Clinical trial NCT02872714: A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: UC (Urothelial Cancer)
Keywords: Urothelial carcinoma
fibroblast growth factor (FGF)
fibroblast growth factor receptor (FGFR)
FGF/FGFR alterations
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen
timeFrame: up to 1138 days
Secondary outcomes:
measure: ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen
timeFrame: up to 817 days
measure: ORR in Participants With All Other FGF/FGFR Alterations
timeFrame: up to 1198 days
measure: ORR in All Participants on an ID or CD Regimen in Combined Cohorts
timeFrame: up to 1198 days
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to approximately 25 weeks
measure: Progression-free Survival (PFS)
timeFrame: up to 1138 days
measure: Duration of Response (DOR)
timeFrame: up to 1075 days
measure: Overall Survival
timeFrame: up to 1610 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates (Wilmot)
state: Arizona
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Care Center
state: California
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Glenwood Springs
country: United States
facility: Calaway-Young Cancer Center at Valley View Hospital
state: Colorado
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Cancer Center
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic Inc. - PARENT ACCOUNT
state: Massachusetts
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Omaha
country: United States
facility: GU Research Network
state: Nebraska
city: Las Vegas
country: United States
facility: TRIO - Comprehensive Cancer Centers of Nevada
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: New Hyde Park
country: United States
facility: Northwell Cancer Institute
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Tualatin
country: United States
facility: Compass Oncology the Northwest Cancer Specialists
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology, P.A. - Austin
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons
state: Texas
city: Houston
country: United States
facility: Texas Oncology
state: Texas
city: Sherman
country: United States
facility: Texas Oncology, P.A. - Sherman
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Health
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Norfolk
country: United States
facility: Virginia Oncology Associates - Hampton
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Madison
country: United States
facility: University of Wisconsic Hospital and Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: AZ Sint-Lucas - Campus Sint-Lucas
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Loofstraat
city: Roeselare
country: Belgium
facility: AZ Delta
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Besancon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
state: Doubs
city: Bordeaux cedex
country: France
facility: Groupe Hospitalier Saint André - Hôpital Saint André
state: Gironde
city: Toulouse cedex 09
country: France
facility: Institut Claudius Regaud-Oncopole
state: Haute Garonne
city: Saint Herblain
country: France
facility: ICO - Site René Gauducheau
state: Loire Atlantique
city: Angers Cedex 9
country: France
facility: ICO - Site Paul Papin
state: Maine Et Loire
city: Paris Cedex 10
country: France
facility: Hopital Saint Louis
state: Paris
city: Lyon Cedex 8
country: France
facility: Centre Leon Berard
state: Rhone
city: Strasbourg
country: France
facility: CHU Strasbourg - Nouvel Hôpital Civil
state: Rhone
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
city: Dresden
country: Germany
facility: Klinikum Dresden Standort Dresden-Friedrichstadt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie Drs. Feyerabend
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofeh Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Rome
country: Italy
facility: University Campus Bio-Medico di Roma
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria alle Scotte
city: Siena
country: Italy
facility: San Camillo-Forlanini Hospital
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
city: Kashihara-shi
country: Japan
facility: Nara Medical University Hospital
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Suita-shi
country: Japan
facility: Osaka University Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis Van Den Haag
city: Terneuzen
country: Netherlands
facility: Zorgsaam Ziekenhuis
city: Venlo
country: Netherlands
facility: Viecuri Medisch Centrum
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Girona
country: Spain
facility: ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: London
country: United Kingdom
facility: University College London Hospitals
state: Greater London
city: London
country: United Kingdom
facility: Guy's Hospital
state: Greater London
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: Greater London
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals City Campus
state: Nottinghamshire
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Strathclyde
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
state: West Midlands
Study officials:
affiliation: Incyte Corporation
name: Ekaterine Asatiani, MD
role: STUDY_DIRECTOR
References: