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

INTRODUCTION

Org Study ID: INCB 54828-201
Secondary ID: N/A
NCT ID: NCT02872714
Sponsor: Incyte Corporation

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.

Overall Status
Recruiting
Start Date
August 31, 2016
Phase
Phase 2
Study Type
Interventional

Primary Outcome 1 - Measure: Objective response rate (ORR) in subjects with FGFR3 mutations based on RECIST v1.1

Primary Outcome 1 - Timeframe: Every 9 weeks throughout the study, up to approximately 6 months

UC (Urothelial Cancer)

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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

Name: Ekaterine Asatiani, MD

Role: Study Director

Affiliation: Incyte Corporation

Name: Ekaterine Asatiani, MD

Phone: 1.855.463.3463

Email: N/A

Facility	Status	Contact
Facility: Arizona Oncology Associates (Wilmot) Tucson, Arizona 85711 United States	Status: Recruiting	Contact: Study Coordinator 520-546-2870
Facility: Sharp Memorial Hospital San Diego, California 92123 United States	Status: Recruiting	Contact: Study Coordinator 858-939-5062
Facility: UCSF Helen Diller Family Comprehensive Care Center San Francisco, California 94158 United States	Status: Recruiting	Contact: Study Coordinator 415-353-4310
Facility: Rocky Mountain Cancer Centers Boulder, Colorado 80303 United States	Status: Recruiting	Contact: Study Coordinator 303-388-0136
Facility: Calaway-Young Cancer Center at Valley View Hospital Glenwood Springs, Colorado 81601 United States	Status: Recruiting	Contact: Study Coordinator 970-384-7574
Facility: Mount Sinai Medical Center Miami Beach, Florida 33140 United States	Status: Recruiting	Contact: Study Coordinator 305-674-2625
Facility: Florida Hospital Cancer Institute Orlando, Florida 32804 United States	Status: Recruiting	Contact: Study Coordinator 407-303-2093
Facility: Emory University School of Medicine Atlanta, Georgia 30322 United States	Status: Recruiting	Contact: Study Coordinator 404-778-3448
Facility: University of Maryland, Greenebaum Cancer Center Baltimore, Maryland 21201 United States	Status: Recruiting	Contact: Study Coordinator 410-328-8610
Facility: Lahey Clinic Inc. - PARENT ACCOUNT Burlington, Massachusetts 01805 United States	Status: Recruiting	Contact: Study Coordinator 781-744-2734
Facility: Minnesota Oncology Hematology, P.A. Woodbury, Minnesota 55125 United States	Status: Recruiting	Contact: Study Coordinator 651-999-8945
Facility: GU Research Network Omaha, Nebraska 68130 United States	Status: Recruiting	Contact: Study Coordinator 402-991-8468
Facility: TRIO - Comprehensive Cancer Centers of Nevada Las Vegas, Nevada 89169-3321 United States	Status: Recruiting	Contact: Study Coordinator 702-952-3439
Facility: New York Oncology Hematology, P.C. Albany, New York 12208 United States	Status: Recruiting	Contact: Study Coordinator 518-262-2768
Facility: Northwell Cancer Institute New Hyde Park, New York 11042 United States	Status: Recruiting	Contact: Study Coordinator 516-734-8812
Facility: University of Rochester Rochester, New York 14642 United States	Status: Recruiting	Contact: Study Coordinator 585-275-3351
Facility: University of North Carolina at Chapel Hill Chapel Hill, North Carolina 27514 United States	Status: Recruiting	Contact: Study Coordinator 919-966-4432
Facility: Oncology Hematology Care, Inc. Cincinnati, Ohio 45242 United States	Status: Recruiting	Contact: Study Coordinator 513-751-2273
