Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients
NCT ID: NCT00936221
Last Updated: 2016-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
385 participants
INTERVENTIONAL
2009-07-31
2014-11-30
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
QUADRUPLE
Study Groups
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1
AZD6244 in combination with dacarbazine
AZD6244
oral capsules, 75mg twice daily
Dacarbazine
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
2
Placebo in combination with dacarbazine
Dacarbazine
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
Placebo
Placebo
Interventions
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AZD6244
oral capsules, 75mg twice daily
Dacarbazine
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumor sample confirmed as BRAF mutation positive
Exclusion Criteria
* 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
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Middleton, Dr
Role: PRINCIPAL_INVESTIGATOR
Churchil Hospital, Oxford, UK
Caroline Robert, Dr
Role: PRINCIPAL_INVESTIGATOR
Institute Gustave Roussy, France
Ian Smith, Dr
Role: STUDY_DIRECTOR
AstraZeneca, Alderley Park, UK
Locations
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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
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São Paulo, , Brazil
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Brno, , Czechia
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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
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Hanover, , Germany
Research Site
Kiel, , Germany
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Tübingen, , Germany
Research Site
Budapest, , Hungary
Research Site
Győr, , Hungary
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Székesfehérvár, , Hungary
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Amsterdam, , Netherlands
Research Site
Nijmegen, , Netherlands
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Oslo, , Norway
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Barcelona, , Spain
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Houston, , Spain
Research Site
Málaga, , Spain
Research Site
Palma de Mallorca, , Spain
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Gothenburg, , Sweden
Research Site
Malmo, , Sweden
Research Site
Stockholm, , Sweden
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Zurich, , Switzerland
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Cambridge, , United Kingdom
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Chelmsford, , United Kingdom
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London, , United Kingdom
Research Site
Manchester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
Research Site
Oxford, , United Kingdom
Research Site
Sutton, , United Kingdom
Countries
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References
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Robert C, Dummer R, Gutzmer R, Lorigan P, Kim KB, Nyakas M, Arance A, Liszkay G, Schadendorf D, Cantarini M, Spencer S, Middleton MR. Selumetinib plus dacarbazine versus placebo plus dacarbazine as first-line treatment for BRAF-mutant metastatic melanoma: a phase 2 double-blind randomised study. Lancet Oncol. 2013 Jul;14(8):733-40. doi: 10.1016/S1470-2045(13)70237-7. Epub 2013 Jun 2.
Related Links
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Other Identifiers
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D1532C00006
Identifier Type: -
Identifier Source: org_study_id
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