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Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209)

NCT05267106•Incyte Corporation

View on ClinicalTrials.gov

Summary

This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histological, cytological, or molecular confirmation of recurrent GBM or other glioma, circumscribed astrocytic glioma, or glioneuronalor neuronal tumors that has recurred.
•Radiographically measurable disease.
•. -Karnofsky performance status ≥ 60.
•Life expectancy ≥ 12 weeks.
•Documentation of an actionable FGFR1-3 gene mutation or fusion/rearrangement from tissue : FGFR1-3 fusions or other rearrangements (FGFR1-3 in-frame fusions, any FGFR2 rearrangement, or FGFR1/3 rearrangement with known partner) or a defined FGFR1-3 activating mutation or in-frame deletion. Only participants with FGFR fusions or rearrangements with an intact kinase domain are eligible.
•MRI-documented objective progression after prior therapy and must have no therapy available that is likely to provide clinical benefit.
•Most recent archival tumor specimen must be a tumor block or a minimum of 15 unstained slides from biopsy or resection of primary tumor or metastasis.
•Willingness to avoid pregnancy or fathering children.

Exclusion Criteria

•Prior receipt of an FGFR inhibitor.
•Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of study drug.
•Participants may have had treatment for an unlimited number of prior relapses but must not have had prior bevacizumab or other VEGF/VEGFR inhibitors (exception: prior bevacizumab is allowed if it was administered for the treatment of radiation necrosis rather than progressive tumor and was stopped at least 12 weeks prior to MRI showing tumor progression).
•Concurrent anticancer therapy
•Candidate for potentially curative surgery.
•Dexamethasone (or equivalent) \> 4 mg daily at the time of study registration
•Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
•Diffuse leptomeningeal disease.
•Radiation therapy administered within 12 weeks before enrollment/first dose of study drug.
•Known additional malignancy that is progressing or requires active systemic treatment.

Locations (79)

Valkyrie Clinical Trials

Beverly Hills, California, United States

City of Hope National Medical Center

Duarte, California, United States

Providence Medical Foundation

Fullerton, California, United States

Usc Norris Comprehensive Cancer Center

Los Angeles, California, United States

Stanford Neuroscience Health Center

Sacramento, California, United States

Sharp Memorial Hospital

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

Providence St Joseph Hospital Orange Center For Cancer Prevention and Treatment

Santa Monica, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Baptist Md Anderson Cancer Center

Jacksonville, Florida, United States

Key Dates

Start Date

May 20, 2022

Primary Completion Date

December 17, 2024

Completion Date

December 17, 2024

Last Updated

December 30, 2025

Enrollment

ACTUAL participants

Conditions

GlioblastomaAdult-type Diffuse Gliomas

Interventions

Pemigatinib

DRUG

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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RECRUITING

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

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