NCT00400023

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

A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of the Dihydropyrimidine Dehydrogenase (Dpd) Inhibitory Action of 5-Chloro-2,4-Dihydroxypyridine (Cdhp) as an S-1 Component

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, randomized, 2-sequence, cross-over, pharmacokinetic (PK) study evaluating the effect of the DPD inhibitory action of CDHP as an S-1 component compared with FT alone on the PK of 5-FU in patients with advanced solid tumors. The study will be conducted in 2 parts (Cross-Over Pharmacokinetic Phase and S-1 Extension Phase).

Conditions

• Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-11-16
• Last updated: 2024-09-03

Locations

3 sites across 1 country: United States