Conditions: Melanoma
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 83
Healthy volunteers: no

Brief summary:
The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma.

Detailed description:
Issues on "Safety" outcomes are addressed in the Adverse Event section.

Arms:
arm 1: Dacarbazine 1000 mg/m\^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)

Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)
Intervention descriptions: intervention 1: Dacarbazine 1000 mg/m\^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)

Protocol document: