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Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
Not Recruiting
Trial ID: NCT04464226
Purpose
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
An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
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.
Intervention(s):
drug: Darolutamide (Nubeqa, BAY1841788)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Denise Haas
+1 650-736-1252