Continued Darolutamide Treatment for Cancer Patients from Previous Bayer Studies

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What is this study about?

This clinical trial focuses on the treatment of cancer using a medication called darolutamide. The study is designed for participants who have already been receiving darolutamide in previous studies sponsored by Bayer. Darolutamide is provided in the form of a film-coated tablet, and the purpose of this study is to continue the treatment for those who are benefiting from it.

Participants in this study will continue taking darolutamide as they have in their previous studies. The study aims to monitor the safety of darolutamide and observe any side effects that may occur during the treatment. The study does not involve any new medications or treatments, and participants will not receive a placebo.

The study will track the occurrence of any treatment-related side effects, including both common and serious ones. It will also look at how often the dosage of darolutamide needs to be adjusted. This study is open-label, meaning that both the participants and the researchers know that darolutamide is being administered. The study will continue until the estimated end date in 2025, allowing participants to maintain their treatment regimen as long as they continue to benefit from it.

1 joining the study

Upon joining the study, you will be required to provide signed informed consent. This document confirms your understanding of the study requirements and your agreement to participate.

You must be currently enrolled in a Bayer-sponsored study involving darolutamide and experiencing clinical benefits from the treatment.

2 medication administration

You will continue to take darolutamide, which is provided in the form of a film-coated tablet. The medication is taken orally.

The dosage and frequency of administration will be consistent with your previous study, and any changes will be communicated by the study team.

3 monitoring and safety

Throughout the study, your health will be monitored to ensure the safety of darolutamide. This includes tracking any new or worsening symptoms, known as treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs).

Regular check-ins with the study team will help manage any side effects and adjust the dosage if necessary.

4 continuation of treatment

The study aims to continue your treatment with darolutamide until the estimated end date of June 25, 2025, or until it is no longer beneficial for you.

Your participation will be evaluated regularly to ensure ongoing clinical benefit.

Who Can Join the Study?

  • Capable of giving signed informed consent, which means you understand the study and agree to follow the rules and restrictions.
  • Currently participating in a Bayer-sponsored study involving darolutamide (a medication used in cancer treatment) and benefiting from the treatment.
  • Have not met any reasons to stop treatment as outlined in the previous study.
  • Willing to continue using acceptable methods of birth control during the study.
  • Only male participants are eligible.

Who Cannot Join the Study?

  • Patients who do not have a diagnosis of cancer cannot participate.
  • Only male patients are eligible to participate.
  • Patients who are considered part of a vulnerable population are not eligible. This means individuals who may have limited ability to protect their own interests.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Jean Perrin Clermont Ferrand France
University Hospital Jena KöR Jena Germany
Zuyderland Medisch Centrum Stichting Geleen The Netherlands

