Cancer
Conditions
Interventions
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 1841788
Other descript
Sponsors
Bayer Consumer Care AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: All male participants with ongoing darolutamide treatment in Bayer-sponsored feeder studies that do not meet any of treatment/study termination criteria in their respective feeder studies and are eligible to continue receiving treatment with darolutamide. Participants enrolled in a blinded darolutamide study can only be enrolled after study unblinding. 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 contraception and birth control with pregnant women and women of child bearing potential (WOCBP) during the study and for 1 week after completion of the treatment. Please refer to Section 8.3.5 for specific details and a list of highly effective contraceptive methods. 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. | — |
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, 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
Outcome results
None listed