A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

Official Title

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicentre 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)

Summary:

The purpose of this study is 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.

Trial Description

Primary Outcome:

  • Progression-free survival
Secondary Outcome:
  • Overall response rate
  • Overall survival
  • Duration of response
  • Disease control rate
  • Number of treatment-emergent adverse events
  • Quality of Life impact as assessed by the EQ-5D-3L questionnaire
  • Quality of Life impact as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire
  • Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society

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