Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
Sponsor
Bayer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04464226
Collaborator
(none)
676
336
1
56.1
2
0
Study Details
Study Description
Brief Summary
The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
676 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies
Actual Study Start Date
:
Oct 20, 2020
Anticipated Primary Completion Date
:
Jun 25, 2025
Anticipated Study Completion Date
:
Jun 25, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Darolutamide (BAY1841788) Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from. |
Drug: Darolutamide (Nubeqa, BAY1841788)
Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment-emergent adverse events (TEAEs) [Up to 4 years]
- Incidence of treatment-emergent serious adverse events (TESAEs) [Up to 4 years]
- Incidence of drug-related TEAEs [Up to 4 years]
- Incidence of drug-related TESAEs [Up to 4 years]
Secondary Outcome Measures
- Number of dose modifications [Up to 4 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
-
Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
-
Participants who have not met any treatment discontinuation criteria in the feeder study protocol.
-
Willingness to continue practicing acceptable methods of birth control during the study.
Exclusion Criteria:
-
Participant is unable to comply with the requirements of the study.
-
Negative benefit/ risk ratio as determined by the investigator.
-
Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Urology Centers of Alabama, PC | Homewood | Alabama | United States | 35209 |
| 2 | Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr. | Chandler | Arizona | United States | 85224 |
| 3 | City of Hope National Medical Center | Duarte | California | United States | 91010 |
| 4 | San Diego Clinical Trials | La Mesa | California | United States | 91942 |
| 5 | Tower Urology, Inc | Los Angeles | California | United States | 90048 |
| 6 | VA Greater Los Angeles Healthcare System | Los Angeles | California | United States | 90073-1003 |
| 7 | Stanford Health Care | Stanford | California | United States | 94305 |
| 8 | Innovative Clinical Research Institute | Whittier | California | United States | 90603 |
| 9 | VA Eastern Colorado Health Care System | Aurora | Colorado | United States | 80045 |
| 10 | The Urology Center Of Colorado | Denver | Colorado | United States | 80211 |
| 11 | Boca Raton Regional Hospital | Boca Raton | Florida | United States | 33486 |
| 12 | Advent Health Medical Group Urology | Orlando | Florida | United States | 32803 |
| 13 | Jesse Brown VA Medical Center | Chicago | Illinois | United States | 60612 |
| 14 | Illinois CancerCare, PC | Peoria | Illinois | United States | 61615-7828 |
| 15 | First Urology PSC | Jeffersonville | Indiana | United States | 47130 |
| 16 | Norton Healthcare Pavilion | Louisville | Kentucky | United States | 40202 |
| 17 | Anne Arundel Health System | Annapolis | Maryland | United States | 21401 |
| 18 | Chesapeake Urology Associates | Baltimore | Maryland | United States | 21204 |
| 19 | Johns Hopkins Hospital/Health System | Baltimore | Maryland | United States | 21287 |
| 20 | TidalHealth Peninsula Regional, Inc. | Salisbury | Maryland | United States | 21801 |
| 21 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114-2696 |
| 22 | Henry Ford Health System | Detroit | Michigan | United States | 48202-2608 |
| 23 | St. Vincent Hospital & Healthcare | Billings | Montana | United States | 59102 |
| 24 | Urology Cancer Center, PC | Omaha | Nebraska | United States | 68130-5606 |
| 25 | GU Research Network, LLC | Omaha | Nebraska | United States | 68130 |
| 26 | New Jersey Urology, LLC | Voorhees | New Jersey | United States | 08043 |
