A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

Trial Profile

A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2017

At a glance

  • Drugs Dabrafenib (Primary) ; Dacarbazine
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms BREAK-3
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 03 Aug 2017 Status changed from active, no longer recruiting to completed.
    • 10 Jun 2017 Biomarkers information updated
    • 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.
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