Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
Launched by BAYER · Jul 7, 2020
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the continuation of a treatment called darolutamide for men with cancer who have already participated in previous studies using this medication. The goal is to provide ongoing treatment to those who are currently benefiting from darolutamide, as determined by their doctor. Participants will receive the same dosage of darolutamide as before and will return to the study centers for doctor visits just like they did in their previous studies.
To be eligible for this trial, participants must be able to give their consent, meaning they agree to the study's terms and understand the treatment. They should have been part of a previous darolutamide study, still receiving the medication, and feeling its benefits. It’s important that they haven’t met any criteria that would require them to stop treatment in the earlier study. Throughout the trial, participants can expect regular check-ins with their healthcare team to monitor their progress and ensure the treatment remains effective and safe.
Gender
MALE
Eligibility criteria
- 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.
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbus, Ohio, United States
Boston, Massachusetts, United States
Bronx, New York, United States
Rochester, New York, United States
Salt Lake City, Utah, United States
Clermont Ferrand, , France
Barcelona, , Spain
Duarte, California, United States
Pierre Benite, , France
Nancy, , France
Dallas, Texas, United States
Louisville, Kentucky, United States
Detroit, Michigan, United States
Boston, Massachusetts, United States
Cincinnati, Ohio, United States
Gent, , Belgium
Toronto, Ontario, Canada
Edmonton, Alberta, Canada
Richmond, Virginia, United States
Canton, Ohio, United States
Baltimore, Maryland, United States
Albuquerque, New Mexico, United States
Villejuif Cedex, , France
Boca Raton, Florida, United States
Barcelona, , Spain
Taipei, , Taiwan
Chicago, Illinois, United States
Nashville, Tennessee, United States
Córdoba, , Spain
Valencia, , Spain
Sevilla, , Spain
Reading, Berkshire, United Kingdom
Colchester, Essex, United Kingdom
Huddersfield, West Yorkshire, United Kingdom
London, , United Kingdom
Cardiff, , United Kingdom
Osaka, , Japan
Paris, , France
Taichung, , Taiwan
Seoul, , Korea, Republic Of
Taichung, , Taiwan
Ulm, , Germany
Rouen Cedex, , France
Rouen, , France
Hamamatsu, Shizuoka, Japan
Taichung, , Taiwan
Stockholm, , Sweden
Uppsala, , Sweden
Gifu, , Japan
Beijing, , China
Toyama, , Japan
Alcorcón, Madrid, Spain
Kaohsiung, , Taiwan
Shinjuku Ku, Tokyo, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyogo, Japan
Mitaka, Tokyo, Japan
Tsu, Mie, Japan
Glasgow, , United Kingdom
Suita, Osaka, Japan
Erlangen, Bayern, Germany
Praha 2, , Czechia
Salamanca, , Spain
Everett, Washington, United States
Utsunomiya, Tochigi, Japan
Belgrade, , Serbia
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Homewood, Alabama, United States
Tianjin, , China
Brno, , Czechia
Barcelona, , Spain
Yokohama, Kanagawa, Japan
Yokosuka, Kanagawa, Japan
Chiba, , Japan
Poitiers, , France
Freiburg, , Germany
San Diego, California, United States
Jinan, Shandong, China
Bunkyo Ku, Tokyo, Japan
Burlington, Ontario, Canada
Tours, , France
Seoul, , Korea, Republic Of
Denver, Colorado, United States
Beijing, Beijing, China
