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Brief Title: Study to Determine Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Subjects Previously Treated With or Without a BRAF Inhibitor

2014-08-27 03:17:06 | BioPortfolio

Summary

MEK113583 is a Phase II open-label, multi-site study to investigate the objective response rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent and highly selective inhibitor of MEK activation and kinase activity.

Description

GSK1120212 will be administered at the recommended phase II dose identified in the ongoing, Phase I clinical trial, MEK111054. The primary objective of this Phase II study is to evaluate the objective response rate in subjects that are administered daily oral GSK1120212. Subjects will be dosed until treatment discontinuation criteria are met.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cancer

Intervention

GSK1120212 Treatment

Location

GSK Investigational Site
Los Angeles
California
United States
90024

Status

Recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:06-0400

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