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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 : March 29, 2023
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE February 15, 2022
First Posted Date  ICMJE March 4, 2022
Last Update Posted Date March 29, 2023
Actual Study Start Date  ICMJE May 20, 2022
Estimated Primary Completion Date January 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2023)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2022)
  • 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).
  • Cohort B: ORR [ Time Frame: Up to 3 months ]
    Defined as the proportion of participants who achieve a CR or PR based on RECIST v1.1. Response will be determined by an ICR review.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2023)
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2022)
  • 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.
  • Cohorts A, B, and C combined: ORR [ Time Frame: Up to 3 months ]
    defined as the proportion of participants in Cohorts A, B, and C combined who achieve a BOR of CR or PR based on RANO as determined by an ICR.
  • Cohort C: ORR [ Time Frame: Up to 3 months ]
    defined as the proportion of participants in Cohort C who achieve a BOR of CR or PR based on RANO as determined by an ICR.
  • Cohorts A, B and C: ORR [ Time Frame: Up to 3 months ]
    proportion of participants in each cohort who achieve a BOR of CR or PR based on RANO as determined by investigator assessment
  • Cohorts A and B: Disease Control Rate (DCR) [ Time Frame: Up to 3 months ]
    described as the proportion of participants who achieve a CR, PR, or SD as assessed by ICR.
  • 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).
  • Cohorts A and B: Duration of Response (DOR) [ Time Frame: Up to 3 months ]
    defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (according to RANO and assessed by an ICR), or death (whichever is first).
  • 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 of any cause.
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 3 months ]
    TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Glioblastoma
  • Adult-type Diffuse Gliomas
Intervention  ICMJE Drug: Pemigatinib
13.5mg tablet taken every morning (unless otherwise directed) for 2 weeks and then 1 week off.
Other Name: NCB054828
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Pemigatinib
  • 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
    Intervention: Drug: Pemigatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2023)
164
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2022)
189
Estimated Study Completion Date  ICMJE January 30, 2026
Estimated Primary Completion Date January 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Denmark,   France,   Germany,   Italy,   Japan,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05267106
Other Study ID Numbers  ICMJE INCB 54828-209
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Current Responsible Party Incyte Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Incyte Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Victoria Ebiana, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP