Myeloproliferative neoplasms (MPN)

A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

Incyte Study ID:
INCB 54828-203
CT.gov ID:
NCT03011372
View Results Summary
Eudra ID:
2016-002596-10
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Myeloproliferative neoplasms (MPN)
    • PRODUCT
  • Drug: Pemigatinib
    • COLLABORATORS
    N/A
    DATE
    Apr 2017 - Oct 2024
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    MD ANDERSON CANCER CENTER
    HOUSTON, TX, US, 77030
    Name
    WASHINGTON UNIVERSITY SCHOOL OF MEDICINE
    SAINT LOUIS, MO, US, 63110
    Name
    STANFORD CANCER INSTITUTE
    STANFORD, CA, US, 94305
    Name
    MAYO CLINIC ARIZONA
    PHOENIX, AZ, US, 85054
    Name
    CITY OF HOPE NATIONAL MEDICAL CENTER
    DUARTE, CA, US, 91010
    Name
    EMORY UNIVERSITY - WINSHIP CANCER INSTITUTE
    ATLANTA, GA, US, 30322

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
    • Eligible subjects must:

    Exclusion Criteria

    • Prior receipt of a selective FGFR inhibitor.
    • History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, except calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.

    Protocol Summary

    Incyte Study ID:
    INCB 54828-203
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    47
    Primary Outcome
    Open

    The proportion of participants who achieve Complete Response (CR) based on response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement

    Timeframe: : Assessed at protocol-defined timepoints through end of study, up to approximately 24 months.

    Secondary Outcome
    Open

    The proportion of subjects who achieve response, defined as a best response of CR or PR, as determined by investigator assessment according to the response criteria

    Timeframe: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months.

    The proportion of subjects who achieve a complete cytogenetic response (CCyR) as assessed by local analysis and investigator evaluation

    Timeframe: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months.

    The proportion of subjects who achieve a partial cytogenetic response (PCyR) as assessed by local analysis and investigator evaluation

    Timeframe: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months.

    Duration of CR, defined as the time from first assessment of CR to the earlier of disease progression or death due to any cause

    Timeframe: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months.

    Duration of response, defined as the time from first assessment of CR or PR to the earlier of disease progression or death due to any cause

    Timeframe: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months.

    Progression-free survival (PFS)

    Timeframe: From the date of first study drug dose until the date of disease progression or until death due to any cause, whichever is earlier, assessed up to approximately 24 months.

    Overall survival

    Timeframe: From date of first study drug dose until death due to any cause, assessed up to approximately 24 months.

    Safety and tolerability as assessed by frequency, duration, and severity of adverse events

    Timeframe: From baseline through 30-35 days after end of treatment, up to 7 months per individual subject