Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
73
Countries
1
Sites
1
Ovarian cancer
Key facts
- Sponsor
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 18 Sep 2024 → ongoing
- Decision date (initial)
- 2024-05-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-501910-79-01
- WHO UTN
- U0000-0000-0000
- ClinicalTrials.gov
- NCT00000000
- ISRCTN
- ISRCTN00000000
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
Fondazione IRCCS Istituto Nazionale Dei Tumori
- Sponsor organisation
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Address
- Via Giacomo Venezian 1
- City
- Milan
- Postcode
- 20133
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Contact name
- Clinical trial contact point
Public contact point
- Organisation
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Contact name
- public relations office
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 73 | 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 |
|---|---|---|---|---|---|
| Italy | 2024-09-18 | 2024-09-26 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-15 | Italy | Acceptable 2024-05-29
|
2024-05-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-27 | Italy | Acceptable 2024-07-25
|
2024-08-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-14 | Italy | Acceptable 2025-09-25
|
2025-09-26 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-01 | Italy | Acceptable 2025-09-25
|
2025-10-01 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-08 | Italy | Acceptable 2025-09-25
|
2025-10-08 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-11 | Italy | Acceptable 2025-09-25
|
2025-12-11 |