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

Incyte

Status and phase

Completed

Phase 2

Conditions

MPN (Myeloproliferative Neoplasms)

Treatments

Drug: Pemigatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03011372

INCB 54828-203

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.