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.
Phase of Trial: Phase II
Latest Information Update: 05 Jun 2015
At a glance
- Drugs Dabrafenib (Primary)
- Indications Brain metastases; Malignant melanoma
- Focus Registrational; Therapeutic Use
- Acronyms Break-MB
- Sponsors GlaxoSmithKline
- 10 Jun 2017 Biomarkers information updated
- 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.