A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
NCT ID: NCT02872714
Last Updated: 2025-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
263 participants
INTERVENTIONAL
2017-01-12
2022-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A-ID (Intermittent Dose) Pemigatinib
Pemigatinib in subjects with FGFR3 mutations or fusions.
pemigatinib
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Cohort A-CD (Continuous Dose) Pemigatinib
Pemigatinib in subjects with FGFR3 mutations or fusions.
pemigatinib
Pemigatinib once a day by mouth continuously.
Cohort B Pemigatinib
Pemigatinib in subjects with other FGF/FGFR alterations.
pemigatinib
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Interventions
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pemigatinib
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
pemigatinib
Pemigatinib once a day by mouth continuously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from urethra, ureters, upper tract, renal pelvis, and bladder.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Life expectancy ≥ 12 weeks.
* Radiographically measurable per RECIST v1.1.
* Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG status or 2) have insufficient renal function.
Exclusion Criteria
* Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
* Inability or unwillingness to swallow pemigatinib or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of pemigatinib.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ekaterine Asatiani, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Arizona Oncology Associates (Wilmot)
Tucson, Arizona, United States
Sharp Memorial Hospital
San Diego, California, United States
UCSF Helen Diller Family Comprehensive Care Center
San Francisco, California, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, United States
Calaway-Young Cancer Center at Valley View Hospital
Glenwood Springs, Colorado, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, United States
Lahey Clinic Inc. - PARENT ACCOUNT
Burlington, Massachusetts, United States
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, United States
GU Research Network
Omaha, Nebraska, United States
TRIO - Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Northwell Cancer Institute
New Hyde Park, New York, United States
University of Rochester
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Compass Oncology the Northwest Cancer Specialists
Tualatin, Oregon, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology, P.A. - Austin
Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons
Dallas, Texas, United States
Texas Oncology
Houston, Texas, United States
Texas Oncology, P.A. - Sherman
Sherman, Texas, United States
Baylor Scott & White Health
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Oncology Associates - Hampton
Norfolk, Virginia, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
University of Wisconsic Hospital and Clinic
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
UZ Antwerpen
Edegem, , Belgium
AZ Sint-Lucas - Campus Sint-Lucas
Ghent, , Belgium
AZ Groeninge Campus Loofstraat
Kortrijk, , Belgium
AZ Delta
Roeselare, , Belgium
Rigshospitalet
Copenhagen, , Denmark
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, France
Groupe Hospitalier Saint André - Hôpital Saint André
Bordeaux, Gironde, France
Institut Claudius Regaud-Oncopole
Toulouse, Haute Garonne, France
ICO - Site René Gauducheau
Saint-Herblain, Loire Atlantique, France
ICO - Site Paul Papin
Angers, Maine Et Loire, France
Hopital Saint Louis
Paris, Paris, France
Centre Leon Berard
Lyon, Rhone, France
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, Rhone, France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
Institut Gustave Roussy
Villejuif, , France
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Klinikum Dresden Standort Dresden-Friedrichstadt
Dresden, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Studienpraxis Urologie Drs. Feyerabend
Nürtingen, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Soroka University Medical Center
Beersheba, , Israel
Assaf Harofeh Medical Center
Be’er Ya‘aqov, , Israel
Meir Medical Center
Kfar Saba, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo
Candiolo, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio
Napoli, , Italy
Ospedale degli Infermi
Rimini, , Italy
University Campus Bio-Medico di Roma
Rome, , Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, , Italy
San Camillo-Forlanini Hospital
Siena, , Italy
Kyushu University Hospital
Fukuoka, , Japan
Saitama Medical University International Medical Center
Hidaka-shi, , Japan
Hirosaki University Hospital
Hirosaki-shi, , Japan
Teikyo University Hospital
Itabashi-ku, , Japan
Nihon University Itabashi Hospital
Itabashi-ku, , Japan
Nara Medical University Hospital
Kashihara-shi, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Saitama Cancer Center
Saitama, , Japan
Osaka University Hospital
Suita-shi, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
VU Medisch Centrum
Amsterdam, , Netherlands
Zorgsaam Ziekenhuis
Terneuzen, , Netherlands
HagaZiekenhuis Van Den Haag
The Hague, , Netherlands
Viecuri Medisch Centrum
Venlo, , Netherlands
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
Girona, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
University College London Hospitals
London, Greater London, United Kingdom
Guy's Hospital
London, Greater London, United Kingdom
Charing Cross Hospital
London, Greater London, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, Nottinghamshire, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Strathclyde, United Kingdom
Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom
Countries
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References
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Zhang C, Huang MN, Shan JQ, Hu ZJ, Li ZW, Liu JY. Pemigatinib, a selective FGFR inhibitor overcomes ABCB1-mediated multidrug resistance in cancer cells. Biochem Biophys Res Commun. 2024 Jan 8;691:149314. doi: 10.1016/j.bbrc.2023.149314. Epub 2023 Nov 24.
Necchi A, Pouessel D, Leibowitz R, Gupta S, Flechon A, Garcia-Donas J, Bilen MA, Debruyne PR, Milowsky MI, Friedlander T, Maio M, Gilmartin A, Li X, Veronese ML, Loriot Y. Pemigatinib for metastatic or surgically unresectable urothelial carcinoma with FGF/FGFR genomic alterations: final results from FIGHT-201. Ann Oncol. 2024 Feb;35(2):200-210. doi: 10.1016/j.annonc.2023.10.794. Epub 2023 Nov 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001321-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 54828-201
Identifier Type: -
Identifier Source: org_study_id
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