) > 60 mL/min)
Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)
Serum creatinine =< 1.5 x ULN; or calculated creatinine clearance >= 50 mL/min (using Cockcroft Gault formula); or measured creatinine clearance >= 50 mL/min
Creatinine clearance greater than or equal to 30 mL/min to less than 45 ml/min (calculated by Cockcroft-Gault formula)
Subject must have adequate renal function as demonstrated by a creatinine clearance greater than or equal to 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula. Note: Investigators should consider measuring a 24-hour creatinine clearance for subjects who are morbidly obese, have fluctuating renal function, or who in the investigator's clinical judgment may yield a more accurate clearance when measured than when calculated.
Serum creatinine =< 1.5 mg/dL or calculated creatinine clearance (CrCL) > 60 mL/min using Cockcroft and Gault formula
Creatinine clearance >= 40 ml/min as determined by 24-hour collection or estimated by the Cockcroft-Gault formula
Calculated creatinine clearance (CrCl) > 50 mL/min using Cockcroft-Gault formula
Creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance >= 30 mL/min (Cockcroft-Gault calculation)
Creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)
Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula
Creatinine clearance > 50 mL/min (assessed by Cockcroft Gault estimation)
Measured or estimated creatinine clearance of >= 30 mL/min, (Cockcroft and Gault)
Renal function: serum creatinine ? 2.0 mg/dL and estimated creatinine clearance of ? 45 mL/min by the Cockcroft-Gault equation
Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula
Calculated creatinine clearance >= 30 mL/min by Cockcroft-Gault within 14 days before enrollment
Serum creatinine clearance >= 50 ml/min by the Cockcroft-Gault formula
Creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Estimated creatinine clearance of >= 50 mL/min, calculated using the formula of Cockroft and Gault
Serum creatinine =< 2.0 g/dL or calculated creatinine clearance (CrCl) >= 60mL/min (Cockcroft-Gault method)
Calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault equation
AT THE TIME OF INFUSION: Creatinine clearance (as estimated by Cockcroft Gault or Schwartz) ? 60 ml/min
Calculated creatinine clearance of >= 40 ml/min; as per Cockcroft-Gault formula
Serum creatinine =< 3.0 mg/dL or a calculated creatinine clearance of at least 15 mL/min (using the Cockcroft and Gault method)
Acceptable renal function defined as serum creatinine ? 1.5 times ULN or calculated creatinine clearance ? 60mL/min (by Cockcroft Gault formula)
Creatine clearance < 45mL/min according to Cockcroft-Gault formula. If creatine clearance calculated from the 24-hour urine sample is ? 45 mL/min, patient will qualify for the study
Subject's estimated creatinine clearance (Cer) is less than 30 milliliter (mL)/minute (min) by the Cockcroft and Gault formula (Creatinine Clearance (mL/min) = (140 - age)(weight (wt) kilogram (kg) / 72 x serum creatinine (milligram (mg)/100 mL) [Cockcroft, 1976] at Screening.
Creatinine >1.5 x ULN concurrent with creatinine clearance <50 mL/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 x ULN
Creatinine clearance < 45 mL/min (either actual or calculated value), at time of screening evaluation; the Cockcroft-Gault formula should be used for calculating creatinine clearance values
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of >= 51 mL/min.
Adequate renal function as evidenced by calculated creatinine clearance > 30 ml/min according to the Cockcroft and Gault formula or by 24 hour urine creatinine clearance
Creatinine clearance >= 60 ml/min using the Cockcroft-Gault method, Modification of Diet in Renal Disease (MDRD), or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. If the calculated creatinine clearance (CrCl) based on Cockcroft-Gault method, MDRD, or CKD-EPI is < 60 mL/min, patient will have a 24 hour (hr) urine collection to measure CrCl.
Adequate renal function as defined by an estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula or serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum creatinine =< 1.5 mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula within 30 days prior to registration
Estimated creatinine clearance (Cockcroft-Gault) > 60 mL/min
Creatinine clearance >= 60 ml/min; creatinine clearance (CrCl) can be measured or estimated using Cockcroft-Gault method, modification of diet in renal disease (MDRD), or chronic kidney disease-epidemiology (CKD-EPI) formulae
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance of >= 40 mL/min by Cockcroft-Gault formula
Creatinine =< 2.0 mg/dL OR creatinine clearance >= 50 mL/min as determined by the Cockcroft-Gault equation or a 24 hour urine collection
Creatinine clearance > 50 mL/minute within 7 days of time of consent, either measured or calculated using a standard formula (e.g., Cockcroft and Gault)
Creatinine =< 1.5 institutional ULN or a calculated creatinine clearance >= 50 mL/min using the Cockcroft Gault equation
Serum creatinine within normal institutional limits or estimated creatinine clearance >= 60 mL/min/1.73 m^2 by the Cockcroft-Gault equation
Calculated creatinine clearance must be > 60 mL/min (by Cockcroft-Gault)
Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula
Creatinine clearance of ? 50 mL/min (measured or calculated using the Cockcroft and Gault formula)
Adequate renal function, defined as calculated creatinine clearance greater than 40 mL/min per the Cockcroft and Gault formula.
Serum creatinine =< 1.5 mg/dL or creatinine clearance > 45 mL/min; use either measured or calculated with Cockcroft-Gault formula
Calculated or measured creatinine clearance (CrCl) rate of ? 30 mL/min calculated using the formula of Cockcroft and Gault [(140 ? age) × mass (kg) / (72 × serum creatinine mg/dL)]. Multiply result by 0.85 if female.
Estimated creatinine clearance >= 30 mL/min (using Cockcroft-Gault)
Creatinine =< 1.5 mg/dL or calculated creatinine clearance >= 40 mL/min per the Cockcroft and Gault formula
Creatinine clearance >= 30 ml/min (as estimated by Cockcroft Gault equation)
Calculated or measured creatinine clearance of >= 50 mL/minute, calculated using the formula of Cockcroft and Gault
Estimated creatinine clearance by Cockcroft-Gault equation > 30 mL/min
Renal function assessed by calculated creatinine clearance as follows:\r\n* Phase Ib subjects must have calculated creatinine clearance >= 50 mL/min by Cockcroft-Gault formula\r\n* Phase IIa subjects must have calculated creatinine clearance >= 30 mL/min by Cockcroft-Gault formula
Creatinine clearance (CrCl) >= 60 mL/min by Cockcroft-Gault calculation
Estimated creatinine clearance by Cockcroft-Gault equation > 30 mL/min
Creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault formula or 24-hour urine creatinine clearance >= 50 mL/min
Creatinine clearance (CrCl) >= 50mL/min per Cockcroft-Gault
Creatinine clearance (CLcr) < 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation) .
Renal function: >= 60 ml/min (actual or calculated by the Cockcroft-Gault method) or a creatinine =< the upper limits of normal
Estimated creatinine clearance < 50 mL/min/1.73m^2 (Cockroft-Gault formula)
Have a creatinine clearance of >= 90 ml/min, as calculated by the Cockroft-Gault formula
Creatinine < 2.0 mg/dl; renal function assessed by calculated creatinine clearance as follows: phase I subjects must have calculated creatinine clearance >= 60 ml/min by Cockcroft-Gault formula
Calculated creatinine clearance must be > 40 mL/min (by Cockcroft-Gault)
Creatinine within normal institutional limits OR creatinine clearance > 40 mL/min per 24 hour (h) urine collection or calculated according to the Cockcroft-Gault formula
creatinine clearance >60 mL/min/ per Cockcroft-Gault equation for patients with creatinine levels above institutional normal.
Patients must have either a normal serum creatinine (=< institutional upper limit of normal [IULN]) OR estimated creatinine clearance >= 60 ml/min (Cockcroft-Gault formula)
Creatinine =< 1.5 X institutional ULN or calculated creatinine clearance >= 60 ml/min as estimated using the Cockroft-Gault formula
Creatinine clearance (CrCL) >= 40 mL/min as measured via Cockcroft-Gault
Within one week of study entry: Creatinine clearance >= 30 ml/min (as estimated by Cockroft Gault equation)
Serum creatinine =< 1.5 X ULN or creatinine clearance >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
Creatinine clearance > 50 mL/min via Cockcroft and Gault
Patients must have calculated creatinine clearance >= 60 ml/min by Cockcroft-Gault formula or 24 hour urine demonstrating creatinine clearance (CrCl) >= 60 ml/min
Cockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN obtained =< 14 days prior to randomization
Renal function assessed by calculated creatinine clearance >= 30ml/min by Cockcroft-Gault formula
Calculated creatinine clearance ? 30 ml/min by Cockcroft-Gault formula • Total bilirubin < = 2 x ULN
Serum creatinine >1.5x ULN or creatinine clearance <40 mL/min (Cockroft-Gault formula) Exclusion Criteria for Arm S and Arm P only:
Adequate renal function as defined by: calculated creatinine clearance must be at least 40 mL/minute (Cockcroft-Gault)
Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min (obtained =< 14 days prior to registration)
Serum creatinine =< 2.5 mg/dL or a calculated creatinine clearance of at least 50 mL/min (using the Cockcroft and Gault method)
Adequate renal function as evidenced by serum creatinine less than 1.5 mg/dL or calculated creatinine clearance greater than 40 mL/min per the Cockcroft and Gault formula.
Creatinine clearance (CrCl) >/= 30 mL/minute within 28 days prior to registration, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
Adequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula > 60 mL/min
Creatine clearance < 55 mL/min, calculated using ideal body weight (IBW) using Cockcroft-Gault equation
Creatinine clearance >= 30 mL/min as measured using either the Cockcroft-Gault method or 24-hour creatinine clearance
Calculated creatinine clearance (CrCl) >= 30 mL/min (Cockcroft-Gault formula), patients with a CrCl >= 15 mL/min can be considered for the trial if patients are not in active renal failure and after discussion with the principal investigator (PI)
Creatinine clearance >= 60 ml/min as determined by 24-hour urine; if a 24-hour urine is not available, the Cockroft-Gault formula will be used for a calculated creatinine clearance
Creatinine clearance >= 20 mL/min/1.73 m^2 by Cockcroft-Gault
Creatinine clearance of ? 60 mL/min as estimated by the Cockcroft-Gault equation
Calculated creatinine clearance >= 60 ml/min (by Cockroft-Gault formula) within 30 days prior to registration
Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)
Calculated creatinine clearance > 30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Inadequate renal function at screening as demonstrated by creatinine clearance < 40 mL/min calculated by Cockcroft-Gault equation.
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Adequate renal function, defined as estimated creatinine clearance >50 mL/min according to Cockcroft-Gault formula or measured 24-hour creatinine clearance (or local institutional standard method).
Adequate renal function, defined as estimated creatinine clearance >30 mL/min according to Cockcroft-Gault formula or measured 24-hour creatinine clearance (or local institutional standard method).
=< 10 days prior to enrollment/randomization: Creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault method
Have adequate renal function as defined by the following criteria: Creatinine ? 1.5 x ULN and CrCl ? 30 ml/min per Cockcroft Gault formula:
Creatinine clearance >= 60 ml/min; creatinine clearance (CrCl) can be measured or estimated using Cockcroft-Gault method
Adequate hepatic and renal function laboratory values within 14 days prior to registration: Calculated (Cockcroft and Gault formula) or measured creatinine clearance >= 30 mL/min
Serum creatinine clearance > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Calculated creatinine clearance >= 60 mL/min calculated by the Cockcroft-Gault formula
Adequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula > 60 mL/min.
Serum creatinine ? 1.5 mg/dL or a calculated creatinine clearance of ? 60 mL/min as determined by the Cockcroft-Gault equation
Calculated creatinine clearance > 50 ml/min using Cockcroft-Gault formula
Serum creatinine < 1.8 mg/dL or creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault equation
Adequate renal function as assessed by calculated creatinine using Cockcroft-Gault estimation of creatinine clearance (CrCl); subjects must have calculated CrCl >= 30 ml/min by Cockcroft-Gault formula
All patients must: Have biopsy proven cancer (i.e. solid tumor) for which there is no standard therapy available. If prior history of ischemic heart disease or exposure to > 200 mg/m^2 of doxorubicin, patients must have a measured ejection fraction (either by MUGA, ECHO or ventriculography) of at least 45%. Have preserved hepatic function as shown by AST (SGOT) levels < 2 x the upper limit of normal and an INR (for patients NOT on anticoagulant therapy) of < 1.4. Have normal serum creatinine (<=1.5) or creatinine clearance (measured by Cockcroft -Gault formula) of >= 20 ml/min.
