drugset / Trial / NCT01128998
Sorafenib Plus S-1 in Advanced Solid Tumors
Phase 1
Completed
30 enrolled
National Health Research Institutes, Taiwan
National Cheng-Kung University Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
Primary Objective: 1. To define the recommended dose for phase II study of S-1 combined with sorafenib 2. To evaluate the dose-limiting toxicities of the combination therapy Secondary Objectives: 1. To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination therapy 2. To investigate the impact of genetic polymorphisms of metabolic genes on the PK of sorafenib and S-1, respectively, as well as on the toxicity profile of the combination. 3. To determine the changes of biomarkers between pre- and post-treatments.
Timeline
- Start
- 2009-11
- Primary completion
- 2009-11
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S-1 | Small molecule | 20 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 40 mg/m2 | Oral |
| Subject | Sorafenib | Small molecule | 200 mg | Oral |