for people ages 18-99 (full criteria)
study started
completion around



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.

Official Title

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)


Glioblastoma, Adult-type Diffuse Gliomas, GBM, gliomas, oligodendroglioma, FGFR1-3 Alteration, FGFR1-3 fusions, FGFR1-3 rearrangements, Central nervous system tumor, isocitrate dehydrogenase, IDH-mutant astocytoma, IDH-wild-type GBM, glioneuronal, neuronal, circumscribed astrocytic glioma, Glioma, Nervous System Neoplasms, Central Nervous System Neoplasms, Pemigatinib, Other gliomas other than GBM


You can join if…

Open to people ages 18-99

  • 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.

You CAN'T join if...

  • 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.


  • University of California San Francisco
    San Francisco California 94143 United States
  • Providence St Joseph Hospital Orange Center For Cancer Prevention and Treatment
    Santa Monica California 90404 United States
  • Valkyrie Clinical Trials
    Beverly Hills California 90211 United States
  • Sharp Memorial Hospital
    San Diego California 92123 United States
  • Usc Norris Comprehensive Cancer Center
    Los Angeles California 90033 United States
  • Providence Medical Foundation
    Fullerton California 92835 United States
  • Stanford Neuroscience Health Center
    Sacramento California 94304 United States
  • City of Hope National Medical Center
    Duarte California 91010 United States


in progress, not accepting new patients
Start Date
Completion Date
Incyte Corporation
Phase 2 research study
Study Type
About 83 people participating
Last Updated