At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed unresectable Stage III or metastatic Stage IV melanoma
- ✓ECOG performance status 0 or 1
- ✓Measurable disease by modified RECIST criteria (at least one accurately and serially measurable lesion)
- ✓Life expectancy of at least 12 weeks
- ✕Primary ocular or mucosal melanoma
- ✕Prior or concurrent cancer distinct in primary site or histology, unless cervical CIS, treated basal cell carcinoma, superficial bladder tumors, or any cancer curatively treated <3 years prior to study entry
- ✕History of cardiac disease
- ✕Known HIV infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Dacarbazine (DTIC) Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma
In Brief
A Phase 2 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006), Placebo, and 1 other intervention for Cancer and Melanoma. Completed, enrolled 101 participants across 14 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21
Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21
Dacarbazine, 1000 mg/m\^2 intravenous on Study Day 1