Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
24
Countries
1
Sites
2
Vulvar Cancer
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 4 Feb 2026 → ongoing
- Decision date (initial)
- 2025-08-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Vulvar Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10047741 | Vulval cancer | 100000004864 |
| 28.0 | PT | 10047746 | Vulval cancer stage I | 100000004864 |
| 28.0 | PT | 10047747 | Vulval cancer stage II | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Stijn Mom
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Stijn Mom
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 24 | 2 |
| 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 |
|---|---|---|---|---|---|
| Netherlands | 2026-02-04 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-16 | Netherlands | Acceptable 2025-08-13
|
2025-08-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-16 | Netherlands | Acceptable 2025-08-13
|
2025-12-16 |