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A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial

Trial Profile

A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2024

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At a glance

  • Drugs Infigratinib (Primary) ; Cisplatin; Gemcitabine
  • Indications Cholangiocarcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms PROOF 301; The PROOF Trial
  • Sponsors QED Therapeutics
  • Most Recent Events

    • 20 Jan 2024 Results assessing safety and efficacy of infigratinib vs. gemcitabine plus cisplatin in patients with advanced cholangiocarcinoma presented at the 2024 Gastrointestinal Cancers Symposium
    • 29 Mar 2023 Status changed from active, no longer recruiting to discontinued.
    • 26 Mar 2023 This trial has been completed in Germany (Date of the global end of the trial: 01-Mar-2023), according to the European Clinical Trials Database record.
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