NCT04464226

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

An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

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

Timeline

• Start date: 2020-10-20
• Primary completion: 2028-06-26
• Completion: 2028-06-26
• First posted: 2020-07-09
• Last updated: 2026-04-15

Locations

335 sites across 39 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study