MedTrace Logo

A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

NCT02150967 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2023-07-03

Study results available
· View outcomes & findings →

Summary

This is a multi-center, open label, single arm phase II study evaluating BGJ398 (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with fibroblast growth factor receptor (FGFR) genetic alterations.

Conditions

  • Advanced Cholangiocarcinoma
  • FGFR2 Gene Mutation

Interventions

DRUG

BGJ398 (infigratinib)

Capsule for oral use

Sponsors & Collaborators

  • Helsinn Healthcare SA

    collaborator INDUSTRY

  • QED Therapeutics, Inc., a Bridgebio company

    lead INDUSTRY

Principal Investigators

  • QED Therapeutics · QED Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-23
Primary Completion
2021-03-01
Completion
2022-02-07
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Italy
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

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 NCT02150967 on ClinicalTrials.gov