NCT01266967

A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain

BRF113929: An Open-Label, Two-Cohort, Multicentre Study of GSK2118436 as a Single Agent in Treatment Naïve and Previously Treated Subjects With BRAF Mutation-Positive Metastatic Melanoma to the Brain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the efficacy, pharmacokinetics, safety, and tolerability of an oral, twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or V600K mutation-positive metastatic melanoma to the brain. Subjects in Cohort A will not have received any local brain therapy, and subjects in Cohort B will have received prior local therapy for brain metastases. Subjects will continue on treatment until disease progression, death, or unacceptable adverse event.

Conditions

• Melanoma and Brain Metastases

Interventions

Type	Name	Description
DRUG	GSK2118436	Subjects in this study receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-11-01
• Completion: 2012-11-01
• First posted: 2010-12-24
• Last updated: 2014-05-08
• Results posted: 2014-03-05

Locations

24 sites across 6 countries: United States, Australia, Canada, France, Germany, Italy