At a glance
ClinicalIndex Comparison Record- ✓Unresectable Stage III or metastatic Stage IV melanoma confirmed histologically or cytologically
- ✓Prior progression on at least one cycle of DTIC or TMZ-containing regimen
- ✓ECOG performance status 0 or 1
- ✓Measurable disease by modified RECIST criteria
- ✕Primary ocular or mucosal melanoma
- ✕Active second cancer (except in situ cervical carcinoma, treated basal cell carcinoma, superficial bladder tumors, or any cancer curatively treated >5 years prior)
- ✕History of cardiac disease
- ✕Known HIV infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Paclitaxel/Carboplatin Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma.
In Brief
A Phase 3 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006), Carboplatin/Paclitaxel, and 1 other intervention for Melanoma. Completed, enrolled 270 participants across 66 sites in 7 countries.
Detailed 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).
Study Details
Timeline
Interventions
Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19
Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1
Placebo, 2 tablets bid Study Days 2-19