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

Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02872714
Collaborator
(none)
263
Enrollment
96
Locations
3
Arms
60.6
Actual Duration (Months)
2.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
263 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jan 12, 2017
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A-ID (Intermittent Dose) Pemigatinib

Pemigatinib in subjects with FGFR3 mutations or fusions.

Drug: pemigatinib
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Other Names:
  • INCB054828

    		•
    Experimental: Cohort A-CD (Continuous Dose) Pemigatinib

    Pemigatinib in subjects with FGFR3 mutations or fusions.

    Drug: pemigatinib
    Pemigatinib once a day by mouth continuously.
    Other Names:
  • INCB054828

    		•
    Experimental: Cohort B Pemigatinib

    Pemigatinib in subjects with other FGF/FGFR alterations.

    Drug: pemigatinib
    Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
    Other Names:
  • INCB054828

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) in subjects with FGFR3 mutations based on RECIST v1.1 [Every 9 weeks throughout the study, up to approximately 6 months]

      Defined as the proportion of subjects with best response (complete response or partial response) by RECIST v1.1.

    Secondary Outcome Measures

    1. Safety and tolerability of pemigatinib as assessed by the frequency, duration, and severity of adverse events [From screening through 30-35 days after end of treatment, up to approximately 6 months]

    2. Overall response rate (ORR) measuring the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable urothelial cancer with different molecular subgroups [From screening through 30-35 days after end of treatment, up to approximately 6 months]

    3. Progression-free survival (PFS) based on RECIST v1.1 [Every 9 weeks throughout the study, up to approximately 6 months]

      Defined as number of days from the first day of taking study drug dose to the earlier of death or disease progression by RECIST v1.1 as assessed by the central radiographic review committee

