Evaluating Patients With Impaired Hepatic Function

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

November 30, 2008

Study Completion Date

March 31, 2009

Conditions
Impaired Hepatic Function
Interventions
DRUG

S-1/Cisplatin

"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."

Trial Locations (6)

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

40536

University of Kentucky/Division of Hematology/Oncology and Blood Marrow Transplantation, Lexington

63110

Washington University School of Medicine, St Louis

78245

The Institute for Drug Development, San Antonio

85260

Premiere Oncology of Arizona, Scottsdale

06520

Yale Cancer Center, New Haven

All Listed Sponsors
lead

Taiho Oncology, Inc.

INDUSTRY

NCT00398424 - Evaluating Patients With Impaired Hepatic Function | Biotech Hunter | Biotech Hunter