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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
Titles & IDs
Public title
Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
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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
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Secondary ID [1]
0
0
2019-003618-15
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Secondary ID [2]
0
0
20321
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
0
0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment-emergent adverse events (TEAEs)
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Assessment method [1]
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0
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Timepoint [1]
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Up to 4 years
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Primary outcome [2]
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Incidence of treatment-emergent serious adverse events (TESAEs)
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Assessment method [2]
0
0
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Timepoint [2]
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Up to 4 years
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Primary outcome [3]
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Incidence of drug-related TEAEs
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Assessment method [3]
0
0
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Timepoint [3]
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Up to 4 years
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Primary outcome [4]
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0
Incidence of drug-related TESAEs
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Assessment method [4]
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0
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Timepoint [4]
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Up to 4 years
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Secondary outcome [1]
0
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Number of dose modifications
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Assessment method [1]
0
0
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Timepoint [1]
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Up to 4 years
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/06/2028
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Actual
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Sample size
Target
678
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Adelaide Cancer Centre Research Pty Ltd - Kurralta Park
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Recruitment postcode(s) [1]
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5037 - Kurralta Park
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Recruitment outside Australia
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Wakayama
Query!
Country [148]
0
0
Korea, Republic of
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State/province [148]
0
0
Chungcheongbugdo
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Country [149]
0
0
Korea, Republic of
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State/province [149]
0
0
Gwangju Gwang''yeogsi
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Country [150]
0
0
Korea, Republic of
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State/province [150]
0
0
Gyeonggido
Query!
Country [151]
0
0
Korea, Republic of
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State/province [151]
0
0
Seoul Teugbyeolsi
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Country [152]
0
0
Korea, Republic of
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State/province [152]
0
0
Busan
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Country [153]
0
0
Korea, Republic of
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State/province [153]
0
0
Daegu
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Country [154]
0
0
Korea, Republic of
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State/province [154]
0
0
Incheon
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Country [155]
0
0
Korea, Republic of
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State/province [155]
0
0
Seoul
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Country [156]
0
0
Latvia
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State/province [156]
0
0
Liepaja
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Country [157]
0
0
Latvia
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State/province [157]
0
0
Riga
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Country [158]
0
0
Lithuania
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State/province [158]
0
0
Kaunas
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Country [159]
0
0
Lithuania
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State/province [159]
0
0
Klaipeda
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Country [160]
0
0
Lithuania
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State/province [160]
0
0
Vilnius
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Country [161]
0
0
Mexico
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State/province [161]
0
0
Nuevo Leon
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Country [162]
0
0
Mexico
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State/province [162]
0
0
Querétaro
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Country [163]
0
0
Netherlands
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State/province [163]
0
0
Amsterdam
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Country [164]
0
0
Netherlands
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State/province [164]
0
0
Den Haag
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Country [165]
0
0
Netherlands
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State/province [165]
0
0
Dordrecht
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Country [166]
0
0
Netherlands
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State/province [166]
0
0
Geleen
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Country [167]
0
0
Netherlands
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State/province [167]
0
0
Hilversum
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Country [168]
0
0
Netherlands
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State/province [168]
0
0
Hoofddorp
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Country [169]
0
0
Netherlands
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State/province [169]
0
0
Tilburg
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Country [170]
0
0
Peru
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State/province [170]
0
0
Arequipa
Query!
Country [171]
0
0
Peru
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State/province [171]
0
0
Lima
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Country [172]
0
0
Poland
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State/province [172]
0
0
Gdansk
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Country [173]
0
0
Poland
Query!
State/province [173]
0
0
Lodz
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Country [174]
0
0
Poland
Query!
State/province [174]
0
0
Lublin
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Country [175]
0
0
Poland
Query!
State/province [175]
0
0
Otwock
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Country [176]
0
0
Poland
Query!
State/province [176]
0
0
Rybnik
Query!
Country [177]
0
0
Poland
Query!
