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Tyrosine Kinase Inhibitor

Infigratinib for Solid Tumors

Phase 2
Waitlist Available
Led By Sameek Roychowdhury, M.D.
Research Sponsored by Sameek Roychowdhury
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 up to 1 year post-treatment
Awards & highlights

Study Summary

This trial is studying how well infigratinib works in treating patients with solid tumors that have spread to other places in the body and have FGFR gene mutations.

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors that have specific FGFR gene mutations. Participants must have tried at least one standard treatment and still show signs of the disease, be able to swallow pills, and comply with study procedures. People can't join if they have primary brain cancer or untreated brain metastases, severe eye disorders, significant tissue calcification, gastrointestinal issues affecting drug absorption, abnormal calcium/phosphate metabolism, recent use of certain drugs including strong CYP3A4 inhibitors/inducers or those prolonging QT interval.Check my eligibility
What is being tested?
The trial tests Infigratinib's effectiveness on patients with advanced solid tumors harboring FGFR gene mutations. It aims to see if this oral medication can stop tumor growth by inhibiting over-active FGFR proteins caused by these genetic changes.See study design
What are the potential side effects?
Infigratinib may cause side effects such as dry eyes or vision problems due to corneal inflammation; high phosphate levels leading to muscle problems; liver enzyme elevations which could indicate liver damage; fatigue; and potential heart rhythm abnormalities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-treatment 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)
Secondary outcome measures
Best overall response (BOR)
Disease control rate
Incidence of adverse events (AEs)
+2 more

Side effects data

From 2023 Phase 2 trial • 158 Patients • NCT02159066
23%
Hypoalbuminaemia
23%
Oedema peripheral
23%
Anaemia
15%
Visual field defect
15%
Blood creatine increased
15%
Gamma-glutamyltransferase increased
15%
Urinary tract infection
15%
Nausea
15%
Diarrhoea
15%
Blood creatine phosphokinase increased
15%
Blood creatinine increased
8%
Colitis
8%
Pyrexia
8%
Femur fracture
8%
Constipation
8%
Blood alkaline phosphatase increased
8%
Pain in extremity
8%
Rash maculo-papular
8%
Cancer pain
8%
Cardiac arrest
8%
Gastrointestinal haemorrhage
8%
Intestinal perforation
8%
Aphasia
8%
Vomiting
8%
Cardiac failure
8%
Fatigue
8%
Alanine aminotransferase increased
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: Treatment (infigratinib)Experimental Treatment1 Intervention
Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

Sameek RoychowdhuryLead Sponsor
2 Previous Clinical Trials
22 Total Patients Enrolled
Sameek Roychowdhury, M.D.Principal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center

Frequently Asked Questions

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

What types of medical goals is Infigratinib typically employed to achieve?

"Infigratinib is a viable treatment option for human patients with unresectable, metastatic cholangiocarcinomas expressing the FGFR2 protein in addition to those who have established advance directives."

Answered by AI

What is the size of the participant cohort in this research endeavor?

"Confirmatively, clinicaltrials.gov shows that this medical trial is in pursuit of qualified individuals. It was first advertised on January 16th 2020 and the most recent update occured February 15th 2022; 50 people are needed to be enrolled at a single location."

Answered by AI

Is enrollment into this research endeavor currently open?

"Affirmative, the clinical trial is currently searching for participants. The original posting date was on January 16th 2020 and it has been updated most recently on February 15th 2022. This medical trial seeks to find 50 patients at one site."

Answered by AI

Has Infigratinib been the subject of prior experimental research?

"Presently, 10 studies are underway analysing the effects of infigratinib. Of those clinical trials, 2 have advanced to Phase 3. Although Columbus, Ohio is the primary research location for this treatment modality, there are 358 centres running some type of trial related to it."

Answered by AI

What adverse effects can be associated with Infigratinib?

"Despite having no clinical data testifying to Infigratinib's efficacy, its safety was rated a 2 based on the existing research available."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations
Sameek Roychowdhury 2020. "Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04233567.
~3 spots leftby Apr 2025
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