Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
72
Countries
1
Sites
4
advanced and metastatic
Key facts
- Sponsor
- Centre Leon Berard
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Apr 2016 → ongoing
- Decision date (initial)
- 2024-11-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516725-31-00
- EudraCT number
- 2015-002412-32
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
advanced and metastatic
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Leon Berard
- Sponsor organisation
- Centre Leon Berard
- Address
- 28 Rue Laennec
- City
- Lyon
- Postcode
- 69008
- Country
- France
Scientific contact point
- Organisation
- Centre Leon Berard
- Contact name
- Pierre Etienne HEUDEL
Public contact point
- Organisation
- Centre Leon Berard
- Contact name
- Project Manager
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 72 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Oscar Lambret
Medical Oncology, 3 Rue Frederic Combemale, 59000, Lille
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
CHU Besancon
Medical Oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
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 | 2016-04-14 | 2016-04-14 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | France | Acceptable 2024-11-22
|
2024-11-27 |