Spots Global Cancer Trial Database for Derazantinib and Atezolizumab in Patients With Urothelial Cancer
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Trial Identification
Brief Title: Derazantinib and Atezolizumab in Patients With Urothelial Cancer
Official Title: An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations
Study ID: NCT04045613
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.
Detailed Description: The study comprised five open-label substudies (1-5) in patients with advanced urothelial cancer harboring FGFR GA (with the exception of substudy 2 which did not require a FGFR GA) who were treated by derazantinib monotherapy or derazantinib in combination with atezolizumab. The study enrolled patients with cisplatin-ineligible status, or patients whose disease progressed after either first-line treatment or prior treatment with FGFR inhibitors.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CTCA Clinical Research Inc., Atlanta, Newnan, Georgia, United States
Englander Institute Weill Cornell Medicine, New York, New York, United States
New York Cancer and Blood Specialists, Port Jefferson Station, New York, United States
University of Texas Southwestern Medical Center (UTSWMC), Dallas, Texas, United States
MD Anderson, Houston, Texas, United States
NEXT Oncology, San Antonio, Texas, United States
Medical Oncology Associates PS (dba Summit Cancer Centers), Spokane, Washington, United States
Coastal Cancer Care, Birtinya, , Australia
Canberra Hospital and Health Services, Canberra, , Australia
John Flynn Private Hospital, Tugun, , Australia
Ballarat Oncology & Haematology Services, Wendouree, , Australia
Westmead Hospital, Westmead, , Australia
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Urologie, Vienna, , Austria
Princess Margaret Hospital, Toronto, Ontario, Canada
Juravinski Cancer Center, Hamilton, , Canada
Fakultni nemocnice u sv. Anny v Brne, Brno, , Czechia
Fakultni Nemocnice Olomouc, Olomouc, , Czechia
Institut Bergonie, Bordeaux, , France
Centre François Baclesse, Caen, , France
CHU Timone / CEPCM, Marseille, , France
Medical Oncology - Pitié-Salpêtrière Hopital, Paris, , France
IUCT-Oncopole de Toulouse, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Campus Charite Mitte, Berlin, , Germany
Universitaetsklinikum Duesseldorf, Duesseldorf, , Germany
University Clinic Erlangen, Erlangen, , Germany
Universitaetsklinikum Magdeburg A.oe.R, Magdeburg, , Germany
Studienpraxis Urologie, Nürtingen, , Germany
National Institute of Oncology, Budapest, , Hungary
Bacs- Kiskun Megyei Korhaz, Kecskemét, , Hungary
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
IRCCS - Istituto Europeo di Oncologia IEO, Milano, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte, Siena, , Italy
ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio, Sondrio, , Italy
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul St. Marys Hospital Catholic University of Korea, Seoul, , Korea, Republic of
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, Lublin, , Poland
Med-Polonia Sp. z o. o., Poznań, , Poland
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., 04-073, Warszawa, Poland, Warszawa, , Poland
Mazowiecki Szpital Onkologiczny, Wieliszew, , Poland
Vall d Hebron Hospital, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
IOB - Hospital Quiron Salud, Barcelona, , Spain
ICO Hospitalet, Barcelona, , Spain
Hospital Universitario HM Sanchinarro CIOCC, Madrid, , Spain
Marques de Valdecilla University Hospital, Santander, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Kantonsspital Graubünden, Chur, , Switzerland
Lausanne University Hospital, Lausanne, , Switzerland
UniversitaetsSpital Zuerich, Zürich, , Switzerland
Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI), London, , United Kingdom
The Sarah Cannon Research Institute, London, , United Kingdom
University College London Hospitals, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
Name: Manuel Häckl, MD
Affiliation: Basilea Pharmaceutica International Ltd, Allschwil
Role: STUDY_DIRECTOR
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