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

A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

NCT03011372•Incyte Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (33)

Mayo Clinic Arizona

Phoenix, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

Stanford Cancer Institute

Stanford, California, United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States

Franciscan St. Francis Health

Indianapolis, Indiana, United States

Washington University School of Medicine

St Louis, Missouri, United States

Weill Cornell Medical Centers

New York, New York, United States

Md Anderson Cancer Center

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz

Linz, Austria

Key Dates

Start Date

April 25, 2017

Primary Completion Date

October 30, 2024

Completion Date

October 30, 2024

Last Updated

November 18, 2025

Enrollment

ACTUAL participants

Conditions

MPN (Myeloproliferative Neoplasms)

Interventions

Pemigatinib

DRUG