Cancer
Conditions
Keywords
Roll-Over Study
Brief 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.
Interventions
Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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 in the feeder study protocol. * Willingness to continue practicing acceptable methods of birth control during the study.
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 |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 4 years |
| Incidence of treatment-emergent serious adverse events (TESAEs) | Up to 4 years |
| Incidence of drug-related TEAEs | Up to 4 years |
| Incidence of drug-related TESAEs | Up to 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of dose modifications | Up to 4 years |
Countries
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, United States
Outcome results
None listed