Title
A Phase 2 Study of Erdafitinib in Patients with Recurrent or Progressive IDH-Wild Type Glioma with an FGFR-TACC Gene Fusion

Description
This phase II trial tests how well erdafitinib works in controlling IDH-wild type (WT) gliomas with FGFR-TACC gene fusion that have returned or that have grown, spread, or gotten worse (progressed). Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals tumor cells to multiply. This may help keep tumor cells from growing and may kill them. Giving erdafitinib may help to slow the growth of or to shrink tumor cells in patients with recurrent or progressive IDH-wild type gliomas with FGFR-TACC gene fusion.

Objective
PRIMARY OBJECTIVE:

I. To assess the preliminary anti-tumor activity of erdafitinib in patients with recurrent or progressive IDH-WT glioma with FGFR-TACC gene fusion as measured by the best response at any time during treatment in terms of objective response rate (ORR).

SECONDARY OBJECTIVES:

I. To determine the safety and tolerability of erdafitinib in patients with recurrent or progressive IDH-WT glioma with FGFR-TACC gene fusion.
II. To assess the overall survival (OS) of erdafitinib in patients with recurrent or progressive IDH-WT glioma with FGFR-TACC gene fusion.
III. To assess the progression free survival (PFS) at 6 months of patient with IDH-WT glioma with FGFR-TACC gene fusion treated with erdafitinib.

OUTLINE: This is a dose-escalation study of erdafitinib followed by a dose-expansion study.

Patients receive erdafitinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI), optical coherence tomography (OCT), and collection of blood samples throughout the trial.

After study completion, patients are followed up every 3 months for 2 years.

Treatment Experimental: Treatment (erdafitinib)
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.

Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names: Biological Sample Collection, Biospecimen Collected, & Specimen Collection

Drug: Erdafitinib
Given PO
Other Names: Balversa, JNJ-42756493

Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Procedure: Optical Coherence Tomography
Undergo OCT
Other Names: OCT & Optical Coherence Tomography (OCT)

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Brain/Central Nervous System

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital