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

  • STATUS
    Recruiting
  • End date
    Jun 25, 2025
  • participants needed
    676
  • sponsor
    Bayer
Updated on 27 October 2022

Summary

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.

Details
Condition Cancer
Treatment Darolutamide (Nubeqa, BAY1841788)
Clinical Study IdentifierNCT04464226
SponsorBayer
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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