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)

  • STATUS
    Recruiting
  • End date
    Jan 30, 2026
  • participants needed
    164
  • sponsor
    Incyte Corporation
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Updated on 28 August 2023
See if I qualify
measurable disease
karnofsky performance status
FGFR1
EGFR
temozolomide
astrocytoma
oligodendroglioma
recurrent tumor
TERT
ccnu

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.

Details
Condition Glioblastoma, Adult-type Diffuse Gliomas
Treatment pemigatinib
Clinical Study IdentifierNCT05267106
SponsorIncyte Corporation
Last Modified on28 August 2023

Eligibility

 Yes No Not Sure

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
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
Life expectancy ≥ 12 weeks
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
Concurrent anticancer therapy
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
Radiation therapy administered within 12 weeks before enrollment/first dose of study drug
Known additional malignancy that is progressing or requires active systemic treatment
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)
Candidate for potentially curative surgery
Diffuse leptomeningeal disease
Clear my responses
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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