Evaluating Patients With Impaired Hepatic Function
This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of hepatic function defined by the NCI classification for hepatic impairment. Patients will be stratified into 4 Cohorts- Normal, Mild, Moderate or Severe.
Six patients will be enrolled inot each cohort and receive S-1.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-Label Study Evaluating The Pharmacokinetics of Components of S-1 Patients With Impaired Hepatic Function|
- To provide specific dosing recommendations for S-1 in patients with hepatic impairment based on the PK of S-1 and its components after single dose and during steady state condition [ Time Frame: The Pharmacokinetic Phase (Part 1) of the study will last 24 days. ] [ Designated as safety issue: No ]
- To assess the antitumor activity and safety profile of S-1 in patients with impaired hepatic function [ Time Frame: Each cycle of the Extension Phase (Part 2) will be 21 days (14 days of S-1 treatment, 7 days recovery). The end of study for the Extension Phase will be 30 days after the last dose of S-1. ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2006|
|Study Completion Date:||March 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
PK Phase (Part 1), Beginning on Day 1 of the Pharmacokinetic Phase, 30 mg/m2 S-1 will be administered orally BID for 14 days (Days 1 through 14), followed by a 1-week recovery period.
On Day -2 and Day 14 of the Pharmacokinetic Phase, all patients will receive a single dose of 30 mg/m2 S-1 administered orally.
Extension Phase, Patients will receive S-1 at the dose that they tolerated in the PK Phase. S-1 will be administered orally BID for 2 weeks (Day 1 through Day 14) followed by a 1-week recovery period (Day 15 through Day 21). This cycle will be repeated every 3 weeks.
|United States, Arizona|
|Premiere Oncology of Arizona|
|Scottsdale, Arizona, United States, 85260|
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06520|
|United States, Kentucky|
|University of Kentucky/Division of Hematology/Oncology and Blood Marrow Transplantation|
|Lexington, Kentucky, United States, 40536|
|United States, Maryland|
|University of Maryland/Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|United States, Missouri|
|Washington University School of Medicine|
|St Louis, Missouri, United States, 63110|
|United States, Texas|
|The Institute for Drug Development|
|San Antonio, Texas, United States, 78245|