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

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

Conditions
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Cancer

Intervention / Treatment
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* Drug: Darolutamide (Nubeqa, BAY1841788)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Darolutamide (BAY1841788)<br>Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from. | Drug: Darolutamide (Nubeqa, BAY1841788)<br>* Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.<br>* Other names: ODM-201;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs) |  | Up to 4 years | 
| Incidence of treatment-emergent serious adverse events (TESAEs) |  | Up to 4 years | 
| Incidence of drug-related TEAEs |  | Up to 4 years | 
| Incidence of drug-related TESAEs |  | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of dose modifications |  | Up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Roll-Over Study