Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
70
Countries
1
Sites
1
cancer patients
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Oct 2023 → ongoing
- Decision date (initial)
- 2023-08-17
- 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
cancer patients
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
| 20.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
| 21.1 | PT | 10057529 | Ovarian cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Eugeniavagen 3
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Rimma Axelsson
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Rimma Axelsson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 70 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Sweden | 2023-10-02 | 2023-10-04 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-15 | Sweden | Acceptable 2023-06-01
|
2023-08-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-05 | Sweden | Acceptable 2024-07-10
|
2024-07-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-19 | Sweden | Acceptable 2025-04-10
|
2025-04-10 |