Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
140
Countries
1
Sites
24
Pancreatic well differentiated neuroendocrine tumors (NET)
Key facts
- Sponsor
- Institut Gustave Roussy
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 25 Jun 2018 → ongoing
- Decision date (initial)
- 2024-03-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505286-84-00
- EudraCT number
- 2017-000741-46
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pancreatic well differentiated neuroendocrine tumors (NET)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Gustave Roussy
- Sponsor organisation
- Institut Gustave Roussy
- Address
- 114 Rue Edouard Vaillant
- City
- Villejuif
- Postcode
- 94800
- Country
- France
Locations
1 EU/EEA country · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 140 | 24 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Edouard Herriot
ONCOLOGIE, 5 Place D Arsonval, 69003, Lyon
Centre Hospitalier Universitaire De Dijon
ONCOLOGIE, 14 Rue Paul Gaffarel, 21000, Dijon
Institut Gustave Roussy
ONCOLOGIE, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire D Orleans
ONCOLOGIE, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Centre Hospitalier Universitaire De Caen Normandie
ONCOLOGIE, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Institut Des Neurosciences De La Timone
ONCOLOGIE, 27 Boulevard Jean Moulin, 13005, Marseille
Institut Regional Du Cancer De Montpellier
ONCOLOGIE, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Hopital Saint Antoine
ONCOLOGIE, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Institut De Cancerologie De Lorraine
ONCOLOGIE, 6 Avenue De Bourgogne, 54500, Vandouvre Les Nancy
Centre Hospitalier Universitaire D'Angers
ONCOLOGIE, 4 Rue Larrey, 49100, Angers
Hôpital Européen George Pompidou
ONCOLOGIE, 20 rue Leblanc, 75015, PARIS
Hôpital Haut‐Lévêque
ONCOLOGIE, Av. Magellan, France, Pessac
Hopital Beaujon
ONCOLOGIE, 100 Boulevard Du General Leclerc, 92110, Clichy
Hospital Hotel Dieu
ONCOLOGIE, 1 Place Alexis Ricordeau, 44000, Nantes
IUCT ‐ Hôpital Rangueil
ONCOLOGIE, 1 Avenue J. Poulhès, 50032, Toulouse
ICO ‐ Centre René Gauducheau
ONCOLOGIE, Bd Jaques Monod, 44800, Saint-Herblain
Groupe Hospitalier Diaconesses Croix Saint Simon
ONCOLOGIE, 125 Rue D Avron, 75020, Paris
CHRU Jean Minjoz
ONCOLOGIE, 3 Boulevard Alexandre Fleming, 25030, Besançon
Institut Curie
ONCOLOGIE, 35 Rue Dailly, 92210, Saint-Cloud
Centre Hospitalier Regional Universitaire De Tours
ONCOLOGIE, Avenue De La Republique, 37170, Chambray Les Tours
Centre Hospitalier Universitaire Reims
ONCOLOGIE, Rue Du General Koenig, 51092, Reims Cedex
Centre Antoine Lacassagne
ONCOLOGIE, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre De Lutte Contre Le Cancer Eugene Marquis
ONCOLOGIE, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Groupe Hospitalier Cochin Saint Vincent de Paul
ONCOLOGIE, 27 rue du Faubourg Saint Jacques, 75679 Paris cedex 14, Paris
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 | 2018-06-25 | 2018-06-25 | 2024-03-27 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-01 | France | Acceptable 2024-03-21
|
2024-03-27 |