Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
60
Countries
3
Sites
7
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Key facts
- Sponsor
- Daiichi Sankyo Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-18
- 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 Castration Resistant Prostate Cancer (mCRPC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Daiichi Sankyo Inc.
- Sponsor organisation
- Daiichi Sankyo Inc.
- Address
- 211 Mount Airy Road
- City
- Basking Ridge
- Postcode
- 07920-2311
- Country
- United States
Scientific contact point
- Organisation
- Daiichi Sankyo Inc.
- Contact name
- Clinical Trial Office
Public contact point
- Organisation
- Daiichi Sankyo Inc.
- Contact name
- Clinical Trial Office
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 4 | 2 |
| Ireland | Authorised, recruiting | 2 | 1 |
| Spain | Authorised, recruiting | 7 | 4 |
| Rest of world
Japan, United States, Australia, China
|
— | 47 | — |
Investigational sites
Centre Leon Berard
Oncology, 28 Rue Laennec, 69008, Lyon
Centre Oscar Lambret
Oncology, 3 Rue Frederic Combemale, 59000, Lille
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital San Pedro
Oncology, Calle Piqueras 98, 26006, Logrono
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 | 2026-05-26 | 2026-05-26 | |||
| Ireland | 2026-04-23 | ||||
| Spain | 2026-05-15 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-05 | Ireland | Acceptable 2026-03-16
|
2026-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-27 | Acceptable | 2026-05-04 |