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 60 mL/min
Subjects with creatinine clearance <40 mL/minute at Screening, as calculated by the Cockcroft-Gault formula.
Creatinine ? 1.5× ULN; or, if serum creatinine > 1.5 × ULN, a measured creatinine clearance must be >60mL/min/1.73m2 as calculated by the Cockcroft and Gault equation for patient to be eligible.
Serum creatinine ? 1.5 mg/dL or calculated creatinine clearance (CrCl) of ? 60 mL/hour by the Cockroft-Gault equation;
Patients must have adequate renal function defined as creatinine clearance of >= 30 ml/minute (Cockcroft-Gault)
Serum creatinine clearance (CL) >= 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Serum creatinine =< 2 x upper limit normal (ULN) or creatinine clearance (CrCl) >= 30 mL/min using the Cockcroft-Gault formula
Calculated creatinine clearance must be >= 30 mL/minute based on Cockcroft-Gault formula
Calculated creatinine clearance (CrCl) >= 45mL/min (using Cockcroft & Gault method)
Calculated by Cockcroft-Gault or measured by 24 hour urine creatinine clearance >= 50 mL/minn
Calculated creatinine clearance greater than 50 ml/min; using the Cockcroft-Gault equation
Serum creatinine ?2 mg/dL or Estimated Creatinine Clearance ?30 mL/min (Cockcroft-Gault).
Creatinine within normal institutional limits OR creatinine clearance >= 30 mL/min calculated using the formula of Cockcroft and Gault
Creatinine clearance > 30 ml/min (Cockcroft-Gault formula using ideal body weight)
Serum creatinine =< 1.5 x the ULN or calculated creatinine clearance >= 50 ml/min using Cockcroft-Gault formula
Serum creatinine ? 1.5 mg/dL or creatinine clearance > 45 mL/min according to Cockcroft?Gault formula; (If creatinine clearance calculated from a 24-hour urine sample is ?45 mL/min, the subject will qualify for the study).
Serum creatinine =< 1.5 x ULN or 24-hour creatinine clearance > 60 mL/min (measured or calculated by Cockcroft-Gault method)
Creatinine clearance >= 30 ml/min or calculated creatinine clearance >= 30 ml/min according to the Cockcroft-Gault formula
A calculated creatinine clearance (Cockcroft Gault) of >= 30 ml/min
Calculated (method of Cockcroft-Gault) creatinine clearance (CrCl) >= 60 mL/min (creatinine clearance may also be obtained by the 24-hour collection method at the investigator’s discretion)
Estimated creatinine clearance using the Cockcroft-Gault formula must be > 40 mL/minute
Creatinine clearance (CrCl) >= 40 mL/min (modified Cockcroft-Gault)
Serum creatinine ?1.5 x ULN and a calculate creatinine clearance (CrCl) ?45 mL/min by the Cockcroft-Gault method
Calculated creatinine clearance (Cockcroft-Gault formula) of >= 45 mL/min
Serum creatinine ?1.5 x upper limit of normal (ULN) or creatinine clearance >60 mL/min calculated using Cockcroft-Gault
Calculated creatinine clearance >= 40 mL/min/1.73 m^2 based on Cockcroft and Gault method
Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula) within 14 days prior to registration
Creatinine =< 1.5 mg/dL or calculated creatinine clearance (CrCL) >= 50 mL/min using the Cockroft Gault equation
Creatinine =< 1.5x institutional upper limit of normal (IULN), and/or an adequate renal function as defined by: calculated creatinine clearance must be >= 40 mL/minute (Cockcroft-Gault)
Creatinine clearance >/=30 milliliters per minute (mL/min) (calculated using the Cockcroft-Gault formula)
Serum creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 by Cockcroft-Gault estimation
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 40 ml/min using the Cockcroft-Gault formula should be obtained with 28 days prior to randomization
Calculated creatinine clearance (Cockcroft-Gault formula) > 50 ml/min OR 24-hour urine creatinine clearance > 50 ml/min
Plasma creatinine =< 1.5 x ULN or creatinine clearance > 50 mL/min (calculated by Cockcroft-Gault method)
Creatinine clearance (CrCl) of greater than or equal to 40 mL/min. using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; if the CrCl based on the CKD-EPI formula is < 40 mL/min, the patient will have a 24 hour (hr) urine collection to measure CrCl; the measured CrCl must also be >= 40 ml/min
Adequate renal function as evidenced by serum creatinine less than or equal to (<=) 1.5 milligram per deciliter (mg/dL) or calculated creatinine clearance >=50 millimeter per minute (mL/min) according to the Cockcroft and Gault formula.
Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min
Creatinine < 1 X institutional upper limit of normal OR creatinine clearance >= 50 mL/min determined by Cockcroft-Gault formula
Creatinine =< 1.5 x ULN OR creatinine clearance >= 40 mL/min/1.73 m^2 (calculated using the Chronic Kidney Disease-Epidemiology Collaboration [CKD-EPI] equation or Cockroft-Gault formula) for patients with creatinine levels above institutional normal
Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min
Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula
Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)
Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
Serum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance >= 60 cc/min using the Cockcroft-Gault formula
Calculated creatinine clearance must be >= 50 ml/min using the applicable Cockcroft-Gault formula
Serum creatinine =< 1.5 mg/dl and calculated creatinine clearance >= 50 mL/min (using the Cockcroft-Gault equation)
Adequate renal function: serum creatinine <1.5 x ULN or calculated CrCl >60 mL/min using Cockcroft-Gault formula
Serum creatinine ? 1.5 × upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula)
Creatinine ? 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) ? 50 mL/min OR 24-hour urine creatinine clearance ? 50 mL/min
Estimated Creatinine Clearance 50 ml/min (Cockcroft-Gault) or serum creatinine 1.5 x ULN
Renal: Serum creatinine ? 1.5 x ULN or creatinine clearance (CrCl) ? 60 ml/min as calculated by the cockcroft-gault method
Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockroft and Gault
Calculated creatinine clearance greater than 45 mg/dl using the Cockcroft-Gault formula
Creatinine clearance >= 60 mg/dL (Cockcroft-Gault equation)
Calculated creatinine clearance < 30 ml/min according to Cockcroft-Gault equation
Serum creatinine > 1.5 x upper limit of normal (ULN); if creatinine 1.0-1.5 x ULN, creatinine clearance, calculated according to Cockcroft-Gault formula, < 60 ml/min will exclude the patient
Has adequate renal function, defined as: Creatinine clearance >= 60 mL/minute, as calculated using the modified Cockroft Gault equation, ([{140 - age in year
Renal function assessed by calculated creatinine clearance as follows:\r\n* Subjects must have calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula (Phase I)\r\n* Subjects must have calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula (Phase II)
Serum creatinine ? 1.5 × ULN OR calculated creatinine clearance (CrCl) or 24-hour urine CrCl ? 50 mL/minute ? Cockcroft-Gault formula will be used to calculate CrCl; 24-hour urine CrCl will be derived using the measured creatinine clearance formula
Creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Serum creatinine ? 1.5 times ULN and creatinine clearance (CLcr) ? 30 mL/min according to the Cockroft-Gault formula
Serum creatinine clearance (Cockcroft-Gault equation) >= 50 mL/minute
Serum creatinine =< 2 mg/dL or a calculated creatinine clearance of >= 50 mL/min (using the Cockcroft and Gault method)
Renal function: A calculated creatinine clearance value of ? 50 mL/min as determined by the Cockcroft Gault formula or a creatinine clearance value of ? 50 mL/min based on a 24-hour urine collection;
Estimated creatinine clearance (CLcr) ? 60 mL/min as calculated using the Cockcroft-Gault equation
CLcr 15-29 mL/min as calculated using the Cockcroft-Gault equation
Clinical laboratory values should be as follows: WBC < 30,000/mL Blasts in PB ? 20,000. Treatment with Hydroxyurea is permitted up to 24 hrs prior to BL-8040 administration to achieve blast counts < 20,000 prior to enrollment. Creatinine < 1.3 mg/dL; if Creatinine is > 1 mg/dL the Creatinine clearance should be > 40 mL/min as calculated using the Cockcroft-Gault formula.
Patients must have adequate renal function, defined as serum creatinine <= 1.5 x upper limit of normal (ULN) for the institution or a calculated creatinine clearance [Cockcroft-Gault method] must be >= 60 mL/min/1.73 m^2).
