A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of S-1 on Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

May 31, 2007

Study Completion Date

May 31, 2007

Conditions
Tumors
Interventions
DRUG

S-1

"During the Cross-Over PK Phase, S-1 will be administered as a 50 mg oral fixed dose and FT will be administered as an 800 mg oral fixed dose.~During the S-1 Extension Phase (Part 2), S-1 30 mg/m2 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."

DRUG

FT

During the Cross-Over PK Phase, S-1 will be administered as a 50 mg oral fixed dose and FT will be administered as an 800 mg oral fixed dose.

Trial Locations (3)

85260

Premiere Oncology of Arizona, Scottsdale

90404

Premiere Oncology, A Medical Corporation, Santa Monica

06520

Yale Cancer Center, New Haven

All Listed Sponsors
lead

Taiho Oncology, Inc.

INDUSTRY

NCT00400023 - A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of S-1 on Advanced Solid Tumors | Biotech Hunter | Biotech Hunter