Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

NCT ID: NCT04464226

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2028-06-26

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Keywords

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Roll-Over Study

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Darolutamide (BAY1841788)

Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.

Group Type EXPERIMENTAL

Darolutamide (Nubeqa, BAY1841788)

Intervention Type DRUG

Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.

Interventions

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Darolutamide (Nubeqa, BAY1841788)

Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.

Intervention Type DRUG

Other Intervention Names

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ODM-201

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urology Centers of Alabama, PC

Homewood, Alabama, United States

Site Status COMPLETED

Ironwood Cancer and Research Centers - Chandler I

Chandler, Arizona, United States

Site Status COMPLETED

City of Hope National Medical Center

Duarte, California, United States

Site Status WITHDRAWN

Tower Urology

Los Angeles, California, United States

Site Status COMPLETED

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Site Status WITHDRAWN

Stanford Cancer Center Palo Alto

Palo Alto, California, United States

Site Status COMPLETED

San Diego Clinical Trials

San Diego, California, United States

Site Status COMPLETED

TOI Clinical Research

Whittier, California, United States

Site Status COMPLETED

VA Eastern Colorado Health Care System

Aurora, Colorado, United States

Site Status COMPLETED

The Urology Center Of Colorado

Denver, Colorado, United States

Site Status COMPLETED

Boca Raton Regional Hospital - Oncology

Boca Raton, Florida, United States

Site Status COMPLETED

Advent Health Medical Group Urology

Orlando, Florida, United States

Site Status WITHDRAWN

Jesse Brown VA Medical Center - Cardiology

Chicago, Illinois, United States

Site Status COMPLETED

Illinois CancerCare - Peoria

Peoria, Illinois, United States

Site Status COMPLETED

First Urology PSC

Jeffersonville, Indiana, United States

Site Status WITHDRAWN

Norton Cancer Institute - Downtown

Louisville, Kentucky, United States

Site Status COMPLETED

Anne Arundel Health System

Annapolis, Maryland, United States

Site Status WITHDRAWN

Chesapeake Urology Associates - Towson

Baltimore, Maryland, United States

Site Status COMPLETED

Johns Hopkins Hospital - Pulmonology

Baltimore, Maryland, United States

Site Status COMPLETED

TidalHealth Peninsula Regional, Inc. - Oncology

Salisbury, Maryland, United States

Site Status COMPLETED

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status WITHDRAWN

Henry Ford Hospital - OB/GYN

Detroit, Michigan, United States

Site Status COMPLETED

St. Vincent Regional Hospital - Oncology

Billings, Montana, United States

Site Status COMPLETED

Urology Cancer Center, PC

Omaha, Nebraska, United States

Site Status WITHDRAWN

XCancer Omaha

Omaha, Nebraska, United States

Site Status COMPLETED

New Jersey Urology - Voorhees

Voorhees Township, New Jersey, United States

Site Status COMPLETED

New Mexico Cancer Center - Albuquerque

Albuquerque, New Mexico, United States

Site Status COMPLETED

URMC Wilmot Cancer Center

Rochester, New York, United States

Site Status COMPLETED

Associated Medical Professionals of NY, PLLC

Syracuse, New York, United States

Site Status WITHDRAWN

New York Cancer & Blood Specialists - Eastchester

The Bronx, New York, United States

Site Status COMPLETED

Montefiore Einstein Center for Cancer Care

The Bronx, New York, United States

Site Status COMPLETED

Gabrail Cancer Center

Canton, Ohio, United States

Site Status COMPLETED

The Urology Group - Norwood Surgery Center

Cincinnati, Ohio, United States

Site Status COMPLETED

The Ohio State University - Arthur G James Cancer Hospital and Richard J Solove Research Institute

