AzTrials
AzTrials

CancerPhase 3DARO ROLL OVERNCT04464226

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

A Phase 3 study testing Darolutamide (Nubeqa, BAY1841788) in people with Cancer, run by Bayer at 335 sites in 39 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Cancer
What is being tested?
Darolutamide (Nubeqa, BAY1841788)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
774 participants
Where
335 sitesin 39 countries
Study dates
20 Oct 2020to 26 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

335 sites in 39 countries.

335 sites in 39 countries

China42 sites

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100083

  • Beijing Cancer Hospital - Oncology Department

    Beijing, Beijing Municipality, 100142

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University

    Changchun, Jilin, 130061

  • Hunan Cancer Hospital - Oncology Department

    Changsha, Hunan, 410013

  • Sichuan University West China Hospital

    Chengdu, Sichuan, 610041

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

    Chengdu, Sichuan, 610041

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

    Chengdu, Sichuan, 610072

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • The First Affiliated hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

  • ZheJiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • ZheJiang Provincial People's Hospital

    Hangzhou, Zhejiang, 314408

  • Anhui Provincial Hospital

    Hefei, Anhui, 230031

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • The First Affiliated Hospital of NanChang University

    Nanchang, Jiangxi, 330006

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210000

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Nantong tumor hospital

    Nantong, Jiangsu, 226361

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • The Affiliated Hospital of Qingdao University

    Shandong, Shandong, 266000

  • Fudan University Shanghai Cancer Center - Oncology Department

    Shanghai, Shanghai Municipality, 200000

  • Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Huadong Hospital, Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • 2nd Affiliated Hosp. of Shantou University Medical College

    Shantou, Guangdong, 515021

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, Guangdong, 518172

  • The 2nd Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • Shanxi Medical University - First Hospital

    Taiyuan, Shanxi, 030001

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300000

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

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

    Wuhan, Hubei, 430030

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

Other trials in China

United States36 sites

  • New Mexico Cancer Center - Albuquerque

    Albuquerque, New Mexico, 87109

  • Rocky Mountain Regional VA Medical Center - Oncology

    Aurora, Colorado, 80045

  • MidLantic Urology - Bala Cynwyd

    Bala-Cynwyd, Pennsylvania, 19004

  • Chesapeake Urology Associates - Towson

    Baltimore, Maryland, 21204

  • Johns Hopkins Hospital - Pulmonology

    Baltimore, Maryland, 21287

  • St. Vincent Regional Hospital - Oncology

    Billings, Montana, 59102

  • Boca Raton Regional Hospital - Oncology

    Boca Raton, Florida, 33486

  • Andrews & Patel Associates

    Camp Hill, Pennsylvania, 17011

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Ironwood Cancer and Research Centers - Chandler I

    Chandler, Arizona, 85224

  • Charleston Oncology - Downtown

    Charleston, South Carolina, 29403

  • Jesse Brown VA Medical Center - Cardiology

    Chicago, Illinois, 60612

  • The Urology Group - Norwood Surgery Center

    Cincinnati, Ohio, 45212

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

    Columbus, Ohio, 43210

  • Urology Clinics of North Texas - Dallas (Walnut HIll Lane)

    Dallas, Texas, 75231

  • The Urology Center Of Colorado

    Denver, Colorado, 80211

  • Henry Ford Hospital - OB/GYN

    Detroit, Michigan, 48202

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Inova Schar Cancer Insitute - Inova Fairfax Hospital

    Fairfax, Washington, 22031

  • Urology Centers of Alabama, PC - Homewood

    Homewood, Alabama, 35209

  • Tower Urology

    Los Angeles, California, 90048

  • Norton Cancer Institute - Downtown

    Louisville, Kentucky, 40202

  • Carolina Urological Research Center

    Myrtle Beach, South Carolina, 29579

  • Urology Associates, PC - Nashville

    Nashville, Tennessee, 37209

  • XCancer Omaha

    Omaha, Nebraska, 68130

  • Stanford Cancer Center Palo Alto

    Palo Alto, California, 94304

  • Illinois CancerCare - Peoria

    Peoria, Illinois, 61615

  • VCU Health Ambulatory Care Center - Cardiology

    Richmond, Virginia, 23284

  • URMC Wilmot Cancer Center

    Rochester, New York, 14642

  • TidalHealth Peninsula Regional, Inc. - Oncology

    Salisbury, Maryland, 21801

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • San Diego Clinical Trials

    San Diego, California, 92120

  • New York Cancer & Blood Specialists - Eastchester

    The Bronx, New York, 10469

  • Montefiore Einstein Center for Cancer Care - Tower at Montefiore Medical Park

    The Bronx, New York, 14061

  • New Jersey Urology - Voorhees

    Voorhees Township, New Jersey, 08043

  • TOI Clinical Research

    Whittier, California, 90603

Other trials in United States

Japan36 sites

  • Asahi General Hospital

    Asahi, Chiba, 289-2511

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • Nippon Medical School Hospital

    Bunkyo-Ku, Tokyo, 113-0022

  • Chiba Cancer Center

    Chiba, 260-8717

  • Gifu Prefectural General Medical Center

    Gifu, 500-8717

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • National hospital Organization Mito Medical Center

    Higashiibaraki, Ibaraki, 311-3193

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

  • University of Miyazaki Hospital

    Miyazaki, 889-1692

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Tokyo Metropolitan Police Hospital

    Nakano-ku, Tokyo, 164-8541

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Osaka General Medical Center

    Osaka, 558-8558

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375

  • Kindai University Hospital

    Sakai, Osaka, 590-0197

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-8741

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • The University of Osaka Hospital

    Suita, Osaka, 565-0871

  • The Fraternity Memorial Hospital

    Sumida-ku, Tokyo, 130-8587

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    tabashi City, Tokyo, 173-0015

  • Toyama University Hospital

    Toyama, 930-0194

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

  • National Hospital Organization Shinshu Ueda Medical Center

    Ueda, Nagano, 386-8610

  • Saiseikai Utsunomiya Hospital

    Utsunomiya, Tochigi, 321-0974

  • Wakayama Medical University Hospital

    Wakayama, 640-8558

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa, 238-8558

  • Tottori University Hospital

    Yonago, Tottori, 683-8504

  • Oita University Hospital

    Yufu, Oita Prefecture, 879-5593

Other trials in Japan

Spain22 sites

  • Hospital Universitario Fundacion Alcorcon | Urologia

    Alcorcón, Madrid, 28922

  • Hospital del Mar | Oncologia

    Barcelona, Catalonia, 08003

  • Hospital Universitari Vall D Hebron | Oncologia

    Barcelona, 08035

  • Hospital Clinic De Barcelona | Urologia

    Barcelona, 08036

  • Hospital De La Santa Creu I Sant Pau | Oncologia

    Barcelona, 8041

  • Hospital San Pedro De Alcantara | Oncologia

    Cáceres, 10003

  • Hospital Universitario Reina Sofia | Oncologia

    Córdoba, 14004

  • Hospital General Universitario De Elche | Urologia

    Elche, Alicante, 3203

  • Bellvitge Hospital Universitari | Urologia

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Lucus Augusti | Urologia

    Lugo, 27003

  • Hospital General Universitario Gregorio Maranon | Urologia

    Madrid, 28007

  • Hospital Universitario Ramon Y Cajal | Oncologia

    Madrid, 28034

  • Hospital Clinico San Carlos | Oncologia

    Madrid, 28040

  • Hospital Universitario Fundacion Jimenez Diaz | Urologia

    Madrid, 28040

  • Hospital Universitario 12 De Octubre | Urologia

    Madrid, 28041

  • Hospital Universitario Virgen De La Victoria | Oncologia

    Málaga, 29010

  • Hospital De Manacor | Urologia

    Manacor, Balearic Islands, 7500

  • University Hospital Son Espases | Oncologia

    Palma de Mallorca, Balearic Islands, 7120

  • Parc Tauli Hospital Universitari | Oncologia

    Sabadell, Barcelona, 08208

  • Hospital Universitario Virgen Del Rocio S.L. | Oncologia

    Seville, 41013

  • Fundacion Instituto Valenciano De Oncologia | Urologia

    Valencia, 46009

  • Hospital Arnau De Vilanova De Valencia | Oncologia

    Valencia, 46015

Other trials in Spain

France19 sites

  • Centre Hospitalier Universitaire - Angers

    Angers, Pays de la Loire Region, 49933

  • Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

    Bordeaux, New Aquitaine, 33000

  • Clinique Lanroze

    Brest, Brittany Region, 29200

  • Centre Jean Perrin

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63011

  • Centre d'Oncologie et de Radiologie du Parc

    Dijon, Bourgogne-Franche-Comté, 21000

  • Unicancer Marseille - Institut Paoli-Calmettes

    Marseille, Provence-Alpes-Côte d'Azur Region, 13273

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

    Montpellier, Occitanie, 34298

  • Hopital Hotel Dieu - Nantes

    Nantes, Pays de la Loire Region, 44000

  • Hôpital Saint Louis

    Paris, Île-de-France Region, 75010

  • HCL - Centre Hospitalier Lyon Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • CHU Poitiers - Hopital de la Miletrie

    Poitiers, New Aquitaine, 86021

  • Institut de Cancerologie Jean Godinot - Departement oncologie medicale

    Reims, Grand Est, 51056

  • CHU Rennes - Hopital Pontchaillou

    Rennes, Brittany Region, 35033

  • Hôpital Charles Nicolle

    Rouen, Normandy, 76031

  • Institut de Cancerologie Ouest - Saint-Herblain

    Saint-Herblain, Pays de la Loire Region, 44800

  • Hôpital d'Instruction des Armées Begin

    Saint-Mandé, Île-de-France Region, 94160

  • Centre Médico-Chirurgical Foch

    Suresnes, Île-de-France Region, 92151

  • CHU Tours - Hopital Bretonneau

    Tours, Centre-Val de Loire, 37044

  • Gustave Roussy - Departement Oncologie-Radiotherapie

    Villejuif, Île-de-France Region, 94805

Other trials in France

Brazil17 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Hospital Evangélico de Cachoeiro de Itapemirim

    Cachoeiro de Itapemirim, Espírito Santo, 29308-020

  • Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Instituto do Cancer do Ceará

    Fortaleza, Ceará, 60430-230

  • Hosp. Araujo Jorge da Associação de Combate ao Câncer

    Goiânia, Goiás, 74605-070

  • Clínica de Neoplasias Litoral Ltda

    Goiânia, Goiás, 88301-220

  • IBCC - Instituto Brasileiro de Controle do Cancer

    Jaú, São Paulo, 03102-002

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

    Natal, Rio Grande do Norte, 59040-000

  • Associação Hospitalar Beneficente São Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Hosp Clínicas Facult. Med. de Ribeirão Preto / USP

    Ribeirão Preto, São Paulo, 14051-140

  • Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246-000

  • Hospital São Rafael

    São Paulo, 41253-190

  • Santa Casa de Misericórdia da Bahia

    São Paulo, 50040-410

  • Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology

    São Paulo, 90020-090

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

    São Paulo, 90619-900

  • COT Centro Oncologico do Triangulo Ltda

    Uberlândia, Minas Gerais, 38408-150

Other trials in Brazil

Russia16 sites

  • Ltd "EVIMED"

    Chelyabinsk, Chelyabinsk Oblast, 454048

  • Chelyabinsk Regional Oncology Dispensary

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, Ivanovo Oblast, 153040

  • Republican Clinical Oncology Dispensary Kazan

    Kazan', Tatarstan Republic, 420029

  • Krasnoyarsk Regional Clinical Oncology Dispensary

    Krasnoyarsk, Krasnoyarsk Krai, 660133

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

    Moscow, 115478

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

    Moscow, 125284

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

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603001

  • LLC Reafan

    Novosibirsk, Novosibirsk Oblast, 630099

  • Medical Center "Avicenna"

