Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
48
Countries
1
Sites
3
metastatic clear cell renal cancer with progressive disease after 2 lines of therapy in the advanced/metastatic setting including at least 1 line of anti-VEGFR and 1 line of immunotherapy.
Key facts
- Sponsor
- Centre Leon Berard, Centre Leon Berard
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Nov 2023 → 16 Jul 2025
- Decision date (initial)
- 2023-08-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
metastatic clear cell renal cancer with progressive disease after 2 lines of therapy in the advanced/metastatic setting including at least 1 line of anti-VEGFR and 1 line of immunotherapy.
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
- Dr GIRAUDET Anne-Laure
Public contact point
- Organisation
- Centre Leon Berard
- Contact name
- Dr GIRAUDET Anne-Laure
Centre Leon Berard
- Sponsor organisation
- Centre Leon Berard
- Address
- 28 Rue Laennec
- City
- Lyon
- Postcode
- 69008
- Country
- France
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 48 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Jean Perrin
Nuclear Medicine, 58 Rue Montalembert, 63000, Clermont-Ferrand
Centre Leon Berard
Nuclear Medicine, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire Grenoble Alpes
Nuclear Medicine, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
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 | 2023-11-16 | 2023-11-16 | 2025-02-17 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-26 | France | Acceptable 2023-07-28
|
2023-08-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-22 | France | Acceptable 2023-10-17
|
2023-11-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-30 | France | Acceptable 2024-06-17
|
2024-06-17 |