At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 385 enrolled
Drug / intervention
AZD6244 +2 moredrug
Likely dose
AZD6244 75mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AZD6244, Dacarbazine, and 1 other intervention for Melanoma. Completed, enrolled 385 participants across 38 sites in 12 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesBrazil, Czechia, France, Germany, Hungary, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedJul 2009
Primary CompletionNov 2011
Study CompletionNov 2014
TodayJul 2026
First PostedJul 9, 2009
Enrollment StartJul 1, 2009
Primary CompletionNov 1, 2011
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.0 years ago
Interventions
AZD6244drug
oral capsules, 75mg twice daily
Dacarbazinedrug
1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
Placebodrug
Placebo