Evaluating Patients With Varying Degrees of Renal Function

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Renal Impairment
Interventions
DRUG

S-1/Cisplatin

"S-1 administration will be determined by degree of renal impairment as follows:~Group A (Control): 30 mg/m2 BID Group B (Mild renal dysfunction): 30 mg/m2 BID Group C (Moderate renal dysfunction): 20 mg/m2 BID Group D (Severe renal dysfunction): 20 mg/m2 QD~Pharmacokinetic Phase (Part 1):~On Days -2 and 14 of the Pharmacokinetic Phase, patients will receive a single dose of S-1 administered orally in the morning.~Treatment will be followed by 1 week of recovery (Days 15 through 21).~Extension Phase (Part 2):~S-1 will be administered orally 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 (9)

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

87131

Cancer Research & Treatment Center/University of New Mexico, Albuquerque

90033

LAC/USC Medical Center, Los Angeles

90404

Premiere Oncology, Santa Monica

06520

Yale Cancer Center, New Haven

All Listed Sponsors
lead

Taiho Oncology, Inc.

INDUSTRY

NCT00398307 - Evaluating Patients With Varying Degrees of Renal Function | Biotech Hunter | Biotech Hunter