Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
40
Countries
3
Sites
4
Platinum Sensitive Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma With Peritoneal Carcinomatosis
Key facts
- Sponsor
- Oncoinvent ASA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Sep 2024 → 8 Sep 2025
- Decision date (initial)
- 2024-09-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511851-16-00
- EudraCT number
- 2018-002802-29
- ClinicalTrials.gov
- NCT03732768
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Platinum Sensitive Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma With Peritoneal Carcinomatosis
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
3 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 10 | 1 |
| Norway | Ended | 18 | 1 |
| Spain | Ended | 12 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Oslo University Hospital HF
Department of Gynaecological cancer, Montebello, Ullernchausséen 70, Oslo
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 | 2024-09-20 | 2025-09-08 | 2024-09-20 | 2024-09-20 | |
| Norway | 2024-09-20 | 2025-09-01 | 2024-09-20 | 2024-09-20 | |
| Spain | 2024-09-20 | 2025-08-26 | 2024-09-20 | 2024-09-20 |
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 2024-09-20
|
2024-09-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-09 | Norway | Acceptable 2024-09-20
|
2025-05-09 |