    Novosibirsk, Novosibirsk Oblast, 630099

  • National Medical Research Radiology Center

    Obninsk, Kaluga Oblast, 249036

  • Clinical Oncological Dispensary of Omsk Region

    Omsk, Omsk Oblast, 644013

  • Leningrad Regional Oncology Dispensary

    Saint Petersburg, 188663

  • Saratov State Medical University

    Saratov, Saratov Oblast, 410054

  • Multi-Field Clinical Medical Center "Medical City"

    Tyumen, Tyumen Oblast, 625041

  • Regional Clinical Oncology Dispensary

    Vladimir, Vladimirskaya Oblast’, 600009

Other trials in Russia

Germany15 sites

  • Städtisches Klinikum Braunschweig GmbH

    Braunschweig, Lower Saxony, 38126

  • Universitätsklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • Urologische Gemeinschaftspraxis Carl-Andreas-Meilinger

    Emmendingen, Baden-Wurttemberg, 79312

  • Universitätsklinikum Erlangen AöR

    Erlangen, Bavaria, 91054

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Friedrich-Schiller-Uni. Jena

    Jena, Thuringia, 7747

  • Medizinische Fakultät der Otto-von-Guericke Universität

    Magdeburg, Saxony-Anhalt, 39120

  • Universitätsmedizin der Johannes Gutenberg, Universität Mainz

    Mainz, Rhineland-Palatinate, 55101

  • Urologische Gemeinschaftspraxis Muehlacker

    Mühlacker, Baden-Wurttemberg, 75417

  • Praxis Drs. Tim Schneider /B. Schneider

    Mülheim, North Rhine-Westphalia, 45468

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622

  • Urologische Gemeinschaftspraxis Dr. Simone Maier

    Reutlingen, Baden-Wurttemberg, 72764

  • Uniklinik Tübingen / Urologie

    Tübingen, Baden-Wurttemberg, 72076

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

    Wuppertal, North Rhine-Westphalia, 42103

Other trials in Germany

United Kingdom12 sites

  • The Clatterbridge Cancer Centre | Aintree

    Bebington, Merseyside, CH63 4JY

  • University Hospital of Wales | Nephrology and Transplant

    Cardiff, Wales, CF14 4XW

  • Colchester General Hospital | Oncology Trials Unit

    Colchester, Essex, CO45JR

  • Russells Hall Hospital | Oncology

    Dudley, West Midlands, DY1 2HQ

  • Beatson West of Scotland Cancer Centre | Clinical Trials Unit

    Glasgow, Scotland, G12 0YN

  • Huddersfield Royal Infirmary | Oncology

    Huddersfield, West Yorkshire, HD3 3EA

  • Prince Philip Hospital | Oncology

    Llanelli, Wales, SA14 8QF

  • Charing Cross Hospital | Cancer Services

    London, Greater London, W68RF

  • University College Hospital | Cancer Clinical Trials Unit

    London, Greater London, WC1E 6AG

  • Royal Berkshire Hospital | Oncology

    Reading, Berkshire, RG1 5AN

  • Scunthorpe General Hospital | Oncology

    Scunthorpe, North East Lincolnshire, DN15 7BH

  • Pinderfields Hospital | Oncology

    Wakefield, West Yorkshire, WF1 4DG

Other trials in United Kingdom

South Korea11 sites

  • Chungbuk National University Hospital | Urology

    Chungcheongbuk-do, North Chungcheong, 28644

  • Kyungpook National University Chilgok Hospital | Urology

    Daegu, 41404

  • Keimyung University Dongsan Medical Center | Urology

    Daegu, 42601

  • Chonnam National University Hospital | Urology

    Gwangju, 61469

  • Gachon University Gil Medical Center | Urology

    Incheon, 21565

  • Seoul National University Hospital | Urology

    Seoul, 03080

  • Severance Hospital | Urology

    Seoul, 03722

  • Asan Medical Center | Urology

    Seoul, 05505

  • Gangnam Severance Hospital | Urology

