An open study for participants who have been on darolutamide treatment in any other Bayer study.

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 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003618-15-HU

Enrollment

500

Registered

2020-05-14

Start date

2020-06-30

Completion date

Unknown

Last updated

2024-02-26

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

Conditions

Cancer

Interventions

Trade Name: Nubeqa Product Name: Darolutamide Product Code: BAY 1841788 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DAROLUTAMIDE CAS Number: 1297538-32-9 Current Sponsor code: BAY 184

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. 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 2. 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. 3. Participants who have not met any treatment discontinuation criteria outlined in the feeder study protocol. 4. Willingness to continue practicing acceptable methods of birth control during the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 475

Exclusion criteria

Exclusion criteria: 1. Participant is unable to comply with the requirements of the study. 2. Negative benefit/ risk ratio as determined by the investigator. 3. Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.

Design outcomes

Primary

Measure	Time frame
Main Objective: •Continuation of darolutamide treatment •Safety of darolutamide ;Secondary Objective: •Documentation of tolerability of darolutamide;Primary end point(s): •Incidence of TEAEs (Treatment-emergent adverse events) •Incidence of TESAEs (Treatment-emergent serious adverse events) •Incidence of drug-related TEAEs and TESAEs ;Timepoint(s) of evaluation of this end point: These will be summarized formally at the end of the study when all patients are complete.	—

Measure

Time frame

Main Objective: •Continuation of darolutamide treatment •Safety of darolutamide ;Secondary Objective: •Documentation of tolerability of darolutamide;Primary end point(s): •Incidence of TEAEs (Treatment-emergent adverse events) •Incidence of TESAEs (Treatment-emergent serious adverse events) •Incidence of drug-related TEAEs and TESAEs ;Timepoint(s) of evaluation of this end point: These will be summarized formally at the end of the study when all patients are complete.

—

Secondary

Measure	Time frame
Secondary end point(s): • Frequency of dose modifications;Timepoint(s) of evaluation of this end point: These will be summarized formally at the end of the study when all patients are complete.	—

Countries

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Netherlands, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com4930300139003

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026