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)


Condition: UC (Urothelial Cancer)

Intervention:

  • Drug: pemigatinib
  • Drug: pemigatinib

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02872714

Sponsor: Incyte Corporation

Primary Outcome Measures:

  • Measure: Objective response rate (ORR) in subjects with FGFR3 mutations based on RECIST v1.1
  • Time Frame: Every 9 weeks throughout the study, up to approximately 6 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Safety and tolerability of pemigatinib as assessed by the frequency, duration, and severity of adverse events
  • Time Frame: From screening through 30-35 days after end of treatment, up to approximately 6 months
  • Safety Issue:
  • Measure: Overall response rate (ORR) measuring the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable urothelial cancer with different molecular subgroups
  • Time Frame: From screening through 30-35 days after end of treatment, up to approximately 6 months
  • Safety Issue:
  • Measure: Progression-free survival (PFS) based on RECIST v1.1
  • Time Frame: Every 9 weeks throughout the study, up to approximately 6 months
  • Safety Issue:
  • Measure: Duration of response
  • Time Frame: Every 9 weeks throughout the study, up to approximately 6 months
  • Safety Issue:

Estimated Enrollment: 240

Study Start Date: August 2016

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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.

Contact:

  • Incyte Corporation Call Center
  • 1.855.463.3463

Locations:

  • 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
  • Gent 9000 Belgium
  • AZ Groeninge Campus Loofstraat
  • Kortrijk 8500 Belgium
  • AZ Delta
  • Roeselare 8800 Belgium
  • Rigshospitalet
  • Copenhagen 2100 Denmark
  • CHU Besançon - Hôpital Jean Minjoz
  • Besancon Cedex Doubs 25030 France
  • Groupe Hospitalier Saint André - Hôpital Saint André
  • Bordeaux cedex Gironde 33075 France
  • Institut Claudius Regaud-Oncopole
  • Toulouse cedex 09 Haute Garonne 31059 France
  • ICO - Site René Gauducheau
  • Saint Herblain Loire Atlantique 44805 France
  • ICO - Site Paul Papin
  • Angers Cedex 9 Maine Et Loire 49933 France
  • Hopital Saint Louis
  • Paris Cedex 10 Paris 75010 France
  • Centre Leon Berard
  • Lyon Cedex 8 Rhone 69373 France
  • CHU Strasbourg - Nouvel Hôpital 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
  • Klinikum Dresden Standort Dresden-Friedrichstadt
  • Dresden 01067 Germany
  • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Dresden 01307 Germany
  • Universitaetsklinikum Hamburg-Eppendorf
  • Hamburg 20246 Germany
  • Universitaetsklinikum Koeln
  • Koeln 50937 Germany
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Mainz 55131 Germany
  • Universitaetsklinikum Muenster
  • Muenster 48149 Germany
  • Studienpraxis Urologie Drs. Feyerabend
  • Nürtingen 72622 Germany
  • Universitaetsklinikum Tuebingen
  • Tuebingen 72076 Germany
  • Soroka University Medical Center
  • Be'er Sheva 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
  • Milano 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-shi 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
  • Saitama Cancer Center
  • Kitaadachi-gun 362-0806 Japan
  • Osaka International Cancer Institute
  • Osaka-shi 541-8567 Japan
  • Osaka University Hospital
  • Suita-shi 565-0871 Japan
  • Jichi Medical University Hospital
  • Tochigi-ken 329-0498 Japan
  • VU Medisch Centrum
  • Amsterdam 1081 HV Netherlands
  • HagaZiekenhuis Van Den Haag
  • Den Haag Netherlands
  • Zorgsaam Ziekenhuis
  • Terneuzen 4535 PA Netherlands
  • Viecuri Medisch Centrum
  • Venlo 5912 BL Netherlands
  • Clinica Universidad de Navarra
  • Pamplona Navarra 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

View trial on ClinicalTrials.gov


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