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Comparison of AZD6244 in combination with dacarbazine versus (vs) dacarbazine alone in BRAF mutation positive melanoma patients
Study identifier:D1532C00006
ClinicalTrials.gov identifier:NCT00936221
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Melanoma
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD6244, Dacarbazine, Placebo
Sex
All
Actual Enrollment
385
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 01 Jul 2009
Primary Completion Date: 01 Nov 2011
Study Completion Date: 01 Nov 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
Belo Horizonte, Brazil
Location
Research Site
Porto Alegre, Brazil
Location
Research Site
Ijuí, Brazil
Location
Research Site
Sao Paulo, Brazil
Location
Research Site
Zürich, Switzerland
Location
Research Site
Novy Jicin, Czech Republic
Location
Research Site
Praha 2, Czech Republic
Location
Research Site
Brno, Czech Republic
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 AZD6244 in combination with dacarbazine | Drug: AZD6244 oral capsules, 75mg twice daily Other Name: selumetinib Drug: Dacarbazine 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle Other Name: DTIC |
| Placebo Comparator: 2 Placebo in combination with dacarbazine | Drug: Dacarbazine 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle Other Name: DTIC Drug: Placebo Placebo |
Contacts
Contact
AstraZeneca Clinical Study Information Center
Investigators
Principal Investigator
Mark Middleton
Churchil Hospital, Oxford, UK
