Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
55
Countries
1
Sites
5
Ovarian Cancer
Key facts
- Sponsor
- Institut Regional Du Cancer De Montpellier
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-09-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515339-30-00
- EudraCT number
- 2019-003357-29
- ClinicalTrials.gov
- NCT04282356
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ovarian Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10033130 | Ovarian cancer NOS | 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
- Pr Pierre-Emmanuel COLOMBO
Public contact point
- Organisation
- Institut Regional Du Cancer De Montpellier
- Contact name
- Gérald LOSSAINT
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 55 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Regional Du Cancer De Montpellier
Surgery, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nice
Surgery, 151 Route De Saint Antoine, 06200, Nice
Institut Bergonie
Surgery, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Hospices Civils De Lyon
Surgery, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Oncopole Claudius Regaud
Surgery, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-18 | France | Acceptable 2024-09-04
|
2024-09-05 |