    4. Duration of response [Every 9 weeks throughout the study, up to approximately 6 months]

      Defined as the number of days from the date of the first confirmed response to the date of the first documented evidence of disease progression or death.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Oncology Associates (Wilmot) Tucson Arizona United States 85711
    2 Sharp Memorial Hospital San Diego California United States 92123
    3 UCSF Helen Diller Family Comprehensive Care Center San Francisco California United States 94158
    4 Rocky Mountain Cancer Centers Boulder Colorado United States 80303
    5 Calaway-Young Cancer Center at Valley View Hospital Glenwood Springs Colorado United States 81601
    6 Mount Sinai Medical Center Miami Beach Florida United States 33140
    7 Florida Hospital Cancer Institute Orlando Florida United States 32804
    8 Emory University School of Medicine Atlanta Georgia United States 30322
    9 University of Maryland, Greenebaum Cancer Center Baltimore Maryland United States 21201
    10 Lahey Clinic Inc. - PARENT ACCOUNT Burlington Massachusetts United States 01805
    11 Minnesota Oncology Hematology, P.A. Woodbury Minnesota United States 55125
    12 GU Research Network Omaha Nebraska United States 68130
    13 TRIO - Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89169-3321
    14 New York Oncology Hematology, P.C. Albany New York United States 12208
    15 Northwell Cancer Institute New Hyde Park New York United States 11042
    16 University of Rochester Rochester New York United States 14642
    17 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27514
    18 Oncology Hematology Care, Inc. Cincinnati Ohio United States 45242
    19 Oregon Health & Science University Portland Oregon United States 97229
    20 Compass Oncology the Northwest Cancer Specialists Tualatin Oregon United States 97062
    21 St. Luke's Hospital Bethlehem Pennsylvania United States 18015
    22 VA Pittsburgh Healthcare System Pittsburgh Pennsylvania United States 15240
    23 Carolina Urologic Research Center Myrtle Beach South Carolina United States 29572
    24 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    25 Texas Oncology, P.A. - Austin Austin Texas United States 78731
    26 Texas Oncology - Baylor Charles A. Sammons Dallas Texas United States 75246
    27 Texas Oncology Houston Texas United States 77024
    28 Texas Oncology, P.A. - Sherman Sherman Texas United States 75090
    29 Baylor Scott & White Health Temple Texas United States 76508
    30 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    31 Virginia Oncology Associates - Hampton Norfolk Virginia United States 23502
    32 Northwest Medical Specialties, PLLC Tacoma Washington United States 98405
    33 University of Wisconsic Hospital and Clinic Madison Wisconsin United States 53792
    34 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    35 UZ Antwerpen Edegem Belgium 2650
    36 AZ Sint-Lucas - Campus Sint-Lucas Gent Belgium 9000
    37 AZ Groeninge Campus Loofstraat Kortrijk Belgium 8500
    38 AZ Delta Roeselare Belgium 8800
    39 Rigshospitalet Copenhagen Denmark 2100
    40 CHU Besançon - Hôpital Jean Minjoz Besancon Cedex Doubs France 25030
    41 Groupe Hospitalier Saint André - Hôpital Saint André Bordeaux cedex Gironde France 33075
    42 Institut Claudius Regaud-Oncopole Toulouse cedex 09 Haute Garonne France 31059
    43 ICO - Site René Gauducheau Saint Herblain Loire Atlantique France 44805
    44 ICO - Site Paul Papin Angers Cedex 9 Maine Et Loire France 49933
    45 Hopital Saint Louis Paris Cedex 10 Paris France 75010
    46 Centre Leon Berard Lyon Cedex 8 Rhone France 69373
    47 CHU Strasbourg - Nouvel Hôpital Civil Strasbourg Rhone France 67091
    48 Groupe Hospitalier Pitie-Salpetriere Paris France 75571
    49 Institut Gustave Roussy Villejuif France 94805
    50 Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin Berlin Germany 12200
    51 Klinikum Dresden Standort Dresden-Friedrichstadt Dresden Germany 01067
    52 Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden Germany 01307
    53 Universitaetsklinikum Hamburg-Eppendorf Hamburg Germany 20246
    54 Universitaetsklinikum Koeln Koeln Germany 50937
    55 Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Mainz Germany 55131
    56 Universitaetsklinikum Muenster Muenster Germany 48149
    57 Studienpraxis Urologie Drs. Feyerabend Nürtingen Germany 72622
    58 Universitaetsklinikum Tuebingen Tuebingen Germany 72076
    59 Soroka University Medical Center Be'er Sheva Israel 8410101
    60 Assaf Harofeh Medical Center Be'er Ya'aqov Israel 70300
    61 Meir Medical Center Kfar-Saba Israel 4428126
    62 Chaim Sheba Medical Center Ramat Gan Israel 52656
    63 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
    64 Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Bologna Italy 40138
    65 Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo Candiolo Italy 20133
    66 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy 20133
    67 Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio Napoli Italy 80131
    68 Ospedale degli Infermi Rimini Italy 47923
    69 University Campus Bio-Medico di Roma Rome Italy 00128
    70 IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo Italy 71013
    71 A.O.U. Senese Policlinico Santa Maria alle Scotte Siena Italy 53100
    72 San Camillo-Forlanini Hospital Siena Italy 53100
    73 Kyushu University Hospital Fukuoka-shi Japan 8128582
    74 Saitama Medical University International Medical Center Hidaka-shi Japan 350-1298
    75 Hirosaki University Hospital Hirosaki-shi Japan 036-8563
    76 Teikyo University Hospital Itabashi-ku Japan 173-8606
    77 Nihon University Itabashi Hospital Itabashi-ku Japan 173-8610
    78 Nara Medical University Hospital Kashihara-shi Japan 634-8522
    79 Osaka International Cancer Institute Osaka-shi Japan 541-8567
    80 Saitama Cancer Center Saitama Japan 362-0806
    81 Osaka University Hospital Suita-shi Japan 565-0871
    82 Jichi Medical University Hospital Tochigi Japan 329-0498
    83 VU Medisch Centrum Amsterdam Netherlands 1081 HV
    84 HagaZiekenhuis Van Den Haag Den Haag Netherlands
    85 Zorgsaam Ziekenhuis Terneuzen Netherlands 4535 PA
    86 Viecuri Medisch Centrum Venlo Netherlands 5912 BL
    87 Clinica Universidad de Navarra Pamplona Navarra Spain 31008
    88 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    89 ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta Girona Spain 17007
    90 Centro Integral Oncologico Clara Campal Madrid Spain 28050
    91 University College London Hospitals London Greater London United Kingdom NW1 2PG
    92 Guy's Hospital London Greater London United Kingdom SE1 9RT
    93 Charing Cross Hospital London Greater London United Kingdom W6 8RF
    94 Nottingham University Hospitals City Campus Nottingham Nottinghamshire United Kingdom NG5 1PB
    95 Beatson West of Scotland Cancer Centre Glasgow Strathclyde United Kingdom G12 OYN
    96 Queen Elizabeth Hospital Birmingham West Midlands United Kingdom B15 2TH

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Ekaterine Asatiani, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02872714
    Other Study ID Numbers:
    • INCB 54828-201
    First Posted:
    Aug 19, 2016
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    Urothelial carcinoma
    fibroblast growth factor (FGF)
    fibroblast growth factor receptor (FGFR)
    FGF/FGFR alterations
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Transitional Cell

    Study Results

    No Results Posted as of Mar 2, 2022