Study identifier:D1532C00006
ClinicalTrials.gov identifier:NCT00936221
EudraCT identifier:N/A
CTIS identifier:N/A
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
Melanoma
Phase 2
No
AZD6244, Dacarbazine, Placebo
All
385
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Feb 2016 by AstraZeneca
AstraZeneca
-
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
Location
Location
Belo Horizonte, Brazil
Location
Porto Alegre, Brazil
Location
Ijuí, Brazil
Location
Sao Paulo, Brazil
Location
Zürich, Switzerland
Location
Novy Jicin, Czech Republic
Location
Praha 2, Czech Republic
Location
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 |
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