MedTrace Logo

Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements

NCT05565794 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-04-13

No results posted yet for this study

Summary

The aim of this phase II study is to determine whether pemigatinib is clinically efficious after curative local therapy such as surgery/ SBRT or ablation in iCCA patients harboring FGFR2 fusion/rearrangement and to assess the safety profile to support the continuation of the concept in a large, randomized trial for further development.

Conditions

  • Intrahepatic Cholangiocarcinoma
  • FGFR2 Gene Mutation
  • FGFR2 Gene Rearrangement
  • FGFR2 Gene Translocation

Interventions

DRUG

Pemigatinib

Intake of up to 3 tablets of pemigatinib (4,5 mg each) daily per oral for 14 days in a 21-day cycle (maximum of 18 cycles in total)

Sponsors & Collaborators

  • Incyte Biosciences International Sàrl

    collaborator INDUSTRY

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Thorsten Goetze, Prof. Dr. · Krankenhaus Nordwest, Frankfurt

  • Salah-Eddin Al-Batran, Prof. Dr. · Institut für Klinische Krebsforschung IKF GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2025-03-27
Completion
2025-03-27

Countries

  • Germany

Study Locations

More Related Trials

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 NCT05565794 on ClinicalTrials.gov