drugset / Trial / NCT01378975
A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma \[except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors\]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Timeline
- Start
- 2011-07
- Primary completion
- 2015-07
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vemurafenib | Small molecule | 960 mg | Oral |