Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
45
Countries
1
Sites
15
Maintenance treatment in patients with locally advanced/metastatic urothelial carcinoma
Key facts
- Sponsor
- Centre Francois Baclesse
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-12-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516182-37-01
- EudraCT number
- 2020-001105-24
- ClinicalTrials.gov
- NCT04678362
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Maintenance treatment in patients with locally advanced/metastatic urothelial carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10046721 | Urothelial carcinoma bladder stage III | 10029104 |
| 21.0 | LLT | 10046722 | Urothelial carcinoma bladder stage IV | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Francois Baclesse
- Sponsor organisation
- Centre Francois Baclesse
- Address
- 3 Avenue Du General Harris, Cs 45026 Cs 45026
- City
- Caen Cedex 5
- Postcode
- 14076
- Country
- France
Scientific contact point
- Organisation
- Centre Francois Baclesse
- Contact name
- GRELLARD Jean-Michel
Public contact point
- Organisation
- Centre Francois Baclesse
- Contact name
- GRELLARD Jean-Michel
Locations
1 EU/EEA country · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 45 | 15 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Francois Baclesse
Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Oncopole Claudius Regaud
Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Hopital Tenon
Oncology, 4 Rue De La Chine, 75970, Paris Cedex 20
Centr Georges Francois Leclerc
Oncology, 1 Rue Professeur Marion, 21000, Dijon
Institut Paoli Calmettes
Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Jean Perrin
Oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand
Hospices Civils De Lyon
Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Leon Berard
Oncology, 28 Rue Laennec, 69008, Lyon
Institut De Cancerologie De L Ouest
Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre De Lutte Contre Le Cancer Eugene Marquis
Oncology, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Groupe Hospitalier Diaconesses Croix Saint Simon
Oncology, 125 Rue D Avron, 75020, Paris
CHU Besancon
Oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Antoine Lacassagne
Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut De Cancerologie De L Ouest
Oncology, 15 Rue Andre Boquel, 49100, Angers
Centre Hospitalier Regional Et Universitaire De Brest
Oncology, 2 Avenue Marechal Foch, 29200, Brest
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-09 | France | Acceptable 2024-09-25
|
2024-12-06 |