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

NCT03656536 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2025-08-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Peter Langmuir, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2025-07-07
Completion
2025-07-07
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • China
  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03656536 on ClinicalTrials.gov