Serum creatinine =< 1.5 x ULN; estimated creatinine clearance using the Cockcroft-Gault formula must be > 50 mL/minute OR a measured 24-hour creatinine clearance must exceed > 50 mL/minute
Adequate renal function as defined by serum creatinine ? 1.5 x ULN. If creatinine >1.5 x ULN, calculated or measured creatinine clearance must be ? 40 mL/minute (Cockcroft-Gault).
Calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula
Creatinine clearance (CrCl) >= 15 mL/minute within 7 days prior to randomization, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
Creatinine* < 2.0 g/dl *or a calculated creatinine clearance > 45/cc (using Cockroft-Gault formula)
Serum creatinine =< 2.0 x upper limit of normal OR calculated creatinine clearance >= 30 ml/min/1.73 M^2 by the modified Cockcroft and Gault formula OR creatinine clearance >= 30 mL/min obtained from a 24-hour urine collection
Patient must not have known dihydropyrimidine dehydrogenase (DPD) deficiency or severe renal impairment (creatinine clearance below 30 mL/min by Cockcroft and Gault formula) as this would prelude use of capecitabine
Calculated creatinine clearance ? 45 mL using the Cockcroft and Gault Method
Serum Creatinine Clearance(CrCl) ? 30 mL/min, either measured or calculated using a standard formula (e.g. Cockcroft and Gault)
Cohort A: Calculated creatinine clearance >= 40 mL/min for patients receiving pemetrexed (by Cockcroft-Gault)
Cohort A: Calculated creatinine clearance >= 30 mL/min for patients receiving gemcitabine or paclitaxel (by Cockcroft-Gault)
Serum creatinine =< 1.5 x ULN, or creatinine clearance (CrCl) >= 30 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
Creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault method
Serum creatinine ? 1.5 × upper limit of normal (ULN) or calculated creatinine clearance ? 60 mL/min using Cockcroft-Gault equation
Creatinine clearance >= 60 mL/min (1.00 mL/s) calculated by the Cockcroft-Gault equation for women
Cr Cl ? 50 mL/min (as determined by the Cockcroft-Gault equation or by 24-hour urine collection)
Calculated or measured creatinine clearance (CrCl) of ? 15 mL/min within 21 days prior to randomization. Calculation should be based on standard formula such as the Cockcroft and Gault: [(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)]; multiply result by 0.85 if female.
Creatinine =< 1.5 x institutional upper limits of normal or creatinine clearance of > 40 mL/min per 24 hour (h) urine collection or calculated according to the Cockcroft-Gault formula
Native kidney function producing creatinine clearance (either measured or estimated by Cockcroft formula) of at least 40 mL/min. Cockcroft formula: CLcr = [(140-age) • wt(kg)]/[72 •Creat (mg/dL)] (For females, multiply by 0.85)
Serum creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min (Cockcroft-Gault calculation)
Calculated creatinine clearance >= 60ml/min by Cockcroft-Gault formula
Renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by the Cockcroft-Gault formula using the patient's actual weight
Adequate renal function defined as calculated creatinine clearance greater than 50 mL/min per the Cockroft and Gault formula.
Creatinine clearance > 15 ml/minute using Cockcroft-Gault formula
Serum creatinine =< ULRR or creatinine clearance >= 50 mL/minute (calculated by Cockcroft-Gault formula or measured in a timed urine collection)
Creatinine clearance 45 ml/min or higher calculated using the Cockcroft-Gault formula
Creatinine =< 1.5 mg/dL or calculated creatinine clearance (CrCL) >= 50 mL/min using the Cockroft Gault equation
Serum creatinine clearance >=50 ml/min (calculated with Cockroft-Gault formula); creatinine for children =<1.5 mg/dl or =< 2 times upper limit of normal for age (whichever is less)
Creatinine clearance (Clcr) < 30 mL/minute as estimated using the Cockroft-Gault formula or on dialysis
Calculated creatinine clearance (CrCl) >= 30 mL/min using the Cockroft Gault equation
Creatinine clearance ? 50 mL/min measured by Cockcroft-Gault method.