Rostov On Don, , Russian Federation
Beijing, , China
Guangzhou, Guangdong, China
Praha 10, , Czechia
Seoul, , Korea, Republic Of
Nagoya, Aichi, Japan
Elche, Alicante, Spain
Bunkyo Ku, Tokyo, Japan
Nagasaki, , Japan
Porto, , Portugal
Elche, Alicante, Spain
Gdansk, , Poland
Sakura, Chiba, Japan
Nis, , Serbia
Ivanovo, , Russian Federation
Osakasayama, Osaka, Japan
Annapolis, Maryland, United States
Barretos, Sao Paulo, Brazil
London, , United Kingdom
Shanghai, , China
Sabadell, Barcelona, Spain
Madrid, , Spain
Kobe, , Japan
Baltimore, Maryland, United States
Tallinn, , Estonia
Seoul, , Korea, Republic Of
London, , United Kingdom
Nanjing, Jiangsu, China
Saratov, , Russian Federation
Yufu, Oita, Japan
Incheon, , Korea, Republic Of
Shenyang, Liaoning, China
Xi'an, Shaanxi, China
Ube, Yamaguchi, Japan
Rybnik, , Poland
Taipei, , Taiwan
Göteborg, , Sweden
Daugavpils, , Latvia
Whittier, California, United States
Kashiwa, , Japan
Goteborg, , Sweden
Den Haag, , Netherlands
Shanghai, Shanghai, China
Valmiera, , Latvia
Praha 10, , Czechia
Asahi, Chiba, Japan
Changsha, Hunan, China
Amsterdam, , Netherlands
Shanghai, , China
Stanford, California, United States
Shinjuku Ku, , Japan
Sagamihara, Kanagawa, Japan
Dudley, West Midlands, United Kingdom
Wroclaw, , Poland
Cáceres, , Spain
Tampere, , Finland
Beijing, , China
Busan, , Korea, Republic Of
Beijing, Beijing, China
Tours, , France
London, , United Kingdom
Liege, , Belgium
Málaga, , Spain
Valencia, , Spain
Jeffersonville, Indiana, United States
Omaha, Nebraska, United States
Siedlce, , Poland
Riga, , Latvia
Nanchang, Jiangxi, China
Chelyabinsk, , Russian Federation
Fuzhou, Fujian, China
Seoul, , Korea, Republic Of
Nanjing, Jiangsu, China
Lublin, , Poland
Syracuse, New York, United States
Ulm, Baden Württemberg, Germany
Debrecen, , Hungary
Magdeburg, , Germany
Maebashi, Gunma, Japan
Yantai, Shandong, China
Hefei, Anhui, China
Passo Fundo, Rio Grande Do Sul, Brazil
Osaka, , Japan
Nakano Ku, Tokyo, Japan
Hangzhou, Zhejiang, China
Hiroshima, , Japan
Aurora, Colorado, United States
Xiamen, Fujian, China
Turku, , Finland
Wenzhou, Zhejiang, China
Medellín, Antioquia, Colombia
Daegu, , Korea, Republic Of
Shanghai, , China
Kumamoto, , Japan
Charleston, South Carolina, United States
Xiamen, , China
Salvador, Bahia, Brazil
Yonago, Tottori, Japan
Nanjing, Jiangsu, China
Zalaegerszeg, , Hungary
Hoofddorp, , Netherlands
Halifax, Nova Scotia, Canada
Daegu, , Korea, Republic Of
Bebington, Merseyside, United Kingdom
Shanghai, , China
Porto Alegre, Rio Grande Do Sul, Brazil
Oulu, , Finland
Xi'an, Shanxi, China
Seoul, , Korea, Republic Of
São Paulo, Sao Paulo, Brazil
Saratov, , Russian Federation
Calgary, Alberta, Canada
Holzminden, Niedersachsen, Germany
Wuhan, Hubei, China
Nürtingen, , Germany
Llanelli, Carmarthenshire, United Kingdom
Changsha, Hunan, China
Hefei, Anhui, China
Nantong, Jiangsu, China
Ankara, , Turkey
Mainz, Rheinland Pfalz, Germany
Chongqing, , China
Bruxelles Brussel, , Belgium
Vilnius, , Lithuania
Wakayama, , Japan
Praha 2, , Czechia
Bucuresti, , Romania
Wieliszew, , Poland
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Szekszard, , Hungary
Turku, , Finland
Barcelona, , Spain
La Mesa, California, United States
Novosibirsk, , Russian Federation
Goiânia, Goiás, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São Paulo, Sao Paulo, Brazil
Montería, Córdoba, Colombia
Floridablanca, Santander, Colombia
Bordeaux Cedex, , France
Poitiers Cedex, , France
Saint Herblain, , France
Düsseldorf, Nordrhein Westfalen, Germany
Padova, Veneto, Italy
Chelyabinsk, , Russian Federation
Kazan, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Madrid, , Spain
Madrid, , Spain
Istanbul, , Turkey
Beer Sheva, , Israel
London, , United Kingdom
Changsha, , China
Dordrecht, , Netherlands
Chandler, Arizona, United States
São Paulo, Sao Paulo, Brazil
Tianjin, , China
Helsinki, , Finland
Angers, , France
Nantes Cedex, , France
Münster, Nordrhein Westfalen, Germany
Osaka, , Japan
Monterrey, Nuevo Leon, Mexico
Omsk, , Russian Federation
Sumida Ku, Tokyo, Japan
Praha 2, , Czechia
Minsk, , Belarus
Peoria, Illinois, United States
Amsterdam, , Netherlands
Palma De Mallorca, Illes Baleares, Spain
Otwock, , Poland
Osaka Shi, Osaka, Japan
Higashiibaraki, Ibaraki, Japan
Mainz, Rheinland Pfalz, Germany
Salvador, Bahia, Brazil
Tianjin, , China
Jinan, , China
Vilnius, , Lithuania
Sofia, , Bulgaria
Novosibirsk, , Russian Federation
Rennes Cedex, , France
Madrid, , Spain
Hamamatsu, , Japan
Tübingen, Baden Württemberg, Germany
Nanjing, Jiangsu, China
St. Petersburg, , Russian Federation
Wien, , Austria
Natal, Rio Grande Do Norte, Brazil
Medellin, Antioquia, Colombia
Torino, Piemonte, Italy
L'hospitalet De Llobregat, Barcelona, Spain
Klaipeda, , Lithuania
Kingston, Ontario, Canada
Malmö, , Sweden
Wuhan, Hubei, China
Cachoeiro De Itapemirim, Espírito Santo, Brazil
Miyazaki, , Japan
Voorhees, New Jersey, United States
Cape Town, Western Cape, South Africa
Namur, , Belgium
Greenville, South Carolina, United States
Toronto, Ontario, Canada
Shengyang, Liaoning, China
Shanghai, , China
Clermont Ferrand Cedex 1, , France
Marseille, , France
Saint Mande, , France
Suresnes, , France
Petah Tikva, , Israel
Krasnoyarsk, , Russian Federation
Taoyuan, , Taiwan
Poznan, , Poland
Riga, , Latvia
Bronx, New York, United States
Zefat, , Israel
Lisboa, , Portugal
Frankfurt, Hessen, Germany
Sayama, Osaka, Japan
Nürtingen, Baden Württemberg, Germany
Rennes Cedex, , France
Seinäjoki, , Finland
Dordrecht, , Netherlands
Ningbo, , China
Cheongju Si, Chungcheongbugdo, Korea, Republic Of
Bala Cynwyd, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Riga, , Latvia
Padova, Veneto, Italy
Matosinhos, Porto, Portugal
Porto, , Portugal
Umeå, , Sweden
Warszawa, , Poland
Kaunas, , Lithuania
Seinäjoki, , Finland
Tampere, , Finland
Ueda, Nagano, Japan
Cheongju, Chungcheongbugdo, Korea, Republic Of
Tilburg, , Netherlands
St. Petersburg, , Russian Federation
Lisboa, , Portugal
Barcelona, Cataluña, Spain
Los Angeles, California, United States
Los Angeles, California, United States
Orlando, Florida, United States
Peoria, Illinois, United States
Salisbury, Maryland, United States
Detroit, Michigan, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Cincinnati, Ohio, United States
Bala Cynwyd, Pennsylvania, United States
Camp Hill, Pennsylvania, United States
Nashville, Tennessee, United States
Falls Church, Virginia, United States
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
Kurralta Park, South Australia, Australia
Lesnoy, , Belarus
Wilrijk, Antwerpen, Belgium
Kortrijk, , Belgium
Salvador, Bahia, Brazil
Fortaleza, Ceará, Brazil
Cachoeiro De Itapemirim, Espírito Santo, Brazil
Uberlandia, Minas Gerais, Brazil
Curitiba, Parana, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Itajaí, Santa Catarina, Brazil
Jaú, Sao Paulo, Brazil
Ribeirão Preto, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Vratsa, , Bulgaria
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Granby, Quebec, Canada
Montreal, Quebec, Canada
Brno, , Czechia
Jablonec Nad Nisou, , Czechia
Praha 2, , Czechia
Praha 6, , Czechia
Jyväskylä, , Finland
Mikkeli, , Finland
Brest, , France
Dijon, , France
Montpellier Cedex, , France
Reims Cedex, , France
Emmendingen, Baden Württemberg, Germany
Kirchheim Unter Teck, Baden Württemberg, Germany
Muehlacker, Baden Württemberg, Germany
Reutlingen, Baden Württemberg, Germany
Braunschweig, Niedersachsen, Germany
Mühlheim, Nordrhein Westfalen, Germany
Wuppertal, Nordrhein Westfalen, Germany
Jena, Thüringen, Germany
Napoli, Campania, Italy
Parma, Emilia Romagna, Italy
Torino, Piemonte, Italy
Itabashi Ku, Tokyo, Japan
Donggu,, Gwangju Gwang''Yeogsi, Korea, Republic Of
Seongnam Si, Gyeonggido, Korea, Republic Of
Liepaja, , Latvia
Riga, , Latvia
Santiago De Querétaro, Querétaro, Mexico
Geleen, , Netherlands
Hilversum, , Netherlands
La Victoria, Arequipa, Peru
Lima, , Peru
Lima, , Peru
Lodz, , Poland
Warszawa, , Poland
Almada, Lisboa, Portugal
Lisboa, , Portugal
Craiova, , Romania
Oradea, , Romania
Targu Mures, , Romania
Moscow, , Russian Federation
Moscow, , Russian Federation
Nizhny Novgorod, , Russian Federation
Novosibirsk, , Russian Federation
Obninsk, , Russian Federation
St. Petersburg, , Russian Federation
Tyumen, , Russian Federation
Vladimir, , Russian Federation
Bratislava, , Slovakia
Bratislava, , Slovakia
Trencin, , Slovakia
George, Eastern Cape, South Africa
Cape Town, Western Cape, South Africa
Jerez De La Frontera, Cádiz, Spain
Manacor, Illes Baleares, Spain
Barcelona, , Spain
Lugo, , Spain
Madrid, , Spain
Stockholm, , Sweden
Chernivtsi, , Ukraine
Dnipro, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Uzhgorod, , Ukraine
Scunthorpe, , United Kingdom
Wakefield, West Yorkshire, United Kingdom
São Paulo, Sao Paulo, Brazil
Kharkiv, , Ukraine
Rondebosch, Western Cape, South Africa
Suzhou, Jiangsu, China
Ribeirão Preto, Sao Paulo, Brazil
Taichung, , Taiwan
Lima, , Peru
Lugo, , Spain
Louisville, Kentucky, United States
Tübingen, Baden Württemberg, Germany
Lima, , Peru
Kingston, Ontario, Canada
Lodz, , Poland
Málaga, , Spain
Helsinki, , Finland
Saint Herblain, , France
Barcelona, , Spain
London, Ontario, Canada
Villejuif Cedex, , France
Whittier, California, United States
Natal, Rio Grande Do Norte, Brazil
L'hospitalet De Llobregat, Barcelona, Spain
Jablonec Nad Nisou, , Czechia
Mlaaga, Málaga, Spain
L'hospitalet De Llobregat, Barcelona, Spain
Magdeburg, Sachsen Anhalt, Germany
Barretos/Sp, Sao Paulo, Brazil
Jaú/Sp, Sao Paulo, Brazil
Ribeirão Preto/Sp, Sao Paulo, Brazil
São Paulo/Sp, Sao Paulo, Brazil
Reims, , France
Itabashi Ku, Tokyo, Japan
Almada, Lisboa, Portugal
Sevilla, , Spain
Münster, Nordrhein Westfalen, Germany
Cachoeiro De Itapemirim, Espírito Santo, Brazil
Cherkasy, , Ukraine
Szekszard, , Hungary
Zalaegerszeg, , Hungary
Angers, , France
Natal, Rio Grande Do Norte, Brazil
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
São Paulo, Sao Paulo, Brazil
Florida Blanca, Santander, Colombia
Colchester, Essex, United Kingdom
Kaohsiung City, Kaohsiung, Taiwan
Cheongju Si, Chungcheongbugdo, Korea, Republic Of
Natal, Rio Grande Do Norte, Brazil
Omaha, Nebraska, United States
Bordeaux, , France
Hefei City, Anhui Province, Anhui, China
Daegu, , Korea, Republic Of
Shanghai, , China