State/province [177]
0
0
Siedlce
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Country [178]
0
0
Poland
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State/province [178]
0
0
Waliszew
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Country [179]
0
0
Poland
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State/province [179]
0
0
Warszawa
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Country [180]
0
0
Poland
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State/province [180]
0
0
Wroclaw
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Country [181]
0
0
Portugal
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State/province [181]
0
0
Porto
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Country [182]
0
0
Portugal
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State/province [182]
0
0
Setúbal
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Country [183]
0
0
Portugal
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State/province [183]
0
0
Lisboa
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Country [184]
0
0
Romania
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State/province [184]
0
0
Bucuresti
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Country [185]
0
0
Romania
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State/province [185]
0
0
Craiova
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Country [186]
0
0
Romania
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State/province [186]
0
0
Oradea
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Country [187]
0
0
Romania
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State/province [187]
0
0
Targu-Mures
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Country [188]
0
0
Russian Federation
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State/province [188]
0
0
Chelyabinsk
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Country [189]
0
0
Russian Federation
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State/province [189]
0
0
Ivanovo
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Country [190]
0
0
Russian Federation
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State/province [190]
0
0
Kazan
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Country [191]
0
0
Russian Federation
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State/province [191]
0
0
Krasnoyarsk
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Country [192]
0
0
Russian Federation
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State/province [192]
0
0
Moscow
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Country [193]
0
0
Russian Federation
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State/province [193]
0
0
Nizhny Novgorod
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Country [194]
0
0
Russian Federation
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State/province [194]
0
0
Novosibirsk
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Country [195]
0
0
Russian Federation
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State/province [195]
0
0
Obninsk
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Country [196]
0
0
Russian Federation
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State/province [196]
0
0
Omsk
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Country [197]
0
0
Russian Federation
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State/province [197]
0
0
Rostov-on-Don
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Country [198]
0
0
Russian Federation
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State/province [198]
0
0
Saratov
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Country [199]
0
0
Russian Federation
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State/province [199]
0
0
St. Petersburg
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Country [200]
0
0
Russian Federation
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State/province [200]
0
0
Tyumen
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Country [201]
0
0
Russian Federation
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State/province [201]
0
0
Vladimir
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Country [202]
0
0
Serbia
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State/province [202]
0
0
Belgrade
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Country [203]
0
0
Serbia
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State/province [203]
0
0
Nis
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Country [204]
0
0
Slovakia
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State/province [204]
0
0
Bratislava
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Country [205]
0
0
Slovakia
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State/province [205]
0
0
Trencin
Query!
Country [206]
0
0
South Africa
Query!
State/province [206]
0
0
Eastern Cape
Query!
Country [207]
0
0
South Africa
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State/province [207]
0
0
Western Cape
Query!
Country [208]
0
0
Spain
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State/province [208]
0
0
Alicante
Query!
Country [209]
0
0
Spain
Query!
State/province [209]
0
0
Barcelona
Query!
Country [210]
0
0
Spain
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State/province [210]
0
0
Cádiz
Query!
Country [211]
0
0
Spain
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State/province [211]
0
0
Illes Baleares
Query!
Country [212]
0
0
Spain
Query!
State/province [212]
0
0
Madrid
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Country [213]
0
0
Spain
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State/province [213]
0
0
Cáceres
Query!
Country [214]
0
0
Spain
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State/province [214]
0
0
Córdoba
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Country [215]
0
0
Spain
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State/province [215]
0
0
Lugo
Query!
Country [216]
0
0
Spain
Query!
State/province [216]
0
0
Málaga
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Country [217]
0
0
Spain
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State/province [217]
0
0
Salamanca
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Country [218]
0
0
Spain
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State/province [218]
0
0
Sevilla
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Country [219]
0
0
Spain
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State/province [219]
0
0
Valencia
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Country [220]
0
0
Sweden
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State/province [220]
0
0
Göteborg
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Country [221]
0
0
Sweden
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State/province [221]
0
0
Malmö
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Country [222]
0
0
Sweden
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State/province [222]
0
0
Stockholm
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Country [223]
0
0
Sweden
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State/province [223]
0
0
Umea
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Country [224]
0
0
Sweden
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State/province [224]
0
0
Uppsala
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Country [225]
0
0
Taiwan
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State/province [225]
0
0
Kaohsiung
Query!
Country [226]
0
0
Taiwan
Query!
State/province [226]
0
0
Taichung
Query!
Country [227]
0
0
Taiwan
Query!
State/province [227]
0
0
Taipei
Query!
Country [228]
0
0
Taiwan
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State/province [228]
0
0
Taoyuan
Query!
Country [229]
0
0
Turkey
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State/province [229]
0
0
Ankara
Query!
Country [230]
0
0
Turkey
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State/province [230]
0
0
Istanbul
Query!
Country [231]
0
0
Ukraine
Query!
State/province [231]
0
0
Chernivtsi
Query!
Country [232]
0
0
Ukraine
Query!
State/province [232]
0
0
Dnipro
Query!
Country [233]
0
0
Ukraine
Query!
State/province [233]
0
0
Kharkiv
Query!
Country [234]
0
0
Ukraine
Query!
State/province [234]
0
0
Kyiv
Query!
Country [235]
0
0
Ukraine
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State/province [235]
0
0
Uzhgorod
Query!
Country [236]
0
0
United Kingdom
Query!
State/province [236]
0
0
Berkshire
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Country [237]
0
0
United Kingdom
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State/province [237]
0
0
Carmarthenshire
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Country [238]
0
0
United Kingdom
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State/province [238]
0
0
Essex
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Country [239]
0
0
United Kingdom
Query!
State/province [239]
0
0
Merseyside
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Country [240]
0
0
United Kingdom
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State/province [240]
0
0
North East Lincolnshire
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Country [241]
0
0
United Kingdom
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State/province [241]
0
0
West Midlands
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Country [242]
0
0
United Kingdom
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State/province [242]
0
0
West Yorkshire
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Country [243]
0
0
United Kingdom
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State/province [243]
0
0
Cardiff
Query!
Country [244]
0
0
United Kingdom
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State/province [244]
0
0
Glasgow
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Country [245]
0
0
United Kingdom
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State/province [245]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bayer
Query!
Address
Query!
Country
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Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04464226
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Bayer Clinical Trials Contact
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
(+)1-888-84 22937
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04464226