drugset / Trial / NCT00398424
Evaluating Patients With Impaired Hepatic 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 hepatic function defined by the NCI classification for hepatic impairment. Patients will be stratified into 4 Cohorts- Normal, Mild, Moderate or Severe. Six patients will be enrolled inot each cohort and receive S-1.
Timeline
- Start
- 2006-02
- Primary completion
- 2008-11
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S-1 | Small molecule | 30 mg/m2 | Oral |
| Background | Cisplatin | Other / unclassified | — | — |
Indications
No indication recorded.