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NCT04464226 · ClinicalTrials.gov record · last posted 2026-07-07

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

StatusActive, Not Recruiting
PhasePhase 3
SponsorBayer
Started2020-10-20
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 66 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 66 times since 2020-07-07; most recent amendment 2026-07-03. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2026-04-13
Status change Recruiting→Active, Not Recruitingv65
2020-11-11
Status change Not Yet Recruiting→Recruitingv5
Trial Details
NCT Number NCT04464226
Lead Sponsor Bayer
Conditions Cancer
Enrollment 402 participants
Start Date 2020-10-20
Primary Completion 2028-06-26 (estimated)
Study Completion 2028-06-26 (estimated)
Updated on ClinicalTrials.gov 2026-07-07