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Kinase Inhibitor

Erdafitinib for Brain Cancer

Phase 2
Recruiting
Led By Macarena I De La Fuente
Research Sponsored by National Cancer Institute (NCI)
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 2 years
Awards & highlights

Summary

This trial will test a drug (erdafitinib) to see if it can help slow/shrink IDH-WT gliomas with an abnormal FGFR protein.

Who is the study for?
Adults with specific brain cancers called IDH-wild type gliomas that have returned or worsened, despite previous treatments. Participants must be over 18 and have tumors with a particular gene fusion (FGFR-TACC). The cancer should show growth on scans and not be due to other conditions like radiation effects or infections.
What is being tested?
The trial is testing Erdafitinib, a drug designed to block abnormal proteins in tumor cells which may slow down or shrink the growth of recurrent or progressive brain tumors. It includes imaging tests like MRI and collecting tissue samples to study the drug's effect.
What are the potential side effects?
Erdafitinib can cause side effects such as fatigue, diarrhea, dry skin, changes in nail and hair health, mouth sores, decreased appetite, altered taste sensation, muscle pain and could potentially affect liver function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate
Secondary study objectives
Incidence of adverse events (AEs) and serious AEs
Incidence of dose-limiting toxicities
Overall survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (erdafitinib)Experimental Treatment4 Interventions
Patients receive erdafitinib PO QD in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI, OCT, and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Optical Coherence Tomography
2016
Completed Phase 2
~2610
Biospecimen Collection
2004
Completed Phase 3
~2020
Erdafitinib
2017
Completed Phase 2
~150
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,965 Total Patients Enrolled
326 Trials studying Glioblastoma
23,147 Patients Enrolled for Glioblastoma
Macarena I De La FuentePrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
~23 spots leftby Oct 2026
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