drugset / Trial / NCT01378975

A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases

NCT01378975

Phase 2 Completed 146 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
Subject Vemurafenib Small molecule 960 mg Oral

Indications