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UC (Urothelial Cancer)Phase 2NCT02872714

A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

A Phase 2 study testing pemigatinib in people with UC (Urothelial Cancer), run by Incyte Corporation at 96 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
UC (Urothelial Cancer)
What is being tested?
pemigatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
263 participants
Where
96 sitesin 11 countries
Study dates
12 Jan 2017to 1 Feb 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 20 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.

Who cannot join

  • 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.

Trial locations and contacts

96 sites in 11 countries.

96 sites in 11 countries

United States34 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Texas Oncology, P.A. - Austin

    Austin, Texas, 78731

  • University of Maryland, Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • Lahey Clinic Inc. - PARENT ACCOUNT

    Burlington, Massachusetts, 01805

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Texas Oncology - Baylor Charles A. Sammons

    Dallas, Texas, 75246

  • Calaway-Young Cancer Center at Valley View Hospital

    Glenwood Springs, Colorado, 81601

  • Texas Oncology

    Houston, Texas, 77024

  • TRIO - Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169-3321

  • University of Wisconsic Hospital and Clinic

    Madison, Wisconsin, 53792

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Northwell Cancer Institute

    New Hyde Park, New York, 11042

  • Virginia Oncology Associates - Hampton

    Norfolk, Virginia, 23502

  • GU Research Network

    Omaha, Nebraska, 68130

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • Oregon Health & Science University

    Portland, Oregon, 97229

  • University of Rochester

    Rochester, New York, 14642

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • UCSF Helen Diller Family Comprehensive Care Center

    San Francisco, California, 94158

  • Texas Oncology, P.A. - Sherman

    Sherman, Texas, 75090

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Baylor Scott & White Health

    Temple, Texas, 76508

  • Compass Oncology the Northwest Cancer Specialists

    Tualatin, Oregon, 97062

  • Arizona Oncology Associates (Wilmot)

    Tucson, Arizona, 85711

  • Minnesota Oncology Hematology, P.A.

    Woodbury, Minnesota, 55125

Other trials in United States

France10 sites

  • ICO - Site Paul Papin

    Angers, Maine Et Loire, 49933

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, Doubs, 25030

  • Groupe Hospitalier Saint André - Hôpital Saint André

    Bordeaux, Gironde, 33075

  • Centre Leon Berard

    Lyon, Rhone, 69373

  • Hopital Saint Louis

    Paris, Paris, 75010

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75571

  • ICO - Site René Gauducheau

    Saint-Herblain, Loire Atlantique, 44805

  • CHU Strasbourg - Nouvel Hôpital Civil

    Strasbourg, Rhone, 67091

  • Institut Claudius Regaud-Oncopole

    Toulouse, Haute Garonne, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Japan10 sites

  • Kyushu University Hospital

    Fukuoka, 8128582

  • Saitama Medical University International Medical Center

    Hidaka-shi, 350-1298

  • Hirosaki University Hospital

    Hirosaki-shi, 036-8563

  • Nara Medical University Hospital

    Kashihara-shi, 634-8522

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Saitama Cancer Center

    Saitama, 362-0806

  • Osaka University Hospital

    Suita-shi, 565-0871

  • Teikyo University Hospital

    tabashi City, 173-8606

  • Nihon University Itabashi Hospital

    tabashi City, 173-8610

  • Jichi Medical University Hospital

    Tochigi, 329-0498

Other trials in Japan

Germany9 sites

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Klinikum Dresden Standort Dresden-Friedrichstadt

    Dresden, 01067

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Studienpraxis Urologie Drs. Feyerabend

    Nürtingen, 72622

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

Italy9 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo

    Candiolo, 20133

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio

    Naples, 80131

  • Ospedale degli Infermi

    Rimini, 47923

  • University Campus Bio-Medico di Roma

    Rome, 00128

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

  • San Camillo-Forlanini Hospital

    Siena, 53100

Other trials in Italy

United Kingdom6 sites

  • Queen Elizabeth Hospital

    Birmingham, West Midlands, B15 2TH

  • Beatson West of Scotland Cancer Centre

    Glasgow, Strathclyde, G12 OYN

  • University College London Hospitals

    London, Greater London, NW1 2PG

  • Guy's Hospital

    London, Greater London, SE1 9RT

  • Charing Cross Hospital

    London, Greater London, W6 8RF

  • Nottingham University Hospitals City Campus

    Nottingham, Nottinghamshire, NG5 1PB

Other trials in United Kingdom

Israel5 sites

  • Assaf Harofeh Medical Center

    Be’er Ya‘aqov, 70300

  • Soroka University Medical Center

    Beersheba, 8410101

  • Meir Medical Center

    Kfar Saba, 4428126

  • Chaim Sheba Medical Center

    Ramat Gan, 52656

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Belgium4 sites

  • UZ Antwerpen

    Edegem, 2650

  • AZ Sint-Lucas - Campus Sint-Lucas

    Ghent, 9000

  • AZ Groeninge Campus Loofstraat

    Kortrijk, 8500

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Netherlands4 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Zorgsaam Ziekenhuis

    Terneuzen, 4535 PA

  • HagaZiekenhuis Van Den Haag

    The Hague

  • Viecuri Medisch Centrum

    Venlo, 5912 BL

Other trials in Netherlands

Spain4 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: 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)

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.

Being tested
pemigatinib
Keywords
Urothelial carcinoma, fibroblast growth factor (FGF), fibroblast growth factor receptor (FGFR), FGF/FGFR alterations
Medical subject headings
Carcinoma, Transitional Cell, Acrocephalosyndactylia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pemigatinibDrug

    Also called INCB054828

    Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.

  • pemigatinibDrug

    Also called INCB054828

    Pemigatinib once a day by mouth continuously.

Study groups in NCT02872714
Study groupRoleWhat they receive
Cohort A-ID (Intermittent Dose) PemigatinibExperimentalPemigatinib in subjects with FGFR3 mutations or fusions.
Receives: Drug: pemigatinib
Cohort A-CD (Continuous Dose) PemigatinibExperimentalPemigatinib in subjects with FGFR3 mutations or fusions.
Receives: Drug: pemigatinib
Cohort B PemigatinibExperimentalPemigatinib in subjects with other FGF/FGFR alterations.
Receives: Drug: pemigatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 1138 days

Secondary outcomes (7)

  1. ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen

    ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST 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.

    Measured: up to 817 days

  2. ORR in Participants With All Other FGF/FGFR Alterations

    ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST 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.

    Measured: up to 1198 days

  3. ORR in All Participants on an ID or CD Regimen in Combined Cohorts

    ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST 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.

    Measured: up to 1198 days

  4. Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.

    Measured: up to approximately 25 weeks

  5. Progression-free Survival (PFS)

    PFS was defined as the length of time from the start of the study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.

    Measured: up to 1138 days

  6. Duration of Response (DOR)

    DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. 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

    Measured: up to 1075 days

  7. Overall Survival

    Overall survival was defined as the length of time from the start of the study drug (Day 1) until the date of death due to any cause.

    Measured: up to 1610 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2016 (estimated)
  2. Study start12 Jan 2017
  3. Primary completion1 Feb 2022
  4. Study completion1 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02872714
Sponsor's protocol ID
INCB 54828-201
Other IDs
2016-001321-14, 2016
Status last verified
Aug 2025
First submitted
16 Aug 2016
Last updated
14 Aug 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Publications

  • 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.

    PubMed 38039831

  • 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.

    PubMed 37956738

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pemigatinib in people with UC (Urothelial Cancer), run by Incyte Corporation at 96 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, France, Japan, Germany, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen (time frame: up to 1138 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02872714, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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