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 Renal function: Estimated creatinine clearance by Cockcroft-Gault formula ? 45 mL/min. 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. Estimated creatinine clearance greater than 40 mL/minute (using the Cockcroft-Gault formula and actual body weight) Estimated creatinine clearance (CrCl) >= 50 mL/min/1.73 m^2 according to the Cockcroft-Gault formula, within 14 days prior to registration Renal: 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). For patients < 13.0 years of age at enrollment: Glomerular Filtration Rate (GFR) estimated by the updated Schwartz formula ? 90 mL/min/1.73 m2. If the estimated GFR is < 90 mL/min/1.73 m^2, then renal function must be measured by 24-hour creatinine clearance or nuclear GFR, and must be > 50 mL/min/1.73 m^2. Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula Renal function: Estimated creatinine clearance by Cockcroft-Gault formula ? 45 mL/min and serum creatinine ? 2 mg/dL Estimated creatinine clearance (eClCR) >45 mL/min (with eCLCR to be calculated by the Cockcroft-Gault formula, or Adequate renal function defined by an estimated creatinine clearance >= 40 mL/min according to the Cockcroft-Gault formula (or local institutional standard method). Estimated creatinine clearance ? 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula 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); Estimated creatinine clearance ? 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) Estimated creatinine clearance >= 30 ml/min (calculated according using Cockcroft–Gault formula) STUDY TREATMENT: Creatinine clearance of 20 ml/min or greater as measured by the Cockroft-Gault formula Estimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault at the time of screening 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 Creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) 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 =< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance >= 60 ml/min per modified Cockcroft-Gault formula 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 Estimated creatinine clearance ? 30mL/min (Cockcroft-Gault formula) Within 21 days prior to C1D1: Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault Creatinine clearance of >= 50 mL/min (estimated by the Cockcroft-Gault [C-G] 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 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 Estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault Severely impaired renal function, defined as creatinine clearance (CrCl) ? 30 mL/min estimated by the Cockcroft-Gault formula Estimated creatinine clearance > 40 mL/min by the Cockcroft-Gault formula Estimated (Cockcroft-Gault formula) or measured creatinine clearance <40 mL/min. Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault 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. Creatinine =< 2.0 x IULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault formula Estimated creatinine clearance of >= 50 mL/min, calculated using the formula of Cockroft and Gault 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. 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) Estimated creatinine clearance < 50 mL/min/1.73m^2 (Cockroft-Gault formula) 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 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). Estimated creatinine clearance using the Cockcroft-Gault formula must be > 40 mL/minute Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockroft and Gault Serum creatinine ? 1.5 times ULN and creatinine clearance (CLcr) ? 30 mL/min according to the Cockroft-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) Creatinine clearance (Clcr) < 30 mL/minute as estimated using the Cockroft-Gault formula or on dialysis Patients must have adequate renal function as defined by a creatinine clearance >= 40 mL/min (measured or estimated by the Cockcroft-Gault formula) Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault Creatinine =< 2.0 x ULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 by 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 Actual creatinine clearance of < 60 utilizing the Cockroft-Gault formula Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min Brain malignancy or metastases to the brain Estimated creatinine clearance (for patients > 12 years) greater than 50.0 mL/minute (using the Cockcroft-Gault formula and actual body weight); for pediatric patients (> 1 year to 12 years), Glomerular Filtration Rate (GFR) estimated by the updated Schwartz formula ? 90.0 mL/min/1.73 m^2. If the estimated creatinine clearance is < 90 mL/min/1.73 m^2, then renal function must be measured by 24-hour creatinine clearance or nuclear GFR, and must be > 70.0 mL/min/1.73 m^2. Estimated creatinine clearance >= 30 mL/min via Cockroft-Gault formula Creatinine =< 2.0 x IULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 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) Estimated creatinine clearance (CrCl) >= 30 mL/min according to the Cockcroft-Gault formula or local institutional standard method Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula serum creatinine ?1.5 X institutional UNL or estimated (Cockcroft-Gault formula) or measured creatinine clearance ? 50 mL/min