Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients

A Phase II, Double-blind, Randomised Study to Assess the Efficacy of AZD6244 in Combination With Dacarbazine Compared With Dacarbazine Alone in First Line Patients With BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma

To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

Inclusion Criteria:

• Histological or cytological confirmation of advanced (inoperable stage III and stage IV) cutaneous or unknown primary melanoma
• Tumor sample confirmed as BRAF mutation positive

Exclusion Criteria:

• Diagnosis of uveal or mucosal melanoma
• Any prior Investigational therapy comprising inhibitors of Ras, Raf or MEK
• Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug