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

Phase 3

Recruiting

• Conditions: Cancer
• Interventions: Drug: Darolutamide (Nubeqa, BAY1841788)

• Registration Number: NCT04464226
• Lead Sponsor: Bayer

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-09
• Study Start: 2020-10-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-19
• Primary Completion: 2028-06-26
• Study Completion: 2028-06-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 402

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Darolutamide (BAY1841788)	Darolutamide (Nubeqa, BAY1841788)	Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of dose modifications	Up to 4 years

Trial Locations

Locations (376)

Urology Centers of Alabama, PC; 🇺🇸 Homewood, Alabama, United States

Ironwood Cancer and Research Centers - Chandler I; 🇺🇸 Chandler, Arizona, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Tower Urology, Inc; 🇺🇸 Los Angeles, California, United States

VA Greater Los Angeles Healthcare System; 🇺🇸 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

VA Eastern Colorado Health Care System; 🇺🇸 Aurora, Colorado, United States

The Urology Center Of Colorado; 🇺🇸 Denver, Colorado, United States

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