Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
20
Countries
1
Sites
5
Metastatic soft tissue sarcoma
Key facts
- Sponsor
- Oncopole Claudius Regaud
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Dec 2023 → ongoing
- Decision date (initial)
- 2024-08-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515551-38-00
- EudraCT number
- 2022-003754-31
- ClinicalTrials.gov
- NCT05821231
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic soft tissue sarcoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oncopole Claudius Regaud
- Sponsor organisation
- Oncopole Claudius Regaud
- Address
- 1 Avenue Irene Joliot Curie
- City
- Toulouse
- Postcode
- 31100
- Country
- France
Scientific contact point
- Organisation
- Oncopole Claudius Regaud
- Contact name
- Dr Thibaud VALENTIN
Public contact point
- Organisation
- Oncopole Claudius Regaud
- Contact name
- Muriel MOUNIER
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 20 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Regional Du Cancer De Montpellier
Medical oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Oncopole Claudius Regaud
Medical oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Oscar Lambret
Medical oncology, 3 Rue Frederic Combemale, 59000, Lille
Centre Leon Berard
Medical oncology, 28 Rue Laennec, 69008, Lyon
Institut Bergonie
Medical oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
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 | 2023-12-12 | 2023-12-12 | 2025-06-17 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-17 | France | Acceptable 2024-08-09
|
2024-08-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-11 | France | Acceptable 2025-01-13
|
2025-01-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-26 | France | Acceptable 2025-10-07
|
2025-10-07 |