| 27 | New Mexico Oncology Hematology Consultants, Ltd. | Albuquerque | New Mexico | United States | 87109 |
| 28 | Montefiore Medical Center | Bronx | New York | United States | 10461 |
| 29 | New York Cancer & Blood Specialists | Bronx | New York | United States | 10469 |
| 30 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 31 | Associated Medical Professionals of NY, PLLC | Syracuse | New York | United States | 13210 |
| 32 | Gabrail Cancer Center | Canton | Ohio | United States | 44718 |
| 33 | The Urology Group | Cincinnati | Ohio | United States | 45212-1979 |
| 34 | Ohio State University | Columbus | Ohio | United States | 43210 |
| 35 | Centers for Advanced Urology, LLC | Bala-Cynwyd | Pennsylvania | United States | 19004 |
| 36 | Andrews & Patel Associates | Camp Hill | Pennsylvania | United States | 17011 |
| 37 | Charleston Oncology | Charleston | South Carolina | United States | 29406 |
| 38 | Bon Secours St. Francis Hospital | Greenville | South Carolina | United States | 29607 |
| 39 | Carolina Urological Research Center | Myrtle Beach | South Carolina | United States | 29579 |
| 40 | Urology Associates, PC / Nashville | Nashville | Tennessee | United States | 37209 |
| 41 | Urology Clinics of North Texas | Dallas | Texas | United States | 75231 |
| 42 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
| 43 | Inova Fairfax Hospital - Falls Church | Falls Church | Virginia | United States | 22031 |
| 44 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298-5054 |
| 45 | Providence Regional Cancer Partnership | Everett | Washington | United States | 98201 |
| 46 | Centro de Urología | Buenos Aires | Ciudad Auton. De Buenos Aires | Argentina | C1120AAT |
| 47 | Adelaide Cancer Centre Research Pty Ltd | Kurralta Park | South Australia | Australia | 5037 |
| 48 | Universitätsklinikum AKH Wien | Wien | Austria | 1090 | |
| 49 | N.N. Alexandrov National Cancer Centre of Belarus | Lesnoy | Belarus | 223040 | |
| 50 | Minsk City Clinical Oncological Dispensary | Minsk | Belarus | 220013 | |
| 51 | GZA Ziekenhuizen | Wilrijk | Antwerpen | Belgium | 2610 |
| 52 | CU Saint-Luc/UZ St-Luc | Bruxelles - Brussel | Belgium | 1200 | |
| 53 | UZ Gent | Gent | Belgium | 9000 | |
| 54 | AZ Groeninge Campus Kennedylaan | Kortrijk | Belgium | 8500 | |
| 55 | CHU de Liège | Liege | Belgium | 4000 | |
| 56 | CHU UCL Namur | Namur | Belgium | 5000 | |
| 57 | Santa Casa de Misericórdia da Bahia | Salvador | Bahia | Brazil | 40050-001 |
| 58 | Hospital São Rafael | Salvador | Bahia | Brazil | 41253-190 |
| 59 | Instituto do Cancer do Ceará | Fortaleza | Ceará | Brazil | 60430-230 |
| 60 | Hospital Evangélico de Cachoeiro de Itapemirim | Cachoeiro de Itapemirim | Espírito Santo | Brazil | 29308-065 |
| 61 | Hosp. Araujo Jorge da Associação de Combate ao Câncer | Goiânia | Goiás | Brazil | 74605-070 |
| 62 | COT Centro Oncologico do Triangulo Ltda | Uberlandia | Minas Gerais | Brazil | 38408-150 |
| 63 | Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner | Curitiba | Parana | Brazil | 81520-060 |
| 64 | Liga Norte Riograndense Contra o Câncer | Natal | Rio Grande Do Norte | Brazil | 59075-740 |
| 65 | Associação Hospitalar Beneficente São Vicente de Paulo | Passo Fundo | Rio Grande Do Sul | Brazil | 99010-080 |
| 66 | Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande Do Sul | Brazil | 90050-170 |
| 67 | União Bras. de Edu. e Assist. Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande Do Sul | Brazil | 90619900 |
| 68 | Clínica de Neoplasias Litoral Ltda | Itajaí | Santa Catarina | Brazil | 88301-220 |
| 69 | Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | Sao Paulo | Brazil | 14784-400 |
