A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborators: Amgen; Onyx Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Niacinamide; Paclitaxel; Sorafenib

Criteria

Inclusion Criteria:

• Subjects who have a life expectancy of at least 12 weeks

• Subjects with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma

• Subjects must have progressed after receiving at least one cycle of DTIC or TMZ containing regimen

• Subjects 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 < 5 years prior to study entry

• History of cardiac disease

• Known history of human immunodeficiency virus (HIV) infection