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

Running, not enrolling · Phase 3

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT04464226

Run by

Bayer

People needed

402

Starts

2020-10-20

Expected to finish

2028-06-26

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ironwood Cancer and Research Centers - Chandler I — Chandler, Arizona, United States
• Tower Urology — Los Angeles, California, United States
• Stanford Cancer Center Palo Alto — Palo Alto, California, United States
• San Diego Clinical Trials — San Diego, California, United States
• TOI Clinical Research — Whittier, California, United States
• Rocky Mountain Regional VA Medical Center - Oncology — Aurora, Colorado, United States
• The Urology Center Of Colorado — Denver, Colorado, United States
• Boca Raton Regional Hospital - Oncology — Boca Raton, Florida, United States
• Jesse Brown VA Medical Center - Cardiology — Chicago, Illinois, United States
• Illinois CancerCare - Peoria — Peoria, Illinois, United States
• Norton Cancer Institute - Downtown — Louisville, Kentucky, United States
• Chesapeake Urology Associates - Towson — Baltimore, Maryland, United States
• Johns Hopkins Hospital - Pulmonology — Baltimore, Maryland, United States
• TidalHealth Peninsula Regional, Inc. - Oncology — Salisbury, Maryland, United States
• Henry Ford Hospital - OB/GYN — Detroit, Michigan, United States
• St. Vincent Regional Hospital - Oncology — Billings, Montana, United States
• XCancer Omaha — Omaha, Nebraska, United States
• New Jersey Urology - Voorhees — Voorhees Township, New Jersey, United States
• New Mexico Cancer Center - Albuquerque — Albuquerque, New Mexico, United States
• URMC Wilmot Cancer Center — Rochester, New York, United States
• New York Cancer & Blood Specialists - Eastchester — The Bronx, New York, United States
• Montefiore Einstein Center for Cancer Care - Tower at Montefiore Medical Park — The Bronx, New York, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• The Urology Group - Norwood Surgery Center — Cincinnati, Ohio, United States
• Urology Centers of Alabama, PC - Homewood — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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