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

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT01974752
Phase
PHASE3
Status
Completed

Conditions

  • Metastatic
  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

Selumetinib therapy in patients with metastatic uveal melanoma.

Key Dates

Start date
Apr 30, 2014
Status verified
Jan 2017
Primary completion
May 31, 2015
Completion
Oct 31, 2016

Study Design

Enrollment
152 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: selumetinib 75mg twice daily
    selumetinib 75mg twice daily in combination with dacarbazine.
  • Placebo Comparator: placebo twice daily
    placebo twice daily in combination with dacarbazine.

Primary Outcome Measure

Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1. [ Time Frame: From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia--
Research SiteAuroraColorado--
Research SiteAtlantaGeorgia--
Research SiteLuthervilleMaryland--
Research SiteSt LouisMissouri--
Research SiteNew YorkNew York--
Research SitePhiladelphiaPennsylvania--

Find similar trials in Los Angeles, CA

By research site
Research Site· Los Angeles, CAResearch Site· Aurora, COResearch Site· Atlanta, GAResearch Site· Lutherville, MDResearch Site· St Louis, MOResearch Site· New York, NY

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