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

 Chronic Myeloproliferative Disorders / Posted 9 months ago

Brief 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.
  • Inclusion Criteria :
    • Ages Eligible for Study: 18 Years and older
    • Sexes Eligible for Study: All
    • Accepts Healthy Volunteers: No
    • 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.
  • Study start date : April 25, 2017
  • Study end date : April 14, 2023
  • Wales-Based Study Contact : Please speak to your clinician
  • Principal Investigator : Philomena Collucci, MD (Incyte Corporation)
Contact details

Oxford University Hospitals Nhs Foundation TrustOxford,England,OX3 7LE  Show Phone Number globalmedinfo@incyte.com

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