A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid / Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
Trial Status: Active
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.
- 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.
- 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.
Mayo Clinic in Arizona
City of Hope Comprehensive Cancer Center
Stanford Cancer Institute Palo Alto
Emory University Hospital / Winship Cancer Institute
Siteman Cancer Center at Washington University
M D Anderson Cancer Center
Salt Lake City
Huntsman Cancer Institute / University of Utah
Trial Phase Phase II
Trial Type Treatment
- Primary ID INCB 54828-203
- Secondary IDs NCI-2017-00141
- Clinicaltrials.gov ID NCT03011372