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

Not Recruiting

Trial ID: NCT04464226


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
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


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

   - 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

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.


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

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