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

Completed · Phase 3 · Has a placebo group

Conditions studied: Melanoma

In brief

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).

Key facts

Study ID

NCT00111007

Run by

Bayer

People needed

270

Starts

2005-05-01

Expected to finish

2009-01-01

Last updated by the study team

2014-10-31

Who can join

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

You may qualify if…

• 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

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 < 5 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 — Los Angeles, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Montclair, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Camperdown, New South Wales, Australia
• Study site — Warartah, New South Wales, Australia
• Study site — Westmead, New South Wales, Australia
• Study site — Brisbane, Queensland, Australia
• Study site — East Melbourne, Victoria, Australia
• Study site — Heidelberg, Victoria, Australia
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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