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Trial record 1 of 1 for:    Fight-209
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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 (FIGHT-209)

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ClinicalTrials.gov Identifier: NCT05267106
Recruitment Status : Recruiting
First Posted : March 4, 2022
Last Update Posted : May 18, 2023
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Glioblastoma Adult-type Diffuse Gliomas Drug: Pemigatinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study consists of 2 cohorts and participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule.
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 20, 2022
Estimated Primary Completion Date : January 30, 2026
Estimated Study Completion Date : January 30, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Pemigatinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A: IDH-wild-type GBM
Participants with histopathologically proven, WHO Grade 4, IDH-wild-type GBM OR molecular diagnosis of IDH-wild-type, diffuse astrocytic glioma with molecular features of Grade 4 GBM that are recurrent, harboring FGFR1-3 fusions/or other rearrangements, or with a defined FGFR1-3 mutation or in-frame deletion.
 Drug: Pemigatinib
13.5mg tablet taken every morning (unless otherwise directed) for 2 weeks and then 1 week off.
Other Name: NCB054828
Experimental: Cohort B: Other gliomas other than GBM
Participants with other histopathologically proven gliomas other than GBM, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors that are recurrent, harboring FGFR1-3 fusions/or other rearrangements or with a defined FGFR1-3 activating mutation or in-frame deletion
 Drug: Pemigatinib
13.5mg tablet taken every morning (unless otherwise directed) for 2 weeks and then 1 week off.
Other Name: NCB054828


Outcome Measures
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Primary Outcome Measures :
  1. Cohort A: Overall Response Rate (ORR) [ Time Frame: Up to 3 months ]
    Defined as the proportion of participants in Cohort A who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Assessment in Neuro-Oncology (RANO) as determined by an Independent Central Radiology (ICR).


Secondary Outcome Measures :
  1. Cohort B : ORR [ Time Frame: up to 3 months ]
    Defined as the proportion of participants who achieve a CR or PR based on RANO. Response will be determined by an ICR review.

  2. Cohorts A and B combined: ORR [ Time Frame: Up to 3 months ]
    Defined as the proportion of participants in Cohorts A and B who achieve a BOR of CR or PR based on RANO as determined by an ICR.

  3. Cohorts A and B: Disease Control Rate (DCR) [ Time Frame: Up to 3 months ]
    Defined as the proportion of participants who achieve a CR, PR, or SD as assessed by ICR in cohorts A and B respectively

  4. Cohorts A and B: Progression-Free Survival (PFS) [ Time Frame: Up to 3 months ]
    Defined as the time from first dose until progressive disease (according to RANO and assessed by an ICR) or death (whichever occurs first) in cohorts A and B, respectively

  5. Cohorts A and B: Overall Survival (OS) [ Time Frame: Up to 3 months ]
    Defined as the time from first dose of study drug to death due to any cause in cohorts A and B respectively

  6. Safety and tolerability [ Time Frame: Up to 3 months ]
    Safety and tolerability in each cohort, assessed by monitoring the frequency and severity of AEs according to NCICTCAE v5.0.

  7. Cohorts A and B : Duration Of Response (DOR) [ Time Frame: up to 3 months ]
    Defined as the time from first assessment of Complete Response (CR) or Partial Response (PR) until progressive disease (according to RANO and assessed by an ICR), or death (whichever occurs first) in cohorts A and B, respectively


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05267106


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Victoria Ebiana, MD Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT05267106    
Other Study ID Numbers: INCB 54828-209
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
glioblastoma
GBM
adult-type diffuse gliomas
gliomas
oligodendroglioma
FGFR1-3 Alteration
FGFR1-3 fusions
FGFR1-3 rearrangements
 Central nervous system tumor
isocitrate dehydrogenase
IDH-mutant astocytoma
IDH-wild-type GBM
glioneuronal
neuronal
circumscribed astrocytic glioma
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases