NCT01378975

A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Vemurafenib	960 mg oral doses twice daily until disease progression, unacceptable toxicity or consent withdrawal.

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-06-23
• Last updated: 2025-06-25
• Results posted: 2016-08-01

Locations

33 sites across 10 countries: United States, Australia, Canada, France, Germany, Israel, Italy, Netherlands, Spain, United Kingdom