Vemurafenib in Chinese patients with BRAF^V600 mutation-positive unresectable or metastatic melanoma: an open-label, multicenter phase I study.

ABSTRACT:

Background

Melanoma is a rare, deadly disease without effective treatment options in China. Vemurafenib is a selective inhibitor of oncogenic BRAF^V600 kinase approved in more than 90 countries, based on results obtained primarily in Caucasian patients. Limited data are available regarding the efficacy and safety of vemurafenib in Asian patients.

Methods

This phase I study investigated the pharmacokinetics, efficacy, and tolerability of vemurafenib (960 mg twice daily) in Chinese patients with BRAF^V600 mutation-positive unresectable or metastatic melanoma. The study included two cohorts: a pharmacokinetic cohort (n = 20) and an expansion cohort (n = 26).

Results

After 21 days of dosing, vemurafenib demonstrated marked accumulation and relatively c

SUBMITTER: Si L 

PROVIDER: S-EPMC5934791 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature