39
Participants
Start Date
March 11, 2020
Primary Completion Date
February 28, 2023
Study Completion Date
February 28, 2023
Infigratinib
Participants randomly assigned to infigratinib will receive hard gelatin capsules for oral administration of infigratinib 125 mg once a day (administered as one 100-mg capsule and one 25-mg capsule) using a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule.
Placebo
Participants randomly assigned to placebo will receive placebo matching in appearance the investigational product (infigratinib), which will be provided as hard gelatin capsules for oral use and will be administered once daily on a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule.
Cliniques Universitaires Saint-Luc, Brussels
CHU de Liège - Sart Tilman, Liège
University Multiprofile Hospital For Active Treatment Deva Maria, Burgas
Azienda Ospedaliero - Universitaria San Luigi Gonzaga, Orbassano
Charité - Universitatsmedizin Berlin, Berlin
Henry Dunant Hospital Center, Athens
Albany Medical Center - Division of Urology, Albany
Associated Medical Professionals - Syracuse, Syracuse
Hospital Universitario Reina Sofía, Córdoba
Ospedale Policlinico San Martino, Genova
Institut Català d'Oncologia Girona, Girona
Georgetown University Medical Center, Washington D.C.
Istituto Europeo di Oncologia, Milan
Johns Hopkins Hospital, Baltimore
Ospedale di Cremona, Cremona
West Virginia University, Morgantown
Wake Forest Baptist Health, Winston-Salem
Accellacare-DuPage Medical Group, Raleigh
Duke University Cancer Center, Durham
MD Anderson Cancer Center Madrid, Madrid
Hospital Universitario Ramon y Cajal, Madrid
Hospital Clinico San Carlos, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario La Paz, Madrid
Hospital Universitario HM Sanchinarro, Madrid
Hospital Universitario Puerta Hierro-Majadahonda, Majadahonda
Hôpital Morvan, Brest
Medical University of South Carolina, Charleston
Emory University, Atlanta
Winship Cancer Institute of Emory University, Atlanta
Institut Claudius Regaud, Toulouse
Mayo Clinic - Jacksonville, Jacksonville
Urological Research Network CORP, Hialeah
Lakeland Regional Health Hollis Cancer Center, Lakeland
Centre Eugène Marquis, Rennes
Centre Hospitalier Privé Saint-Grégoire, Saint-Grégoire
Urology Associates, Nashville
Ospedale di Trento - Presidio Ospedaliero Santa Chiara, Trento
Universitätsklinikum Düsseldorf, Düsseldorf
Hospital Universitario Virgen del Rocio, Seville
Arcispedale Santa Maria Nuova, Reggio Emilia
The Ohio State University College of Medicine, Columbus
University of Toledo, Arlington
The University of Toledo Medical Center, Toledo
Cleveland Clinic, Cleveland
Clinique Mutualiste de l'Estuaire, Saint-Nazaire
Marien Hospital Herne - Universitätsklinikum der Ruhr-Universität Bochum, Herne
Hospital Virgen De La Salud, Toledo
Universitätsklinikum Essen, Essen
Oncology Hematology Care, Cincinnati
Fundacion Instituto Valenciano de Oncologia, Valencia
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola
Urologicum Duisburg, Duisburg
Bioclinic Thessalonikis, Thessaloniki
Azienda Ospedaliero-Universitaria Pisana, Pisa
DuPage Medical Group - Warrenville Road, Lisle
Northwestern University Feinberg School of Medicine, Chicago
UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park, Chicago
Saint Louis University- SLUCare Academic Pavilion, St Louis
Institut de Cancerologie Strasbourg Europe, Strasbourg
University of Nebraska Medical Center, Omaha
Centre de Lutte Contre le Cancer - Centre Léon Bérard, Lyon
Tulane University/Southeastern Louisiana VA Health Care, New Orleans
Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari, Bari
Stephenson Cancer Center, Oklahoma City
Hôpital Universitaire Pitié Salpêtrière, Paris
Hôpital Européen Georges-Pompidou, Paris
CHU de Nantes Hopital Hotel Dieu, Paris
UT Southwestern, Richardson
Harold C. Simmons Comprehensive Cancer Center, Dallas
Bayor College of Medicine, Houston
Houston Methodist Hospital- Department of Urology, Houston
The University of Texas MD Anderson Cancer Center, Houston
Urology San Antonio, San Antonio
University of Colorado Cancer Center, Aurora
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli
The Urology Center of Colorado, Denver
Huntsman Cancer Institute and Hospital, Salt Lake City
IRCCS Centro di Riferimento Oncologico di Basilicata, Rionero in Vulture
Arizona Oncology Associates, Tucson
USC Norris Comprehensive Cancer Center, Los Angeles
City of Hope - Duarte, Duarte
City of Hope, Duarte
Loma Linda University Faculty Medical Clinics, Loma Linda
Caritas-Krankenhaus St. Josef Klinik für Urologie, Regensburg
Gustave Roussy, Villejuif
Seattle Cancer Care Alliance, Seattle
Dartmouth-Hitchcock Medical Center, Lebanon
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack
New Jersey Urology - Saddle Brook, Saddle Brook
New Jersey Urology, Voorhees Township
ZNA Middelheim, Antwerp
Universitair Ziekenhuis Leuven, Leuven
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD, Pleven
"Multiprofile Hospital For Active Treatment Sveta Sofia", Sofia
BC Cancer - Vancouver, Vancouver
CHU de Nantes Hopital Hotel Dieu, Nantes
Hopital Bichat - Claude - Bernard, Paris
Institut De Cancerologie De L'ouest - Site Saint-Herblain, Saint-Herblain
Gustave Roussy, Villejuif
Charite Universitaetsmedizin Berlin, Berlin
Urologie, Berlin
University Hospital Duesseldorf, Düsseldorf
Universitätsklinikum des Saarlandes Klinik für Urologie & Kinderurologie, Homburg
Universitatsklinikum des Saarlandes Klinik fur Urologie & Kinderurologie, Homburg/saar
Universitatsklinikum Magdeburg, Magdeburg
Universitätsklinikum Tübingen, Tübingen
Anassa General Clinic, Volos
Centro di Riferimento Oncologico, Aviano
A.O.U.C. Polclinico di Bari U.O. Oncologia Medica Universitaria, Bari
ASST Cremona, Casalmaggiore
Ospedale Policlinico San Martino Irccs, Genova
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola
Fondazione IRCCS INT Milano, Milan
Istituto Europeo di Oncologia, Milan
Int Pascale Napoli, Napoli
AOU San Luigi Gonzaga, Orbassano
Azienda Ospedaliero-Universitaria Pisana, Pisa
IRCCS di Reggio Emilia, Reggio Emilia
Policlinico Universitario Campus Biomedico, Roma
Citta Della Salute e Della Scienz - Torino, Torino
Ospedale di Trento - Presidio Ospedaliero Santa Chiara, Trento
IRCCS Centro di Riferimento Oncologico di Basilicata, Volterra
The Netherlands Cancer Institute, Amsterdam
Zuyderland MC locatie Sittard, Geleen
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital del Mar, Barcelona
Althaia Xarxa Assistencial Universitària de Manresa, Manresa
Guy's and St Thomas' NHS Foundation Trust, London
Lister Hospital, Stevenage
Cross Cancer Institute, Edmonton
BC Cancer- Vancouver, Vancouver
Princess Margaret Cancer Centre, Toronto
McGill University Health Centre (MUHC), Montreal
CHU de Québec Université Laval, Québec
Università Campus Bio-Medico di Roma, Roma
Canisius-Wilhelmina Ziekenhuis, Nijmegen
VHIO, Barcelona
Sofia, Barcelona
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona
Institut Català d'Oncologia Badalona, Badalona
Hospital Parc Taulí de Sabadell, Sabadell
Collaborators (1)
Helsinn Healthcare SA
INDUSTRY
QED Therapeutics, Inc., a Bridgebio company
INDUSTRY