Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
20
Countries
1
Sites
1
Breast cancer
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 May 2026 → ongoing
- Decision date (initial)
- 2025-10-15
- 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
Breast cancer
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
- Anne-Jaël Elskamp
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Anne-Jaël Elskamp
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Amsterdam UMC Stichting
Clinical Pharmacology and Pharmacy, De Boelelaan 1117, 1081 HV, Amsterdam
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 | 2026-05-26 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-10 | Netherlands | Acceptable 2025-10-10
|
2025-10-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-25 | Netherlands | Acceptable 2025-10-10
|
2026-02-25 |