Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
33
Countries
1
Sites
6
metastatic colorectal cancer
Key facts
- Sponsor
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 31 Dec 2020 → ongoing
- Decision date (initial)
- 2024-08-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515580-64-00
- EudraCT number
- 2020-002315-22
- WHO UTN
- U0000-0000-0000
- ClinicalTrials.gov
- NCT00000000
- ISRCTN
- ISRCTN00000000
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
metastatic colorectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10052362 | Metastatic colorectal cancer | 10029104 |
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
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
- S.C. Oncologia medica
Public contact point
- Organisation
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Contact name
- public relations office
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 33 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Azienda Ospedaliero Universitaria Pisana
Oncologia, Via Paradisa 2, 56124, Pisa
Azienda Unita Sanitaria Locale Della Romagna
Oncologia, Viale Stradone 9, 48018, Faenza
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Istituto Oncologico Veneto
Oncologia medica, Via Gattamelata 64, 35128, Padova
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
department of medical and surgical sciences, Largo Francesco Vito 1, 00168, Rome
Azienda Sanitaria Universitaria Friuli Centrale
Oncologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
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 | 2020-12-31 | 2020-12-31 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-05 | Italy | Acceptable 2024-07-17
|
2024-08-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-19 | Italy | Acceptable 2025-03-17
|
2025-04-10 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-23 | Italy | Acceptable 2025-03-17
|
2025-05-23 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-22 | Italy | Acceptable 2025-03-17
|
2025-12-22 |