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 5 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.
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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.
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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)