drugset / Trial / NCT00955721
A Study of Combination of Gemcitabine, Oxaliplatin (GEMOX)-Sorafenib in Patients With Advanced Biliary Tract Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to build on the efficacy of the GEMOX regimen by adding Sorafenib in the treatment of Biliary Tract Cancer. Since there is no data on the combination of these three agents, the investigators plan to evaluate the safety in a run-in phase I portion in order to define the recommended phase II dose (RPTD). The phase II trial will enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary estimate of progression-free survival (primary endpoint of the trial) in the target population.
Timeline
- Start
- 2009-08
- Primary completion
- 2014-07
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 750 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Sorafenib | Small molecule | 200 mg | Oral |