Spots Global Cancer Trial Database for Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma
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Trial Identification
Brief Title: Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma
Official Title: A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy
Study ID: NCT03410693
Conditions
Study Description
Brief Summary: This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Clinical Research Center, LLC, Anchorage, Alaska, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
University of Southern California, Los Angeles, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
Sansum Clinic, Santa Barbara, California, United States
Rocky Mountain Cancer Centers, Littleton, Colorado, United States
UF Cancer Center at Orlando Health, Orlando, Florida, United States
University of Kansas Medical Center, Westwood, Kansas, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Compass Oncology, Tigard, Oregon, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Bon Secours St. Francis Hospital, Greenville, South Carolina, United States
Texas Oncology-Denton South, Denton, Texas, United States
Houston Methodist Hospital, Houston, Texas, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Summit Cancer Center, Spokane, Washington, United States
Mid North Coast Cancer Institute, Coffs Harbour, New South Wales, Australia
Northern Cancer Institute, St Leonards, New South Wales, Australia
Macquarie University Hospital, Sydney, New South Wales, Australia
Riverina Cancer Care Centre, Wagga Wagga, New South Wales, Australia
Sydney Adventist Hospital, Wahroonga, New South Wales, Australia
Pindara Private Hospital, Benowa, Queensland, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Landesklinikum Krems, Krems, , Austria
Krankenhaus der Barmherzigen Brüder, Wien, , Austria
Universitätsklinikum AKH Wien, Wien, , Austria
Klinik Ottakring - Wilhelminenspital, Wien, , Austria
UZ Gent, Gent, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Clinique Saint-Pierre, Ottignies, , Belgium
Princess Margaret Hospital-University Health Network, Toronto, Ontario, Canada
Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada
Ottawa Hospital-General Campus, Ottawa, , Canada
FuJian Medical University Union Hospital, Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Hubei Cancer Hospital, Wuhan, Hubei, China
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School, Nanjing, Jiangsu, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Liaoning Cancer Hospital and Institute, Shengyang, Liaoning, China
Fifth Medical Center, General Hospital of the Chinese People, Beijing, , China
First Affiliated Hospital of Guangzhou Medical University, Guangzhou, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Huadong Hospital, Affiliated to Fudan University, Shanghai, , China
Fakultni nemocnice Ostrava, Ostrava, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha 10, , Czechia
Fakultni Thomayerova Nemocnice, Praha 4 - Krc, , Czechia
Bata Hospital, Zlin, , Czechia
Aarhus Universitetshospital, Skejby, Aarhus N, , Denmark
Herlev Hospital - Oncology Research Dept., Herlev, , Denmark
Rigshospitalet, København, , Denmark
Docrates Klinikka, Helsinki, , Finland
Hopital Jean Minjoz, Besancon, , France
Hôpital Saint André - Bordeaux, Bordeaux, , France
Centre de Lutte Contre le Cancer François Baclesse, Caen Cedex 5, , France
Centre Jean Perrin, Clermont Ferrand Cedex 1, , France
Centre Oscar Lambret - Lille, Lille Cedex, , France
Centre Léon Bérard, Lyon Cedex, , France
Institut Paoli-Calmettes - Marseille, Marseille, , France
Cochin - Paris, Paris, , France
Hôpital d'Instruction des Armées Begin, Saint Mande, , France
Clinique Saint Anne, Strasbourg, , France
Centre Médico-Chirurgical Foch, Suresnes, , France
Eberhard-Karls-Universität Tübingen, Tübingen, Baden-Württemberg, Germany
Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Nordrhein-Westfalen, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz, Rheinland-Pfalz, Germany
Prince of Wales Hospital Hong Kong, Shatin, , Hong Kong
MH Egeszsegugyi Kozpont, Budapest, , Hungary
Orszagos Onkologiai Intezet, Budapest, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont, Pecs, , Hungary
Cork University Hospital, Cork, , Ireland
AMNCH, Dublin, , Ireland
Rambam Health Corporation, Haifa, , Israel