Creatinine clearance >= 30 mL/min by Modified Diet in Renal Disease (MDRD) equation or Cockcroft-Gault
Creatinine clearance >= 30 mL/min calculated using the Cockcroft-Gault formula (within four weeks prior to the study)
Serum creatinine =< 1.5 x IULN OR creatinine clearance by Cockcroft-Gault >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x IULN
Creatinine clearance of > 50 mL/min per 24 hour urine collection of the Cockcroft-Gault formula
Patients must have adequate renal function as defined by a creatinine clearance >= 40 mL/min (measured or estimated by the Cockcroft-Gault formula)
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Creatinine clearance =< 50 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour)
Creatinine =< 1.5 mg/dL or creatinine clearance >= 40mL/mon (using Cockcroft-Gault formula)
Calculated (e.g. using Cockcroft-Gault formula) or measured creatinine clearance < 50 ml/min
Serum creatinine =< 1.5 x ULN or estimated creatinine clearance >= 60 mL/min by the Cockcroft-Gault equation
Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault
Calculated creatinine clearance >= 50 ml/min by Cockcroft-Gault formula using actual body weight
Creatinine =< 2.0 x ULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault formula
Calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula
Creatinine =< 1.5 mg/dL, or calculated creatinine clearance (determined as per Cockcroft-Gault) >= 50 mL/min
Calculated (calc.) creatinine clearance >= 60 mL/min calculated using the Cockcroft-Gault formula
Calculated creatinine clearance* >= 60 ml/min\r\n* Using the Cockcroft-Gault equation
Have adequate renal function defined as a creatinine clearance ?50 mL/minute (calculated according to the formula of Cockcroft and Gault 1976) or serum creatinine <1.5 mg/dL.
Serum creatinine ? 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) ? 40 mL/min (measured using the Cockcroft-Gault formula)
Calculated creatinine clearance > 40 ml/min using Cockcroft-Gault method
Renal: serum creatinine >=60 milliliter per minute (mL/min) either as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours).
Adequate renal function as evidenced by calculated creatinine clearance ?30 milliliters (mL)/minute according to the Cockcroft and Gault formula
Creatinine clearance >= 30 mL/min as calculated by Cockcroft-Gault equation (obtained within 28 days prior to the first study treatment)
Creatinine clearance >= 50 mL/min/1.73 m^2 (Cockcroft-Gault formula)
Creatinine clearance < 30 mL/min by Cockcroft-Gault estimate
The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m^2 as calculated by the Cockcroft-Gault formula
Actual creatinine clearance of < 60 utilizing the Cockroft-Gault formula
Obtained =< 30 days prior to randomization: Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula
Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable; creatinine within institutional limits of normal or creatinine clearance (CrCl) > 50 mL/min calculated using the Cockcroft-Gault equation
Adequate renal function defined as: a. Creatinine clearance >50 mL/min, as calculated with the modified Cockcroft Gault equation
Serum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 40 mL/min (using the Cockcroft-Gault equation)
Calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula
Estimated creatinine clearance >= 30 ml/min (Cockcroft-Gault)
Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min Brain malignancy or metastases to the brain
Calculated creatinine clearance of > 50 mL/min using Cockcroft Gault equation equation or 24-hour urine sampling
Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min using the modified Cockcroft-Gault formula
Arm C: Calculated creatinine clearance(CrCl) > 50 ml/min using the Cockcroft-Gault equation
Serum creatinine > 1.5 x ULRR or creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula)
Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula obtained =< 30 days prior to registration
Serum creatinine ? 2.0 mg/dL or creatinine clearance ? 40 mL/min measured or calculated by Cockcroft-Gault equation.
Estimated creatinine clearance >= 30 mL/min via Cockroft-Gault formula
Calculated creatinine clearance > 40 cc/min by the modified Cockcroft-Gault formula
Calculated creatinine clearance >= 30 mL/min (based on the Cockcroft and Gault method)
eGFR > 40 mL/min using the Cockcroft-Gault equation
Creatinine =< 2.0 x IULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault formula
Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
Calculated creatinine clearance > 30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Creatinine clearance >50 mL/min/1.73 m2 based on Cockcroft Gault equation.
