CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 146 enrolled
Drug / intervention
Vemurafenibdrug
Likely dose
Vemurafenib 960 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01378975
NCT01378975Phase 2Completed
CompareCT.gov

An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

Hoffmann-La Roche·interventional·Posted Jun 23, 2011·Updated Jun 25, 2025

In Brief

A Phase 2 clinical trial evaluating Vemurafenib for Malignant Melanoma. Completed, enrolled 146 participants across 33 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesAustralia, Canada, France, Germany, Israel, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2011
Enrollment StartJul 1, 2011
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 15.0 years ago

Interventions

Vemurafenibdrug

960 mg oral doses twice daily until disease progression, unacceptable toxicity or consent withdrawal.