    Seoul, 06273

  • Samsung Medical Center | Urology

    Seoul, 06351

  • Seoul St Mary's Hospital | Urology

    Seoul, 06591

Other trials in South Korea

Canada9 sites

  • G. Kenneth Jansz Medicine Professional Corporation

    Burlington, Ontario, L7N 3V2

  • Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9

  • Cross Cancer Institute | Oncology

    Edmonton, Alberta, T6G 1Z2

  • Queen Elizabeth II Health Sciences Centre | Oncology

    Halifax, Nova Scotia, B3H 2Y9

  • Victoria Hospital | Oncology

    London, Ontario, N6A 4L6

  • Centre Hospitalier de l'Universite de Montreal (CHUM) | Oncology

    Montreal, Quebec, H2X 0C1

  • Centre hospitalier universitaire de Sherbrooke (CHUS) | Oncology

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences Centre | Oncology

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre | Oncology

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Finland7 sites

  • HUS, Meilahden sairaala

    Helsinki, Uusimaa, 00029

  • Keski-Suomen sairaala Nova

    Jyväskylä, Central Finland, 40620

  • Mikkelin keskussairaala

    Mikkeli, South Savo, 50100

  • Oulu University Hospital, Oulun yliopistollinen sairaala (OYS)

    Oulu, North Ostrobothnia, 90220

  • Seinäjoen keskussairaala

    Seinäjoki, South Ostrobothnia, 60220

  • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)

    Tampere, Pirkanmaa, 33520

  • Turun yliopistollinen keskussairaala

    Turku, Southwest Finland, 20520

Other trials in Finland

Netherlands7 sites

  • Academisch Medisch Centrum (AMC)

    Amsterdam, North Holland, 1105 AZ

  • Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department

    Dordrecht, South Holland, 3318 AT

  • Zuyderland Medical Centre | Internal Medicine Department

    Geleen, Limburg, 6162 BG

  • Tergooi MC | Hilversum - Wetenschapsbureau

    Hilversum, North Holland, 1213 VG

  • Spaarne Gasthuis

    Hoofddorp, North Holland, 2134 TM

  • HagaZiekenhuis

    The Hague, South Holland, 2545 CH

  • ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis)

    Tilburg, North Brabant, 5042 AD

Other trials in Netherlands

Ukraine7 sites

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

    Cherkasy, Cherkasy Oblast, 18009

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

    Chernivtsi, Chernivtsi Oblast, 58001

  • Municipal Non-commercial Enterprise 'City Clinical Hospital #4' of Dnipro City Council - City Сhemotherapy Сenter

    Dnipro, Dnipropetrovsk Oblast, 49102

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

    Kharkiv, Kharkiv Oblast, 61037

  • Kyiv City Hospital #3 - Department of Urology

    Kyiv, Kyiv City, 02660

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

    Kyiv, Kyiv City, 252053

  • Zakarpattia Anti-Tumor Centre - Chemotherapy Department

    Uzhhorod, Zakarpattia Oblast, 88014

Other trials in Ukraine

Czechia6 sites

  • Masarykuv onkologicky ustav

    Brno, South Moravian, 656 53

  • Nemocnice Jablonec nad Nisou

    Jablonec nad Nisou, Liberec Region, 466 01

  • Fakultní nemocnice Kralovské Vinohrady

    Prague, Prague, 100 34

  • Urocentrum Praha, s.r.o.

    Prague, Prague, 120 00

  • Všeobecná fakultní nemocnice v Praze

    Prague, Prague, 128 08

  • ANDROGEOS, spol. s r.o.

    Prague, Prague, 160 00

Other trials in Czechia

Latvia6 sites

  • Daugavpils Regional Hospital

    Daugavpils, Daugavpils City, LV-5417

  • Litavniece Dzintra practice in urology and oncological chem.

    Liepāja, Liepāja City, LV-3401

  • P. Stradins Clinical University Hospital

    Riga, Riga City, LV-1002

  • AS "Association of Health Centers" polyclinic "Elite"

    Riga, Riga City, LV-1029

  • Riga East Clinical University Hospital "Gailezers"

    Riga, Riga City, LV-1038

  • Vidzemes Hospital

    Valmiera, Valmiera City, LV-4201

Other trials in Latvia

Portugal6 sites

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

    Almada, Setúbal District, 2805-267

  • IPO Lisboa

    Lisbon, 1099-023

  • CHLC - Hospital Sao Jose

    Lisbon, 1150-199

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

    Lisbon, 1500-650

  • IPO Porto

    Porto, 4200-072

  • Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Urologia

    Porto, 4200-319

Other trials in Portugal

South Africa6 sites

  • Dept Radiation and Oncology Tygerberg Academic Hospital

    Cape Town, Western Cape, 7505

  • Cape Gate Oncology Centre

    Cape Town, Western Cape, 7570

  • Cancercare Outeniqua

    George, Western Cape, 6529

  • Langehoven Drive Oncology Centre

    Port Elizabeth, Eastern Cape, 6045

  • University of Pretoria, Clinical Research Unit

    Pretoria, Gauteng, 2

  • Cancercare Rondebosch Oncology

    Rondebosch, Western Cape, 7700

Other trials in South Africa

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807377

  • China Medical University Hospital

    Taichung, 404327

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, 33305

Other trials in Taiwan

Italy5 sites

  • IRCCS Istituto Nazionale Tumori Fondazione Pascale

    Naples, Campania, 80131

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica

    Orbassano, Piedmont, 10043

  • Istituto Oncologico Veneto_Padova - UOC Oncologia 1

    Padova, Veneto, 35128

  • Azienda Ospedaliero Universitaria Parma

    Parma, Emilia-Romagna, 43126

  • Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS

    Turin, Piedmont, 10060

Other trials in Italy

Poland5 sites

  • ETG Network Spolka z o.o.

    Lodz, Łódź Voivodeship, 90-302

  • Velocity Clinical Research Lublin

    Lublin, Lublin Voivodeship, 20-362

  • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

    Otwock, Masovian Voivodeship, 05-400

  • Urologica Praktyka Lekarska Adam Marcheluk

    Siedlce, Masovian Voivodeship, 08-110

  • Szpital Grochowski im. dr.med. Rafała Masztaka

    Warsaw, Masovian Voivodeship, 04-073

Other trials in Poland

Lithuania4 sites

  • Hospital of LT University of Health Sciences Kaunas Clinics

    Kaunas, Kaunas County, LT-50161

  • PI Klaipedos University Hospital

    Klaipėda, Klaipėda County, LT-92288

  • National Cancer Institute

    Vilnius, Vilnius County, LT-08660

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, Vilnius County, LT-08661

Other trials in Lithuania

Sweden4 sites

  • Sahlgrenska Universitetssjukhuset - Sahlgrenska Sjukhuset - Neurologi

    Gothenburg, Västra Götaland County, 413 45

  • Obsolete_Karolinska Universitetssjukhuset

    Stockholm, Stockholm County, 171 76

  • Norrlands Universitetssjukhus Umeå

    Umeå, Västerbotten County, 901 85

  • Akademiska sjukhuset i Uppsala

    Uppsala, Uppsala County, 752 37

Other trials in Sweden

Belgium3 sites

  • AZ Groeninge Campus Kennedylaan

    Kortrijk, West Flanders, 8500

  • CHU de Liège

    Liège, 4000

  • GZA Ziekenhuizen

    Wilrijk, Antwerp, 2610

Other trials in Belgium

Colombia3 sites

  • Fundación Oftalmológica de Santander Carlos Ardila Lule

    Floridablanca, Santander Department, 681004

  • Hospital Pablo Tobón Uribe

    Medellín, Antioquia, 050034

  • Oncomédica S.A.

