Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
17
Countries
1
Sites
1
High grade serous ovarian cancer
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Sep 2024 → 23 Dec 2025
- Decision date (initial)
- 2024-09-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516781-10-00
- EudraCT number
- 2020-003600-13
- ClinicalTrials.gov
- NCT04739527
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
High grade serous ovarian cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- H.W. Nijman
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- H.W. Nijman
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 17 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Groningen
Obstetrics and gynecology, Hanzeplein 1, 9713 GZ, Groningen
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 | 2024-09-16 | 2025-12-23 | 2024-09-16 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-19 | Netherlands | Acceptable with conditions 2024-09-16
|
2024-09-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-17 | Netherlands | Acceptable 2024-10-30
|
2024-10-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-13 | Netherlands | Acceptable 2024-11-19
|
2024-11-19 |