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Continued Darolutamide Treatment for Cancer Patients from Previous Bayer Studies

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

3 criteria

  • 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.
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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.

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in the form of tablets. It is currently being studied in clinical trials for its continued use in treating cancer, specifically in patients who have participated in previous studies sponsored by Bayer. The main therapeutic indication for darolutamide is the treatment of certain types of cancer. At the molecular level, darolutamide works by blocking the action of male hormones, such as testosterone, which can promote the growth of cancer cells. It is classified pharmacologically as an androgen receptor inhibitor.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502084-38-00Protocol codeBAY1841788/20321Estimated enrolment531 patientsSponsorBayer Consumer Care AG

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