Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
30
Countries
1
Sites
3
non-metastatic soft tissue sarcoma
Key facts
- Sponsor
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Jan 2022 → 9 Dec 2025
- Decision date (initial)
- 2024-10-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514907-32-00
- EudraCT number
- 2021-000042-17
- ClinicalTrials.gov
- NCT05116254
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
non-metastatic soft tissue sarcoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Sponsor organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Address
- Plesmanlaan 121
- City
- Amsterdam
- Postcode
- 1066 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Contact name
- Prinicipal Investigator
Public contact point
- Organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Contact name
- Prinicipal Investigator
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 30 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Radboud universitair medisch centrum / RADBOUDUMC
Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Radiotherapy, Plesmanlaan 121, 1066 CX, Amsterdam
Leids Universitair Medisch Centrum (LUMC)
Radiotherapy, Albinusdreef 2, 2333 ZA, Leiden
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 | 2022-01-21 | 2025-12-09 | 2022-07-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-30 | Netherlands | Acceptable 2024-10-24
|
2024-10-24 |