Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma

Completed · Phase 2 · Has a placebo group

Conditions studied: Cancer, Melanoma

In brief

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.

Key facts

Study ID

NCT00110994

Run by

Bayer

People needed

101

Starts

2005-04-01

Expected to finish

2008-03-01

Last updated by the study team

2015-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Aurora, Colorado, United States
• Study site — Lakeland, Florida, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Hilton Head Island, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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