NCT03656536

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

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: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unresectable Cholangiocarcinoma
• Metastatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Pemigatinib	Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).
DRUG	Gemcitabine	Gemcitabine 1000 mg/m\^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.
DRUG	Cisplatin	Cisplatin 25 mg/m\^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.

Timeline

• Start date: 2019-06-03
• Primary completion: 2025-07-07
• Completion: 2025-07-07
• First posted: 2018-09-04
• Last updated: 2025-08-24

Locations

215 sites across 19 countries: United States, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study