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Tyrosine Kinase Inhibitor

BGJ398 for Cholangiocarcinoma

Phase 3
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 approximately 15 months on average
Awards & highlights

Study Summary

This trial is testing a new drug, infigratinib, to see if it is better than the current standard of care chemotherapy for treating people with a certain type of cancer, cholangiocarcinoma, that has a specific gene mutation.

Eligible Conditions
  • Cholangiocarcinoma
  • FGFR2 Mutation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 15 months on average
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 15 months on average for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (central imaging assessment)
Secondary outcome measures
Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by best overall response (BOR) determined by blinded independent central assessment and the investigator.
Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by disease control rate (PR+CR+SD) determined by blinded independent central assessment and the investigator.
Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by duration of response (DOR) determined by blinded independent central assessment and the investigator.
+4 more

Side effects data

From 2023 Phase 2 trial • 158 Patients • NCT02159066
23%
Hypoalbuminaemia
23%
Oedema peripheral
23%
Anaemia
15%
Gamma-glutamyltransferase increased
15%
Urinary tract infection
15%
Nausea
15%
Diarrhoea
15%
Blood creatine increased
15%
Visual field defect
15%
Blood creatine phosphokinase increased
15%
Blood creatinine increased
8%
Femur fracture
8%
Cancer pain
8%
Cardiac arrest
8%
Gastrointestinal haemorrhage
8%
Blood alkaline phosphatase increased
8%
Intestinal perforation
8%
Pyrexia
8%
Aphasia
8%
Vomiting
8%
Pain in extremity
8%
Rash maculo-papular
8%
Cardiac failure
8%
Colitis
8%
Fatigue
8%
Alanine aminotransferase increased
8%
Constipation
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

2Treatment groups
Experimental Treatment
Active Control
Group I: Infigratinib (BGJ398) 125 mgExperimental Treatment1 Intervention
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
Group II: Gemcitabine + CisplatinActive Control2 Interventions
Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib if certain criteria are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BGJ398
2009
Completed Phase 2
~480

Find a Location

Who is running the clinical trial?

QED Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
934 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
143 Patients Enrolled for Cholangiocarcinoma
Helsinn Healthcare SAIndustry Sponsor
41 Previous Clinical Trials
9,527 Total Patients Enrolled
2 Trials studying Cholangiocarcinoma
143 Patients Enrolled for Cholangiocarcinoma
Clinical DevelopmentStudy DirectorQED Therapeutics
34 Previous Clinical Trials
88,596 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
21 Patients Enrolled for Cholangiocarcinoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are included in the data pool for this research?

"Though this study was posted over 2 years ago and last updated less than a year ago, it is not currently recruiting patients. However, there are 1018 trials for BGJ398 that are currently admitting participants and 212 trials actively looking for participants with fgfr2 gene mutation."

Answered by AI

Does a wealth of research exist for BGJ398?

"At the moment, there are 1,018 ongoing clinical trials for BGJ398. Of these, 347 are in Phase 3. The majority of the trials for BGJ398 are based in Shanghai, but there are also 5,262 other locations around the world where studies are taking place."

Answered by AI

In how many different medical centers is this clinical trial being performed today?

"To limit travel as a barrier to participation, this study is recruiting patients from 29 sites that are close to major population centres. If you are interested in participating, please select the closest location to you from the list of 29."

Answered by AI

Will BGJ398 have any negative effects on patients?

"BGJ398 was given a 3 because, as a Phase 3 trial, there is both evidence of efficacy and extensive safety data."

Answered by AI

What maladies has BGJ398 shown to be an effective treatment for?

"BGJ398, while frequently used to treat patients that have undergone adjuvant anthracycline-based therapy in the past, can also be used to palliate a variety of other conditions, including neoplasm metastasis and urinary bladder cancer."

Answered by AI

Are there any remaining vacancies for test subjects in this experiment?

"This study is not looking for new participants at the moment. According to the latest update on clinicaltrials.gov, this trial was last updated on October 17th, 2022. If you are interested in other trials, there are 212 studies that are actively admitting patients with the fgfr2 gene mutation and 1018 trials for BGJ398 that are enrolling patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
2019. "Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03773302.
~9 spots leftby Apr 2025
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