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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
Not Recruiting
Trial ID: NCT05267106
Purpose
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)
Stanford Investigator(s)
Michael Lim, M.D.
Professor of Neurosurgery and, by courtesy, of Radiation Oncology (Radiation Therapy), of Medicine (Oncology), of Otolaryngology - Head & Neck Surgery (OHNS) and of Neurology
Eligibility
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.
Intervention(s):
drug: Pemigatinib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Leeza Kopaeva
650-723-4467