Conditions: Melanoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 270
Healthy volunteers: no

Brief summary:
The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).

Detailed description:

Arms:
arm 1: Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die \[twice daily\]) on Study Days 2 to 19 + Paclitaxel (225 mg/m\^2 iv \[Intravenous\]) and Carboplatin (AUC \[area under the curve\] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. arm 2: Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.

Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Carboplatin/Paclitaxel intervention 3: Placebo
Intervention descriptions: intervention 1: Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19 intervention 2: Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 intervention 3: Placebo, 2 tablets bid Study Days 2-19

Protocol document: