Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
9
Metastatic colorectal cancer
Key facts
- Sponsor
- Association Gercor
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Apr 2022 → ongoing
- Decision date (initial)
- 2024-10-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516313-20-00
- EudraCT number
- 2021-005146-15
- ClinicalTrials.gov
- NCT05310643
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic colorectal cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Association Gercor
- Sponsor organisation
- Association Gercor
- Address
- 151 Rue Du Faubourg Saint Antoine
- City
- Paris
- Postcode
- 75011
- Country
- France
Scientific contact point
- Organisation
- Association Gercor
- Contact name
- Marie-line GARCIA LARNICOL
Public contact point
- Organisation
- Association Gercor
- Contact name
- Nelly ROLDAN
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 30 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
CHU Besancon
Oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Institut Regional Du Cancer De Montpellier
Oncology, 208 Avenue Des Apothicaires, 34090, Montpellier
Centre Antoine Lacassagne
Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Hospitalier Et Universitaire De Limoges
Oncology, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire De Lille
Oncology, Rue Michel Polonovski, 59037, Lille Cedex
Institut Bergonie
Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Hopital Saint Antoine
Oncology, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Hospitalier Universitaire De Poitiers
Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Centre De Recherche En Cancerologie De Lyon
Oncology, 28 Rue Laennec, 69008, Lyon
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 | 2022-04-19 | 2022-04-19 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-23 | France | Acceptable 2024-10-07
|
2024-10-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-06 | France | Acceptable 2025-02-06
|
2025-02-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-03 | France | Acceptable 2026-03-09
|
2026-03-13 |