A single-arm, open-label, expanded access study of vemurafenib in patients with metastatic melanoma in the United States.

ABSTRACT:

Purpose

This open-label, multicenter study was designed to allow access to vemurafenib for patients with metastatic melanoma, bridging the time between end of enrollment in the phase III registration trial (December 2010) and commercial availability following US Food and Drug Administration approval of vemurafenib for the treatment of unresectable or metastatic BRAF-mutated melanoma (August 2011).

Patients and methods

Eligible patients had metastatic melanoma with a BRAF mutation (detected by the cobas 4800 BRAF V600 Mutation Test). Unlike previous vemurafenib trials, patients with poor performance status (PS) and treated brain metastases were permitted. Enrolled patients received oral vemurafenib 960 mg twice daily.

Results

Of 374 patients enrolled at 29 US sites (De

SUBMITTER: Flaherty L 

PROVIDER: S-EPMC4705837 | biostudies-literature | 2014 Jan-Feb

REPOSITORIES: biostudies-literature