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

NCT01974752 · SUMIT Phase 3Completed

Lead sponsor
AstraZeneca (Industry)
Enrollment
152 (actual)
Start date
1 Apr 2014
Primary completion
May 2015 (actual)
Study completion
1 Oct 2016
Last update posted
5 Jan 2017

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • 75mg selumetinib Drug
  • placebo Drug
  • Dacarbazine Drug

Conditions and primary outcome

  • Metastatic
  • Uveal Melanoma

Primary outcome

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. (From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT01974752 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. 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
    Measure
    Number
    Unit
    number of progression events

    • Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 vs Placebo + Dacarbazine 1000 mg/m2Superiority or other

      Estimate
      0.78Hazard Ratio (HR)
      95% CI, two-sided
      0.48 to 1.27
      p-value
      0.3195
      Method
      Log Rank

Serious adverse events

Time frame: From informed consent up until end of double blind period

Participants with serious adverse events per group for SUMIT, as posted
GroupAffectedAt risk
Placebo + Dacarbazine 1000 mg/m2232
Selumetinib 75 mg BD + Dacarbazine 1000 mg/m22097

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

  1. Selumetinib in Combination With Dacarbazine in Patients With Metastatic Uveal Melanoma: A Phase III, Multicenter, Randomized Trial (SUMIT).

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018 Apr 20

    PubMed 29528792 (opens in a new tab)DOI 10.1200/JCO.2017.74.1090 (opens in a new tab)

  2. Study design and rationale for a randomised, placebo-controlled, double-blind study to assess the efficacy of selumetinib (AZD6244; ARRY-142886) in combination with dacarbazine in patients with metastatic uveal melanoma (SUMIT).

    BMC cancer · 2015 Jun 10

    PubMed 26059332 (opens in a new tab)DOI 10.1186/s12885-015-1470-z (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.