This study has been transitioned to CTIS with ID 2022-502084-38-00 check the CTIS register for the current data. Primary- Continuation of treatment- SafetySecondairy- Documentation of tolerability
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Incidence of Treatment-emergent adverse events (TEAEs)
- Incidence of Treatment-emergent serious adverse events (TESAEs)
- Incidence of drug-related TEAEs and TESAEs
Secondary outcome
- Frequency of dose modifications
Background summary
Darolutamide works as an androgen receptor inhibitor. In a prostate cancer
cell, the androgen (male hormone) *testosterone* connects with the androgen
receptor, which may cause the growth of the tumor cell. Darolutamide helps to
prevent the attachment of testosterone to the androgen receptor and thus
prevents prostate tumor growth.
The study drug will be given in conjunction with the current hormonal
treatment, as known by the patient.
Study objective
This study has been transitioned to CTIS with ID 2022-502084-38-00 check the CTIS register for the current data.
Primary
- Continuation of treatment
- Safety
Secondairy
- Documentation of tolerability
Study design
This is an open-label, single-arm roll-over study (ROS) to enable participants
receiving darolutamide in any Bayer-sponsored feeder study, to continue
receiving darolutamide treatment beyond the feeder study primary completion or
closure.
Intervention
Darolutamide
Twice daily 600 mg (2 x 300 mg tablets), total daily dose 1200 mg
Orally taken with food
In addition to standard of care.
Study burden and risks
The investigator of the feeder study is expected to assess the overall
benefit/risk for each participant. When the study investigator deems there is a
positive benefit/risk assessment and no treatment withdrawal criteria of the
feeder study have been met, the participant can continue to receive treatment
in this roll-over study.
Energieweg 1
Mijdrecht 3641 RT
NL
Energieweg 1
Mijdrecht 3641 RT
NL
Listed location countries
Age
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.
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
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2022-502084-38-00 |
| EudraCT | EUCTR2019-003618-15-NL |
| ClinicalTrials.gov | NCT04464226 |
| CCMO | NL78045.058.21 |