Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
54
Countries
2
Sites
2
Peritoneal carcinomatosis (PC) from colorectal carcinoma
Key facts
- Sponsor
- Oncoinvent ASA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 May 2020 → 23 Apr 2025
- Decision date (initial)
- 2024-09-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511853-23-00
- EudraCT number
- 2018-002803-33
- ClinicalTrials.gov
- NCT03732781
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Peritoneal carcinomatosis (PC) from colorectal carcinoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oncoinvent ASA
- Sponsor organisation
- Oncoinvent ASA
- Address
- Gullhaugveien 7
- City
- Oslo
- Postcode
- 0484
- Country
- Norway
Scientific contact point
- Organisation
- Oncoinvent ASA
- Contact name
- Information Desk
Public contact point
- Organisation
- Oncoinvent ASA
- Contact name
- Information Desk
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ended | 40 | 1 |
| Sweden | Ended | 14 | 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 |
|---|---|---|---|---|---|
| Norway | 2020-05-12 | 2025-05-14 | 2020-05-14 | 2023-11-30 | |
| Sweden | 2020-10-22 | 2025-04-23 | 2020-12-07 | 2023-11-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-29 | Norway | Acceptable 2024-09-23
|
2024-09-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-09 | Norway | Acceptable 2024-09-23
|
2025-05-09 |