We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04464226
Ethics application status
Date submitted
7/07/2020
Date registered
9/07/2020
Date last updated
14/04/2021

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
Gender
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
N/A
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment postcode(s) [1] 0 0
5037 - Kurralta Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad Auton. De Buenos Aires
Country [16] 0 0
Austria
State/province [16] 0 0
Wien
Country [17] 0 0
Belarus
State/province [17] 0 0
Lesnoy
Country [18] 0 0
Belarus
State/province [18] 0 0
Minsk
Country [19] 0 0
Belgium
State/province [19] 0 0
Kortrijk
Country [20] 0 0
Belgium
State/province [20] 0 0
Liege
Country [21] 0 0
Brazil
State/province [21] 0 0
Bahia
Country [22] 0 0
Brazil
State/province [22] 0 0
Ceará
Country [23] 0 0
Brazil
State/province [23] 0 0
Goiás
Country [24] 0 0
Brazil
State/province [24] 0 0
Minas Gerais
Country [25] 0 0
Brazil
State/province [25] 0 0
Parana
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio Grande Do Sul
Country [27] 0 0
Brazil
State/province [27] 0 0
Santa Catarina
Country [28] 0 0
Brazil
State/province [28] 0 0
Sao Paulo
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Sofia
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
Nova Scotia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Colombia
State/province [34] 0 0
Antioquia
Country [35] 0 0
Colombia
State/province [35] 0 0
Córdoba
Country [36] 0 0
Colombia
State/province [36] 0 0
Santander
Country [37] 0 0
Czechia
State/province [37] 0 0
Jablonec nad Nisou
Country [38] 0 0
Czechia
State/province [38] 0 0
Praha 2
Country [39] 0 0
Czechia
State/province [39] 0 0
Praha 6
Country [40] 0 0
Estonia
State/province [40] 0 0
Tallinn
Country [41] 0 0
Finland
State/province [41] 0 0
Helsinki
Country [42] 0 0
Finland
State/province [42] 0 0
Seinäjoki
Country [43] 0 0
Finland
State/province [43] 0 0
Tampere
Country [44] 0 0
Finland
State/province [44] 0 0
Turku
Country [45] 0 0
France
State/province [45] 0 0
Angers
Country [46] 0 0
France
State/province [46] 0 0
Bordeaux Cedex
Country [47] 0 0
France
State/province [47] 0 0
Clermont Ferrand Cedex 1
Country [48] 0 0
France
State/province [48] 0 0
Dijon
Country [49] 0 0
France
State/province [49] 0 0
Nancy
Country [50] 0 0
France
State/province [50] 0 0
Nantes Cedex
Country [51] 0 0
France
State/province [51] 0 0
Paris
Country [52] 0 0
France
State/province [52] 0 0
Pierre Benite
Country [53] 0 0
France
State/province [53] 0 0
POITIERS cedex
Country [54] 0 0
France
State/province [54] 0 0
REIMS cedex
Country [55] 0 0
France
State/province [55] 0 0
Rennes Cedex
Country [56] 0 0
France
State/province [56] 0 0
Rouen Cedex
Country [57] 0 0
France
State/province [57] 0 0
Saint Mande
Country [58] 0 0
France
State/province [58] 0 0
Suresnes
Country [59] 0 0
France
State/province [59] 0 0
Tours
Country [60] 0 0
France
State/province [60] 0 0
Villejuif Cedex
Country [61] 0 0
Germany
State/province [61] 0 0
Baden-Württemberg
Country [62] 0 0
Germany
State/province [62] 0 0
Hessen
Country [63] 0 0
Germany
State/province [63] 0 0
Niedersachsen
Country [64] 0 0
Germany
State/province [64] 0 0
Nordrhein-Westfalen
Country [65] 0 0
Germany
State/province [65] 0 0
Rheinland-Pfalz
Country [66] 0 0
Germany
State/province [66] 0 0
Magdeburg
Country [67] 0 0
Hungary
State/province [67] 0 0
Debrecen
Country [68] 0 0
Hungary
State/province [68] 0 0
Szekszard
Country [69] 0 0
Hungary
State/province [69] 0 0
Zalaegerszeg
Country [70] 0 0
Italy
State/province [70] 0 0
Campania
Country [71] 0 0
Italy
State/province [71] 0 0
Emilia-Romagna
Country [72] 0 0
Italy
State/province [72] 0 0
Piemonte
Country [73] 0 0
Japan
State/province [73] 0 0
Gunma
Country [74] 0 0
Japan
State/province [74] 0 0
Hokkaido
Country [75] 0 0
Japan
State/province [75] 0 0
Ibaraki
Country [76] 0 0
Japan
State/province [76] 0 0
Kanagawa
Country [77] 0 0
Japan
State/province [77] 0 0
Nagano
Country [78] 0 0
Japan
State/province [78] 0 0
Oita
Country [79] 0 0
Japan
State/province [79] 0 0
Osaka
Country [80] 0 0
Japan
State/province [80] 0 0
Shizuoka
Country [81] 0 0
Japan
State/province [81] 0 0
Tochigi
Country [82] 0 0
Japan
State/province [82] 0 0
Tokyo
Country [83] 0 0
Japan
State/province [83] 0 0
Yamaguchi
Country [84] 0 0
Japan
State/province [84] 0 0
Hiroshima
Country [85] 0 0
Japan
State/province [85] 0 0
Kashiwa
Country [86] 0 0
Japan
State/province [86] 0 0
Toyama
Country [87] 0 0
Korea, Republic of
State/province [87] 0 0
Chungcheongbugdo
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Gwangju Gwang''yeogsi
Country [89] 0 0
Korea, Republic of
