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An Open-Label Phase I Dose-Escalation Study of Sorafenib Plus S-1 in Advanced Solid Tumors
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.
Details
| Lead sponsor | National Health Research Institutes, Taiwan |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2009-11 |
| Completion | 2015-10 |
Conditions
- Advanced Solid Tumors
Interventions
- Sorafenib
- S-1
Primary outcomes
- Determination of MTD/RD — First two cycles
Countries
Taiwan