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Pauls Stradins Clinical University Hospital Riga Latvia
Haga Hospital Hague The Netherlands
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Karolinska University Hospital Solna Sweden
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Turku University Hospital Turku Finland
Gasthuiszusters Antwerpen Antwerp Belgium
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Spitalul Clinic Judetean Mures Targu Mures Romania
Vidzemes Slimnica SIA Valmiera Latvia
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Del Mar Barcelona Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Tergooiziekenhuizen Hilversum The Netherlands
Servei De Salut De Les Illes Balears Palma Spain
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Hospital San Pedro De Alcantara Caceres Spain
Ko-Med Centra Kliniczne Sp. z o.o. Lublin Poland
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Santa Sp. z o.o. Lodz Poland
Urocentrum Praha s.r.o. Prague Czechia
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Daugavpils regionala slimnica SIA Daugavpils Latvia
Spaarne Gasthuis Hoofddorp The Netherlands
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o. Warsaw Poland
Central Finland Hospital District Central Finland Hospital Nova Jyvaskyla Finland
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Clinique Pasteur Lanroze Brest France
Institut Godinot Reims France
Elisabeth-Tweesteden Ziekenhuis Tilburg The Netherlands
Etelae-Savon hyvinvointialue Mikkeli Finland
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
Pohjois-Pohjanmaan hyvinvointialue Oulu Finland
Virgen del Rocío University Hospital Sevilla Spain
Region Vaesterbotten Umea Sweden
Centre Hospitalier Lyon Sud Pierre Benite France
J. Breza Medical s.r.o. Bratislava Slovakia
Androgeos spol. s r.o. Prague Czechia
North Estonia Medical Centre Foundation Tallin Estonia
Complex Oncology Center Vratsa EOOD Vratsa Bulgaria
Hospital Universitario Virgen De La Victoria Malaga Spain
Institut De Cancerologie De L Ouest Saint-Herblain France
Pbkt Ttjid Hmzvvhbw Uupcxigvyvxy Sabadell Spain
Imnorxhx Rexkmfxe Dm Chffoj Dq Mjcrjnvacdm Montpellier France
Rbqna Anpeswir ktbymkdn uflprnnewbomr sbxmtekx Snq Riga Latvia
Uemnkjqdmwynjlciqfhzb Mawszcyj Asf Munster Germany
Hotvusce Da Lo Swsfn Ckvf I Sxzk Ppk Barcelona Spain
Awbcnhnlg Uux Amsterdam The Netherlands
Hyloitiw Udkmenolat Cebjymx Hkvqtcrf Helsinki Finland
Uhluxel Ucrrertyhp Hdptvqlj Uppsala Sweden
Stfqytfsudn Ulfxkowvhc Hzdpeyvvrglrpdn Gjisxxilciiiqnjcg Gothenburg Sweden
Hirgghde Vbxe dhilfits Barcelona Spain
Vslpqamlc irhqgpis Vnzsomnl ukpcxvlluzoj lfcsdmqyc Svleafmc kdwejqp fnmlbzqr Nhakuzsdaldo vpvvm cviwcqe Vilnius Lithuania
Iewhmanh Pipxzwcnrdmpjxh Crrzgs Cgikoj Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
20.10.2020
Bulgaria Bulgaria
Not recruiting
20.10.2020
Czechia Czechia
Not recruiting
20.10.2020
Estonia Estonia
Not recruiting
20.10.2020
Finland Finland
Not recruiting
20.10.2020
France France
Not recruiting
20.10.2020
Germany Germany
Not recruiting
20.10.2020
Hungary Hungary
Not recruiting
20.10.2020
Italy Italy
Not recruiting
20.10.2020
Latvia Latvia
Not recruiting
20.10.2020
Lithuania Lithuania
Not recruiting
20.10.2020
Poland Poland
Not recruiting
20.10.2020
Romania Romania
Not recruiting
20.10.2020
Slovakia Slovakia
Not recruiting
20.10.2020
Spain Spain
Not recruiting
20.10.2020
Sweden Sweden
Not recruiting
20.10.2020
The Netherlands The Netherlands
Not recruiting
20.10.2020

Trial locations

Investigated drugs:

Darolutamide is a medication used in this clinical trial. It is designed to help treat prostate cancer by blocking the effects of male hormones that can promote the growth of cancer cells. This medication is part of a class of drugs known as androgen receptor inhibitors, which work by interfering with the signals that tell cancer cells to grow. In this trial, participants who were already receiving darolutamide in previous studies continue to use it to assess its long-term safety and effectiveness.

Investigated diseases:

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. These cells can invade nearby tissues and form tumors, which may disrupt normal bodily functions. As cancer progresses, it can metastasize, meaning it spreads to other parts of the body through the bloodstream or lymphatic system. The progression of cancer varies depending on the type and location of the cancer, as well as individual factors. Some cancers grow slowly and may remain localized, while others can be aggressive and spread rapidly. The disease can affect almost any part of the body and is often named after the organ or tissue where it originates.

Trial ID:
2022-502084-38-00
Protocol code:
BAY1841788/20321
NCT ID:
NCT04464226
Trial Phase:
Therapeutic confirmatory (Phase III)

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