Trial Condition(s):

Cancer, Melanoma

Treatment for Subjects with Unresectable Stage III or Stage IV Melanoma

Bayer Identifier:

11715

ClinicalTrials.gov Identifier:

NCT00110994

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
101
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Vanderbilt University Medical School

Nashville, United States, 37232-6307

Status
Completed
 
Locations

University of Pittsburgh Medical Center Health System

Pittsburgh, United States, 15232

Status
Completed
 
Locations

Beth Israel Deaconess Medical Center

Boston, United States, 02215

Status
Completed
 
Locations

University of Arizona Cancer Center

Tucson, United States, 85724

Status
Completed
 
Locations

Dana-Farber Cancer Institute

Boston, United States, 02115-6084

Status
Completed
 
Locations

Advocate Lutheran General Hospital

Park Ridge, United States, 60068

Status
Completed
 
Locations

University of Colorado Health Sciences Center

Aurora, United States, 80045

Status
Completed
 
Locations

South Carolina Cancer Specialists

Hilton Head Island, United States, 29926-2739

Status
Completed
 
Locations

Nebraska Methodist Hospital

Omaha, United States, 68114

Status
Completed
 
Locations

Lakeland Regional Medical Center

Lakeland, United States, 33805

Status
Completed
 
Locations

Institute for Drug Development

San Antonio, United States, 78229

Status
Completed
 
Locations

Carolinas Medical Center

Charlotte, United States, 28203

Status
Completed
 
Locations

Washington University School of Medicine

St. Louis, United States, 63110-1093

Status
Completed
 
Locations

Massachusetts General Hospital

Boston, United States, 02114

Status
Completed
 

Trial Design