An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies
Condition: Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT04464226
Sponsor: Bayer
Phase: Phase 3
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
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.
View trial on ClinicalTrials.gov