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

Sponsor: Bayer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04464226

Patient View

This study allows patients from previous Bayer-supported darolutamide trials to continue treatment if beneficial. Eligible participants must have been in a feeder study, show clinical benefit, and comply with study requirements. They will maintain the same darolutamide dosage and visit schedule. Exclusions include inability to comply or negative benefit/risk assessment.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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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