Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated … (NCT05267106) | Clinical Trial Compass
TerminatedPhase 2
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: Recruitment ceased after a pre-planned futility interim analysis indicated a low probability to confer a clinically meaningful improvement in objective response when compared to currently available therapies. There were no safety related concerns.
United States83 participantsStarted 2022-05-20
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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 rath…
What they're measuring
1
Objective Response Rate (ORR) in Participants With Recurrent Glioblastoma Based on Independent Central Review