Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
54
Countries
1
Sites
8
For patients with advanced/metastatic gastric adenocarcinomas in progression
Key facts
- Sponsor
- Hospices Civils De Lyon
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Mar 2021 → ongoing
- Decision date (initial)
- 2024-11-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517816-31-00
- EudraCT number
- 2020-000297-17
- ClinicalTrials.gov
- NCT04739202
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
For patients with advanced/metastatic gastric adenocarcinomas in progression
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10071114 | Metastatic gastric adenocarcinoma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospices Civils De Lyon
- Sponsor organisation
- Hospices Civils De Lyon
- Address
- 3 Quai Des Celestins, Bp 2251 Bp 2251
- City
- Lyon Cedex 02
- Postcode
- 69229
- Country
- France
Scientific contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Pr Benoit YOU
Public contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Pr Benoit YOU
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 54 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Hospices Civils De Lyon
Hépato-Gastroentérologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Bordeaux
Hépato-Gastroentérologie, 66 Avenue De Magellan, 33608, Pessac Cedex
Centre Hospitalier Universitaire De Toulouse
Oncologie médicale digestive, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Hospices Civils De Lyon
Oncologie médicale, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centr Georges Francois Leclerc
Oncologie médicale, 1 Rue Professeur Marion, 21000, Dijon
Assistance Publique Hopitaux De Paris
Hépato-Gastroentérologie, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Regional De Marseille
Hépatogastroentérologie, 264 Rue Saint Pierre, 13005, Marseille
Hospices Civils De Lyon
Hépatogastroentérologie digestive, 5 Place D Arsonval, 69437, Lyon Cedex 03
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 | 2021-03-19 | 2024-11-17 | 2024-11-17 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-08 | France | Acceptable 2024-11-13
|
2024-11-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-28 | France | Acceptable 2026-03-05
|
2026-04-02 |