Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
47
Countries
1
Sites
1
metastatic colon cancer, advanced cancer of the colon
Key facts
- Sponsor
- Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Sep 2019 → 1 Dec 2025
- Decision date (initial)
- 2024-05-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-509457-31-00
- EudraCT number
- 2017-004752-34
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
metastatic colon cancer, advanced cancer of the colon
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. A.D. Bins
Public contact point
- Organisation
- Amsterdam UMC
- Contact name
- Dr. A.D. Bins
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 47 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Stichting Amsterdam UMC
Medical Oncology, 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 | 2019-09-01 | 2025-12-01 | 2019-09-13 | 2023-12-31 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-08 | Netherlands | Acceptable 2024-05-13
|
2024-05-13 |