Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
87
Countries
1
Sites
17
Advanced/metastatic gynecological cancer overexpressing FGFR2b
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
- completed 7 Nov 2025
- Decision date (initial)
- 2025-07-08
- 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
Advanced/metastatic gynecological cancer overexpressing FGFR2b
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
- Pr Ray-Coquard
Public contact point
- Organisation
- Centre Leon Berard
- Contact name
- Project manager
Locations
1 EU/EEA country · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 87 | 17 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Regional Du Cancer De Montpellier
Medical oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Assistance Publique Hopitaux De Paris
Medical oncology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Institut Paoli Calmettes
Medical oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
CHU Besancon
Medical oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Et Universitaire De Limoges
Medical oncology, 2 Avenue Martin Luther King, 87000, Limoges
Centre Oscar Lambret
Medical oncology, 3 Rue Frederic Combemale, 59000, Lille
Centre Jean Perrin
Medical oncology, 58 Rue Montalembert, 63011, Clermont Ferrand Cedex1
Centr Georges Francois Leclerc
Medical oncology, 1 Rue Professeur Marion, 21000, Dijon
Institut Gustave Roussy
Medical oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Oncopole Claudius Regaud
Medical oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Bergonie
Medical oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut De Cancerologie De L Ouest
Medical oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Groupe Hospitalier Diaconesses Croix Saint Simon
Medical oncology, 125 Rue D Avron, 75020, Paris
Institut Curie
Medical oncology, 35 Rue Dailly, 92210, Saint-Cloud
Centre Francois Baclesse
Medical oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Leon Berard
Medical oncology, 28 Rue Laennec, 69008, Lyon
Centre De Lutte Contre Le Cancer Eugene Marquis
Medical oncology, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-09 | France | Acceptable 2025-07-08
|
2025-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-11 | France | Acceptable 2025-09-30
|
2025-09-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-16 | France | Acceptable | 2025-10-28 |