Facility: Oregon Health & Science University Portland, Oregon 97229 United States	Status: Recruiting	Contact: Study Coordinator 503-494-3618
Facility: Compass Oncology the Northwest Cancer Specialists Tualatin, Oregon 97062 United States	Status: Recruiting	Contact: Study Coordinator 503-291-6233
Facility: St. Luke's Hospital Bethlehem, Pennsylvania 18015 United States	Status: Recruiting	Contact: Study Coordinator 484-503-4150
Facility: VA Pittsburgh Healthcare System Pittsburgh, Pennsylvania 15240 United States	Status: Recruiting	Contact: Study Coordinator 412-360-6230
Facility: Carolina Urologic Research Center Myrtle Beach, South Carolina 29572 United States	Status: Recruiting	Contact: Study Coordinator 843-449-1010
Facility: Vanderbilt University Medical Center Nashville, Tennessee 37232 United States	Status: Recruiting	Contact: Study Coordinator 615-875-8605
Facility: Texas Oncology, P.A. - Austin Austin, Texas 78731 United States	Status: Recruiting	Contact: Study Coordinator 512-421-4100
Facility: Texas Oncology - Baylor Charles A. Sammons Dallas, Texas 75246 United States	Status: Recruiting	Contact: Study Coordinator 214-370-1000
Facility: Texas Oncology Houston, Texas 77024 United States	Status: Recruiting	Contact: Study Coordinator 713-467-1722
Facility: Texas Oncology, P.A. - Sherman Sherman, Texas 75090 United States	Status: Recruiting	Contact: Study Coordinator 903-868-4783
Facility: Baylor Scott & White Health Temple, Texas 76508 United States	Status: Recruiting	Contact: Study Coordinator 254-724-5939
Facility: Huntsman Cancer Institute Salt Lake City, Utah 84112 United States	Status: Recruiting	Contact: Study Coordinator 801-587-4765
Facility: Virginia Oncology Associates - Hampton Norfolk, Virginia 23502 United States	Status: Recruiting	Contact: Study Coordinator 757-213-5615
Facility: Northwest Medical Specialties, PLLC Tacoma, Washington 98405 United States	Status: Recruiting	Contact: Study Coordinator 253-306-0532
Facility: University of Wisconsic Hospital and Clinic Madison, Wisconsin 53792 United States	Status: Recruiting	Contact: Study Coordinator 608-263-7107
Facility: Medical College of Wisconsin Milwaukee, Wisconsin 53226 United States	Status: Recruiting	Contact: Study Coordinator 414-805-8921
Facility: UZ Antwerpen Edegem, 2650 Belgium	Status: Recruiting	Contact: 3238215681
Facility: AZ Sint-Lucas - Campus Sint-Lucas Gent, 9000 Belgium	Status: Recruiting	Contact: Study Coordinator 3292245297
Facility: AZ Groeninge Campus Loofstraat Kortrijk, 8500 Belgium	Status: Recruiting	Contact: Study Coordinator 3256633941
Facility: AZ Delta Roeselare, 8800 Belgium	Status: Recruiting	Contact: Study Coordinator +3251238011
Facility: Rigshospitalet Copenhagen, 2100 Denmark	Status: Recruiting	Contact: Study Coordinator 4535455072
Facility: CHU Besançon - Hôpital Jean Minjoz Besancon Cedex, Doubs 25030 France	Status: Recruiting	Contact: Study Coordinator +33381669386
Facility: Groupe Hospitalier Saint André - Hôpital Saint André Bordeaux cedex, Gironde 33075 France	Status: Recruiting	Contact: Study Coordinator 33556794708
Facility: Institut Claudius Regaud-Oncopole Toulouse cedex 09, Haute Garonne 31059 France	Status: Recruiting	Contact: Study Coordinator 33531155818
Facility: ICO - Site René Gauducheau Saint Herblain, Loire Atlantique 44805 France	Status: Recruiting	Contact: Study Coordinator 33240679900
Facility: ICO - Site Paul Papin Angers Cedex 9, Maine Et Loire 49933 France	Status: Recruiting	Contact: Study Coordinator 33241352875
