Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
30
Countries
1
Sites
1
Cervical Cancer
Key facts
- Sponsor
- Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Oct 2024 → 29 May 2026
- Decision date (initial)
- 2024-02-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505968-11-00
- ClinicalTrials.gov
- NCT06095674
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cervical Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10008229 | Cervical cancer | 10029104 |
| 21.1 | LLT | 10008233 | Cervical cancer stage I | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC
- Sponsor organisation
- Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC
- Contact name
- Dr. C.H. Mom
Public contact point
- Organisation
- Amsterdam UMC
- Contact name
- Dr. C.H. Mom
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Amsterdam UMC
Obstetrics & Gynaecology, 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 | 2024-10-15 | 2026-05-29 | 2024-10-15 | 2026-02-04 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-07 | Netherlands | Acceptable 2024-02-19
|
2024-02-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-06 | Netherlands | Acceptable 2024-02-19
|
2025-05-06 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-16 | Netherlands | Acceptable 2024-02-19
|
2025-12-16 |