Status:
RECRUITING
Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
Lead Sponsor:
Bayer
Conditions:
Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 26 2028
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT04464226
Start Date
October 20 2020
End Date
June 26 2028
Last Update
November 6 2025
Active Locations (383)
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1
Urology Centers of Alabama, PC
Homewood, Alabama, United States, 35209
2
Ironwood Cancer and Research Centers - Chandler I
Chandler, Arizona, United States, 85224
3
City of Hope National Medical Center
Duarte, California, United States, 91010
4
Tower Urology
Los Angeles, California, United States, 90048