Conditions: Cancer
Keywords: Metastatic melanoma melanoma BRAF mutant Advanced melanoma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 251
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Subjects in this arm will receive GSK2118436 150 mg twice daily. arm 2: Subjects will receive intravenous dacarbazine (DTIC) 1000 mg/m2 every 3 weeks arm 3: Subjects who initially receive DTIC will be allowed to receive GSK2118436 after initial progression.

Interventions: intervention 1: GSK2118436 intervention 2: Dacarbazine (DTIC)
Intervention descriptions: intervention 1: 150 mg twice daily intervention 2: Intravenous (IV), 1000 mg/m2 every 3 weeks until initial progression

Protocol document: