At a glance
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A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
In Brief
A Phase 3 clinical trial evaluating GSK2118436 and Dacarbazine (DTIC) for Cancer. Completed, enrolled 251 participants across 94 sites in 12 countries.
Detailed Summary
BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436.
Study Details
Timeline
Interventions
150 mg twice daily
Intravenous (IV), 1000 mg/m2 every 3 weeks until initial progression