Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
88
Countries
1
Sites
1
Ovarian cancer
Key facts
- Sponsor
- Kancera AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Oct 2023 → ongoing
- Decision date (initial)
- 2023-10-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ovarian cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kancera AB
- Sponsor organisation
- Kancera AB
- Address
- Banvaktsvagen 22
- City
- Solna
- Postcode
- 171 48
- Country
- Sweden
Scientific contact point
- Organisation
- Kancera AB
- Contact name
- Thomas Olin
Public contact point
- Organisation
- Kancera AB
- Contact name
- Thomas Olin
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 88 | 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 |
|---|---|---|---|---|---|
| Finland | 2023-10-30 | 2024-04-08 | 2023-11-01 | 2024-04-08 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-18 | Finland | Acceptable 2023-09-29
|
2023-10-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-10-30 | Finland | Acceptable 2023-09-29
|
2023-10-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-11-10 | Acceptable 2023-09-29
|
||
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2023-11-28 | Finland | Acceptable 2023-09-29
|
2023-11-28 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2024-02-07 | Finland | Acceptable 2023-09-29
|
2024-02-07 |