Columbus, Ohio, United States

Site Status COMPLETED

MidLantic Urology - Bala Cynwyd

Bala-Cynwyd, Pennsylvania, United States

Site Status COMPLETED

Andrews & Patel Associates

Camp Hill, Pennsylvania, United States

Site Status COMPLETED

Charleston Oncology - Downtown

Charleston, South Carolina, United States

Site Status COMPLETED

Bon Secours St. Francis Hospital

Greenville, South Carolina, United States

Site Status WITHDRAWN

Carolina Urological Research Center

Myrtle Beach, South Carolina, United States

Site Status COMPLETED

Urology Associates, PC

Nashville, Tennessee, United States

Site Status COMPLETED

Urology Clinics of North Texas

Dallas, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status COMPLETED

Inova Schar Cancer Insitute - Inova Fairfax Hospital

Fairfax, Virginia, United States

Site Status COMPLETED

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status COMPLETED

Providence Regional Cancer Partnership

Everett, Washington, United States

Site Status COMPLETED

Centro de Urología

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Site Status COMPLETED

Adelaide Cancer Centre Research Pty Ltd

Kurralta Park, South Australia, Australia

Site Status COMPLETED

Universitätsklinikum AKH Wien

Vienna, , Austria

Site Status COMPLETED

N.N. Alexandrov National Cancer Centre of Belarus - Oncology Department

Lesnoy, , Belarus

Site Status COMPLETED

Minsk City Clinical Oncological Dispensary - Oncology Department

Minsk, , Belarus

Site Status COMPLETED

GZA Ziekenhuizen

Wilrijk, Antwerpen, Belgium

Site Status COMPLETED

CU Saint-Luc/UZ St-Luc

Bruxelles - Brussel, , Belgium

Site Status WITHDRAWN

UZ Gent

Ghent, , Belgium

Site Status WITHDRAWN

AZ Groeninge Campus Kennedylaan

Kortrijk, , Belgium

Site Status COMPLETED

CHU de Liège

Liège, , Belgium

Site Status COMPLETED

CHU UCL Namur

Namur, , Belgium

Site Status WITHDRAWN

Instituto do Cancer do Ceará

Fortaleza, Ceará, Brazil

Site Status COMPLETED

Hospital Evangélico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Site Status COMPLETED

Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Site Status COMPLETED

Santa Casa de Misericórdia da Bahia

Salvador, Estado de Bahia, Brazil

Site Status COMPLETED

Hosp. Araujo Jorge da Associação de Combate ao Câncer

Goiânia, Goiás, Brazil

Site Status COMPLETED

COT Centro Oncologico do Triangulo Ltda

Uberlândia, Minas Gerais, Brazil

Site Status COMPLETED

Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

Curitiba, Paraná, Brazil

Site Status ACTIVE_NOT_RECRUITING

Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

Natal, Rio Grande do Norte, Brazil

Site Status COMPLETED

Associação Hospitalar Beneficente São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Site Status COMPLETED

Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology

Porto Alegre, Rio Grande do Sul, Brazil

Site Status COMPLETED

União Bras. de Edu. e Assist. Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status COMPLETED

Clínica de Neoplasias Litoral Ltda

Itajaí, Santa Catarina, Brazil

Site Status COMPLETED

Fundacao Pio XII - Hospital de Cancer de Barretos

Barretos/SP, São Paulo, Brazil

Site Status ACTIVE_NOT_RECRUITING

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Site Status COMPLETED

Hosp Clínicas Facult. Med. de Ribeirão Preto / USP

Ribeirão Preto, São Paulo, Brazil

Site Status COMPLETED

IEP São Lucas

São Paulo, São Paulo, Brazil

Site Status WITHDRAWN

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status COMPLETED

IBCC - Instituto Brasileiro de Controle do Cancer

São Paulo, São Paulo, Brazil

Site Status COMPLETED

Inst. de Assistência Médica ao Sérvidor Público Estadual

São Paulo, São Paulo, Brazil

Site Status WITHDRAWN

Medical Center Kalimat

Sofia, , Bulgaria

Site Status COMPLETED

Complex Oncology Center - Vratsa

Vratsa, , Bulgaria

Site Status COMPLETED

Prostate Cancer Centre

Calgary, Alberta, Canada

Site Status COMPLETED

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status COMPLETED

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Site Status COMPLETED

G. Kenneth Jansz Medicine Professional Corporation

Burlington, Ontario, Canada

Site Status COMPLETED

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status WITHDRAWN

London Health Sciences Centre

London, Ontario, Canada

Site Status COMPLETED

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status COMPLETED

Princess Margaret Hospital-University Health Network

Toronto, Ontario, Canada

Site Status COMPLETED

CIUSSS de l'Estrie- Centre Haute-Yamaska

Granby, Quebec, Canada

Site Status COMPLETED

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Site Status COMPLETED

The Second Hospital of Anhui medical university

Hefei, Anhui, China

Site Status RECRUITING

Anhui Provincial Hospital

Hefei City, Anhui Province, Anhui, China

Site Status RECRUITING

Beijing Cancer Hospital - Oncology Department

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Cancer Hospital - Oncology Department

Beijing, Beijing Municipality, China

Site Status ACTIVE_NOT_RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status RECRUITING

