(20321) 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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502084-38-00

Acronym

BAY1841788/20321

Enrollment

250

Registered

2023-05-23

Start date

2020-10-16

Completion date

Unknown

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

Incidence of TEAEs (Treatment-emergent adverse events), Incidence of TESAEs (Treatment-emergent serious adverse events), Incidence of drug-related TEAEs and TESAEs

Detailed description

Frequency of dose modifications

Interventions

DRUGBAY 1841788

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of TEAEs (Treatment-emergent adverse events), Incidence of TESAEs (Treatment-emergent serious adverse events), Incidence of drug-related TEAEs and TESAEs	—

Secondary

Measure	Time frame
Frequency of dose modifications	—

Countries

Belgium, Bulgaria, Czechia, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026