LIVER DYSFUNCTION GROUPS Patients entering this study will be stratified into five groups or cohorts (A: normal, B: mild dysfunction, C: moderate dysfunction, D: severe dysfunction, E: liver transplant) according to their hepatic function as outlined in the following table: Group Group A Group B Group C Group D Group E Liver Liver Mild Moderate Severe Transplant Function B1: ULN Total >1.5x 3x – ULN B2: >1.0x >3x ULN Any – Bilirubin ULN 1.5x ULN B1: > ULN SGOT/AST ULN Any Any Any B2: Any 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. is given intravenously as a (For example, “Agent XXX 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 Group D Group E Moderate Normal liver Mild liver liver Severe liver Liver Dose function dysfunction dysfunction dysfunction transplant Level (units) * (units) * (units) * (units) * (units) * ** Level -1 ** Level 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 5.1.1 for the Group E dosing scheme.) ** Note: This schema is not to be used for determining dosage for any individual patient.
LIVER DYSFUNCTION GROUPS Patients entering this study will be stratified into five groups or cohorts (A: normal, B: mild dysfunction, C: moderate dysfunction, D: severe dysfunction, E: liver transplant) according to their hepatic function as outlined in the following table: Group Liver Function Group A Group B Mild Group C Moderate Group D Severe Group E Liver Transplant Total Bilirubin ULN B1: ULN B2: >1.0x – 1.5x ULN >1.5x – 3x ULN >3x ULN Any SGOT/AST ULN B1: > ULN B2: Any Any Any Any 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 Group D Group E Dose Level Normal liver function (units) * Mild liver dysfunction (units) * Moderate liver dysfunction (units) * Severe liver dysfunction (units) * Liver transplant (units) * Level -1 ** Level 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 5.1.1 for the Group E dosing scheme.) Note: This schema is not to be used for determining dosage for any individual patient.
Hepatic_Dysfunction_Template_v4.docx