Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

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.

Official Title

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)

Keywords

Unresectable Cholangiocarcinoma, Metastatic Cholangiocarcinoma, Cholangiocarcinoma, fibroblast growth factor receptor inhibitor, FGFR, FGFR rearrangement, Gemcitabine, Pemigatinib, Cisplatin, Gemcitabine + Cisplatin

Eligibility

Locations

  • UC Irvine Medical Center
    Orange California 92868-3201 United States
  • Marin Cancer Care
    Greenbrae California 94904 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT03656536
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 167 people participating
Last Updated