Status:
COMPLETED
A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma
Lead Sponsor:
Bayer
Collaborating Sponsors:
Amgen
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 P...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00111007
Start Date
May 1 2005
End Date
January 1 2009
Last Update
October 31 2014
Active Locations (66)
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1
Birmingham, Alabama, United States, 35243
2
Tucson, Arizona, United States, 85724
3
Los Angeles, California, United States, 90025
4
Aurora, Colorado, United States, 80045