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

Completed · Phase 2

Conditions studied: MPN (Myeloproliferative Neoplasms)

In brief

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.

Key facts

Study ID

NCT03011372

Run by

Incyte Corporation

People needed

47

Starts

2017-04-25

Expected to finish

2024-10-30

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Medical University of Vienna — Vienna, Austria
• Iii Med. Abteilung For Hematologie and Onkologie Hanuscfhkrankenhaus — Vienna, Austria
• Universitair Ziekenhuis (Uz) Leuven — Leuven, Belgium
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• Centre Leon Berard — Lyon, France
• Chu de Nice - Hospital L Archet — Nice, France
• Hospital Saint Louis — Paris, France
• Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole — Toulouse, France
• University Medical Center Rwth Aachen — Aachen, Germany
• Universitatsklinikum Halle (Saale) — Halle, Germany
• Universitatsklinikum Jena — Jena, Germany
• Universitatsklinikum Leipzig — Leipzig, Germany
• University Hospital Mannheim — Mannheim, Germany
• Johannes Wesling Klinikum Minden — Minden, Germany
• Ospedale Papa Giovanni Xxiii — Bergamo, Italy

Full record on ClinicalTrials.gov

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