Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
35
Countries
3
Sites
3
Adult subjects with de novo or treatment-emergent neuroendocrine prostate cancer
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Apr 2021 → 23 Jul 2024
- Decision date (initial)
- 2024-08-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513316-10-00
- EudraCT number
- 2020-003508-15
- WHO UTN
- U1111-1307-9413
- ClinicalTrials.gov
- NCT04702737
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Adult subjects with de novo or treatment-emergent neuroendocrine prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | PT | 10082915 | Neuroendocrine carcinoma of prostate | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1730
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Locations
3 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 5 | 1 |
| France | Ended | 5 | 1 |
| Netherlands | Ended | 1 | 1 |
| Rest of world
Australia, United Kingdom, Japan, United States
|
— | 24 | — |
Investigational sites
Institut Gustave Roussy
Oncology Medicine Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
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 |
|---|---|---|---|---|---|
| Belgium | 2021-04-20 | 2024-07-22 | 2021-05-21 | 2023-05-26 | |
| France | 2021-12-21 | 2024-06-23 | 2022-03-02 | 2023-05-26 | |
| Netherlands | 2021-09-30 | 2024-06-07 | 2022-03-22 | 2023-05-26 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-04 | Belgium | Acceptable with conditions 2024-08-01
|
2024-08-02 |