Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
90
Countries
1
Sites
4
Patients with unresectable locally advanced or metastatic pancreatic cancer in first line of chemotherapy
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
- 1 Feb 2024 → ongoing
- Decision date (initial)
- 2023-10-03
- 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
Patients with unresectable locally advanced or metastatic pancreatic cancer in first line of chemotherapy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10033606 | Pancreatic cancer non-resectable | 10029104 |
| 21.1 | LLT | 10033605 | Pancreatic cancer metastatic | 10029104 |
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
- Head of project
Public contact point
- Organisation
- Centr Georges Francois Leclerc
- Contact name
- Head of project
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 90 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Besancon University Hospital Center
Oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Institut Godinot
Oncology, 1 Rue Du General Koenig, 51100, Reims
Centr Georges Francois Leclerc
Oncology, 1 Rue Professeur Marion, 21000, Dijon
Hopital Prive Sainte Marie Chalon
Oncologie, 4 Allee De Saint Jean Des Vignes, 71100, Chalon Sur Saone
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 | 2024-02-01 | 2024-02-12 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-20 | France | Acceptable 2023-10-03
|
2023-10-03 |