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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02872714
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
UC (Urothelial Cancer) Drug: pemigatinib Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 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)
Study Start Date : August 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: INCB054828




Primary Outcome Measures :
  1. 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 ]
    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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872714


Contacts
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Contact: Incyte Corporation Call Center 1.855.463.3463

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Locations
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United States, Arizona
Arizona Oncology Associates (Wilmot) Recruiting
Tucson, Arizona, United States, 85711
Contact: Study Coordinator    520-546-2870      
United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Study Coordinator    858-939-5062      
UCSF Helen Diller Family Comprehensive Care Center Recruiting
San Francisco, California, United States, 94158
Contact: Study Coordinator    415-353-4310      
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Boulder, Colorado, United States, 80303
Contact: Study Coordinator    303-388-0136      
Calaway-Young Cancer Center at Valley View Hospital Recruiting
Glenwood Springs, Colorado, United States, 81601
Contact: Study Coordinator    970-384-7574      
United States, Florida
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Study Coordinator    305-674-2625      
Florida Hospital Cancer Institute Recruiting
Orlando, Florida, United States, 32804
Contact: Study Coordinator    407-303-2093      
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Study Coordinator    404-778-3448      
United States, Maryland
University of Maryland, Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Study Coordinator    410-328-8610      
United States, Massachusetts
Lahey Clinic Inc. - PARENT ACCOUNT Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Study Coordinator    781-744-2734      
United States, Minnesota
Minnesota Oncology Hematology, P.A. Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Study Coordinator    651-999-8945      
United States, Nebraska
GU Research Network Recruiting
Omaha, Nebraska, United States, 68130
Contact: Study Coordinator    402-991-8468      
United States, Nevada
TRIO - Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169-3321
Contact: Study Coordinator    702-952-3439      
United States, New York
New York Oncology Hematology, P.C. Recruiting
Albany, New York, United States, 12208
Contact: Study Coordinator    518-262-2768      
Northwell Cancer Institute Recruiting
New Hyde Park, New York, United States, 11042
Contact: Study Coordinator    516-734-8812      
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Study Coordinator    585-275-3351      
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Study Coordinator    919-966-4432      
United States, Ohio
Oncology Hematology Care, Inc. Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Study Coordinator    513-751-2273 ext 27116      
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97229
Contact: Study Coordinator    503-494-3618      
Compass Oncology the Northwest Cancer Specialists Recruiting
Tualatin, Oregon, United States, 97062
Contact: Study Coordinator    503-291-6233      
United States, Pennsylvania
St. Luke's Hospital Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Study Coordinator    484-503-4150      
VA Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Study Coordinator    412-360-6230      
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Study Coordinator    843-449-1010 ext 265      
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Study Coordinator    615-875-8605      
United States, Texas
Texas Oncology, P.A. - Austin Recruiting
Austin, Texas, United States, 78731
Contact: Study Coordinator    512-421-4100      
Texas Oncology - Baylor Charles A. Sammons Recruiting
Dallas, Texas, United States, 75246
Contact: Study Coordinator    214-370-1000      
Texas Oncology Recruiting
Houston, Texas, United States, 77024
Contact: Study Coordinator    713-467-1722      
