(20321) 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 primary objective of this study is the **continuation** of darolutamide treatment in participants who were previously enrolled in Bayer-sponsored studies. This objective is clinically relevant as it allows for the ongoing evaluation of the **safety** of darolutamide, a critical aspect in the management of patients with cancer. Ensuring the safety of long-term treatment is essential for maintaining patient health and optimizing therapeutic outcomes.

Secondary objectives include the documentation of the **tolerability** of darolutamide. This is important for understanding the side effect profile and ensuring that the treatment is manageable for patients over extended periods. By assessing tolerability, the study aims to provide comprehensive data on the long-term use of darolutamide, contributing to informed clinical decision-making.

The clinical trial involves a total of **414 participants** who are exclusively male, as indicated by the study's focus on a male-only population. The participants are adults, with an **age range** corresponding to categories 3 and 4, which typically include middle-aged and older adults. The study population was selected from individuals who were previously enrolled in any Bayer-sponsored darolutamide feeder study and are currently receiving darolutamide, experiencing clinical benefit from the treatment. These participants have not met any treatment discontinuation criteria outlined in the feeder study protocol. The trial does not include a vulnerable population, and participants are required to be capable of giving signed informed consent, which includes compliance with the study's requirements and restrictions. Additionally, participants must be willing to continue practicing acceptable methods of birth control during the study. The primary medical condition under investigation is **cancer**, and the trial aims to continue the treatment with darolutamide while assessing its safety. The study does not specify any particular lifestyle considerations such as diet or physical activity.

The clinical trial is designed as an **open-label**, single-arm, roll-over study aimed at providing continued treatment with **darolutamide** in participants previously enrolled in Bayer-sponsored studies. The primary objective is to ensure the continuation of darolutamide treatment and assess its safety. The trial will monitor the incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs), as well as the frequency of dose modifications. The study is expected to conclude by June 25, 2025, with recruitment having commenced on October 20, 2020.

Participants eligible for inclusion are those who were enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, are currently receiving darolutamide, and are experiencing clinical benefit from the treatment. They must be capable of providing informed consent and willing to continue practicing acceptable methods of birth control during the study. Participants who have met any treatment discontinuation criteria outlined in the feeder study protocol will be excluded.

The trial involves a sequence of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on the criteria mentioned. Follow-up visits will be scheduled to monitor the safety and efficacy of the treatment, with assessments focusing on the primary and secondary endpoints. The end-of-study visit will mark the conclusion of the participant's involvement, which is expected to last until the study's estimated end date, unless early termination is warranted. Conditions for early termination include the occurrence of significant adverse events or if the participant no longer derives clinical benefit from the treatment.

Participants will receive the investigational product, BAY 1841788, in the form of a film-coated tablet, administered orally. The maximum daily dose is set at 1200 mg, with a total maximum treatment period of 72 weeks. The study is not classified as a low-intervention trial and is categorized as a phase 3 trial, focusing on the treatment of **cancer**. The trial's design ensures rigorous monitoring and documentation of all safety and efficacy parameters, adhering to the highest standards of clinical research.

The clinical trial involves the administration of the experimental medication **darolutamide**, marketed under the product name BAY 1841788. This medication is provided in the form of a **film-coated tablet** and is intended for **oral use**. Each tablet contains 300 mg of darolutamide, a chemical-origin active substance. The maximum daily dose is set at 1200 mg, with a total maximum dose of 2592 mg over the course of the treatment period. The treatment duration is capped at 72 weeks. The medication is manufactured by Bayer AG and is not a pediatric formulation. Participants are required to adhere to the prescribed dosing schedule to ensure compliance, which will be monitored throughout the study.

In this open-label, single-arm, roll-over study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are utilized. The primary objective is to continue the treatment with darolutamide and assess its safety profile in participants who were previously enrolled in Bayer-sponsored studies. The study does not involve any additional medicinal products or devices. Compliance with the dosing regimen is critical, and participants' adherence will be closely monitored to ensure the integrity of the trial data.

Efficacy in this clinical trial will be assessed primarily through the incidence of **Treatment-emergent adverse events (TEAEs)** and **Treatment-emergent serious adverse events (TESAEs)**, as well as the incidence of drug-related TEAEs and TESAEs. These parameters will provide insight into the safety profile of **darolutamide** during the continuation of treatment. Additionally, the frequency of dose modifications will be evaluated as a secondary endpoint, offering further understanding of the treatment's tolerability and required adjustments.