Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
60
Countries
4
Sites
8
Prostate cancer
Key facts
- Sponsor
- Bayer Consumer Care AG, Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Aug 2020 → 6 Aug 2025
- Decision date (initial)
- 2024-02-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506435-15-00
- EudraCT number
- 2019-000475-17
- ClinicalTrials.gov
- NCT04521361
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer Consumer Care AG
- Sponsor organisation
- Bayer Consumer Care AG
- Address
- Peter Merian-Strasse 84
- City
- Basel
- Postcode
- 4052
- Country
- Switzerland
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- -
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
4 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 6 | 1 |
| France | Ended | 25 | 4 |
| Italy | Ended | 10 | 1 |
| Lithuania | Ended | 10 | 2 |
| Rest of world
United Kingdom, Israel
|
— | 9 | — |
Investigational sites
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Universitätsklinik für Nuklearmedizin und Endokrinologie, Muellner Hauptstrasse 48, 5020, Salzburg
Centre Hospitalier Lyon Sud
Medical Oncology, Chemin Du Grand Revoyet, 69310, Pierre Benite
Institut De Cancerologie De L Ouest
Nuclear Medicine, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut Universitaire Du Cancer Toulouse-Oncopole
Medical Imaging, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Regional Du Cancer De Montpellier
Nuclear Medicine, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Azienda USL IRCCS Di Reggio Emilia
medical oncology, Viale Risorgimento 80, 42123, Reggio Emilia
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2020-10-30 | 2024-07-09 | 2021-07-21 | 2023-02-23 | |
| France | 2020-08-25 | 2025-04-10 | 2020-11-16 | 2023-02-23 | |
| Italy | 2022-04-28 | 2024-09-17 | 2022-10-19 | 2023-02-23 | |
| Lithuania | 2021-10-14 | 2025-05-23 | 2022-06-16 | 2023-02-23 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-08 | Lithuania | Acceptable 2024-02-20
|
2024-02-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-13 | Lithuania | Acceptable 2024-02-20
|
2024-06-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-22 | Lithuania | Acceptable 2024-02-20
|
2025-04-22 |