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A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

Trial Profile

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Mar 2024

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At a glance

  • Drugs Pemigatinib (Primary) ; Cisplatin; Gemcitabine
  • Indications Cholangiocarcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms FIGHT-302
  • Sponsors Incyte Corporation
  • Most Recent Events

    • 17 Oct 2022 Planned End Date changed from 18 Feb 2028 to 27 Jul 2028.
    • 17 Oct 2022 Planned primary completion date changed from 20 Mar 2027 to 26 Oct 2027.
    • 16 Feb 2022 Planned number of patients changed from 432 to 434.
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