Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Melanoma

In brief

To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

Key facts

Study ID

NCT00936221

Run by

AstraZeneca

People needed

385

Starts

2009-07-01

Expected to finish

2014-11-01

Last updated by the study team

2016-03-14

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological or cytological confirmation of advanced (inoperable stage III and stage IV) cutaneous or unknown primary melanoma
• Tumor sample confirmed as BRAF mutation positive

You may not qualify if…

• Diagnosis of uveal or mucosal melanoma
• Any prior Investigational therapy comprising inhibitors of Ras, Raf or MEK
• Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug

Where it is running

• Research Site — Aurora, Colorado, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Belo Horizonte, Brazil
• Research Site — Ijuí, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — São Paulo, Brazil
• Research Site — Brno, Czechia
• Research Site — Nový Jičín, Czechia
• Research Site — Prague, Czechia
• Research Site — Lille, France
• Research Site — Marseille, France
• Research Site — Villejuif, France
• Research Site — Berlin, Germany
• Research Site — Essen, Germany
• Research Site — Hanover, Germany
• Research Site — Kiel, Germany
• Research Site — Tübingen, Germany
• Research Site — Budapest, Hungary
• Research Site — Győr, Hungary
• Research Site — Székesfehérvár, Hungary
• Research Site — Amsterdam, Netherlands
• Research Site — Nijmegen, Netherlands
• Research Site — Oslo, Norway
• Research Site — Barcelona, Spain
• Research Site — Houston, Spain

Full record on ClinicalTrials.gov

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