A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
NCT ID: NCT03011372
Last Updated: 2025-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2017-04-25
2024-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pemigatinib
Pemigatinib
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Participants will receive either the intermittent dose (as written) or continuous dosing.
Interventions
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Pemigatinib
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Participants will receive either the intermittent dose (as written) or continuous dosing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Philomena Collucci, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence, , Italy
Kindai University Hospital
Osaka, , Japan
Ntt Medical Center Tokyo
Tokyo, , Japan
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Inselspital - Universitaetsspital Bern
Bern, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Guys and St Thomas Nhs Foundation Trust
London, , United Kingdom
Oxford University Hospitals Nhs Foundation Trust
Oxford, , United Kingdom
Countries
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References
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Al-Bazaz M, Forstreuter A, Hammada I, Hille J, Wagner JN, Reinert J, Wehrhahn J, Bokemeyer C, Fiedler W. Acute Lymphoblastic Leukemia Characterized by Rare BCR::FGFR1 Translocation: A Case Report With Literature Review. Case Rep Hematol. 2025 Oct 23;2025:8892036. doi: 10.1155/crh/8892036. eCollection 2025.
Verstovsek S, Kiladjian JJ, Vannucchi AM, Patel JL, Rambaldi A, Shomali WE, Oh ST, Usuki K, Harrison CN, Ritchie EK, Akard LP, Hernandez-Boluda JC, Huguet F, Colucci P, Zhen H, Oliveira N, Gilmartin A, Langford C, George TI, Reiter A, Gotlib J. Pemigatinib for Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement. NEJM Evid. 2025 Sep;4(9):EVIDoa2500017. doi: 10.1056/EVIDoa2500017. Epub 2025 Aug 26.
Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002596-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 54828-203
Identifier Type: -
Identifier Source: org_study_id
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