drugset / Trial / NCT01174238
A Two Arm Trial of Axitinib and Carboplatin/Paclitaxel in Melanoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a two arm prospective Phase II pilot trial designed to determine the optimal duration of break between axitinib and chemotherapy with carboplatin/paclitaxel in melanoma. In this study, 6 patients will be enrolled to Arm A, the FLT PET scan (3'deoxy-3'-18F-Fluorothymidine positron emission tomography scans)cohort. 30 patients will be enrolled to Arm B, the treatment-only cohort. 36 total patients will be enrolled. The treatment schedule will be the same in either cohort, with the exception of the FLT PET scans.
Timeline
- Start
- 2010-07
- Primary completion
- 2013-08
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Axitinib | Small molecule | 5 mg | Oral |
| Subject | Carboplatin | Small molecule | 5 unknown | — |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | — |