From MMDM
NCT01266967
| 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
