Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
162
Countries
1
Sites
8
Metastatic pancreatic adenocarcinoma
Key facts
- Sponsor
- Institut Regional Du Cancer De Montpellier
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Not possible to specify, Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Jan 2022 → ongoing
- Decision date (initial)
- 2024-09-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508594-84-00
- EudraCT number
- 2021-001353-31
- ClinicalTrials.gov
- NCT05065801
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic pancreatic adenocarcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10026314 | Malignant neoplasm of pancreas metastatic | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Regional Du Cancer De Montpellier
- Sponsor organisation
- Institut Regional Du Cancer De Montpellier
- Address
- 208 Avenue Des Apothicaires
- City
- Montpellier Cedex 5
- Postcode
- 34298
- Country
- France
Scientific contact point
- Organisation
- Institut Regional Du Cancer De Montpellier
- Contact name
- Dr Fabienne Portalès
Public contact point
- Organisation
- Institut Regional Du Cancer De Montpellier
- Contact name
- catherine fiess
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 162 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Catalan D'oncologie
Pyrénées-orientales, 80 Rue Pascal Marie Agasse, 66000, Perpignan
Institut Regional Du Cancer De Montpellier
Hérault, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier Universitaire Grenoble Alpes
Isère, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Montpellier
Hérault, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier De Perpignan
Pyrénées-orientales, 20 Avenue Du Languedoc, Cs 49954, Perpignan Cedex
Institut Godinot
Marne, 1 Rue Du General Koenig, 51100, Reims
Centre Hospitalier Universitaire De Saint Etienne
Loire, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Centr Georges Francois Leclerc
Côte d'or, 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 | 2022-01-11 | 2022-01-11 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-19 | France | No conclusion 2024-09-09
|
2024-09-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-23 | France | Acceptable 2025-12-03
|
2025-12-08 |