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Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib (GSK1120212) Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer

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Trial Profile

Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib (GSK1120212) Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 21 Apr 2023

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At a glance

  • Drugs Trametinib (Primary) ; Capecitabine; Fluorouracil; Folinic acid
  • Indications Biliary cancer; Cholangiocarcinoma; Gallbladder cancer; Liver cancer
  • Focus Therapeutic Use

    • Most Recent Events

    • 29 Mar 2020 Interim results of planned futility analysis (data cutoff: 24 April 2015) of unselected population were published in the European Journal of Cancer
    • 06 Jun 2017 Status changed from active, no longer recruiting to discontinued based on the lack of measurable response in the trametinib arm, according to the results presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
    • 06 Jun 2017 Primary endpoint (Overall survival) has not been met, according to the results presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
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