drugset / Trial / NCT00400023
A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of S-1 on Advanced Solid Tumors
RandomizedCrossoverOpen-labelTreatment
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).
Timeline
- Start
- 2006-09
- Primary completion
- 2007-05
- Completion
- 2007-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | FT | Unknown | 800 mg | Oral |
| Subject | S-1 | Small molecule | 30 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 50 mg | Oral |