Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
301
Countries
2
Sites
4
Advanced 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
- 8 Mar 2024 → ongoing
- Decision date (initial)
- 2024-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Prostate Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10060862 | Prostate cancer | 100000004864 |
| 21.1 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
| 21.1 | PT | 10062904 | Hormone-refractory prostate cancer | 100000004864 |
| 21.0 | PT | 10036911 | Prostate cancer recurrent | 100000004864 |
| 21.0 | PT | 10036920 | Prostate cancer stage IV | 100000004864 |
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
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 55 | 3 |
| Netherlands | Not authorised | 16 | 1 |
| Rest of world
China, United States, Japan, Australia
|
— | 230 | — |
Investigational sites
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
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 | 2024-03-08 | 2024-04-03 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-13 | France | Acceptable 2024-02-19
|
2024-02-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-20 | France | Acceptable 2024-06-10
|
2024-06-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-09 | France | Acceptable 2024-08-29
|
2024-08-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-21 | France | Acceptable 2024-08-29
|
2024-11-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-27 | France | Acceptable 2025-01-06
|
2025-01-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-07 | France | Acceptable with conditions 2025-06-30
|
2025-06-30 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-19 | France | Acceptable 2025-10-20
|
2025-10-20 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-01-07 | France | Acceptable 2026-01-27
|
2026-01-27 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-04-30 | France | Acceptable 2026-06-02
|
2026-06-02 |