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

Israel3 sites

  • Clalit Health | Soroka Medical Center

    Beersheba, Southern District, 8410101

  • Rabin Medical Center | Beilinson Campus

    Petah Tikva, Central District, 4941492

  • Ziv Medical Center

    Safed, Northern District, 1311001

Other trials in Israel

Peru3 sites

  • Centro Medico Monte Carmelo | Arequipa, Peru

    La Victoria, Lima Province (Provincia de Lima), 15036

  • Instituto Peruano de Oncologia y Radioterapia | Sede Principal

    Lima, Lima Province (Provincia de Lima), 15036

  • Hospital Central de la Fuerza Aerea del Perú

    Lima, Lima Province (Provincia de Lima), 15046

Other trials in Peru

Belarus2 sites

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

    Lyasny, Minsk Oblast, 223040

  • Minsk City Clinical Oncological Dispensary - Oncology Department

    Minsk, Minsk Oblast, 220013

Other trials in Belarus

Bulgaria2 sites

  • Medical Center Kalimat

    Sofia, Sofia City Province, 1680

  • Complex Oncology Center - Vratsa

    Vratsa, Vratsa Province, 3000

Other trials in Bulgaria

Hungary2 sites

  • Tolna Vármegyei Balassa János Kórház

    Szekszárd, Tolna County, 7100

  • Zala Varmegyei Szent Rafael Korhaz

    Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Mexico2 sites

  • Hospital Universitario "José Eleuterio González"

    Monterrey, Nuevo León, 64460

  • INBIOMEDyC Querétaro

    Querétaro City, Querétaro, 76000

Other trials in Mexico

Romania2 sites

  • Institutul Clinic Fundeni, sectia Nefrologie Clinica

    Bucharest, Bucharest Municipality, 22328

  • Spitalul Clinic Judetean Mures

    Târgu Mureş, Mureș County, 540103

Other trials in Romania

Serbia2 sites

  • Clinical Hospital Center Bezanijska kosa

    Belgrade, 11080

  • Clinical Center Nis

    Niš, 18105

Other trials in Serbia

Slovakia2 sites

  • CUIMED s.r.o

    Bratislava, 851 01

  • J. BREZA MEDICAL s. r. o.

    Bratislava, 851 01

Other trials in Slovakia

Argentina1 site

  • Centro de Urología

    Buenos Aires, C1120AAT

Other trials in Argentina

Australia1 site

  • Adelaide Cancer Centre Research Pty Ltd

    Kurralta Park, South Australia, 5037

Other trials in Australia

Austria1 site

  • Universitätsklinikum AKH Wien

    Vienna, State of Vienna, 1090

Other trials in Austria

Estonia1 site

  • Sihtasutus Põhja-Eesti Regionaalhaigla - Onkoloogia- ja hematoloogiakliinik

    Tallinn, Harju, 13419

Other trials in Estonia

Turkey (Türkiye)1 site

  • Gazi Universitesi Tip Fakultesi

    Ankara, 6560

Other trials in Turkey (Türkiye)

About this study

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

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.

Conditions
Cancer
Being tested
Darolutamide (Nubeqa, BAY1841788)
Keywords
Roll-Over Study
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Darolutamide (Nubeqa, BAY1841788)Drug

    Also called ODM-201

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

Study groups in NCT04464226
Study groupRoleWhat they receive
Darolutamide (BAY1841788)ExperimentalParticipants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.
Receives: Drug: Darolutamide (Nubeqa, BAY1841788)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Measured: Up to 4 years

  2. Incidence of treatment-emergent serious adverse events (TESAEs)

    Measured: Up to 4 years

  3. Incidence of drug-related TEAEs

    Measured: Up to 4 years

  4. Incidence of drug-related TESAEs

    Measured: Up to 4 years

Secondary outcomes (1)

  1. Number of dose modifications

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2020
  2. Study start20 Oct 2020
  3. Primary completion26 Jun 2028 (estimated)
  4. Study completion26 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
774 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04464226
Sponsor's protocol ID
20321
Other IDs
2022-502084-38-00
Acronym
DARO ROLL OVER
Status last verified
23 Jul 2026
First submitted
7 Jul 2020
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darolutamide (Nubeqa, BAY1841788) in people with Cancer, run by Bayer at 335 sites in 39 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 335 sites in China, United States, Japan, Spain, France and 34 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs) (time frame: Up to 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04464226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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