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A Phase II, Open-label, Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib

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Trial Profile

A Phase II, Open-label, Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Aug 2023

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At a glance

  • Drugs Dabrafenib (Primary) ; Trametinib (Primary)
  • Indications Adenocarcinoma; Anaplastic astrocytoma; Biliary cancer; Cholangiocarcinoma; Gallbladder cancer; Gastrointestinal stromal tumours; Germ cell cancer; Glioblastoma; Glioma; Hairy cell leukaemia; Intestinal cancer; Multiple myeloma; Thyroid cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ROAR
  • Sponsors GlaxoSmithKline; GSK; Novartis; Novartis Pharmaceuticals

    • Most Recent Events

    • 01 May 2023 Results published in the Nature Medicine
    • 19 Apr 2023 Results assessing the efficacy and safety of dabrafenib (150 mg BD) plus trametinib (2 mg OD) in patients (eight cohorts) with BRAFV600E-mutated advanced rare cancers, presented at the 114th Annual Meeting of the American Association for Cancer Research.
    • 15 Sep 2022 Results (n=55) reporting efficacy and safety of dabrafenib plus trametinib in patients with relapsed/refractory BRAF V600E mutation-positive HCL published in the Blood
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