Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
194
Countries
3
Sites
7
Metastatic castration-resistant prostate cancer
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Jul 2021 → ongoing
- Decision date (initial)
- 2024-01-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506585-31-00
- EudraCT number
- 2020-005970-83
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic castration-resistant prostate cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 50 | 3 |
| Netherlands | Ongoing, recruitment ended | 18 | 1 |
| Spain | Ongoing, recruitment ended | 35 | 3 |
| Rest of world
China, Japan, United States
|
— | 91 | — |
Investigational sites
Institut Gustave Roussy
Departement d'innovation therapeutique et d'essais precoces, 114 Rue Edouard Vaillant, 94800, Villejuif
Assistance Publique Hopitaux De Marseille
Oncologie medicale, 264 Rue Saint Pierre, 13005, Marseille
Centre Leon Berard
Oncologie medicale, 28 Rue Laennec, 69008, Lyon
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Hospital Universitario Virgen De La Victoria
Phase I Clinical Trial Unit, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
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 |
|---|---|---|---|---|---|
| France | 2021-07-09 | 2021-07-13 | 2025-01-15 | ||
| Netherlands | 2021-08-25 | 2021-10-15 | 2024-07-15 | ||
| Spain | 2021-08-05 | 2021-08-13 | 2025-05-19 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-21 | Netherlands | Acceptable 2024-01-11
|
2024-01-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-14 | Netherlands | Acceptable 2024-05-06
|
2024-05-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-31 | Netherlands | Acceptable 2024-11-04
|
2024-11-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-20 | Netherlands | Acceptable 2025-05-26
|
2025-05-28 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-21 | Netherlands | Acceptable 2025-09-04
|
2025-09-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-21 | Netherlands | Acceptable 2026-02-17
|
2026-02-17 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-05-20 | Acceptable | 2026-06-02 |