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Clinical Trial 21785

Cancer Type: Neurologic Oncology
Study Type: Treatment
NCT#: NCT05267106

Phase: Phase II
Principal Investigator: Pina, Yolanda (Yoly)

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study 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)

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.

Objective

Primary Objectives: To determine the efficacy of pemigatinib in participants with recurrent GBM or other primary CNS tumors with an activating FGFR1-3 mutation or fusion/rearrangement. Secondary Objectives: - To determine the efficacy of pemigatinib in participants with recurrent GBM or other primary CNS tumors with an activating FGFR1-3 mutation or fusion/rearrangement. - To determine the safety and tolerability of pemigatinib in participants with recurrent GBM or other primary CNS tumors with an activating FGFR1-3 mutation and/or fusion/rearrangement.

Treatments

Therapies

Therapy (NOS)

Medications

Pemigatinib ()

Inclusion Criteria

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.
  • Other criteria may apply

    • Exclusion Criteria

    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.
  • Other criteria may apply

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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