drugset / Trial / NCT00398307
Evaluating Patients With Varying Degrees of Renal Function
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase I, open-label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of renal function. Patients will be stratified by baseline 24-hour creatinine clearance(CrCL) into 4 cohorts using the normal clearance formula: Group A: Control Group B:Mild renal dysfunction Group C:Moderate renal function and Group D: Severe renal dysfunction. Six patients will be enrolled into each cohort.
Timeline
- Start
- 2006-02
- Primary completion
- 2010-09
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S-1 | Small molecule | 20 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 30 mg/m2 | Oral |
| Background | Cisplatin | Other / unclassified | — | — |