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BRF113929: An Open-Label, Two-Cohort, Multicentre Study of GSK2118436 as a Single Agent in Treatment Naive and Previously Treated Subjects With BRAF Mutation-Positive Metastatic Melanoma to the Brain.

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Trial Profile

BRF113929: An Open-Label, Two-Cohort, Multicentre Study of GSK2118436 as a Single Agent in Treatment Naive and Previously Treated Subjects With BRAF Mutation-Positive Metastatic Melanoma to the Brain.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Dec 2022

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At a glance

  • Drugs Dabrafenib (Primary)
  • Indications Brain metastases; Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms Break-MB
  • Sponsors GlaxoSmithKline; GSK

Most Recent Events

  • 07 Dec 2022 Results assessing molecular and immunological changes associated with dabrafenib in MBMs and extracranial (ECM) metastases published in the Clinical Cancer Research
  • 02 Sep 2013 Dabrafenib was approved by the EC as oral monotherapy for unresectable/metastatic melanoma in patients with BRAF V600 mutation, based on data from BREAK-MB and BREAK-2 and -3, according to a GlaxoSmithKline media release.
  • 08 Jun 2012 Actual patients number is 172 as reported by ClinicalTrials.gov.

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