Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
48
Countries
1
Sites
2
Patients with metastatic colorectal cancer
Key facts
- Sponsor
- Centr Georges Francois Leclerc, Centr Georges Francois Leclerc
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 29 Oct 2018 → ongoing
- Decision date (initial)
- 2024-08-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515908-39-00
- EudraCT number
- 2018-001452-36
- ClinicalTrials.gov
- NCT03795311
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with metastatic colorectal cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centr Georges Francois Leclerc
- Sponsor organisation
- Centr Georges Francois Leclerc
- Address
- 1 Rue Professeur Marion
- City
- Dijon
- Postcode
- 21000
- Country
- France
Scientific contact point
- Organisation
- Centr Georges Francois Leclerc
- Contact name
- Dr Jean-David FUMET
Public contact point
- Organisation
- Centr Georges Francois Leclerc
- Contact name
- Sophie Parnalland
Centr Georges Francois Leclerc
- Sponsor organisation
- Centr Georges Francois Leclerc
- Address
- 1 Rue Professeur Marion
- City
- Dijon
- Postcode
- 21000
- Country
- France
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 48 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Centr Georges Francois Leclerc
Oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier William Morey
Oncology, 4 Rue Capitaine Drillien, Cs 80120, Chalon Sur Saone Cedex
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 |
|---|---|---|---|---|---|
| France | 2018-10-29 | 2018-10-29 | 2023-01-16 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-01 | France | Acceptable 2024-08-02
|
2024-08-02 |