Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
190
Countries
1
Sites
15
Metastatic colorectal cancer patients
Key facts
- Sponsor
- 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
- 27 Sep 2022 → ongoing
- Decision date (initial)
- 2024-11-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517024-20-00
- EudraCT number
- 2022-001400-18
- ClinicalTrials.gov
- NCT05201352
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic colorectal cancer patients
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
- Pr François GHIRINGHELLI
Public contact point
- Organisation
- Centr Georges Francois Leclerc
- Contact name
- Emilie REDERSTORFF
Locations
1 EU/EEA country · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 190 | 15 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Sainte Catherine
Oncology, 250 Chemin De Baigne Pieds, 84000, Avignon
Centre Hospitalier Regional Universitaire De Tours
Hepatogastroenterology and digestive oncology, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Institut Bergonie
Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
CHU Besancon
Oncology, 3 Boulevard Alexandre Fleming, 25000, Besancon
IHFB Cognacq Jay
Oncology, 4 Rue Kleber, 92300, Levallois-Perret
Institut De Cancerologie De L Ouest
Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Universitaire De Nantes
Oncology, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Centre Hospitalier Et Universitaire De Limoges
Oncology, 2 Avenue Martin Luther King, 87000, Limoges
Institut De Cancerologie De L Ouest
Oncology, 15 Rue Andre Boquel, 49100, Angers
CHU d'Estaing
Oncology, 1 place Lucie et Raymond Aubrac, 63100, Clermont-Ferrand
CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
Oncology, 10 Rue Francois Jacob, 22190, Plerin
Centre Hospitalier Universitaire De Poitiers
Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Dijon
Oncology, 14 Rue Paul Gaffarel, 21000, Dijon
Institut Godinot
Oncology, 1 Rue Du General Koenig, 51100, Reims
Centr Georges Francois Leclerc
Oncology, 1 Rue Professeur Marion, 21000, Dijon
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 | 2022-09-27 | 2022-09-27 | 2025-06-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | France | Acceptable 2024-11-22
|
2024-11-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-21 | France | Acceptable 2025-05-16
|
2025-05-16 |