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.
Brief Title
Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
(+)1-888-84 22937
Central Contact Email
clinical-trials-contact@bayer.com
Completion Date
Completion Date Type
Estimated
Conditions
Cancer
Eligibility 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 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.
* 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.
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 in the feeder study protocol.
* Willingness to continue practicing acceptable methods of birth control during the study.
* 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.
Gender
Male
Gender Based
false
Keywords
Roll-Over Study
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04464226
Org Class
Industry
Org Full Name
Bayer
Org Study Id
20321
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies
Primary Outcomes
Outcome Measure
Incidence of treatment-emergent adverse events (TEAEs)
Outcome Time Frame
Up to 4 years
Outcome Measure
Incidence of treatment-emergent serious adverse events (TESAEs)
Outcome Time Frame
Up to 4 years
Outcome Measure
Incidence of drug-related TEAEs
Outcome Time Frame
Up to 4 years
Outcome Measure
Incidence of drug-related TESAEs
Outcome Time Frame
Up to 4 years
Secondary Ids
Secondary Id
2019-003618-15
Secondary Outcomes
Outcome Time Frame
Up to 4 years
Outcome Measure
Number of dose modifications
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Gartrell
Investigator Email
bgartrel@montefiore.org
Investigator Phone
718-405-8404