Hadassah Hebrew University Hospital Ein Kerem, Jerusalem, , Israel
Meir Medical Center, Kfar Saba, , Israel
Clalit Health Services Rabin Medical Center-Beilinson Campus, Petah Tikva, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
IRST Istituto Scientifico Romagnolo per studio e cura tumori, Forlì Cesena, Emilia-Romagna, Italy
AUSL Modena, Modena, Emilia-Romagna, Italy
A.O.U. di Modena - Policlinico, Modena, Emilia-Romagna, Italy
A.O. San Camillo-Forlanini, Roma, Lazio, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
IRCCS Istituto Europeo di Oncologia s.r.l. (IEO), Milano, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, Lombardia, Italy
A.O.U. San Luigi Gonzaga, Torino, Piemonte, Italy
A.O.U. Pisana, Pisa, Toscana, Italy
A.O.U.I. Verona, Verona, Veneto, Italy
Nagoya University Hospital, Nagoya, Aichi, Japan
Hirosaki University Hospital, Hirosaki, Aomori, Japan
Gunma University Hospital, Maebashi, Gunma, Japan
Gunma Prefectural Cancer Center, Ota, Gunma, Japan
Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan
University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital, Morioka, Iwate, Japan
Yokohama City University Hospital, Yokohama, Kanagawa, Japan
Kindai University Hospital, Osakasayama, Osaka, Japan
Saitama Medical University International Medical Center, Hidaka, Saitama, Japan
Nippon Medical School Hospital, Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan
Keio University Hospital, Shinjuku-ku, Tokyo, Japan
Akita University Hospital, Akita, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Hiroshima City Hiroshima Citizens Hospital, Hiroshima, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Niigata University Medical and Dental Hospital, Niigata, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Toyama University Hospital, Toyama, , Japan
National Cancer Center, Goyang-si, Gyeonggido, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Nederlands Kanker Instituut, Amsterdam, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Centrum Onkologii im. Prof. Franciszka Lukaszczyka, Bydgoszcz, , Poland
Swietokrzyskie Centrum Onkologii, Kielce, , Poland
Przychodnia Lekarska KOMED, Konin, , Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Olsztyn, , Poland
Szpital Kliniczny Przemienienia Panskiego, Poznan, , Poland
Uniwersytecki Szpital Kliniczny UM we Wroclawiu, Wroclaw, , Poland
Hospital Beatriz Angelo, Loures, Lisboa, Portugal
IPO Coimbra, Coimbra, , Portugal
Hospital CUF Infante Santo, Lisboa, , Portugal
CHULN - Hospital Santa Maria, Lisboa, , Portugal
Centro Hospitalar Universitario do Porto, Porto, , Portugal
Krasnoyarsk Regional Clinical Oncology Dispensary, Krasnoyarsk, , Russian Federation
Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen, Moscow, , Russian Federation
Volga District Med Center FMBA, Nizhny Novgorod, , Russian Federation
Clinical Oncological Dispensary of Omsk Region, Omsk, , Russian Federation
Bashkir State Medical University, Ufa, , Russian Federation
National University Hospital, Singapore, , Singapore
National Cancer Center Singapore, Singapore, , Singapore
Narodny onkologicky ustav, Bratislava, , Slovakia
UROEXAM, spol. s r.o., Nitra, , Slovakia
POKO Poprad s.r.o., Poprad, , Slovakia
Institut Català d'Oncologia Badalona, Badalona, Barcelona, Spain
Institut Català d'Oncologia Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari Son Espases, Palma de Mallorca, Illes Baleares, Spain
Hospital del Mar, Barcelona, , Spain
Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona, , Spain
Hospital San Pedro de Alcántara, Cáceres, , Spain
Hospital Reina Sofía, Córdoba, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Virgen de la Victoria, Málaga, , Spain
Instituto Valenciano de Oncología, Valencia, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Södersjukhuset, Stockholm, , Sweden
Karolinska Institutet, Stockholm, , Sweden
Universitätsspital Basel, Basel, Basel-Stadt, Switzerland
Kantonsspital Graubünden, Chur, Graubünden, Switzerland
Kantonsspital St. Gallen, St. Gallen, Sankt Gallen, Switzerland
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital at Linkou, Taoyuan, , Taiwan
Clatterbridge Centre for Oncology, Bebington, Merseyside, United Kingdom
Royal Marsden Hospital (London), London, , United Kingdom
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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