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NCT01266967

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Title: A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain
Inclusion Model:
Status: Active, not recruiting
Link: ClinicalTrials.gov
Interventions: GSK2118436
Conditions:
Sponsor:
Tests: BRAF
Subtypes: Subtype 1.1
Must Have:
Must Not Have:
Inclusion Criteria:
Minimum Age:
Maximum Age:
Gender:
Phase: Phase 2
Comments:




Purpose: The present 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.

Study Type: Interventional

Study Design: Intervention

Model: Single Group Assignment

Primary Purpose: Treatment

Official Title: 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

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