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A Phase II (BRF113710) single-arm, open-label study of GSK2118436 (dabrafenib) in BRAF mutant metastatic melanoma

Trial Profile

A Phase II (BRF113710) single-arm, open-label study of GSK2118436 (dabrafenib) in BRAF mutant metastatic melanoma

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Sep 2023

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At a glance

  • Drugs Dabrafenib (Primary)
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms BREAK-2
  • Sponsors GlaxoSmithKline; GSK
  • Most Recent Events

    • 18 Dec 2019 Results assessing long term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy using data from phase 2 and 3 clinical trials (BREAK-2, NCT01153763; BREAK-3, NCT01227889) published in the European Journal of Cancer
    • 06 Jun 2017 Results of 5 year landmark analysis for phase II BREAK 2 (data cutoff date 17 Jun 2016) and phase III BREAK 3 (data cutoff date 6 Sep 2016) studies evaluating dabrafenib monotherapy in patients with BRAF V600-mutant melanoma, presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 31 May 2014 Planned End Date changed from 1 Aug 2012 to 1 Feb 2016 as reported by ClinicalTrials.gov record.
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