NCT01974752

Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

Selumetinib therapy in patients with metastatic uveal melanoma.

Detailed description

A randomised double-blind study to assess the efficacy of selumetinib (AZD6244, Hyd-Sulfate) in combination with Dacarbazine compared with placebo in combination with Dacarbazine as first systemic therapy in patients with metastatic uveal melanoma (SUMIT)

Conditions

• Metastatic
• Uveal Melanoma

Interventions

Type	Name	Description
DRUG	75mg selumetinib	selumetinib tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
DRUG	placebo	placebo tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
DRUG	Dacarbazine	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.

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-05-01
• Completion: 2016-10-01
• First posted: 2013-11-04
• Last updated: 2017-01-05
• Results posted: 2016-09-28

Locations

31 sites across 11 countries: United States, Belgium, Canada, Czechia, Finland, France, Germany, Israel, Netherlands, Spain, United Kingdom