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Tyrosine Kinase Inhibitor

BGJ398 (infigratinib) for Cholangiocarcinoma

Phase 2
Waitlist Available
Research Sponsored by QED Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up analysis conducted when all subjects in cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. data cutoff 01 march 2021.
Awards & highlights

Summary

This trial is testing a drug called BGJ398 on patients with a certain kind of cancer. The drug is designed to target tumors with genetic alterations in a protein called FGFR.

Eligible Conditions
  • Cholangiocarcinoma
  • FGFR2 Mutation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~analysis was conducted when all subjects in cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. data cutoff 01 march 2021.
This trial's timeline: 3 weeks for screening, Varies for treatment, and analysis was conducted when all subjects in cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. data cutoff 01 march 2021. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR)
Secondary outcome measures
Best Overall Response (BOR)
Disease Control Rate (DCR)
Duration of Response (DOR)
+4 more
Other outcome measures
Growth Modulation Index (GMI)

Side effects data

From 2023 Phase 2 trial • 158 Patients • NCT02159066
23%
Anaemia
23%
Oedema peripheral
23%
Hypoalbuminaemia
15%
Blood creatine increased
15%
Visual field defect
15%
Urinary tract infection
15%
Diarrhoea
15%
Nausea
15%
Blood creatine phosphokinase increased
15%
Blood creatinine increased
15%
Gamma-glutamyltransferase increased
8%
Blood alkaline phosphatase increased
8%
Pain in extremity
8%
Femur fracture
8%
Pyrexia
8%
Colitis
8%
Intestinal perforation
8%
Cardiac failure
8%
Cardiac arrest
8%
Gastrointestinal haemorrhage
8%
Cancer pain
8%
Aphasia
8%
Constipation
8%
Vomiting
8%
Fatigue
8%
Alanine aminotransferase increased
8%
Rash maculo-papular
8%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part II: Encorafenib + Binimetinib + Capmatinib
Part I: Encorafenib + Binimetinib (Naive)
Part I: Encorafenib + Binimetinib (Non-naive)
Part II: Encorafenib + Binimetinib + Ribociclib
Part II: Encorafenib + Binimetinib + Infigratinib
Part II: Encorafenib + Binimetinib + Buparlisib

Trial Design

1Treatment groups
Experimental Treatment
Group I: BGJ398 (infigratinib)Experimental Treatment1 Intervention
To estimate the anti-tumor activity of BGJ398 (infigratinib)

Find a Location

Who is running the clinical trial?

QED Therapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
985 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
48 Patients Enrolled for Cholangiocarcinoma
Helsinn Healthcare SAIndustry Sponsor
41 Previous Clinical Trials
9,318 Total Patients Enrolled
2 Trials studying Cholangiocarcinoma
48 Patients Enrolled for Cholangiocarcinoma
QED TherapeuticsStudy DirectorQED Therapeutics
~13 spots leftby Sep 2025
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