Study to cotinue 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 - Darolutamide roll-over study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200304

Enrollment

500

Registered

2021-01-15

Start date

2020-12-11

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Cancer

Interventions

Participant will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.

Eligibility

Sex/Gender

Male

Inclusion criteria

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 outlined in the feeder study protocol. - Willingness to continue practicing acceptable methods of birth control during the study.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Number of dose modifications	—

Countries

Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, Colombia, Czechia, Estonia, Finland, France, Germany, Hungary, Italy, Japan, Korea, Latvia, Lithuania, Peru, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, USA

Contacts

Public ContactDedicated contact

Bayer Yakuhin, Ltd.

byl_ct_contact@bayer.com+81-6-6133-6363

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026