Conditions: Malignant Melanoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 675
Healthy volunteers: no

Brief summary:
This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Vemurafenib intervention 2: Dacarbazine
Intervention descriptions: intervention 1: 960 mg (as 240 mg tables) orally twice daily intervention 2: 1000 mg/m2 intravenously every 3 weeks

Protocol document: