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

Stopped early · Phase 2

Conditions studied: Glioblastoma, Adult-type Diffuse Gliomas

In brief

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.

Key facts

Study ID

NCT05267106

Run by

Incyte Corporation

People needed

83

Starts

2022-05-20

Expected to finish

2024-12-17

Last updated by the study team

2025-12-30

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• 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
• Miami Cancer Institute — Miami, Florida, United States
• Orlando Health Cancer Institute Downtown Orlando — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute Hospital — Tampa, Florida, United States
• University of Illinois Hospital & Health Sciences System — Chicago, Illinois, United States
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• University of Minnesota Health Clinics and Surgery Center — Minneapolis, Minnesota, United States
• Northwell Health — Lake Success, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• UC Health At Cincinnati Va Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Valkyrie Clinical Trials — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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