Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients
A Phase II, Double-blind, Randomised Study to Assess the Efficacy of AZD6244 in Combination With Dacarbazine Compared With Dacarbazine Alone in First Line Patients With BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma
1 other identifier
interventional
385
12 countries
38
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2009
Longer than P75 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 8, 2009
CompletedFirst Posted
Study publicly available on registry
July 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
December 9, 2015
CompletedMarch 14, 2016
February 1, 2016
2.3 years
July 8, 2009
November 4, 2015
February 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.
From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later
Secondary Outcomes (3)
Progression Free Survival
From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
Objective Response Rate
From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
Change in Target Lesion Tumour Size at Week 12
randomization to week 12
Study Arms (2)
1
ACTIVE COMPARATORAZD6244 in combination with dacarbazine
2
PLACEBO COMPARATORPlacebo in combination with dacarbazine
Interventions
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (38)
Research Site
Aurora, Colorado, United States
Research Site
Boston, Massachusetts, United States
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Belo Horizonte, Brazil
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Ijuí, Brazil
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Porto Alegre, Brazil
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São Paulo, Brazil
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Brno, Czechia
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Nový Jičín, Czechia
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Prague, Czechia
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Lille, France
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Marseille, France
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Villejuif, France
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Berlin, Germany
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Essen, Germany
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Hanover, Germany
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Kiel, Germany
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Tübingen, Germany
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Budapest, Hungary
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Győr, Hungary
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Székesfehérvár, Hungary
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Amsterdam, Netherlands
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Nijmegen, Netherlands
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Oslo, Norway
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Barcelona, Spain
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Houston, Spain
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Málaga, Spain
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Palma de Mallorca, Spain
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Gothenburg, Sweden
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Malmo, Sweden
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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
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Oxford, United Kingdom
Research Site
Sutton, United Kingdom
Related Publications (1)
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.
PMID: 23735514DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gabriella Mariani
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Middleton, Dr
Churchil Hospital, Oxford, UK
- PRINCIPAL INVESTIGATOR
Caroline Robert, Dr
Institute Gustave Roussy, France
- STUDY DIRECTOR
Ian Smith, Dr
AstraZeneca, Alderley Park, UK
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2009
First Posted
July 9, 2009
Study Start
July 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2014
Last Updated
March 14, 2016
Results First Posted
December 9, 2015
Record last verified: 2016-02