Piaseczno, , Poland
Changchun City, Jilin, China
Barretos/Sp, Sao Paulo, Brazil
Madrid, , Spain
Umea, , Sweden
São Paulo, Sao Paulo, Brazil
Geleen, , Netherlands
Lisboa, , Portugal
Beijing, , China
Barretos/Sp, Sao Paulo, Brazil
Fortaleza, Ceará, Brazil
Tianjin, , China
Yokosuka, , Japan
Geleen, , Netherlands
Ankara, , Turkey
Shenzhen, , China
Jinan, Shandong, China
Vitória, Espírito Santo, Brazil
Dordrecht, , Netherlands
Porto Alegre, Rio Grande Do Sul, Brazil
Lesnoy, , Belarus
Minsk, , Belarus
Hilversum, , Netherlands
La Victoria, Arequipa, Peru
Lima, , Peru
Waliszew, , Poland
Almada, Lisboa, Portugal
St. Petersburg, , Russian Federation
Manacor, Illes Baleares, Spain
Barcelona, , Spain
Madrid, , Spain
Beer Sheva, , Israel
Petach Tikva, , Israel
Falls Church, Virginia, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Jinan, Shandong, China
Nantes, , France
Jena, Thüringen, Germany
Napoli, Campania, Italy
Bunkyo Ku, Tokyo, Japan
Wakayama, , Japan
Gwangju, Gwangju Gwang''Yeogsi, Korea, Republic Of
Monterrey, Nuevo Leon, Mexico
Almada, Setúbal, Portugal
Porto, , Portugal
Palma De Mallorca, Illes Baleares, Spain
Barcelona, , Spain
Chengdu, Sichuan, China
Chengdu, , China
Orbassano, Piemonte, Italy
Padova, Veneto, Italy
Shantou, Guangdong, China
Taiyuan, Shanxi, China
Chengdu, Sichuan, China
Shandong, , China
Zhejiang, , China
Salvador, Bahia, Brazil
Parma, Emilia Romagna, Italy
Padova, Veneto, Italy
Kyiv, , Ukraine
Charleston, South Carolina, United States
Salt Lake City, Utah, United States
Kharkiv, , Ukraine
Helsinki, Uusimaa, Finland
Hilversum, , Netherlands
Chernivtsi, , Ukraine
Dnipro, , Ukraine
Jinan, Shandong, China
Bordeaux, , France
Praha 6, , Czechia
Reading, Berkshire, United Kingdom
Boca Raton, Florida, United States
Baltimore, Maryland, United States
Kyiv, , Ukraine
Colchester, Essex, United Kingdom
Dudley, West Midlands, United Kingdom
Huddersfield, West Yorkshire, United Kingdom
Wakefield, West Yorkshire, United Kingdom
Bordeaux, , France
Reims, , France
Pierre Benite, , France
Reims, , France
Villejuif Cedex, , France
Chandler, Arizona, United States
Chicago, Illinois, United States
Fairfax, Virginia, United States
Saint Herblain, , France
Suita, Osaka, Japan
Montpellier Cedex, , France
Baltimore, Maryland, United States
Detroit, Michigan, United States
Bronx, New York, United States
Fairfax, Virginia, United States
Tallinn, , Estonia
Torino, Piemonte, Italy
Voorhees, New Jersey, United States
Albuquerque, New Mexico, United States
Bronx, New York, United States
Columbus, Ohio, United States
Ribeirao Preto, Sao Paulo, Brazil
Jena, Thuringen, Germany
Sabadell, Barcelona, Spain
Palma De Mallorca, Illes Baleares, Spain
Alcorcón, Madrid, Spain
Kyiv, , Ukraine
Madrid, , Spain
Cardiff, , United Kingdom
Goiânia, , Brazil
Montería, , Colombia
Palo Alto, California, United States
Billings, Montana, United States
Fortaleza, , Brazil
Cachoeiro De Itapemirim, , Brazil
Emmendingen, , Germany
Kirchheim Unter Teck, , Germany
Muehlacker, , Germany
Reutlingen, , Germany
Tübingen, , Germany
Santiago De Querétaro, , Mexico
Almada, , Portugal
Elche, Alicante, Spain
Jerez De La Frontera, , Spain
Manacor, Illes Baleares, Spain
Cáceres, , Spain
Córdoba, , Spain
Lugo, , Spain
Málaga, , Spain
Sevilla, , Spain
Valencia, , Spain
Scunthorpe, North East Lincolnshire, United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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