Facility: Hopital Saint Louis Paris Cedex 10, Paris 75010 France	Status: Recruiting	Contact: Study Coordinator 33142385100
Facility: Centre Leon Berard Lyon Cedex 8, Rhone 69373 France	Status: Recruiting	Contact: Study Coordinator 33426556842
Facility: CHU Strasbourg - Nouvel Hôpital Civil Strasbourg, Rhone 67091 France	Status: Recruiting	Contact: Study Coordinator 33388116284
Facility: Groupe Hospitalier Pitie-Salpetriere Paris, 75571 France	Status: Recruiting	Contact: Study Coordinator 33142160461
Facility: Institut Gustave Roussy Villejuif, 94805 France	Status: Recruiting	Contact: Study Coordinator 33142114953
Facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin Berlin, 12200 Germany	Status: Recruiting	Contact: Study Coordinator +49 3084452575
Facility: Klinikum Dresden Standort Dresden-Friedrichstadt Dresden, 01067 Germany	Status: Recruiting	Contact: Study Coordinator +49 3514804553
Facility: Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden, 01307 Germany	Status: Recruiting	Contact: Study Coordinator +49 3814947572
Facility: Universitaetsklinikum Hamburg-Eppendorf Hamburg, 20246 Germany	Status: Recruiting	Contact: Study Coordinator +49 40741053994
Facility: Universitaetsklinikum Koeln Koeln, 50937 Germany	Status: Recruiting	Contact: Study Coordinator +49 22147882113
Facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Mainz, 55131 Germany	Status: Recruiting	Contact: Study Coordinator +49 68411621622
Facility: Universitaetsklinikum Muenster Muenster, 48149 Germany	Status: Recruiting	Contact: Study Coordinator +49 251 8349949
Facility: Studienpraxis Urologie Drs. Feyerabend Nürtingen, 72622 Germany	Status: Recruiting	Contact: Study Coordinator +49 702234641
Facility: Universitaetsklinikum Tuebingen Tuebingen, 72076 Germany	Status: Recruiting	Contact: Study Coordinator +49 70712987235
Facility: Soroka University Medical Center Be'er Sheva, 8410101 Israel	Status: Recruiting	Contact: Study Coordinator 972-8-6-244127
Facility: Assaf Harofeh Medical Center Be'er Ya'aqov, 70300 Israel	Status: Recruiting	Contact: Study Coordinator 972-8-9778003
Facility: Meir Medical Center Kfar-Saba, 4428126 Israel	Status: Recruiting	Contact: Study Coordinator 972 9747 2337
Facility: Chaim Sheba Medical Center Ramat Gan, 52656 Israel	Status: Recruiting	Contact: Study Coordinator 972-3-5307031
Facility: Tel Aviv Sourasky Medical Center Tel Aviv, 64239 Israel	Status: Recruiting	Contact: Study Coordinator 972-52-7360166
Facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Bologna, 40138 Italy	Status: Recruiting	Contact: Study Coordinator 39051-2142204
Facility: Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo Candiolo, 20133 Italy	Status: Recruiting	Contact: Study Coordinator 39 0119933398
Facility: Fondazione IRCCS Istituto Nazionale dei Tumori Milano, 20133 Italy	Status: Recruiting	Contact: Study Coordinator 39 0223903766
Facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio Napoli, 80131 Italy	Status: Recruiting	Contact: Study Coordinator +39 0817972223
Facility: Ospedale degli Infermi Rimini, 47923 Italy	Status: Recruiting	Contact: Study Coordinator 39 0541705413
Facility: University Campus Bio-Medico di Roma Rome, 00128 Italy	Status: Recruiting	Contact: Study Coordinator 39 0622541116
Facility: IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo, 71013 Italy	Status: Recruiting	Contact: Study Coordinator +39 0882410716
Facility: A.O.U. Senese Policlinico Santa Maria alle Scotte Siena, 53100 Italy	Status: Recruiting	Contact: Study Coordinator +390577586335