2nd Affiliated Hosp. of Shantou University Medical College

Shantou, Guangdong, China

Site Status RECRUITING

Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

Wuhan, Hubei, China

Site Status RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Hunan Cancer Hospital - Oncology Department

Changsha, Hunan, China

Site Status RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

Nanjing, Jiangsu, China

Site Status RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Nantong tumor hospital

Nantong, Jiangsu, China

Site Status RECRUITING

The 2nd Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

The First Affiliated Hospital of NanChang University

Nanchang, Jiangxi, China

Site Status RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Liaoning Cancer Hospital and Institute

Shengyang, Liaoning, China

Site Status RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status WITHDRAWN

Qilu Hosp., Shandong Univ.

Jinan, Shandong, China

Site Status RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Site Status RECRUITING

Shanxi Medical University - First Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status RECRUITING

University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)

Chengdu, Sichuan, China

Site Status RECRUITING

Sichuan University West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Sichuan University West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

ZheJiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)

Chengdu, , China

Site Status RECRUITING

Chongqing Cancer Hospital

Chongqing, , China

Site Status COMPLETED

Sun Yat-sen University Cancer Center

Guangzhou, , China

Site Status RECRUITING

Ningbo First Hospital

Ningbo, , China

Site Status RECRUITING

The Affiliated Hospital of Qingdao University

Shandong, , China

Site Status RECRUITING

Fudan University Shanghai Cancer Center - Oncology Department

Shanghai, , China

Site Status RECRUITING

Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine

Shanghai, , China

Site Status ACTIVE_NOT_RECRUITING

Zhongshan Hospital, Fudan University - Oncology Department

Shanghai, , China

Site Status COMPLETED

Huadong Hospital, Affiliated to Fudan University

Shanghai, , China

Site Status RECRUITING

Shanghai Tenth People's Hospital

Shanghai, , China

Site Status WITHDRAWN

Shanghai General Hospital

Shanghai, , China

Site Status RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, , China

Site Status RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, , China

Site Status RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, , China

Site Status RECRUITING

ZheJiang Provincial People's Hospital

Zhejiang, , China

Site Status RECRUITING

Hospital Pablo Tobón Uribe

Medellín, Antioquia, Colombia

Site Status COMPLETED

Oncomédica S.A.

Montería, Departamento de Córdoba, Colombia

Site Status COMPLETED

Fundación Oftalmológica de Santander Carlos Ardila Lule

Floridablanca, Santander Department, Colombia

Site Status COMPLETED

Masarykuv onkologicky ustav

Brno, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Nemocnice Jablonec nad Nisou

Jablonec nad Nisou, , Czechia

Site Status COMPLETED

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Urocentrum Praha, s.r.o.

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Všeobecná fakultní nemocnice v Praze

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

ANDROGEOS, spol. s r.o.

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Sihtasutus Põhja-Eesti Regionaalhaigla - Onkoloogia- ja hematoloogiakliinik

Tallinn, , Estonia

Site Status COMPLETED

HUS, Meilahden sairaala

Helsinki, Uusimaa, Finland

Site Status COMPLETED

Keski-Suomen sairaala Nova

Jyväskylä, , Finland

Site Status COMPLETED

Mikkelin keskussairaala

Mikkeli, , Finland

Site Status COMPLETED

Oulun yliopistollinen sairaala

Oulu, , Finland

Site Status COMPLETED

Seinäjoen keskussairaala

Seinäjoki, , Finland

Site Status COMPLETED

Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)

