Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
230
Countries
1
Sites
9
Patients with solid cancers
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] - Neoplasms [C04]
- Trial duration
- 3 Feb 2020 → ongoing
- Decision date (initial)
- 2024-10-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518069-89-00
- EudraCT number
- 2018-002971-17
- ClinicalTrials.gov
- NCT04169841
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with solid cancers
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
- François GHIRINGHELLI
Public contact point
- Organisation
- Centr Georges Francois Leclerc
- Contact name
- Emilie REDERSTORFF
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 230 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Centr Georges Francois Leclerc
Oncology, 1 Rue Professeur Marion, 21000, Dijon
IHFB Cognacq Jay
Oncology, 4 Rue Kleber, 92300, Levallois-Perret
Institut Bergonie
Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Oscar Lambret
Oncology, 3 Rue Frederic Combemale, 59000, Lille
Centre Hospitalier Universitaire De Dijon
HGE, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Leon Berard
Oncology, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire De Poitiers
Oncology, 2 Rue De La Miletrie, 86000, Poitiers
CHU Besancon
Oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Hospices Civils De Lyon
Oncology, 3 Quai Des Celestins, Bp 2251, Lyon Cedex 02
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 | 2020-02-03 | 2020-02-03 | 2023-06-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | France | Acceptable 2024-10-11
|
2024-10-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-05 | France | Acceptable 2025-12-17
|
2026-01-07 |