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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04464226




Registration number
NCT04464226
Ethics application status
Date submitted
7/07/2020
Date registered
9/07/2020
Date last updated
3/07/2024

Titles & IDs
Public title
Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
Scientific 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
Secondary ID [1] 0 0
2019-003618-15
Secondary ID [2] 0 0
20321
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darolutamide (Nubeqa, BAY1841788)

Experimental: Darolutamide (BAY1841788) - Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.


Treatment: Drugs: Darolutamide (Nubeqa, BAY1841788)
Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Up to 4 years
Primary outcome [2] 0 0
Incidence of treatment-emergent serious adverse events (TESAEs)
Timepoint [2] 0 0
Up to 4 years
Primary outcome [3] 0 0
Incidence of drug-related TEAEs
Timepoint [3] 0 0
Up to 4 years
Primary outcome [4] 0 0
Incidence of drug-related TESAEs
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Number of dose modifications
Timepoint [1] 0 0
Up to 4 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/06/2028
Actual
Sample size
Target
678
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Adelaide Cancer Centre Research Pty Ltd - Kurralta Park
Recruitment postcode(s) [1] 0 0
5037 - Kurralta Park
Recruitment outside Australia
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Carmarthenshire
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Essex
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Merseyside
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North East Lincolnshire
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West Midlands
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West Yorkshire
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Glasgow
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04464226
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
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Bayer Clinical Trials Contact
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(+)1-888-84 22937
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04464226