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Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

NCT03773302 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-05-08

Study results available
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Summary

Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.

Conditions

  • Advanced Cholangiocarcinoma
  • FGFR2 Gene Mutation

Interventions

DRUG

BGJ398

Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.

DRUG

Cisplatin

Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.

Sponsors & Collaborators

  • Helsinn Healthcare SA

    collaborator INDUSTRY

  • QED Therapeutics, Inc., a Bridgebio company

    lead INDUSTRY

Principal Investigators

  • Clinical Development · QED Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-27
Primary Completion
2023-03-02
Completion
2023-03-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Italy
  • Portugal
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03773302 on ClinicalTrials.gov