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BRIEF TITLE: 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)

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)


  • Org Study ID: INCB 54828-201
  • Secondary ID:
  • NCT ID: NCT02872714
  • NCT Alias:
  • Sponsor: Incyte Corporation - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: August 2016 Phase 2 Interventional

Primary Outcomes:

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

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

Condition:

  • UC (Urothelial Cancer)

Eligibility

Criteria:
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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Ekaterine Asatiani, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: Incyte Corporation Call Center

Phone: 1.855.463.3463

Email:

Locations

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