A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)
2 other identifiers
interventional
263
11 countries
96
Brief Summary
The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2017
Longer than P75 for phase_2
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedStudy Start
First participant enrolled
January 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedResults Posted
Study results publicly available
March 24, 2023
CompletedAugust 14, 2025
August 1, 2025
5.1 years
August 16, 2016
January 30, 2023
August 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
up to 1138 days
Secondary Outcomes (7)
ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen
up to 817 days
ORR in Participants With All Other FGF/FGFR Alterations
up to 1198 days
ORR in All Participants on an ID or CD Regimen in Combined Cohorts
up to 1198 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
up to approximately 25 weeks
Progression-free Survival (PFS)
up to 1138 days
- +2 more secondary outcomes
Study Arms (3)
Cohort A-ID (Intermittent Dose) Pemigatinib
EXPERIMENTALPemigatinib in subjects with FGFR3 mutations or fusions.
Cohort A-CD (Continuous Dose) Pemigatinib
EXPERIMENTALPemigatinib in subjects with FGFR3 mutations or fusions.
Cohort B Pemigatinib
EXPERIMENTALPemigatinib in subjects with other FGF/FGFR alterations.
Interventions
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Eligibility Criteria
You may qualify if:
- years and older in Japan
- 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.
You may not qualify if:
- Prior receipt of a selective FGFR inhibitor.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
Arizona Oncology Associates (Wilmot)
Tucson, Arizona, 85711, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
UCSF Helen Diller Family Comprehensive Care Center
San Francisco, California, 94158, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303, United States
Calaway-Young Cancer Center at Valley View Hospital
Glenwood Springs, Colorado, 81601, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Lahey Clinic Inc. - PARENT ACCOUNT
Burlington, Massachusetts, 01805, United States
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, 55125, United States
GU Research Network
Omaha, Nebraska, 68130, United States
TRIO - Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321, United States
New York Oncology Hematology, P.C.
Albany, New York, 12208, United States
Northwell Cancer Institute
New Hyde Park, New York, 11042, United States
University of Rochester
Rochester, New York, 14642, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
Oregon Health & Science University
Portland, Oregon, 97229, United States
Compass Oncology the Northwest Cancer Specialists
Tualatin, Oregon, 97062, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Oncology, P.A. - Austin
Austin, Texas, 78731, United States
Texas Oncology - Baylor Charles A. Sammons
Dallas, Texas, 75246, United States
Texas Oncology
Houston, Texas, 77024, United States
Texas Oncology, P.A. - Sherman
Sherman, Texas, 75090, United States
Baylor Scott & White Health
Temple, Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Virginia Oncology Associates - Hampton
Norfolk, Virginia, 23502, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
University of Wisconsic Hospital and Clinic
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
UZ Antwerpen
Edegem, 2650, Belgium
AZ Sint-Lucas - Campus Sint-Lucas
Ghent, 9000, Belgium
AZ Groeninge Campus Loofstraat
Kortrijk, 8500, Belgium
AZ Delta
Roeselare, 8800, Belgium
Rigshospitalet
Copenhagen, 2100, Denmark
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, 25030, France
Groupe Hospitalier Saint André - Hôpital Saint André
Bordeaux, Gironde, 33075, France
Institut Claudius Regaud-Oncopole
Toulouse, Haute Garonne, 31059, France
ICO - Site René Gauducheau
Saint-Herblain, Loire Atlantique, 44805, France
ICO - Site Paul Papin
Angers, Maine Et Loire, 49933, France
Hopital Saint Louis
Paris, Paris, 75010, France
Centre Leon Berard
Lyon, Rhone, 69373, France
CHU Strasbourg - Nouvel HĂ´pital Civil
Strasbourg, Rhone, 67091, France
Groupe Hospitalier Pitie-Salpetriere
Paris, 75571, France
Institut Gustave Roussy
Villejuif, 94805, France
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12200, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Klinikum Dresden Standort Dresden-Friedrichstadt
Dresden, 01067, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131, Germany
Universitaetsklinikum Muenster
MĂ¼nster, 48149, Germany
Studienpraxis Urologie Drs. Feyerabend
NĂ¼rtingen, 72622, Germany
Universitaetsklinikum Tuebingen
TĂ¼bingen, 72076, Germany
Soroka University Medical Center
Beersheba, 8410101, Israel
Assaf Harofeh Medical Center
Be’er Ya‘aqov, 70300, Israel
Meir Medical Center
Kfar Saba, 4428126, Israel
Chaim Sheba Medical Center
Ramat Gan, 52656, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo
Candiolo, 20133, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio
Napoli, 80131, Italy
Ospedale degli Infermi
Rimini, 47923, Italy
University Campus Bio-Medico di Roma
Rome, 00128, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, 53100, Italy
San Camillo-Forlanini Hospital
Siena, 53100, Italy
Kyushu University Hospital
Fukuoka, 8128582, Japan
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298, Japan
Hirosaki University Hospital
Hirosaki-shi, 036-8563, Japan
Teikyo University Hospital
Itabashi-ku, 173-8606, Japan
Nihon University Itabashi Hospital
Itabashi-ku, 173-8610, Japan
Nara Medical University Hospital
Kashihara-shi, 634-8522, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
Osaka University Hospital
Suita-shi, 565-0871, Japan
Jichi Medical University Hospital
Tochigi, 329-0498, Japan
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Zorgsaam Ziekenhuis
Terneuzen, 4535 PA, Netherlands
HagaZiekenhuis Van Den Haag
The Hague, Netherlands
Viecuri Medisch Centrum
Venlo, 5912 BL, Netherlands
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
Girona, 17007, Spain
Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
University College London Hospitals
London, Greater London, NW1 2PG, United Kingdom
Guy's Hospital
London, Greater London, SE1 9RT, United Kingdom
Charing Cross Hospital
London, Greater London, W6 8RF, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Strathclyde, G12 OYN, United Kingdom
Queen Elizabeth Hospital
Birmingham, West Midlands, B15 2TH, United Kingdom
Related Publications (2)
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.
PMID: 38039831DERIVEDNecchi 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.
PMID: 37956738DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Ekaterine Asatiani, MD
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 16, 2016
First Posted
August 19, 2016
Study Start
January 12, 2017
Primary Completion
February 1, 2022
Study Completion
February 1, 2022
Last Updated
August 14, 2025
Results First Posted
March 24, 2023
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
- Access Criteria
- Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency