Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
40
Countries
1
Sites
1
Metastatic Prostate Cancer
Key facts
- Sponsor
- Arvinas Androgen Receptor Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Jul 2022 → 10 Apr 2025
- Decision date (initial)
- 2024-10-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516661-37-00
- EudraCT number
- 2021-003046-21
- ClinicalTrials.gov
- NCT05177042
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic Prostate Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Arvinas Androgen Receptor Inc.
- Sponsor organisation
- Arvinas Androgen Receptor Inc.
- Address
- 5 Science Park
- City
- New Haven
- Postcode
- 06511-1966
- Country
- United States
Scientific contact point
- Organisation
- Arvinas Androgen Receptor Inc.
- Contact name
- Clinical Trial Information Desk
Public contact point
- Organisation
- Arvinas Androgen Receptor Inc.
- Contact name
- Clinical Trial Information Desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 4 | 1 |
| Rest of world
United Kingdom, Canada, United States
|
— | 36 | — |
Investigational sites
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 | 2022-07-27 | 2024-12-10 | 2022-11-17 | 2023-07-31 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-05 | France | Acceptable 2024-10-29
|
2024-10-29 |