| 70 | Hospital Amaral Carvalho | Jaú | Sao Paulo | Brazil | 17210-120 |
| 71 | Hosp Clínicas Facult. Med. de Ribeirão Preto / USP | Ribeirão Preto | Sao Paulo | Brazil | 14048-900 |
| 72 | IEP São Lucas | São Paulo | Sao Paulo | Brazil | 01236-030 |
| 73 | Instituto do Câncer do Estado de São Paulo | São Paulo | Sao Paulo | Brazil | 01246-000 |
| 74 | IBCC - Instituto Brasileiro de Controle do Cancer | São Paulo | Sao Paulo | Brazil | 04014-002 |
| 75 | Inst. de Assistência Médica ao Sérvidor Público Estadual | São Paulo | Sao Paulo | Brazil | 04039-004 |
| 76 | Medical Center Kalimat | Sofia | Bulgaria | 1680 | |
| 77 | Complex Oncology Center - Vratsa | Vratsa | Bulgaria | 3000 | |
| 78 | Prostate Cancer Centre | Calgary | Alberta | Canada | T2V 1P9 |
| 79 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
| 80 | Nova Scotia Health Authority | Halifax | Nova Scotia | Canada | B3H 3G1 |
| 81 | G. Kenneth Jansz Medicine Professional Corporation | Burlington | Ontario | Canada | L7N 3V2 |
| 82 | Kingston Health Sciences Centre | Kingston | Ontario | Canada | K7L 3J7 |
| 83 | London Health Sciences Centre | London | Ontario | Canada | N0P 2C0 |
| 84 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 85 | Princess Margaret Hospital-University Health Network | Toronto | Ontario | Canada | M5G 2M9 |
| 86 | CIUSSS de l'Estrie- Centre Haute-Yamaska | Granby | Quebec | Canada | J2G 1T7 |
| 87 | Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopi | Montreal | Quebec | Canada | H2X 3E4 |
| 88 | Anhui Provincial Hospital | Hefei | Anhui | China | 230001 |
| 89 | The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China | 361003 |
| 90 | Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech. | Wuhan | Hubei | China | 430030 |
| 91 | Hubei Cancer Hospital | Wuhan | Hubei | China | 430079 |
| 92 | Hunan Cancer Hospital | Changsha | Hunan | China | 410013 |
| 93 | Jiangsu Cancer Hospital | Nanjing | Jiangsu | China | 210009 |
| 94 | Liaoning Cancer Hospital and Institute | Shengyang | Liaoning | China | 110042 |
| 95 | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | China | 710061 |
| 96 | Qilu Hospital of Shandong University | Jinan | Shandong | China | 250012 |
| 97 | ZheJiang Provincial People's Hospital | Hangzhou | Zhejiang | China | 310014 |
| 98 | The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China | 325000 |
| 99 | Beijing Cancer Hospital | Beijing | China | 100142 | |
| 100 | Beijing Hospital | Beijing | China | 100730 | |
| 101 | Chongqing Cancer Hospital | Chongqing | China | 400030 | |
| 102 | Fudan University Shanghai Cancer Center | Shanghai | China | 200032 | |
| 103 | Zhongshan Hospital, Fudan University | Shanghai | China | 200032 | |
| 104 | Huadong Hospital, Affiliated to Fudan University | Shanghai | China | 200040 | |
| 105 | Tianjin Medical University Cancer Institiute & Hospital | Tianjin | China | 300060 | |
| 106 | Hospital Pablo Tobón Uribe | Medellín | Antioquia | Colombia | 050034 |
| 107 | Oncomédica S.A. | Montería | Córdoba | Colombia | 230002 |
| 108 | Fundación Oftalmológica de Santander Carlos Ardila Lule | Floridablanca | Santander | Colombia | 681004 |
| 109 | Masarykuv onkologicky ustav | Brno | Czechia | 602 00 | |
| 110 | Nemocnice Jablonec nad Nisou | Jablonec nad Nisou | Czechia | 466 60 | |
| 111 | Fakultni nemocnice Kralovske Vinohrady | Praha 10 | Czechia | 100 34 | |
| 112 | Urocentrum Praha, s.r.o. | Praha 2 | Czechia | 120 00 | |
| 113 | Vseobecna fakultni nemocnice v Praze | Praha 2 | Czechia | 128 08 | |
| 114 | Androgeos - private center of urology and andrology | Praha 6 | Czechia | 160 00 | |
| 115 | North Estonia Medical Centre Foundation | Tallinn | Estonia | 13419 | |