Obtained within 28 days prior to registration: Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula will be used to calculate creatinine clearance)
Adequate renal function as defined by calculated creatinine clearance =< 40 mL/min (Cockcroft-Gault formula)
Creatinine clearance =< 30 mL/minute (calculated by Cockcroft-Gault formula)
Estimated creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight)
Estimated creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight)
Calculated creatinine clearance >= 60 mL/min (Cockcroft-Gault formula)
Participants must have adequate renal function with a calculated creatinine clearance of > 60 ml/min from a serum specimen collection at baseline using the Cockcroft-Gault formula
Creatinine =< 1.5 mg/dl OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 ml/min OR 24-hour urine creatinine clearance >= 50 ml/min
Creatinine < 1.5 x upper limit of normal (ULN) or estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation)
Creatinine < 1.5 x upper limit of normal (ULN) or estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation)
Renal dysfunction as defined as creatinine clearance < 70 mL/min by Cockcroft-Gault equation
HEALTHY VOLUNTEER: An estimated creatinine clearance of =< 80 ml/min based on the Cockcroft-Gault equation; an actual creatinine clearance, as determined by a 24 hour urine collection, may be used in place of the Cockcroft-Gault equation; subjects who have an actual or estimated creatinine clearance 70 ml/min may be enrolled at the discretion of the investigator
Estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation)
Serum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) >= 50 mL/min as determined by the Cockcroft-Gault equation
Creatinine =< 1.5 times the upper limit of normal with creatinine clearance >= 50 mL/min using the modified Cockcroft-Gault method
Serum creatinine =< 1.5 x ULN or measured calculated creatinine clearance >= 40 ml/min for subject with creatinine levels > 1.5 x institutional ULN (per Cockcroft-Gault formula) obtained =< 14 days prior to registration
Serum creatinine ?1.5 mg/dL, and creatinine clearance ? 50 ml/min as measured by Cockcroft and Gault formula
Creatinine clearance (as estimated by Cockcroft Gault) ? 60 cc/min
Estimated creatinine clearance (CrCl) >= 30 mL/min according to the Cockcroft-Gault formula or local institutional standard method
Estimated creatinine clearance by the Cockcroft Gault equation >= 50 mL/min
Calculated/estimated or measured creatinine clearance at least 50 ml/min; note: creatinine clearance should be calculated using the Cockcroft-Gault formula; patients who will receive pemetrexed/cisplatin therapy must be obtained within 2 weeks of registration
Pemetrexed/cisplatin therapy; note: patients who will receive pemetrexed/cisplatin therapy must meet all eligibility criteria below:\r\n* Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell histology\r\n* Calculated creatinine clearance must be obtained within 2 weeks of registration and calculated creatinine clearance (CrCl) must be >= 45mL/min using the standard Cockcroft and Gault formula, or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA) must be used to calculate CrCl
Serum creatinine ? 1.7 mg/dL or calculated creatinine clearance ? 50 mL/min per the Cockcroft and Gault formula
Creatinine clearance > 50 mL/min (assessed by Cockcroft Gault estimation) and creatinine < 1.5 x ULN
Adequate renal function defined as serum creatinine <1.5×ULN (or calculated creatinine clearance ?50 mL/min per the Cockcroft and Gault formula).
Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula
Creatinine clearance >= 50 mL/min (assessed by Cockcroft Gault estimation)
Calculated creatinine clearance (CrCl) ? 50 ml/minute (using Cockcroft and Gault's formula; see APPENDIX 2).
Renal: serum creatinine <=1.5*ULN or creatinine clearance >=60 milliliter per minute (mL/min) as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours).
Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)
Estimated serum creatinine clearance of ? 60 mL/min using the Cockcroft-Gault equation.
Creatinine clearance must be greater than or equal to (>=) 60 milliliter per (mL/) minute as estimated by the Cockcroft Gault equation or based on urine collection (12 or 24 hours).
Creatinine clearance ?40 mL/min based on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection.
Adequate renal function as demonstrated by serum creatinine ?1.5 x ULN or creatinine clearance calculation ?60 mL/min as calculated by the Cockcroft and Gault formula
Adequate renal function defined as calculated creatinine clearance ?30 mL/min per the Cockcroft and Gault formula.
serum creatinine ?1.5 X institutional UNL or estimated (Cockcroft-Gault formula) or measured creatinine clearance ? 50 mL/min
Serum creatinine =< 1.5 X upper limit of normal (ULN) OR calculated creatinine clearance >= 30 mL/min as calculated by Cockcroft-Gault formula or by 24 hour urine collection, performed within 10 days of protocol enrollment
Serum creatinine < 1.5 times institutional upper limit of normal OR calculated creatinine clearance (CrCl) >= 40 mL/min (based upon the Cockcroft-Gault equation)