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

NCT04464226 · tracked via the Priya Life Science USA tracker

Sponsor

Bayer

Phase

Phase 3

Started

2020-10-20

Last updated

2026-07-07

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

Darolutamide (Nubeqa, BAY1841788)

Darolutamide (Nubeqa, BAY1841788): Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.

Study 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 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.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of treatment-emergent adverse events (TEAEs) — Up to 4 years
Incidence of treatment-emergent serious adverse events (TESAEs) — Up to 4 years
Incidence of drug-related TEAEs — Up to 4 years
Incidence of drug-related TESAEs — Up to 4 years

Trial sites (335)

Facility	City	Region
Urology Centers of Alabama, PC - Homewood	Homewood	Alabama
Ironwood Cancer and Research Centers - Chandler I	Chandler	Arizona
Tower Urology	Los Angeles	California
Stanford Cancer Center Palo Alto	Palo Alto	California
San Diego Clinical Trials	San Diego	California
TOI Clinical Research	Whittier	California
Rocky Mountain Regional VA Medical Center - Oncology	Aurora	Colorado
The Urology Center Of Colorado	Denver	Colorado
Boca Raton Regional Hospital - Oncology	Boca Raton	Florida
Jesse Brown VA Medical Center - Cardiology	Chicago	Illinois
Illinois CancerCare - Peoria	Peoria	Illinois
Norton Cancer Institute - Downtown	Louisville	Kentucky
Chesapeake Urology Associates - Towson	Baltimore	Maryland
Johns Hopkins Hospital - Pulmonology	Baltimore	Maryland
TidalHealth Peninsula Regional, Inc. - Oncology	Salisbury	Maryland
Henry Ford Hospital - OB/GYN	Detroit	Michigan
St. Vincent Regional Hospital - Oncology	Billings	Montana
XCancer Omaha	Omaha	Nebraska
New Jersey Urology - Voorhees	Voorhees Township	New Jersey
New Mexico Cancer Center - Albuquerque	Albuquerque	New Mexico
URMC Wilmot Cancer Center	Rochester	New York
New York Cancer & Blood Specialists - Eastchester	The Bronx	New York
Montefiore Einstein Center for Cancer Care - Tower at Montefiore Medical Park	The Bronx	New York
Gabrail Cancer Center	Canton	Ohio
The Urology Group - Norwood Surgery Center	Cincinnati	Ohio
The Ohio State University - Arthur G James Cancer Hospital and Richard J Solove Research Institute	Columbus	Ohio
MidLantic Urology - Bala Cynwyd	Bala-Cynwyd	Pennsylvania
Andrews & Patel Associates	Camp Hill	Pennsylvania
Charleston Oncology - Downtown	Charleston	South Carolina
Carolina Urological Research Center	Myrtle Beach	South Carolina
Urology Associates, PC - Nashville	Nashville	Tennessee
Urology Clinics of North Texas - Dallas (Walnut HIll Lane)	Dallas	Texas
Huntsman Cancer Institute	Salt Lake City	Utah
Providence Regional Cancer Partnership	Everett	Washington
Inova Schar Cancer Insitute - Inova Fairfax Hospital	Fairfax	Washington
VCU Health Ambulatory Care Center - Cardiology	Virginia	Washington
Centro de Urología	Buenos Aires	Argentina
Adelaide Cancer Centre Research Pty Ltd	Kurralta Park	South Australia
Universitätsklinikum AKH Wien	Vienna	State of Vienna
N.N. Alexandrov National Cancer Centre of Belarus - Oncology Department	Lyasny	Minsk Oblast

+ 295 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04464226 on ClinicalTrials.gov ↗ ← All trials in the USA