drugset / Trial / NCT03656536

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

NCT03656536

Phase 3 Terminated 167 enrolled Incyte Corporation
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-06-03
Primary completion
2025-07-07
Completion
2025-07-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 25 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Pemigatinib Small molecule 13.5 mg Oral

Indications