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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
Trial ID: NCT05267106
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.
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)
- 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.
- 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
- 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
- Diffuse leptomeningeal disease.
- Radiation therapy administered within 12 weeks before enrollment/first dose of study
- Known additional malignancy that is progressing or requires active systemic treatment.
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