| 116 | HUS, Meilahden sairaala | Helsinki | Finland | 00290 | |
| 117 | Keski-Suomen sairaala Nova | Jyväskylä | Finland | 40620 | |
| 118 | Mikkelin keskussairaala | Mikkeli | Finland | FIN-50100 | |
| 119 | Oulun yliopistollinen sairaala | Oulu | Finland | 90220 | |
| 120 | Seinäjoen keskussairaala | Seinäjoki | Finland | FIN 60220 | |
| 121 | Tampereen yliopistollinen sairaala, keskussairaala | Tampere | Finland | 33520 | |
| 122 | Turun yliopistollinen keskussairaala, kantasairaala | Turku | Finland | 20520 | |
| 123 | Turun yliopistollinen keskussairaala, kantasairaala | Turku | Finland | 20520 | |
| 124 | Centre Hospitalier Universitaire - Angers | Angers | France | 49100 | |
| 125 | Institut Bergonié - Unicancer Nouvelle Aquitaine | Bordeaux Cedex | France | 33076 | |
| 126 | Clinique Lanroze | Brest | France | 29200 | |
| 127 | Centre Jean Perrin | Clermont Ferrand Cedex 1 | France | 63011 | |
| 128 | Centre d'Oncologie et de Radiologie du Parc | Dijon | France | 21000 | |
| 129 | Institut Paoli-Calmettes - Marseille | Marseille | France | 13273 | |
| 130 | Institut du Cancer de Montpellier - Val d'Aurelle | Montpellier Cedex | France | 34298 | |
| 131 | Centre d'Oncologie de Gentilly | Nancy | France | 54100 | |
| 132 | Hopital Hotel Dieu - Nantes | Nantes Cedex | France | 44093 | |
| 133 | Hôpital Saint Louis | Paris | France | 75010 | |
| 134 | Centre Hospitalier Lyon Sud | Pierre Benite | France | 69495 | |
| 135 | Hôpital de la Milétrie | POITIERS cedex | France | 86021 | |
| 136 | Institut de Cancérologie Jean Godinot | REIMS cedex | France | 51726 | |
| 137 | Hôpital Pontchaillou | Rennes Cedex | France | 35033 | |
| 138 | Hôpital Charles Nicolle | Rouen Cedex | France | 76031 | |
| 139 | Institut de Cancérologie de l'Ouest - Saint Herblain | Saint Herblain | France | 44805 | |
| 140 | Hôpital d'Instruction des Armées Begin | Saint Mande | France | 94160 | |
| 141 | Centre Médico-Chirurgical Foch | Suresnes | France | 92151 | |
| 142 | Hôpital Bretonneau | Tours | France | 37044 | |
| 143 | Institut Gustave Roussy | Villejuif Cedex | France | 94805 | |
| 144 | Urologische Gemeinschaftspraxis Carl-Andreas-Meilinger | Emmendingen | Baden-Württemberg | Germany | 79312 |
| 145 | Universitätsklinikum Freiburg | Freiburg | Baden-Württemberg | Germany | 79106 |
| 146 | Urologische GemPraxis Dr. R. Rudolph | Kirchheim unter Teck | Baden-Württemberg | Germany | 73230 |
| 147 | Urologische Gemeinschaftspraxis Muehlacker | Muehlacker | Baden-Württemberg | Germany | 75417 |
| 148 | Studienpraxis Urologie | Nürtingen | Baden-Württemberg | Germany | 72622 |
| 149 | Urologische Gemeinschaftspraxis Dr. Simone Maier | Reutlingen | Baden-Württemberg | Germany | 72764 |
| 150 | Eberhard-Karls-Universität Tübingen | Tübingen | Baden-Württemberg | Germany | 72076 |
| 151 | Universitätsklinikum Ulm | Ulm | Baden-Württemberg | Germany | 89075 |
| 152 | Universitätsklinikum Erlangen | Erlangen | Bayern | Germany | 91054 |
| 153 | Universitätsklinikum der Johann Wolfgang Goethe Universität | Frankfurt | Hessen | Germany | 60590 |
| 154 | Städtisches Klinikum Braunschweig gGmbH | Braunschweig | Niedersachsen | Germany | 38126 |
| 155 | Gesundheitszentrum Holzminden | Holzminden | Niedersachsen | Germany | 37603 |
| 156 | Heinrich-Heine-Universität Düsseldorf | Düsseldorf | Nordrhein-Westfalen | Germany | 40225 |
| 157 | Praxis Drs. Tim Schneider /B. Schneider | Mühlheim | Nordrhein-Westfalen | Germany | 45468 |
| 158 | Universitätsklinikum Münster (UKM) | Münster | Nordrhein-Westfalen | Germany | 48149 |
| 159 | Uro-Gyn-Zentrum Wall Hr. Dr. Jochen Gleißner | Wuppertal | Nordrhein-Westfalen | Germany | 42103 |
