Melanoma Clinical Trial

Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

101

Study ID:

NCT00110994

Recruitment Status:

Completed

Sponsor:

Bayer

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There are 14 Locations for this study

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Tucson Arizona, 85724, United States

Aurora Colorado, 80045, United States

Lakeland Florida, 33805, United States

Park Ridge Illinois, 60068, United States

Boston Massachusetts, 02114, United States

Boston Massachusetts, 02115, United States

Boston Massachusetts, 02215, United States

St. Louis Missouri, 63110, United States

Omaha Nebraska, 68114, United States

Charlotte North Carolina, 28203, United States

Pittsburgh Pennsylvania, 15232, United States

Hilton Head Island South Carolina, 29926, United States

Nashville Tennessee, 37232, United States

San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

101

Study ID:

NCT00110994

Recruitment Status:

Completed

Sponsor:


Bayer

How clear is this clinincal trial information?

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