Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
58
Countries
1
Sites
5
Advanced/ metastatic soft tissue sarcomas
Key facts
- Sponsor
- Centre Leon Berard
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 May 2022 → ongoing
- Decision date (initial)
- 2024-11-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-510706-86-00
- EudraCT number
- 2020-005494-26
- ClinicalTrials.gov
- NCT05180695
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced/ metastatic soft tissue sarcomas
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10075333 | Soft tissue sarcoma | 100000004864 |
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 Jean Yves BLAY
Public contact point
- Organisation
- Centre Leon Berard
- Contact name
- Clinical project manager
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 58 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Oncopole Claudius Regaud
Medical oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Gustave Roussy
Medical oncology, 39 Rue Camille Desmoulins, 94805, Villejuif Cedex
Institut Bergonie
Medical oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Paoli Calmettes
Medical oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Leon Berard
Medical oncology, 28 Rue Laennec, 69008, Lyon
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 | 2022-05-16 | 2022-05-16 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | France | Acceptable 2024-11-05
|
2024-11-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-17 | France | Acceptable 2024-11-05
|
2025-06-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-20 | France | Acceptable 2025-07-17
|
2025-07-24 |