drugset / Trial / NCT00941863
Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors. The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.
Timeline
- Start
- 2002-07
- Primary completion
- 2005-05
- Completion
- 2008-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sorafenib | Small molecule | 100 mg | — |
| Subject | Sorafenib | Small molecule | 200 mg | — |
| Subject | Sorafenib | Small molecule | 400 mg | — |