Facility: San Camillo-Forlanini Hospital Siena, 53100 Italy	Status: Recruiting	Contact: Study Coordinator +390658704846
Facility: Kyushu University Hospital Fukuoka-shi, 8128582 Japan	Status: Recruiting	Contact: Study Coordinator +81926411151
Facility: Saitama Medical University International Medical Center Hidaka-shi, 350-1298 Japan	Status: Recruiting	Contact: Study Coordinator +81429844111
Facility: Hirosaki University Hospital Hirosaki-shi, 036-8563 Japan	Status: Recruiting	Contact: Study Coordinator +81172395295
Facility: Teikyo University Hospital Itabashi-ku, 173-8606 Japan	Status: Recruiting	Contact: Study Coordinator +81339649358
Facility: Nihon University Itabashi Hospital Itabashi-ku, 173-8610 Japan	Status: Recruiting	Contact: Study Coordinator +81339728111
Facility: Nara Medical University Hospital Kashihara-shi, 634-8522 Japan	Status: Recruiting	Contact: Study Coordinator +81744223051
Facility: Saitama Cancer Center Kitaadachi-gun, 362-0806 Japan	Status: Recruiting	Contact: Study Coordinator +81487221111
Facility: Osaka International Cancer Institute Osaka-shi, 541-8567 Japan	Status: Recruiting	Contact: Study Coordinator +81647063210
Facility: Osaka University Hospital Suita-shi, 565-0871 Japan	Status: Recruiting	Contact: Study Coordinator +81647077007
Facility: Jichi Medical University Hospital Tochigi-ken, 329-0498 Japan	Status: Recruiting	Contact: Study Coordinator +81285587195
Facility: VU Medisch Centrum Amsterdam, 1081 HV Netherlands	Status: Recruiting	Contact: Study Coordinator 31020-4444254
Facility: HagaZiekenhuis Van Den Haag Den Haag, Netherlands	Status: Recruiting	Contact: Study Coordinator 31702102605
Facility: Zorgsaam Ziekenhuis Terneuzen, 4535 PA Netherlands	Status: Recruiting	Contact: Study Coordinator 31115688291
Facility: Viecuri Medisch Centrum Venlo, 5912 BL Netherlands	Status: Recruiting	Contact: Study Coordinator 31077-3205634
Facility: Clinica Universidad de Navarra Pamplona, Navarra 31008 Spain	Status: Recruiting	Contact: Study Coordinator +34 948 255400 5868
Facility: Hospital Universitari Vall d'Hebron Barcelona, 08035 Spain	Status: Recruiting	Contact: Study Coordinator 34932746085
Facility: ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta Girona, 17007 Spain	Status: Recruiting	Contact: Study Coordinator +34972225828
Facility: Centro Integral Oncologico Clara Campal Madrid, 28050 Spain	Status: Recruiting	Contact: Study Coordinator +3491 756 79 84
Facility: University College London Hospitals London, Greater London NW1 2PG United Kingdom	Status: Recruiting	Contact: Study Coordinator 44 2034474698
Facility: Guy's Hospital London, Greater London SE1 9RT United Kingdom	Status: Recruiting	Contact: Study Coordinator +442071883761
Facility: Charing Cross Hospital London, Greater London W6 8RF United Kingdom	Status: Recruiting	Contact: Study Coordinator +44 2033110277
Facility: Nottingham University Hospitals City Campus Nottingham, Nottinghamshire NG5 1PB United Kingdom	Status: Recruiting	Contact: Study Coordinator 4115 969 1169
Facility: Beatson West of Scotland Cancer Centre Glasgow, Strathclyde G12 OYN United Kingdom	Status: Recruiting	Contact: Study Coordinator +4414103017000
Facility: Queen Elizabeth Hospital Birmingham, West Midlands B15 2TH United Kingdom	Status: Recruiting	Contact: Study Coordinator +44 121 371 3157

Brief Title: 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)

INTRODUCTION

BRIEF SUMMARY

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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