Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
45
Countries
1
Sites
1
Patients with advanced, irresectable peritoneal metastases (PM) originating from gastrointestinal (GI) cancer (colorectal, small bowel, appendix, stomach, pancreatic, cholangiocarcinoma)
Key facts
- Sponsor
- Universitair Ziekenhuis Gent
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Nov 2022 → ongoing
- Decision date (initial)
- 2023-12-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509135-17-00
- EudraCT number
- 2021-006266-20
- ClinicalTrials.gov
- NCT05277766
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with advanced, irresectable peritoneal metastases (PM) originating from gastrointestinal (GI) cancer (colorectal, small bowel, appendix, stomach, pancreatic, cholangiocarcinoma)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Ziekenhuis Gent
- Sponsor organisation
- Universitair Ziekenhuis Gent
- Address
- Corneel Heymanslaan 10
- City
- Gent
- Postcode
- 9000
- Country
- Belgium
Scientific contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Wim Ceelen
Public contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- HIRUZ CTU
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 45 | 1 |
| 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 |
|---|---|---|---|---|---|
| Belgium | 2022-11-18 | 2022-11-21 | 2026-05-06 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-17 | Belgium | Acceptable 2023-12-01
|
2023-12-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-13 | Belgium | Acceptable 2023-12-01
|
2025-06-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-13 | Belgium | Acceptable 2023-12-01
|
2025-06-13 |