Texas Oncology, P.A. - Sherman Recruiting
Sherman, Texas, United States, 75090
Contact: Study Coordinator    903-868-4783      
Baylor Scott & White Health Recruiting
Temple, Texas, United States, 76508
Contact: Study Coordinator    254-724-5939      
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Study Coordinator    801-587-4765      
United States, Virginia
Virginia Oncology Associates - Hampton Recruiting
Norfolk, Virginia, United States, 23502
Contact: Study Coordinator    757-213-5615      
United States, Washington
Northwest Medical Specialties, PLLC Recruiting
Tacoma, Washington, United States, 98405
Contact: Study Coordinator    253-306-0532      
United States, Wisconsin
University of Wisconsic Hospital and Clinic Recruiting
Madison, Wisconsin, United States, 53792
Contact: Study Coordinator    608-263-7107      
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Study Coordinator    414-805-8921      
Belgium
UZ Antwerpen Recruiting
Edegem, Belgium, 2650
Contact    3238215681      
AZ Sint-Lucas - Campus Sint-Lucas Recruiting
Gent, Belgium, 9000
Contact: Study Coordinator    3292245297      
AZ Groeninge Campus Loofstraat Recruiting
Kortrijk, Belgium, 8500
Contact: Study Coordinator    3256633941      
AZ Delta Recruiting
Roeselare, Belgium, 8800
Contact: Study Coordinator    +3251238011      
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Study Coordinator    4535455072      
France
CHU Besançon - Hôpital Jean Minjoz Recruiting
Besancon Cedex, Doubs, France, 25030
Contact: Study Coordinator    +33381669386      
Groupe Hospitalier Saint André - Hôpital Saint André Recruiting
Bordeaux cedex, Gironde, France, 33075
Contact: Study Coordinator    33556794708      
Institut Claudius Regaud-Oncopole Recruiting
Toulouse cedex 09, Haute Garonne, France, 31059
Contact: Study Coordinator    33531155818      
ICO - Site René Gauducheau Recruiting
Saint Herblain, Loire Atlantique, France, 44805
Contact: Study Coordinator    33240679900      
ICO - Site Paul Papin Recruiting
Angers Cedex 9, Maine Et Loire, France, 49933
Contact: Study Coordinator    33241352875      
Hopital Saint Louis Recruiting
Paris Cedex 10, Paris, France, 75010
Contact: Study Coordinator    33142385100      
Centre Leon Berard Recruiting
Lyon Cedex 8, Rhone, France, 69373
Contact: Study Coordinator    33426556842      
CHU Strasbourg - Nouvel Hôpital Civil Recruiting
Strasbourg, Rhone, France, 67091
Contact: Study Coordinator    33388116284      
Groupe Hospitalier Pitie-Salpetriere Recruiting
Paris, France, 75571
Contact: Study Coordinator    33142160461      
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Study Coordinator    33142114953      
Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Study Coordinator    +49 3084452575      
Klinikum Dresden Standort Dresden-Friedrichstadt Recruiting
Dresden, Germany, 01067
Contact: Study Coordinator    +49 3514804553      
Universitaetsklinikum Carl Gustav Carus TU Dresden Recruiting
Dresden, Germany, 01307
Contact: Study Coordinator    +49 3814947572      
Universitaetsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Study Coordinator    +49 40741053994      
Universitaetsklinikum Koeln Recruiting
Koeln, Germany, 50937
Contact: Study Coordinator    +49 22147882113      
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Recruiting
Mainz, Germany, 55131
Contact: Study Coordinator    +49 68411621622      
Universitaetsklinikum Muenster Recruiting
Muenster, Germany, 48149
Contact: Study Coordinator    +49 251 8349949      
Studienpraxis Urologie Drs. Feyerabend Recruiting
Nürtingen, Germany, 72622
Contact: Study Coordinator    +49 702234641      
Universitaetsklinikum Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Study Coordinator    +49 70712987235      
Israel
Soroka University Medical Center Recruiting
Be'er Sheva, Israel, 8410101
Contact: Study Coordinator    972-8-6-244127      
Assaf Harofeh Medical Center Recruiting
Be'er Ya'aqov, Israel, 70300
Contact: Study Coordinator    972-8-9778003      
Meir Medical Center Recruiting
Kfar-Saba, Israel, 4428126
Contact: Study Coordinator    972 9747 2337      
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 52656
Contact: Study Coordinator    972-3-5307031      
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Study Coordinator    972-52-7360166      
Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Recruiting
