Spots Global Cancer Trial Database for Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
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Trial Identification
Brief Title: Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
Official Title: Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF 302)
Study ID: NCT04197986
Study Description
Brief Summary: This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, Tucson, Arizona, United States
City of Hope - Duarte, Duarte, California, United States
City of Hope, Duarte, California, United States
Loma Linda University Faculty Medical Clinics, Loma Linda, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
The Urology Center of Colorado, Denver, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Urological Research Network CORP, Hialeah, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Lakeland Regional Health Hollis Cancer Center, Lakeland, Florida, United States
Emory University, Atlanta, Georgia, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park, Chicago, Illinois, United States
DuPage Medical Group - Warrenville Road, Lisle, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Tulane University/Southeastern Louisiana VA Health Care, New Orleans, Louisiana, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Saint Louis University- SLUCare Academic Pavilion, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
New Jersey Urology - Saddle Brook, Saddle Brook, New Jersey, United States
New Jersey Urology, Voorhees, New Jersey, United States
Albany Medical Center - Division of Urology, Albany, New York, United States
Associated Medical Professionals - Syracuse, Syracuse, New York, United States
Duke University Cancer Center, Durham, North Carolina, United States
Accellacare-DuPage Medical Group, Raleigh, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
University of Toledo, Arlington, Ohio, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
The Ohio State University College of Medicine, Columbus, Ohio, United States
The University of Toledo Medical Center, Toledo, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Urology Associates, Nashville, Tennessee, United States
Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas, United States
Bayor College of Medicine, Houston, Texas, United States
Houston Methodist Hospital- Department of Urology, Houston, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
UT Southwestern, Richardson, Texas, United States
Urology San Antonio, San Antonio, Texas, United States
Huntsman Cancer Institute and Hospital, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
West Virginia University, Morgantown, West Virginia, United States
CHU de Liège - Sart Tilman, Liège, Liège/Belgium, Belgium
ZNA Middelheim, Antwerpen, , Belgium
Cliniques Universitaires Saint-Luc, Brussel, , Belgium
Universitair Ziekenhuis Leuven, Leuven, , Belgium
University Multiprofile Hospital For Active Treatment Deva Maria, Burgas, , Bulgaria
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD, Pleven, , Bulgaria
Multiprofile Hospital For Active Treatment "Sveta Sofia", Sofia, , Bulgaria
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer- Vancouver, Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
McGill University Health Centre (MUHC), Montréal, Quebec, Canada
CHU de Québec Université Laval, Québec, , Canada
BC Cancer - Vancouver, Vancouver, , Canada
Hôpital Universitaire Pitié Salpêtrière, Paris, Ile-de-France, France
Hôpital Européen Georges-Pompidou, Paris, Ile-de-France, France
CHU de Nantes Hopital Hotel Dieu, Paris, Paris/France, France
Centre de Lutte Contre le Cancer - Centre Léon Bérard, Lyon, Rhone-Alpes, France
Institut de Cancerologie Strasbourg Europe, Strasbourg, Strasbourg/France, France
Institut Claudius Regaud, Toulouse, Toulouse/France, France
Gustave Roussy, Villejuif, Villejuif/France, France
Hôpital Morvan, Brest, , France
CHU de Nantes Hopital Hotel Dieu, Nantes, , France
Hopital Bichat - Claude - Bernard, Paris, , France
Centre Eugène Marquis, Rennes, , France
Centre Hospitalier Privé Saint-Grégoire, Saint-Grégoire, , France
Institut De Cancerologie De L'ouest - Site Saint-Herblain, Saint-Herblain, , France
Clinique Mutualiste de l'Estuaire, Saint-Nazaire, , France
Gustave Roussy, Villejuif, , France
Charité - Universitatsmedizin Berlin, Berlin, Berlin/Germany, Germany
Universitätsklinikum Düsseldorf, Duesseldorf, Nordrhein-Westfalen, Germany
Urologicum Duisburg, Duisburg, Nordrhein-WestFalen, Germany
Universitätsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Marien Hospital Herne - Universitätsklinikum der Ruhr-Universität Bochum, Herne, Nordrhein-Westfalen, Germany
Charite Universitaetsmedizin Berlin, Berlin, , Germany
Urologie, Berlin, , Germany
University Hospital Duesseldorf, Duesseldorf, , Germany
Universitatsklinikum des Saarlandes Klinik fur Urologie & Kinderurologie, Homburg/saar, , Germany
Universitätsklinikum des Saarlandes Klinik für Urologie & Kinderurologie, Homburg, , Germany
Universitatsklinikum Magdeburg, Magdeburg, , Germany
Caritas-Krankenhaus St. Josef Klinik für Urologie, Regensburg, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Henry Dunant Hospital Center, Athens, Attica, Greece
Bioclinic Thessalonikis, Thessaloníki, Makedonia, Greece
Anassa General Clinic, Volos, , Greece
Ospedale di Cremona, Cremona, Cremona/Italy, Italy
Ospedale Policlinico San Martino, Genova, Genova/Italy, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Meldola/Italy, Italy
Istituto Europeo di Oncologia, Milano, Milano/Italy, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Naples, Italy
Azienda Ospedaliero-Universitaria Pisana, Pisa, Pisa/italy, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata, Rionero In Vulture, Potenza, Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, Reggio Emilia/Italy, Italy
Università Campus Bio-Medico di Roma, Roma, Roma/Italy, Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga, Orbassano, Torino, Italy
Ospedale di Trento - Presidio Ospedaliero Santa Chiara, Trento, Trentino, Italy
Centro di Riferimento Oncologico, Aviano, , Italy
Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari, Bari, , Italy
A.O.U.C. Polclinico di Bari U.O. Oncologia Medica Universitaria, Bari, , Italy
ASST Cremona, Casalmaggiore, , Italy
Ospedale Policlinico San Martino Irccs, Genova, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Fondazione IRCCS INT Milano, Milan, , Italy
Istituto Europeo di Oncologia, Milan, , Italy
Int Pascale Napoli, Napoli, , Italy
AOU San Luigi Gonzaga, Orbassano, , Italy
Azienda Ospedaliero-Universitaria Pisana, Pisa, , Italy
IRCCS di Reggio Emilia, Reggio Emilia, , Italy
Policlinico Universitario Campus Biomedico, Roma, , Italy
Citta Della Salute e Della Scienz - Torino, Torino, , Italy
Ospedale di Trento - Presidio Ospedaliero Santa Chiara, Trento, , Italy
IRCCS Centro di Riferimento Oncologico di Basilicata, Volterra, , Italy
Canisius-Wilhelmina Ziekenhuis, Nijmegen, Gelderland, Netherlands
The Netherlands Cancer Institute, Amsterdam, , Netherlands
Zuyderland MC locatie Sittard, Geleen, , Netherlands
VHIO, Barcelona, Barcelona/Spain, Spain
Sofia, Barcelona, Barcelona/Spain, Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona, Barcelona/Spain, Spain
Institut Català d'Oncologia Badalona, Badalona, Barcelona, Spain
Hospital Parc Taulí de Sabadell, Sabadell, Barcelona, Spain
Hospital Universitario Reina Sofía, Córdoba, Córdoba/Spain, Spain
Institut Català d'Oncologia Girona, Girona, Girona/Spain, Spain
MD Anderson Cancer Center Madrid, Madrid, Madrid/Spain, Spain
Hospital Universitario Ramon y Cajal, Madrid, Madrid/Spain, Spain
Hospital Clinico San Carlos, Madrid, Madrid/Spain, Spain
Hospital Universitario 12 de Octubre, Madrid, Madrid/Spain, Spain
Hospital Universitario La Paz, Madrid, Madrid/Spain, Spain
Hospital Universitario HM Sanchinarro, Madrid, Madrid/Spain, Spain
Hospital Universitario Puerta Hierro-Majadahonda, Majadahonda, Madrid, Spain
Hospital Universitario Virgen del Rocio, Sevilla, Sevilla/Spain, Spain
Hospital Virgen De La Salud, Toledo, Toledo/Spain, Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, València, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Althaia Xarxa Assistencial Universitària de Manresa, Manresa, , Spain
Guy's and St Thomas' NHS Foundation Trust, London, , United Kingdom
Lister Hospital, Stevenage, , United Kingdom
Contact Details
Name: David van Veenhuyzen, M.B., Ch.B., M.Pharm.Med.
Affiliation: QED Therapeutics, Inc.
Role: STUDY_DIRECTOR
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