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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

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 (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