Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
18
Countries
1
Sites
1
Mesothelioma
Key facts
- Sponsor
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Oct 2019 → 24 Oct 2025
- Decision date (initial)
- 2024-08-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508756-19-00
- EudraCT number
- 2018-000500-42
- ClinicalTrials.gov
- NCT03546426
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Mesothelioma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10027406 | Mesothelioma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Sponsor organisation
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Address
- Via Piero Maroncelli 40
- City
- Meldola
- Postcode
- 47014
- Country
- Italy
Scientific contact point
- Organisation
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Contact name
- Laura Ridolfi
Public contact point
- Organisation
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Contact name
- Oriana Nanni
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 18 | 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 | 2019-10-29 | 2019-10-30 | 2024-09-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-10 | Italy | Acceptable 2024-07-24
|
2024-08-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-22 | Italy | Acceptable 2025-10-13
|
2025-10-14 |