| 160 | Universitätsmedizin der Johannes Gutenberg Universität Mainz | Mainz | Rheinland-Pfalz | Germany | 55131 |
| 161 | Friedrich-Schiller-Uni. Jena | Jena | Thüringen | Germany | 07747 |
| 162 | Medizinische Fakultät der Otto-von-Guericke Universität | Magdeburg | Germany | 39120 | |
| 163 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | 4032 | |
| 164 | Tolna Megyei Balassa Janos Korhaz | Szekszard | Hungary | 7100 | |
| 165 | Zala Megyei Szent Rafael Korhaz | Zalaegerszeg | Hungary | 8900 | |
| 166 | Soroka University Medical Center | Beer Sheva | Israel | 8410101 | |
| 167 | Clalit Health Services Rabin Medical Center-Beilinson Campus | Petah Tikva | Israel | 4941492 | |
| 168 | Health Corporation of the Ziv Medical Center (R.A.) | Zefat | Israel | 1311001 | |
| 169 | Istituto Nazionale Tumori IRCCS Fondazione G.Pascale | Napoli | Campania | Italy | 80131 |
| 170 | A.O.U. di Parma | Parma | Emilia-Romagna | Italy | 43126 |
| 171 | A.O.U. San Luigi Gonzaga | Torino | Piemonte | Italy | 10043 |
| 172 | IRCCS Fondazione del Piemonte per l'Oncologia | Torino | Piemonte | Italy | 10060 |
| 173 | Istituto Oncologico Veneto IRCCS (IOV) | Padova | Veneto | Italy | 35128 |
| 174 | Gunma University Hospital | Maebashi | Gunma | Japan | 371-8511 |
| 175 | Sapporo Medical University Hospital | Sapporo | Hokkaido | Japan | 060-8543 |
| 176 | National hospital Organization Mito Medical Center | Higashiibaraki | Ibaraki | Japan | 311-3193 |
| 177 | Kitasato University Hospital | Sagamihara | Kanagawa | Japan | 252-0375 |
| 178 | Yokohama City University Medical Center | Yokohama | Kanagawa | Japan | 232-0024 |
| 179 | Yokosuka Kyosai Hospital | Yokosuka | Kanagawa | Japan | 238-8558 |
| 180 | National Hospital Organization Shinshu Ueda Medical Center | Ueda | Nagano | Japan | 386-8610 |
| 181 | Oita University Hospital | Yufu | Oita | Japan | 879-5593 |
| 182 | Kindai University Hospital | Osakasayama | Osaka | Japan | 589-8511 |
| 183 | Hamamatsu University Hospital | Hamamatsu | Shizuoka | Japan | 431-3192 |
| 184 | Saiseikai Utsunomiya Hospital | Utsunomiya | Tochigi | Japan | 321-0974 |
| 185 | Juntendo University Hospital | Bunkyo-ku | Tokyo | Japan | 113-8431 |
| 186 | Nippon Medical School Hospital | Bunkyo-ku | Tokyo | Japan | 113-8603 |
| 187 | Tokyo Metropolitan Geriatric Hospital | Itabashi-ku | Tokyo | Japan | 173-0015 |
| 188 | Kyorin University Hospital | Mitaka | Tokyo | Japan | 181-8611 |
| 189 | Tokyo Metropolitan Police Hospital | Nakano-ku | Tokyo | Japan | 164-8541 |
| 190 | The Fraternity Memorial Hospital | Sumida-ku | Tokyo | Japan | 130-8587 |
| 191 | Yamaguchi University Hospital | Ube | Yamaguchi | Japan | 755-8505 |
| 192 | Hiroshima City Hiroshima Citizens Hospital | Hiroshima | Japan | 730-8518 | |
| 193 | National Cancer Center Hospital East | Kashiwa | Japan | 277-8577 | |
| 194 | Osaka International Cancer Institute | Osaka | Japan | 541-8567 | |
| 195 | Osaka Metropolitan University Hospital | Osaka | Japan | 545-8586 | |
| 196 | Osaka General Medical Center | Osaka | Japan | 558-8558 | |
| 197 | Toyama University Hospital | Toyama | Japan | 930-0194 | |
| 198 | Chungbuk National University Hospital | Cheongju | Chungcheongbugdo | Korea, Republic of | 28644 |
| 199 | Chonnam National University Hospital | Donggu, | Gwangju Gwang''yeogsi | Korea, Republic of | 61469 |
| 200 | Seoul National Univ. Bundang Hospital | Seongnam-si | Gyeonggido | Korea, Republic of | 13620 |
| 201 | Seoul National University Hospital | Seoul | Seoul Teugbyeolsi | Korea, Republic of | 03080 |
| 202 | Inje University Busan Paik Hospital | Busan | Korea, Republic of | 47392 | |
| 203 | Kyungpook National University Chilgok Hospital | Daegu | Korea, Republic of | 41404 | |
| 204 | Keimyung University Dongsan Medical Center | Daegu | Korea, Republic of | 42601 | |
| 205 | Gachon University Gil Medical Center | Incheon | Korea, Republic of | 21565 | |
| 206 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
| 207 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
| 208 | Seoul St. Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
| 209 | Gangnam Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 135-720 | |
| 210 | Asan Medical Center | Seoul | Korea, Republic of | 138736 | |
| 211 | Litavniece Dzintra practice in urology and oncological chem. | Liepaja | Latvia | LV-3401 | |
| 212 | URO Ltd. | Riga | Latvia | LV-1001 | |
| 213 | P. Stradins Clinical University Hospital | Riga | Latvia | LV-1002 | |
| 214 | AS "Association of Health Centers" polyclinic "Elite" | Riga | Latvia | LV-1029 | |
| 215 | Riga East Clinical University Hospital "Gailezers" | Riga | Latvia | LV-1038 | |
| 216 | Hospital of LT University of Health Sciences Kaunas Clinics | Kaunas | Lithuania | LT-50161 | |
| 217 | PI Klaipedos University Hospital | Klaipeda | Lithuania | LT-92288 | |
| 218 | National Cancer Institute | Vilnius | Lithuania | LT-08660 | |
| 219 | Vilnius University Hospital Santaros Klinikos | Vilnius | Lithuania | LT-08661 | |
| 220 | Hospital Universitario "José Eleuterio González" | Monterrey | Nuevo Leon | Mexico | 64460 |
| 221 | INBIOMEDyC Querétaro | Santiago de Querétaro | Querétaro | Mexico | 76000 |
| 222 | Nederlands Kanker Instituut | Amsterdam | Netherlands | 1066 CX | |
| 223 | Academisch Medisch Centrum (AMC) | Amsterdam | Netherlands | 1105 AZ | |
| 224 | HagaZiekenhuis | Den Haag | Netherlands | 2545 CH | |
| 225 | Albert Schweitzer Ziekenhuis, Locatie Dordwijk | Dordrecht | Netherlands | 3318 AT | |
| 226 | Zuyderland Medisch Centrum Sittard-Geleen | Geleen | Netherlands | 6162 BG | |
| 227 | Tergooiziekenhuizen Hilversum | Hilversum | Netherlands | 1213 XZ | |
| 228 | Spaarne Gasthuis | Hoofddorp | Netherlands | 2134 TM | |
| 229 | ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis) | Tilburg | Netherlands | 5042 AD | |
| 230 | Centro Médico Monte Carmelo | La Victoria | Arequipa | Peru | 4001 |
| 231 | Hospital Central de la Fuerza Aerea del Perú | Lima | Peru | 15046 | |
| 232 | Instituto de Oncología y Radioterapia de la Clínica Ricardo | Lima | Peru | 27 | |
| 233 | Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | 80-214 | |
| 234 | ETG Network Spolka z o.o. | Lodz | Poland | 90-302 | |
| 235 | KO-MED Centra Kliniczne Lublin II | Lublin | Poland | 20-362 | |
| 236 | Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina | Otwock | Poland | 05-400 | |
| 237 | SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 | Rybnik | Poland | 44-200 | |
| 238 | Urologica Praktyka Lekarska Adam Marcheluk | Siedlce | Poland | 08-110 | |
| 239 | Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie | Warszawa | Poland | 02-781 | |
| 240 | Szpital Grochowski im. dr.med. Rafala Masztaka | Warszawa | Poland | 04-073 | |
| 241 | Mazowiecki Szpital Onkologiczny | Wieliszew | Poland | 05-135 | |
| 242 | EMC Instytut Medyczny SA | Wroclaw | Poland | 54-144 | |
| 243 | Hospital Garcia de Orta | Almada | Lisboa | Portugal | 2801-951 |
| 244 | ULSM - Hospital Pedro Hispano | Matosinhos | Porto | Portugal | 4464-513 |
| 245 | IPO Lisboa | Lisboa | Portugal | 1093 CODEX | |
| 246 | CHLC - Hospital Sao Jose | Lisboa | Portugal | 1150-199 | |
| 247 | Hospital da Luz - Lisboa | Lisboa | Portugal | 1500-650 | |
| 248 | IPO Porto | Porto | Portugal | 4200-072 | |
| 249 | CHUSJ - Hospital Sao Joao | Porto | Portugal | 4200-319 | |
| 250 | Institutul Clinic Fundeni | Bucuresti | Romania | 22328 | |
| 251 | Sf. Nectarie Oncology Center | Craiova | Romania | 200542 | |
| 252 | Spitalul Clinic Judetean de Urgenta Oradea | Oradea | Romania | 410159 | |
| 253 | Spitalul Clinic Judetean Mures | Targu-Mures | Romania | 540103 | |
| 254 | Ltd "EVIMED" | Chelyabinsk | Russian Federation | 454048 | |
| 255 | Chelyabinsk Regional Oncology Dispensary | Chelyabinsk | Russian Federation | 454087 | |
| 256 | Ivanovo Regional Oncology Dispensary | Ivanovo | Russian Federation | 153040 | |
| 257 | Republican Clinical Oncology Dispensary Kazan | Kazan | Russian Federation | 420029 | |
| 258 | Krasnoyarsk Regional Clinical Oncology Dispensary | Krasnoyarsk | Russian Federation | 660133 | |
| 259 | Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS | Moscow | Russian Federation | 115552 | |
| 260 | Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen | Moscow | Russian Federation | 125284 | |
| 261 | City clinical hospital #40 Moscow | Moscow | Russian Federation | 129301 | |
| 262 | City Outpatient Clinic #1 of Privolzhsky Regional Med. Cent. | Nizhny Novgorod | Russian Federation | 603001 | |
| 263 | Medical Center "Avicenna" | Novosibirsk | Russian Federation | 630007 | |
| 264 | LLC Reafan | Novosibirsk | Russian Federation | 630099 | |
| 265 | National Medical Research Radiology Center | Obninsk | Russian Federation | 249036 | |
| 266 | Clinical Oncological Dispensary of Omsk Region | Omsk | Russian Federation | 644013 | |
| 267 | Rostov State Medical University | Rostov-on-Don | Russian Federation | 344022 | |
| 268 | Saratov State Medical University | Saratov | Russian Federation | 410012 | |
| 269 | Leningrad Regional Oncology Dispensary | St. Petersburg | Russian Federation | 191014 | |
| 270 | St. Petersburg Clinical Hospital of RAS | St. Petersburg | Russian Federation | 194017 | |
| 271 | St. Petersburg Medical University n.a. I.P. Pavlov | St. Petersburg | Russian Federation | 197022 | |
| 272 | Multi-Field Clinical Medical Center "Medical City" | Tyumen | Russian Federation | 625041 | |
| 273 | Regional Clinical Oncology Dispensary | Vladimir | Russian Federation | 600009 | |
| 274 | Clinical Hospital Center Bezanijska kosa | Belgrade | Serbia | 11080 | |
| 275 | Clinical Center Nis | Nis | Serbia | 18000 | |
| 276 | J. BREZA MEDICAL s. r. o. | Bratislava | Slovakia | 851 01 | |
| 277 | CUIMED s.r.o | Bratislava | Slovakia | 85101 | |
| 278 | Privatna urologicka ambulancia, s.r.o. | Trencin | Slovakia | 91101 | |
| 279 | Cancercare Outeniqua | George | Eastern Cape | South Africa | 6530 |
| 280 | Dept Radiation and Oncology Tygerberg Academic Hospital | Cape Town | Western Cape | South Africa | 7505 |
| 281 | Cancercare Rondebosch Oncology | Cape Town | Western Cape | South Africa | 7700 |
| 282 | Hospital General de Elche | Elche | Alicante | Spain | 03203 |
| 283 | Ciutat Sanitària i Universitària de Bellvitge | L'Hospitalet de Llobregat | Barcelona | Spain | 08907 |
| 284 | Corporació Sanitària Parc Taulí | Sabadell | Barcelona | Spain | 08208 |
| 285 | Hospital SAS de Jerez de la Frontera | Jerez de la Frontera | Cádiz | Spain | 11407 |
| 286 | Hospital de Manacor | Manacor | Illes Baleares | Spain | 07500 |
| 287 | Hospital Universitari Son Espases | Palma de Mallorca | Illes Baleares | Spain | 07120 |
| 288 | Fundación Hospital Alcorcón | Alcorcón | Madrid | Spain | 28922 |
| 289 | Hospital del Mar | Barcelona | Spain | 08003 | |
| 290 | Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona | Spain | 08035 | |
| 291 | Hospital Clínic i Provincial de Barcelona | Barcelona | Spain | 08036 | |
| 292 | Hospital de la Santa Creu i de Sant Pau | Oncología | Barcelona | Spain | 08041 | |
| 293 | Hospital San Pedro de Alcántara | Cáceres | Spain | 10003 | |
| 294 | Hospital Reina Sofía | Córdoba | Spain | 14004 | |
| 295 | Hopsital Lucus Agustí | Lugo | Spain | 27003 | |
| 296 | Hospital General Universitario Gregorio Marañón | Oncología | Madrid | Spain | 28007 | |
| 297 | Hospital Ramón y Cajal | Oncología | Madrid | Spain | 28034 | |
| 298 | Fundacion Jimenez Diaz (Clinica de la Concepcion) | Madrid | Spain | 28040 | |
| 299 | Hospital Clinico Universitario San Carlos | Oncologia | Madrid | Spain | 28040 | |
| 300 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 301 | Hospital Virgen de la Victoria | Málaga | Spain | 29010 | |
| 302 | Hospital Clínico de Salamanca | Salamanca | Spain | 37007 | |
| 303 | Hospital Universitario Virgen del Rocío | Sevilla | Spain | 41013 | |
| 304 | Instituto Valenciano de Oncología | Valencia | Spain | 46009 | |
| 305 | Hospital Arnau de Vilanova de Valencia | Valencia | Spain | 46015 | |
| 306 | Sahlgrenska Universitetssjukhuset | Göteborg | Sweden | 413 45 | |
| 307 | Skånes Universitetssjukhus Malmö | Malmö | Sweden | 205 02 | |
| 308 | Karolinska Universitetssjukhuset | Stockholm | Sweden | 171 64 | |
| 309 | Norrlands Universitetssjukhus, Umeå | Umeå | Sweden | 901 85 | |
| 310 | Akademiska Sjukhuset | Uppsala | Sweden | 751 85 | |
| 311 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | Taiwan | 807 | |
| 312 | China Medical University Hospital | Taichung | Taiwan | 40447 | |
| 313 | Taichung Veterans General Hospital | Taichung | Taiwan | 40705 | |
| 314 | National Taiwan University Hospital | Taipei | Taiwan | 100 | |
| 315 | Taipei Veterans General Hospital | Taipei | Taiwan | 11217 | |
| 316 | Chang Gung Memorial Hospital at Linkou | Taoyuan | Taiwan | 33305 | |
| 317 | Gazi Universitesi Tip Fakultesi | Ankara | Turkey | 06500 | |
| 318 | TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has | Istanbul | Turkey | 34724 | |
| 319 | Bukovinian State Medical University | Chernivtsi | Ukraine | 58002 | |
| 320 | City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA | Dnipro | Ukraine | 49102 | |
| 321 | Kharkiv Medical Academy of postgraduate education | Kharkiv | Ukraine | 61037 | |
| 322 | Academy of Medical Science of Ukraine | Kyiv | Ukraine | 252053 | |
| 323 | Kyiv City Hospital #3 | Kyiv | Ukraine | 2660 | |
| 324 | Transkarpathian Regional Oncology Center | Uzhgorod | Ukraine | 88014 | |
| 325 | Royal Berkshire Hospital | Reading | Berkshire | United Kingdom | RG1 5AN |
| 326 | Prince Philip Hospital | Llanelli | Carmarthenshire | United Kingdom | SA14 8QF |
| 327 | Colchester General Hospital | Colchester | Essex | United Kingdom | CO4 5JL |
| 328 | Clatterbridge Centre for Oncology | Bebington | Merseyside | United Kingdom | CH63 4JY |
| 329 | Scunthorpe General Hospital | Scunthorpe | North East Lincolnshire | United Kingdom | DN15 7BH |
| 330 | Russells Hall Hospital | Dudley | West Midlands | United Kingdom | DY1 2HQ |
| 331 | Huddersfield Royal Infirmary | Huddersfield | West Yorkshire | United Kingdom | HD3 3EA |
| 332 | Pinderfields Hospital The Mid Yorkshire Hospitals NHS Trust | Wakefield | West Yorkshire | United Kingdom | WF1 4DG |
| 333 | University Hospital of Wales | Cardiff | United Kingdom | CF14 4XW | |
| 334 | Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom | G12 0YN | |
| 335 | University College London Hospitals NHS Foundation Trust | London | United Kingdom | NW1 2PG | |
| 336 | Charing Cross Hospital | London | United Kingdom | W6 8RF |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT04464226
Other Study ID Numbers:
- 20321
- 2019-003618-15
First Posted:
Jul 9, 2020
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Bayer