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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
No Placebo-Only Group

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR)
Secondary study objectives
Best overall response (BOR)
Disease control rate
Incidence of adverse events (AEs)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infigratinib
2020
Completed Phase 2
~20

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
~0 spots leftby Dec 2024
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