Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Not authorised
Participants planned
6
Countries
1
Sites
1
metastatic prostate cancer
Key facts
- Sponsor
- Institut De Cancerologie De L Ouest
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-09-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
metastatic prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10001186 | Adenocarcinoma of prostate | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Cancerologie De L Ouest
- Sponsor organisation
- Institut De Cancerologie De L Ouest
- Address
- Bd Du Professeur Jacques Monod
- City
- St Herblain
- Postcode
- 44800
- Country
- France
Scientific contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- Caroline ROUSSEAU
Public contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- Nadia ALLAM
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Not authorised | 6 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Nuclear Medicine, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-13 | France | Not acceptable 2024-09-02
|
2024-09-09 |