This is a 2-part, study to determine the safety, tolerability and pharmacokinetics of oral dabrafenib in children and adolescent subjects with advanced BRAF V600 mutation-positive solid tumors.

Principal Investigator:
Ashley Plant, MD

Research Coordinator:
Laura Gates
(714) 509-8646

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  • Clinical Trial Info
  • IRB Number: 130995
  • Sponsor: GlaxoSmithKline
  • Protocol Number: GSK Dabrafenib
  • NCT Number: NCT01677741
  • Research Type: Brain Tumor/ Centra Nervous System/Neuro-Oncology, Solid Tumors
  • Phase: I / II
  • Status: Active

Key Inclusion Criteria:

  • Age:  >=12 months and <18 years of age at the time of signing the informed consent form.
  • BRAF V600 mutation-positive tumor as confirmed in a Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory or equivalent (the local BRAF testing may be subject to subsequent verification by centralized testing; centralized testing can confirm V600E and V600K mutations only).
  • Must have adequate organ function

Key Exclusion Criteria:

  • Part 2 ONLY: Previous treatment with dabrafenib, another RAF inhibitor, or a mitogen-activated protein kinase (MEK) inhibitor (exception: prior treatment with sorafenib is permitted).
  • Malignancy OTHER than the BRAF mutant malignancy under study.
  • Had chemotherapy or radiotherapy within 3 weeks prior to administration of the first dose of study treatment.
  • Autologous or allogeneic stem cell transplant within 3 months prior to enrolment [NOTE: subjects with evidence of active graph versus host disease are excluded].
  • History of myocardial infarction, severe or unstable angina, peripheral vascular disease or familial QTc prolongation.
  • Subjects with abnormal cardiac valve morphology (>=grade 2) documented by echocardiogram
  • Subjects with moderate valvular thickening.
  • Known, uncontrolled cardiac