Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruitment ended
Participants planned
141
Countries
3
Sites
4
Metastatic castration-resistant prostate cancer (mCRPC)
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
- 26 Nov 2020 → ongoing
- Decision date (initial)
- 2024-05-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508150-26-00
- EudraCT number
- 2019-000137-39
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic castration-resistant prostate cancer (mCRPC)
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 · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 11 | 1 |
| Poland | Ongoing, recruitment ended | 19 | 2 |
| Spain | Ongoing, recruitment ended | 11 | 1 |
| Rest of world
Georgia, United States, Moldova, Republic of, Russian Federation, United Kingdom, Ukraine
|
— | 100 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
medical 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 |
|---|---|---|---|---|---|
| Netherlands | 2020-12-07 | 2020-12-10 | 2021-10-01 | ||
| Poland | 2020-11-26 | 2021-01-11 | 2021-10-01 | ||
| Spain | 2021-02-08 | 2021-02-23 | 2021-10-01 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-28 | Poland | Acceptable 2024-05-06
|
2024-05-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-12 | Poland | Acceptable 2024-10-28
|
2024-10-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-25 | Poland | Acceptable 2025-11-07
|
2025-11-11 |