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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

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

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.


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

PRIMARY OUTCOMES

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

CONDITION

  • UC (Urothelial Cancer)

ELIGIBILITY


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

OFFICIAL INFORMATION

Name: Ekaterine Asatiani, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: Ekaterine Asatiani, MD

Phone: 1.855.463.3463

Email: N/A

LOCATION

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