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Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG) P/260/2017

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Trial Profile

Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG) P/260/2017

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 18 Dec 2023

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At a glance

  • Drugs Dabrafenib (Primary) ; Trametinib (Primary) ; Carboplatin; Vincristine
  • Indications Glioma
  • Focus Registrational; Therapeutic Use
  • Acronyms TADPOLE
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals

    • Most Recent Events

    • 12 Sep 2023 Results (n=110) assessing OR and PFS in patients with pediatric low-grade glioma with BRAF V600 mutations who were scheduled to receive first-line therapy, published in the New England Journal of Medicine.
    • 29 Aug 2023 Results (n=41) in pediatric patients, published in the Journal of Clinical Oncology
    • 31 May 2023 The trial has been completed in Finland, according to European Clinical Trials Database record.
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