Conditions: Melanoma and Brain Metastases
Keywords: GSK2118436 Metastatic melanoma to the brain Brain metastases Braf mutation Brain neoplasm BRAF inhibitor
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 172
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Single arm with 2 cohorts; Cohort A no previous brain therapy and Cohort B previous brain therapy

Interventions: intervention 1: GSK2118436
Intervention descriptions: intervention 1: Subjects in this study receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.

Protocol document: