Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
2
metastatic pancreatic cancer
Key facts
- Sponsor
- iOnctura SA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Oct 2024 → 22 Jul 2025
- Decision date (initial)
- 2024-09-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515674-27-00
- EudraCT number
- 2022-000414-33
- ClinicalTrials.gov
- NCT05586516
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
metastatic pancreatic cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
iOnctura SA
- Sponsor organisation
- iOnctura SA
- Address
- Campus Biotech Innovation Park, Avenue De Secheron 15/f2 Avenue De Secheron 15/f2
- City
- Geneva
- Postcode
- 1202
- Country
- Switzerland
Scientific contact point
- Organisation
- iOnctura SA
- Contact name
- Michael Lahn
Public contact point
- Organisation
- iOnctura SA
- Contact name
- Lars van den Veen
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 16 | 2 |
| Rest of world
United Kingdom
|
— | 8 | — |
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 |
|---|---|---|---|---|---|
| Italy | 2024-10-01 | 2024-10-01 | 2025-01-08 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-30 | Italy | Acceptable 2024-09-12
|
2024-09-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-22 | Italy | Acceptable 2025-02-24
|
2025-02-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-04 | Italy | Acceptable 2025-02-24
|
2025-04-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-01 | Italy | Acceptable 2025-02-24
|
2025-07-01 |