Bologna, Italy, 40138
Contact: Study Coordinator    39051-2142204      
Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo Recruiting
Candiolo, Italy, 20133
Contact: Study Coordinator    39 0119933398      
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Italy, 20133
Contact: Study Coordinator    39 0223903766      
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +39 0817972223      
Ospedale degli Infermi Recruiting
Rimini, Italy, 47923
Contact: Study Coordinator    39 0541705413      
University Campus Bio-Medico di Roma Recruiting
Rome, Italy, 00128
Contact: Study Coordinator    39 0622541116      
IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Italy, 71013
Contact: Study Coordinator    +39 0882410716      
A.O.U. Senese Policlinico Santa Maria alle Scotte Recruiting
Siena, Italy, 53100
Contact: Study Coordinator    +390577586335      
San Camillo-Forlanini Hospital Recruiting
Siena, Italy, 53100
Contact: Study Coordinator    +390658704846      
Japan
Kyushu University Hospital Recruiting
Fukuoka-shi, Japan, 8128582
Contact: Study Coordinator    +81926411151      
Saitama Medical University International Medical Center Recruiting
Hidaka-shi, Japan, 350-1298
Contact: Study Coordinator    +81429844111      
Hirosaki University Hospital Recruiting
Hirosaki-shi, Japan, 036-8563
Contact: Study Coordinator    +81172395295      
Teikyo University Hospital Recruiting
Itabashi-ku, Japan, 173-8606
Contact: Study Coordinator    +81339649358      
Nihon University Itabashi Hospital Recruiting
Itabashi-ku, Japan, 173-8610
Contact: Study Coordinator    +81339728111      
Nara Medical University Hospital Recruiting
Kashihara-shi, Japan, 634-8522
Contact: Study Coordinator    +81744223051      
Saitama Cancer Center Recruiting
Kitaadachi-gun, Japan, 362-0806
Contact: Study Coordinator    +81487221111      
Osaka International Cancer Institute Recruiting
Osaka-shi, Japan, 541-8567
Contact: Study Coordinator    +81647063210      
Osaka University Hospital Recruiting
Suita-shi, Japan, 565-0871
Contact: Study Coordinator    +81647077007      
Jichi Medical University Hospital Recruiting
Tochigi-ken, Japan, 329-0498
Contact: Study Coordinator    +81285587195      
Netherlands
VU Medisch Centrum Recruiting
Amsterdam, Netherlands, 1081 HV
Contact: Study Coordinator    31020-4444254      
HagaZiekenhuis Van Den Haag Recruiting
Den Haag, Netherlands
Contact: Study Coordinator    31702102605      
Zorgsaam Ziekenhuis Recruiting
Terneuzen, Netherlands, 4535 PA
Contact: Study Coordinator    31115688291      
Viecuri Medisch Centrum Recruiting
Venlo, Netherlands, 5912 BL
Contact: Study Coordinator    31077-3205634      
Spain
Clinica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Study Coordinator    +34 948 255400 5868      
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Study Coordinator    34932746085      
ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta Recruiting
Girona, Spain, 17007
Contact: Study Coordinator    +34972225828 ext 4028      
Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
Contact: Study Coordinator    +3491 756 79 84      
United Kingdom
University College London Hospitals Recruiting
London, Greater London, United Kingdom, NW1 2PG
Contact: Study Coordinator    44 2034474698      
Guy's Hospital Recruiting
London, Greater London, United Kingdom, SE1 9RT
Contact: Study Coordinator    +442071883761      
Charing Cross Hospital Recruiting
London, Greater London, United Kingdom, W6 8RF
Contact: Study Coordinator    +44 2033110277      
Nottingham University Hospitals City Campus Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Study Coordinator    4115 969 1169 ext 55713/59606      
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Strathclyde, United Kingdom, G12 OYN
Contact: Study Coordinator    +4414103017000      
Queen Elizabeth Hospital Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Contact: Study Coordinator    +44 121 371 3157      
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Ekaterine Asatiani, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02872714     History of Changes
Other Study ID Numbers: INCB 54828-201
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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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:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action