State/province [89] 0 0
Daegu
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Incheon
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Seoul
Country [92] 0 0
Latvia
State/province [92] 0 0
Liepaja
Country [93] 0 0
Latvia
State/province [93] 0 0
Riga
Country [94] 0 0
Lithuania
State/province [94] 0 0
Kaunas
Country [95] 0 0
Lithuania
State/province [95] 0 0
Klaipeda
Country [96] 0 0
Lithuania
State/province [96] 0 0
Vilnius
Country [97] 0 0
Peru
State/province [97] 0 0
Arequipa
Country [98] 0 0
Peru
State/province [98] 0 0
Lima
Country [99] 0 0
Poland
State/province [99] 0 0
Gdansk
Country [100] 0 0
Poland
State/province [100] 0 0
Lodz
Country [101] 0 0
Poland
State/province [101] 0 0
Otwock
Country [102] 0 0
Poland
State/province [102] 0 0
Siedlce
Country [103] 0 0
Poland
State/province [103] 0 0
Warszawa
Country [104] 0 0
Poland
State/province [104] 0 0
Wroclaw
Country [105] 0 0
Portugal
State/province [105] 0 0
Lisboa
Country [106] 0 0
Portugal
State/province [106] 0 0
Porto
Country [107] 0 0
Romania
State/province [107] 0 0
Bucuresti
Country [108] 0 0
Romania
State/province [108] 0 0
Craiova
Country [109] 0 0
Romania
State/province [109] 0 0
Oradea
Country [110] 0 0
Romania
State/province [110] 0 0
Targu-Mures
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Ivanovo
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Kazan
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Krasnoyarsk
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Moscow
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Nizhny Novgorod
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Novosibirsk
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Obninsk
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Omsk
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Rostov-on-Don
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Saratov
Country [121] 0 0
Russian Federation
State/province [121] 0 0
St. Petersburg
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Tyumen
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Vladimir
Country [124] 0 0
Serbia
State/province [124] 0 0
Belgrade
Country [125] 0 0
Slovakia
State/province [125] 0 0
Bratislava
Country [126] 0 0
Slovakia
State/province [126] 0 0
Trencin
Country [127] 0 0
South Africa
State/province [127] 0 0
Eastern Cape
Country [128] 0 0
South Africa
State/province [128] 0 0
Western Cape
Country [129] 0 0
Spain
State/province [129] 0 0
Alicante
Country [130] 0 0
Spain
State/province [130] 0 0
Barcelona
Country [131] 0 0
Spain
State/province [131] 0 0
Cádiz
Country [132] 0 0
Spain
State/province [132] 0 0
Illes Baleares
Country [133] 0 0
Spain
State/province [133] 0 0
Madrid
Country [134] 0 0
Spain
State/province [134] 0 0
Lugo
Country [135] 0 0
Spain
State/province [135] 0 0
Málaga
Country [136] 0 0
Spain
State/province [136] 0 0
Salamanca
Country [137] 0 0
Spain
State/province [137] 0 0
Sevilla
Country [138] 0 0
Spain
State/province [138] 0 0
Valencia
Country [139] 0 0
Sweden
State/province [139] 0 0
Göteborg
Country [140] 0 0
Sweden
State/province [140] 0 0
Stockholm
Country [141] 0 0
Sweden
State/province [141] 0 0
Uppsala
Country [142] 0 0
Taiwan
State/province [142] 0 0
Kaohsiung
Country [143] 0 0
Taiwan
State/province [143] 0 0
Taichung
Country [144] 0 0
Taiwan
State/province [144] 0 0
Taipei
Country [145] 0 0
Taiwan
State/province [145] 0 0
Taoyuan
Country [146] 0 0
Turkey
State/province [146] 0 0
Ankara
Country [147] 0 0
Turkey
State/province [147] 0 0
Istanbul
Country [148] 0 0
Ukraine
State/province [148] 0 0
Chernivtsi
Country [149] 0 0
Ukraine
State/province [149] 0 0
Dnipro
Country [150] 0 0
Ukraine
State/province [150] 0 0
Kharkiv
Country [151] 0 0
Ukraine
State/province [151] 0 0
Kyiv
Country [152] 0 0
Ukraine
State/province [152] 0 0
Uzhgorod
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Berkshire
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Carmarthenshire
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Merseyside
Country [156] 0 0
United Kingdom
State/province [156] 0 0
North East Lincolnshire
Country [157] 0 0
United Kingdom
State/province [157] 0 0
West Midlands
Country [158] 0 0
United Kingdom
State/province [158] 0 0
West Yorkshire
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Cardiff
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Glasgow

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/show/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
Email 0 0
Contact person for public queries
Name 0 0
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
clinical-trials-contact@bayer.com
Contact person for scientific queries

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