At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 152 enrolled
Drug / intervention
75mg selumetinib +2 moredrug
Likely dose
75mg selumetinibfrom 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 Randomised, Double-Blind Study to Assess the Efficacy of Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine as First Systemic Therapy in Patients With Metastatic Uveal Melanoma (SUMIT)
In Brief
A Phase 3 clinical trial evaluating 75mg selumetinib, placebo, and 1 other intervention for Metastatic and Uveal Melanoma. Completed, enrolled 152 participants across 31 sites in 11 countries.
Detailed Summary
Selumetinib therapy in patients with metastatic uveal melanoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic, Uveal Melanoma
CountriesBelgium, Canada, Czechia, Finland, France, Germany, Israel, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartApr 2014
Primary CompletionMay 2015
Study CompletionOct 2016
TodayJul 2026
First PostedNov 4, 2013
Enrollment StartApr 1, 2014
Primary CompletionMay 1, 2015
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.7 years ago
Interventions
75mg selumetinibdrug
selumetinib tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
placebodrug
placebo tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
Dacarbazinedrug
dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle taken in combination with either selumetinib or placebo tablets p.o. twice daily.