Patients entering this study will be stratified into five groups or cohorts (A: normal, B: mild dysfunction, C: moderate dysfunction, D: severe dysfunction, E: renal dialysis) according to their renal function based on their estimated body-surface area (BSA)-indexed creatinine clearance (CrCl) as defined by the following table: Group A Group B C Group D Group E Function Mild Moderate Severe Dialysis >60 40-59 20-39 <20 Any BSA-indexed CrCl* * The BSA-indexed CrCl is determined using the procedure described in Section 5.1. INVESTIGATIONAL AGENT Please state route and schedule of Study Agent administration, and enter exact doses for each dose level and group in the table below. (For example, XXX is given intravenously as a “Agent 1-hour infusion on days 1, 3, and 5 of a 21-day cycle.) is given on of a cycle. Study Agent (route/duration) (day/days) (#)-day Group A Group B Group C D Group E Moderate Severe Normal renal Mild renal renal renal Renal Dose function dysfunction dysfunction dysfunction dialysis (units) (units) (units) (units) Level ( )* ( )* ( )* ( )* ( )* ** Level –1 ** 1 ** Level 2 ** Level 3 ** Level 4 * Doses are stated as exact dose in units (e.g., mg/m2, mcg/kg, etc.) rather than as a percentage. ** (See Section 5.1 for the Group E dosing scheme.) Note: This schema is not to be used for determining dosage for any individual patient. For specific dosing information, please refer to Sections 5 and 6.
Patients entering this study will be stratified into five groups or cohorts (A: normal, B: mild dysfunction, C: moderate dysfunction, D: severe dysfunction, E: renal dialysis) according to their renal function based on their estimated body-surface area (BSA)-indexed creatinine clearance (CrCl) as defined by the following table: Group Function A Group B Mild C Moderate Group D Severe Group E Dialysis BSA-indexed CrCl* >60 40-59 20-39 <20 Any * The BSA-indexed CrCl is determined using the procedure described in Section 5.1. INVESTIGATIONAL AGENT Please state route and schedule of Study Agent administration, and enter exact doses for each dose level and group in the table below. (For example, “Agent XXX is given intravenously as a 1-hour infusion on days 1, 3, and 5 of a 21-day cycle.) Study Agent is given (route/duration) on (day/days) of a (#)-day cycle. Group A Group B Group C D Group E Dose Level Normal renal function ( )* Mild renal dysfunction ( (units) )* Moderate renal dysfunction ( (units) )* Severe renal dysfunction ( (units) )* Renal dialysis ( (units) )* Level –1 ** 1 ** Level 2 ** Level 3 ** Level 4 ** * Doses are stated as exact dose in units (e.g., mg/m2, mcg/kg, etc.) rather than as a percentage. ** (See Section 5.1 for the Group E dosing scheme.) Note: This schema is not to be used for determining dosage for any individual patient. For specific dosing information, please refer to Sections 5 and 6.
Renal_Dysfunction_Template_v4.docx