Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
NCT ID: NCT00110994
Last Updated: 2015-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2005-04-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sorafenib (Nexavar, BAY43-9006) + Dacarbazine
Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
Sorafenib (Nexavar, BAY43-9006)
Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21
Dacarbazine
Dacarbazine, 1000 mg/m\^2 intravenous on Study Day 1
Placebo + Dacarbazine
Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
Placebo
Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21
Dacarbazine
Dacarbazine, 1000 mg/m\^2 intravenous on Study Day 1
Interventions
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Sorafenib (Nexavar, BAY43-9006)
Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21
Placebo
Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21
Dacarbazine
Dacarbazine, 1000 mg/m\^2 intravenous on Study Day 1
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Tucson, Arizona, United States
Aurora, Colorado, United States
Lakeland, Florida, United States
Park Ridge, Illinois, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Charlotte, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Hilton Head Island, South Carolina, United States
Nashville, Tennessee, United States
San Antonio, Texas, United States
Countries
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References
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McDermott DF, Sosman JA, Gonzalez R, Hodi FS, Linette GP, Richards J, Jakub JW, Beeram M, Tarantolo S, Agarwala S, Frenette G, Puzanov I, Cranmer L, Lewis K, Kirkwood J, White JM, Xia C, Patel K, Hersh E. Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group. J Clin Oncol. 2008 May 1;26(13):2178-85. doi: 10.1200/JCO.2007.14.8288.
Other Identifiers
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11715
Identifier Type: -
Identifier Source: org_study_id
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