Recruiting

Erdafitinib for Recurrent or Progressive IDH-Wild Type Glioma with FGFR-TACC Fusion

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Study Aim

This study aims to evaluate the effectiveness of erdafitinib in treating adults with recurrent or progressive brain tumors that have a specific gene fusion but lack IDH mutation, by measuring the rate of tumor response.

What is being tested

Biospecimen Collection

+ Erdafitinib

+ Magnetic Resonance Imaging

ProcedureDrug
Who is being recruted

Glioma+5

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 4, 2024

Actual date on which the first participant was enrolled.

This clinical trial focuses on a specific group of patients with a type of brain tumor called IDH-wild type (IDH-WT) glioma. This glioma has a unique feature known as FGFR-TACC gene fusion. The main goal of this study is to test the effectiveness of a drug called erdafitinib in treating this condition. Researchers hope that this drug can help control or reduce the growth of these tumors, potentially leading to improved care for those affected by this form of glioma. In this study, participants will receive erdafitinib orally, once a day, for 28 days in a cycle. This cycle will repeat every 28 days unless there is disease progression or unacceptable side effects. Throughout the trial, patients will undergo regular magnetic resonance imaging (MRI), optical coherence tomography (OCT), and blood sample collection. There is also an optional tissue sample collection. The study's primary outcome is to measure the tumor's response to the treatment, while secondary outcomes include assessing the safety and tolerability of erdafitinib, overall survival, and progression-free survival at 6 months.

Official TitleA Phase 2 Study of Erdafitinib in Patients With Recurrent or Progressive IDH-Wild Type Glioma With an FGFR-TACC Gene Fusion
NCT05859334
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

GliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, Neuroepithelial

Criteria

23 inclusion criteria required to participate
Patient must be >= 18 years of age
Tumor tissue should be positive for FGFR-TACC gene fusion as per any local next generation sequencing (NGS) (Clinical Laboratory Improvement Act [CLIA]-approved) assay described in background section
There must be measurable disease (enhancing or non-enhancing as per Response Assessment in Neuro-Oncology [RANO] or RANO-low-grade glioma [LGG] criteria), as evaluated on pre-treatment MRI
Absolute neutrophil count >= 1000/uL
Show More Criteria
7 exclusion criteria prevent from participating
Corrected QT interval (QTc) prolongation as confirmed by electrocardiography (ECG) at screening (Fridericia; QTc > 480 milliseconds)
Pregnant women are excluded from this study because erdafitinib is an FGFR inhibitor agent with the potential for teratogenic or abortifacient effects
Patients who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to erdafitinib
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive erdafitinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI, OCT, and collection of blood samples throughout the trial. Additionally, patients may optionally undergo collection of tissue samples on study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 27 locations

Recruiting

UCHealth University of Colorado Hospital

Aurora, United StatesOpen UCHealth University of Colorado Hospital in Google Maps
Recruiting

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, United States
Recruiting

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, United States
Recruiting

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, United States
Recruiting
27 Study Centers