Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma

Bayer

Status and phase: Completed; Phase 2

Conditions: Melanoma; Cancer

Treatments: Drug: Dacarbazine; Drug: Placebo; Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00110994

11715 (Registry Identifier)

Details and patient eligibility

About

This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have a life expectancy of at least 12 weeks
• Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
• Patients who have an ECOG PS of 0, or 1
• Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria

Exclusion criteria

• Primary ocular or mucosal melanoma
• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"] & T1 [Tumor invades subepithelial connective tissue]) or any cancer curatively treated < 3 years prior to study entry
• History of cardiac disease
• Known history of human immunodeficiency virus (HIV) infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 2 patient groups

Sorafenib (Nexavar, BAY43-9006) + Dacarbazine

Experimental group

Description:

Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous 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.

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)

Drug: Dacarbazine

Placebo + Dacarbazine

Active Comparator group

Description:

Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous 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.

Treatment:

Drug: Placebo

Drug: Dacarbazine