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

  • STATUS
    Recruiting
  • End date
    Nov 25, 2022
  • participants needed
    46
  • sponsor
    Incyte Corporation
Updated on 28 January 2021

Summary

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.

Details
Condition MPN
Treatment INCB054828, pemigatinib
Clinical Study IdentifierNCT03011372
SponsorIncyte Corporation
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

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
Have relapsed after stem cell transplantation or after other disease modifying therapy, OR
Not be current candidates for stem cell transplantation or other disease modifying therapies
Note: All relapsed/refractory subjects must have evidence of either cytogenetic or hematological disease and have no evidence of residual toxicity (eg, graft-versus-host disease requiring treatment)
Life expectancy 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

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
Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, as confirmed by ophthalmologic examination
Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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