Tampere, , Finland

Site Status COMPLETED

Turun yliopistollinen keskussairaala

Turku, , Finland

Site Status WITHDRAWN

Turun yliopistollinen keskussairaala

Turku, , Finland

Site Status COMPLETED

Centre Hospitalier Universitaire - Angers

Angers, , France

Site Status COMPLETED

Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

Bordeaux, , France

Site Status COMPLETED

Clinique Lanroze

Brest, , France

Site Status COMPLETED

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status COMPLETED

Centre d'Oncologie et de Radiologie du Parc

Dijon, , France

Site Status COMPLETED

Institut Paoli-Calmettes - Marseille

Marseille, , France

Site Status COMPLETED

ICM - Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, , France

Site Status COMPLETED

Centre d'Oncologie de Gentilly

Nancy, , France

Site Status WITHDRAWN

Hopital Hotel Dieu - Nantes

Nantes, , France

Site Status COMPLETED

Hôpital Saint Louis

Paris, , France

Site Status COMPLETED

HCL - Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status COMPLETED

Hôpital de la Milétrie

Poitiers, , France

Site Status COMPLETED

Institut de Cancerologie Jean Godinot - Departement oncologie medicale

Reims, , France

Site Status COMPLETED

CHU Rennes - Hopital Pontchaillou

Rennes, , France

Site Status COMPLETED

Hôpital Charles Nicolle

Rouen, , France

Site Status COMPLETED

Institut de Cancerologie Ouest - Saint-Herblain

Saint-Herblain, , France

Site Status COMPLETED

Hôpital d'Instruction des Armées Begin

Saint-Mandé, , France

Site Status COMPLETED

Centre Médico-Chirurgical Foch

Suresnes, , France

Site Status COMPLETED

CHU Tours - Hopital Bretonneau

Tours, , France

Site Status COMPLETED

Gustave Roussy - Departement Oncologie-Radiotherapie

Villejuif, , France

Site Status COMPLETED

Urologische Gemeinschaftspraxis Carl-Andreas-Meilinger

Emmendingen, Baden-Wurttemberg, Germany

Site Status COMPLETED

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status COMPLETED

Urologische GemPraxis Dr. R. Rudolph

Kirchheim unter Teck, Baden-Wurttemberg, Germany

Site Status WITHDRAWN

Urologische Gemeinschaftspraxis Muehlacker

Mühlacker, Baden-Wurttemberg, Germany

Site Status COMPLETED

Studienpraxis Urologie

Nürtingen, Baden-Wurttemberg, Germany

Site Status COMPLETED

Urologische Gemeinschaftspraxis Dr. Simone Maier

Reutlingen, Baden-Wurttemberg, Germany

Site Status COMPLETED

Uniklinik Tübingen / Urologie

Tübingen, Baden-Wurttemberg, Germany

Site Status COMPLETED

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Site Status WITHDRAWN

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Site Status COMPLETED

Universitätsklinikum der Johann Wolfgang Goethe Universität

Frankfurt am Main, Hesse, Germany

Site Status WITHDRAWN

Städtisches Klinikum Braunschweig gGmbH

Braunschweig, Lower Saxony, Germany

Site Status COMPLETED

Gesundheitszentrum Holzminden

Holzminden, Lower Saxony, Germany

Site Status WITHDRAWN

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status COMPLETED

Praxis Drs. Tim Schneider /B. Schneider

Mülheim, North Rhine-Westphalia, Germany

Site Status COMPLETED

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Site Status COMPLETED

Uro-Gyn-Zentrum Wall Hr. Dr. Jochen Gleißner

Wuppertal, North Rhine-Westphalia, Germany

Site Status COMPLETED

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status COMPLETED

Medizinische Fakultät der Otto-von-Guericke Universität

Magdeburg, Saxony-Anhalt, Germany

Site Status COMPLETED

Friedrich-Schiller-Uni. Jena

Jena, Thuringia, Germany

Site Status COMPLETED

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Site Status WITHDRAWN

Tolna Varmegyei Balassa Janos Korhaz

Szekszárd, , Hungary

Site Status ACTIVE_NOT_RECRUITING

Zala Varmegyei Szent Rafael Korhaz

Zalaegerszeg, , Hungary

Site Status COMPLETED

Clalit Health | Soroka Medical Center - Internal Medicine Department

Beersheba, , Israel

Site Status ACTIVE_NOT_RECRUITING

Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department

Petah Tikva, , Israel

Site Status ACTIVE_NOT_RECRUITING

Health Corporation of the Ziv Medical Center (R.A.)

Safed, , Israel

Site Status ACTIVE_NOT_RECRUITING

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Napoli, Campania, Italy

Site Status COMPLETED

Azienda Ospedaliero Universitaria Parma

Parma, Emilia-Romagna, Italy

Site Status COMPLETED

Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica

Orbassano, Piedmont, Italy

Site Status COMPLETED

Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS

Turin, Piedmont, Italy

Site Status COMPLETED

Istituto Oncologico Veneto_Padova - UOC Oncologia 1

Padua, Veneto, Italy

Site Status COMPLETED

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Site Status ACTIVE_NOT_RECRUITING

Asahi General Hospital

Asahi, Chiba, Japan

Site Status ACTIVE_NOT_RECRUITING

Toho University Sakura Medical Center

Sakura, Chiba, Japan

Site Status COMPLETED

Gunma University Hospital

Maebashi, Gunma, Japan

Site Status ACTIVE_NOT_RECRUITING

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Site Status ACTIVE_NOT_RECRUITING

Kobe University Hospital

Kobe, Hyōgo, Japan

Site Status ACTIVE_NOT_RECRUITING

National hospital Organization Mito Medical Center

Higashiibaraki, Ibaraki, Japan

Site Status ACTIVE_NOT_RECRUITING

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Site Status ACTIVE_NOT_RECRUITING

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Site Status ACTIVE_NOT_RECRUITING

Yokosuka Kyosai Hospital

Yokosuka, Kanagawa, Japan

Site Status COMPLETED

Mie University Hospital

Tsu, Mie-ken, Japan

Site Status ACTIVE_NOT_RECRUITING

National Hospital Organization Shinshu Ueda Medical Center

Ueda, Nagano, Japan

Site Status COMPLETED

Oita University Hospital

Yufu, Oita Prefecture, Japan

Site Status ACTIVE_NOT_RECRUITING

Osaka International Cancer Institute

Osaka, Osaka, Japan

Site Status COMPLETED

Kindai University Hospital

Sayama, Osaka, Japan

Site Status ACTIVE_NOT_RECRUITING

The University of Osaka Hospital

Suita, Osaka, Japan

Site Status COMPLETED

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Site Status ACTIVE_NOT_RECRUITING

Saiseikai Utsunomiya Hospital

Utsunomiya, Tochigi, Japan

Site Status ACTIVE_NOT_RECRUITING

Nippon Medical School Hospital

Bunkyo-Ku, Tokyo, Japan

Site Status COMPLETED

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Site Status ACTIVE_NOT_RECRUITING

Tokyo Metropolitan Institute for Geriatrics and Gerontology

Itabashi-ku, Tokyo, Japan

Site Status COMPLETED

Kyorin University Hospital

Mitaka, Tokyo, Japan

Site Status COMPLETED

Tokyo Metropolitan Police Hospital

Nakano-ku, Tokyo, Japan

Site Status ACTIVE_NOT_RECRUITING

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Site Status ACTIVE_NOT_RECRUITING

The Fraternity Memorial Hospital

Sumida-ku, Tokyo, Japan

Site Status ACTIVE_NOT_RECRUITING

Tottori University Hospital

Yonago, Tottori, Japan

Site Status COMPLETED

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Site Status ACTIVE_NOT_RECRUITING

Chiba Cancer Center

Chiba, , Japan

Site Status ACTIVE_NOT_RECRUITING

Gifu Prefectural General Medical Center

Gifu, , Japan

Site Status ACTIVE_NOT_RECRUITING

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, , Japan

Site Status COMPLETED

National Cancer Center Hospital East

Kashiwa, , Japan

Site Status WITHDRAWN

National Hospital Organization Kumamoto Medical Center

Kumamoto, , Japan

Site Status ACTIVE_NOT_RECRUITING

University of Miyazaki Hospital

Miyazaki, , Japan

Site Status ACTIVE_NOT_RECRUITING

Nagasaki University Hospital

Nagasaki, , Japan

Site Status ACTIVE_NOT_RECRUITING

Osaka Metropolitan University Hospital

Osaka, , Japan

Site Status WITHDRAWN

Osaka General Medical Center

Osaka, , Japan

Site Status COMPLETED

Toyama University Hospital

Toyama, , Japan

Site Status COMPLETED

Wakayama Medical University Hospital

Wakayama, , Japan

Site Status ACTIVE_NOT_RECRUITING

Daugavpils Regional Hospital

Daugavpils, , Latvia

Site Status ACTIVE_NOT_RECRUITING

Litavniece Dzintra practice in urology and oncological chem.

Liepāja, , Latvia

Site Status COMPLETED

P. Stradins Clinical University Hospital

Riga, , Latvia

Site Status ACTIVE_NOT_RECRUITING

AS "Association of Health Centers" polyclinic "Elite"

Riga, , Latvia

Site Status COMPLETED

Riga East Clinical University Hospital "Gailezers"

Riga, , Latvia

Site Status ACTIVE_NOT_RECRUITING

Vidzemes Hospital

Valmiera, , Latvia

Site Status ACTIVE_NOT_RECRUITING

Hospital of LT University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Site Status ACTIVE_NOT_RECRUITING

PI Klaipedos University Hospital

Klaipėda, , Lithuania

Site Status COMPLETED

National Cancer Institute

Vilnius, , Lithuania

Site Status ACTIVE_NOT_RECRUITING

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario "José Eleuterio González"

Monterrey, Nuevo León, Mexico

Site Status COMPLETED

INBIOMEDyC Querétaro

Querétaro City, Querétaro, Mexico

Site Status COMPLETED

Nederlands Kanker Instituut

Amsterdam, , Netherlands

Site Status WITHDRAWN

Academisch Medisch Centrum (AMC)

Amsterdam, , Netherlands

Site Status COMPLETED

Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department

Dordrecht, , Netherlands

Site Status COMPLETED

Zuyderland Medical Centre | Internal Medicine Department

Geleen, , Netherlands

Site Status COMPLETED

Tergooi MC | Hilversum - Wetenschapsbureau

Hilversum, , Netherlands

Site Status COMPLETED

Spaarne Gasthuis

Hoofddorp, , Netherlands

Site Status COMPLETED

HagaZiekenhuis

The Hague, , Netherlands

Site Status COMPLETED

ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis)

Tilburg, , Netherlands

Site Status COMPLETED

Centro Médico Monte Carmelo - Oncology Department

La Victoria, Arequipa, Peru

Site Status ACTIVE_NOT_RECRUITING

Hospital Central de la Fuerza Aerea del Perú

Lima, , Peru

Site Status COMPLETED

Instituto Peruano de Oncología & Radioterapia - Oncologia SA - Oncology Department

Lima, , Peru

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status WITHDRAWN

ETG Network Spolka z o.o.

Lodz, , Poland

Site Status COMPLETED

KO-MED Centra Kliniczne Lublin II

Lublin, , Poland

Site Status ACTIVE_NOT_RECRUITING

Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

Otwock, , Poland

Site Status COMPLETED

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3

Rybnik, , Poland

Site Status WITHDRAWN

Urologica Praktyka Lekarska Adam Marcheluk

Siedlce, , Poland

Site Status COMPLETED

Mazowiecki Szpital Onkologiczny

Waliszew, , Poland

Site Status WITHDRAWN

Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

Warsaw, , Poland

Site Status WITHDRAWN

Szpital Grochowski im. dr.med. Rafala Masztaka

Warsaw, , Poland

Site Status COMPLETED

EMC Instytut Medyczny SA

Wroclaw, , Poland

Site Status WITHDRAWN

ULSM - Hospital Pedro Hispano

Matosinhos Municipality, Porto District, Portugal

Site Status WITHDRAWN

Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research Department

Almada, Setúbal District, Portugal

Site Status COMPLETED

IPO Lisboa

Lisbon, , Portugal

Site Status COMPLETED

CHLC - Hospital Sao Jose

Lisbon, , Portugal

Site Status COMPLETED

Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica

Lisbon, , Portugal

Site Status COMPLETED

IPO Porto

Porto, , Portugal

Site Status COMPLETED

Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos

Porto, , Portugal

Site Status COMPLETED

Institutul Clinic Fundeni

Bucharest, , Romania

Site Status COMPLETED

Sf. Nectarie Oncology Center

Craiova, , Romania

Site Status WITHDRAWN

Spitalul Clinic Judetean de Urgenta Oradea

Oradea, , Romania

Site Status WITHDRAWN

Spitalul Clinic Judetean Mures

Târgu Mureş, , Romania

Site Status ACTIVE_NOT_RECRUITING

Ltd "EVIMED"

Chelyabinsk, , Russia

Site Status COMPLETED

Chelyabinsk Regional Oncology Dispensary

Chelyabinsk, , Russia

Site Status COMPLETED

Ivanovo Regional Oncology Dispensary

Ivanovo, , Russia

Site Status COMPLETED

Republican Clinical Oncology Dispensary Kazan

Kazan', , Russia

Site Status COMPLETED

Krasnoyarsk Regional Clinical Oncology Dispensary

Krasnoyarsk, , Russia

Site Status COMPLETED

Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

Moscow, , Russia

Site Status COMPLETED

Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen

Moscow, , Russia

Site Status COMPLETED

City clinical hospital #40 Moscow

Moscow, , Russia

Site Status WITHDRAWN

City Outpatient Clinic #1 of Privolzhsky Regional Med. Cent.

Nizhny Novgorod, , Russia

Site Status COMPLETED

LLC Reafan

Novosibirsk, , Russia

Site Status COMPLETED

Medical Center "Avicenna"

Novosibirsk, , Russia

Site Status COMPLETED

National Medical Research Radiology Center

Obninsk, , Russia

Site Status COMPLETED

Clinical Oncological Dispensary of Omsk Region

Omsk, , Russia

Site Status COMPLETED

Rostov State Medical University

Rostov-on-Don, , Russia

Site Status WITHDRAWN

Leningrad Regional Oncology Dispensary

Saint Petersburg, , Russia

Site Status COMPLETED

St. Petersburg Clinical Hospital of RAS

Saint Petersburg, , Russia

Site Status WITHDRAWN

St. Petersburg Medical University n.a. I.P. Pavlov

Saint Petersburg, , Russia

Site Status WITHDRAWN

Saratov State Medical University

Saratov, , Russia

Site Status COMPLETED

Multi-Field Clinical Medical Center "Medical City"

Tyumen, , Russia

Site Status COMPLETED

Regional Clinical Oncology Dispensary

Vladimir, , Russia

Site Status COMPLETED

Clinical Hospital Center Bezanijska kosa

Belgrade, , Serbia

Site Status COMPLETED

Clinical Center Nis

Niš, , Serbia

Site Status ACTIVE_NOT_RECRUITING

J. BREZA MEDICAL s. r. o.

Bratislava, , Slovakia

Site Status COMPLETED

CUIMED s.r.o

Bratislava, , Slovakia

Site Status COMPLETED

Privatna urologicka ambulancia, s.r.o.

Trenčín, , Slovakia

Site Status WITHDRAWN

Cancercare Outeniqua

George, Eastern Cape, South Africa

Site Status COMPLETED

Langehoven Drive Oncology Centre

Port Elizabeth, Eastern Cape, South Africa

Site Status ACTIVE_NOT_RECRUITING

University of Pretoria, Clinical Research Unit

Pretoria, Gauteng, South Africa

Site Status ACTIVE_NOT_RECRUITING

Dept Radiation and Oncology Tygerberg Academic Hospital

Cape Town, Western Cape, South Africa

Site Status ACTIVE_NOT_RECRUITING

Cape Gate Oncology Centre

Cape Town, Western Cape, South Africa

Site Status ACTIVE_NOT_RECRUITING

Cancercare Rondebosch Oncology

Rondebosch, Western Cape, South Africa

Site Status ACTIVE_NOT_RECRUITING

Chonnam National University Hospital

Gwangju, Gwangju Gwang''yeogsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggido, South Korea

Site Status WITHDRAWN

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Site Status ACTIVE_NOT_RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Asan Medical Center - Oncology Department

Seoul, Seoul Teugbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Inje University Busan Paik Hospital

Busan, , South Korea

Site Status WITHDRAWN

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status COMPLETED

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Samsung Medical Center - Oncology Department

Seoul, , South Korea

Site Status ACTIVE_NOT_RECRUITING

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Hospital General de Elche - Urologia

Elche, Alicante, Spain

Site Status COMPLETED

Parc Tauli Hospital Universitari - Oncologia

Sabadell, Barcelona, Spain

Site Status COMPLETED

Hospital SAS de Jerez de la Frontera

Jerez de la Frontera, Cádiz, Spain

Site Status WITHDRAWN

Hospital de Manacor - Urologia

Manacor, Illes Baleares, Spain

Site Status COMPLETED

Hospital Universitari Son Espases - Oncologia

Palma de Mallorca, Illes Baleares, Spain

Site Status COMPLETED

Hospital Universitario Fundacion Alcorcon - Urologia

Alcorcón, Madrid, Spain

Site Status COMPLETED

Hospital del Mar

Barcelona, , Spain

Site Status COMPLETED

Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, , Spain

Site Status COMPLETED

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Site Status COMPLETED

Hospital de la Santa Creu i de Sant Pau | Oncología

Barcelona, , Spain

Site Status COMPLETED

Hospital Universitari de Bellvitge (HUB)

Barcelona, , Spain

Site Status COMPLETED

Hospital San Pedro de Alcántara - Oncologia

Cáceres, , Spain

Site Status COMPLETED

Hospital Universitario Reina Sofia - Oncologia

Córdoba, , Spain

Site Status COMPLETED

Hospital Universitario Lucus Augusti - Urologia

Lugo, , Spain

Site Status COMPLETED

Hospital General Universitario Gregorio Maranon | Oncologia

Madrid, , Spain

Site Status COMPLETED

Hospital Universitario Ramon Y Cajal - Oncologia

Madrid, , Spain

Site Status COMPLETED

Hospital Clinico Universitario San Carlos | Oncologia

Madrid, , Spain

Site Status COMPLETED

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Site Status COMPLETED

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status COMPLETED

Hospital Universitario Virgen De La Victoria - Oncology

Málaga, , Spain

Site Status COMPLETED

Hospital Clínico de Salamanca

Salamanca, , Spain

Site Status WITHDRAWN

Hospital Universitario Virgen Del Rocio S.L. - Oncologia

Seville, , Spain

Site Status COMPLETED

Instituto Valenciano de Oncología

Valencia, , Spain

Site Status COMPLETED

Hospital Arnau De Vilanova De Valencia - Oncologia

Valencia, , Spain

Site Status COMPLETED

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status COMPLETED

Skånes Universitetssjukhus Malmö

Malmo, , Sweden

Site Status WITHDRAWN

Karolinska Universitetssjukhuset

Stockholm, , Sweden

Site Status COMPLETED

Norrlands Universitetssjukhus, Umea

Umeå, , Sweden

Site Status COMPLETED

Akademiska Sjukhuset

Uppsala, , Sweden

Site Status COMPLETED

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status COMPLETED

China Medical University Hospital

Taichung, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Chang Gung Memorial Hospital at Linkou

Taoyuan District, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Gazi Universitesi Tip Fakultesi

Ankara, , Turkey (Türkiye)

Site Status COMPLETED

TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

Istanbul, , Turkey (Türkiye)

Site Status WITHDRAWN

CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"

Cherkasy, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Regional communal non-profit enterprise 'Chernivtsi regional clinical hospital' - Urological department

Chernivtsi, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Municipal Non-commercial Enterprise 'City Clinical Hospital #4' of Dnipro City Council - City ?hemotherapy ?enter

Dnipro, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Regional Medical Clinical Center of Urology and Nephrology n.a. V. I. Shapoval - Department of Oncologic Urology #5

Kharkiv, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Kyiv City Hospital #3 - Department of Urology

Kyiv, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

SE "Academician O.F. Vozianov Institute of Urology" of NAMSU - Division of Reconstructive Urology and Advanced Technologies

Kyiv, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Zakarpattia Anti-Tumor Centre - Chemotherapy Department

Uzhhorod, , Ukraine

Site Status COMPLETED

Royal Berkshire NHS Foundation Trust¦Royal Berkshire Hospital - Oncology

Reading, Berkshire, United Kingdom

Site Status COMPLETED

Prince Philip Hospital

Llanelli, Carmarthenshire, United Kingdom

Site Status COMPLETED

East Suffolk and North Essex NHS Foundation Trust¦Colchester General Hospital - Oncology Trials Unit

Colchester, Essex, United Kingdom

Site Status COMPLETED

Clatterbridge Centre for Oncology

Bebington, Merseyside, United Kingdom

Site Status COMPLETED

Scunthorpe General Hospital

Scunthorpe, North East Lincolnshire, United Kingdom

Site Status COMPLETED

Dudley Group NHS Foundation Trust ¦Russells Hall Hopsital - Oncology

Dudley, West Midlands, United Kingdom

Site Status COMPLETED

Calderdale and Huddersfield NHS Foundation Trust¦Huddersfield Royal Infirmary - Oncology

Huddersfield, West Yorkshire, United Kingdom

Site Status COMPLETED

Mid Yorkshire Teaching NHS Trust¦Pinderfields Hospital - Oncology

Wakefield, West Yorkshire, United Kingdom

Site Status COMPLETED

Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant

Cardiff, , United Kingdom

Site Status COMPLETED

NHS Greater Glasgow & Clyde | Beatson West of Scotland Cancer Centre - Clinical Research Unit

Glasgow, , United Kingdom

Site Status COMPLETED

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

Site Status COMPLETED

Charing Cross Hospital

London, , United Kingdom

Site Status COMPLETED

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Estonia Finland France Germany Hungary Israel Italy Japan Latvia Lithuania Mexico Netherlands Peru Poland Portugal Romania Russia Serbia Slovakia South Africa South Korea Spain Sweden Taiwan Turkey (Türkiye) Ukraine United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bayer Clinical Trials Contact

Role: CONTACT

Phone: (+)1-888-84 22937

Email: [email protected]

Related Links

Access external resources that provide additional context or updates about the study.

https://clinicaltrials.bayer.com/

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-003618-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20321

Identifier Type: -

Identifier Source: org_study_id