Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
52
Countries
1
Sites
10
pancreatic ductal adenocarcinoma
Key facts
- Sponsor
- University Hospital Grenoble
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 24 Mar 2023 → 16 Jun 2025
- Decision date (initial)
- 2022-11-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
pancreatic ductal adenocarcinoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Hospital Grenoble
- Sponsor organisation
- University Hospital Grenoble
- Address
- Boulevard De La Chantourne, Cs 10217 La Tronche, La Tronche Cs 10217 La Tronche La Tronche
- City
- Grenoble Cedex 9
- Postcode
- 38043
- Country
- France
Scientific contact point
- Organisation
- University Hospital Grenoble
- Contact name
- Anna BOROWIK
Public contact point
- Organisation
- University Hospital Grenoble
- Contact name
- Anna BOROWIK
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 52 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
hepatogastroenterologie, Avenue De Magellan, 33600, Pessac
Hopital Prive Jean Mermoz
hepatogastroenterologie, 55 Avenue Jean Mermoz, 69008, Lyon
Assistance Publique Hopitaux De Paris
hepatogastroenterologie, 125 Rue De Stalingrad, 93000, Bobigny
Centre Hospitalier Universitaire De Poitiers
hepatogastroenterologie, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Rennes
hepatogastroenterologie, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Centre Hospitalier Universitaire De Reims
hepatogastroenterologie, Rue Du General Koenig, 51092, Reims Cedex
Centre Leon Berard
Medical oncology, 28 Rue Laennec, 69008, Lyon
CHU Lille
oncology, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire Grenoble Alpes
hepatogastroenterologie, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
Centre Hospitalier Universitaire De Saint Etienne
hepatogastroenterologie, Avenue Albert Raimond, 42270, Saint-Priest-En-Jarez
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 | 2023-03-24 | 2025-06-16 | 2023-03-28 | 2024-06-20 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-08-18 | France | Acceptable 2022-11-14
|
2022-11-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-12-22 | France | Acceptable 2023-03-17
|
2023-03-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-06-26 | France | Acceptable 2023-08-23
|
2023-09-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-01 | France | Acceptable 2024-05-06
|
2024-05-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-28 | France | Acceptable 2024-07-31
|
2024-07-31 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-15 | France | Acceptable 2024-12-02
|
2024-12-02 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-11 | France | Acceptable | 2025-04-08 |