A Study of Vemurafenib in Participants With Metastatic Melanoma

• Status: Completed
• Trial end date: 2016-02-24
• Target enrollment: 0
• Participant gender: All

Summary

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Vemurafenib

Criteria

Inclusion Criteria:

• Participants with Histologically confirmed metastatic melanoma (surgically incurable and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had confirmation from a surgical oncologist

• Participants with either measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1

• Participants may or may not have received prior systemic therapy for metastatic melanoma

• Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2

• Adequate hematologic, renal and liver function

Exclusion Criteria:

• Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib

• Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix

• Concurrent administration of any anti-cancer therapies other than those administered in the study

• Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug

• Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption