Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
114
Countries
2
Sites
4
Locally advanced/metastatic breast or non-small cell lung cancer
Key facts
- Sponsor
- Daiichi Sankyo Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Feb 2020 → ongoing
- Decision date (initial)
- 2024-11-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-509866-39-00
- EudraCT number
- 2018-002489-38
- ClinicalTrials.gov
- NCT04042701
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally advanced/metastatic breast or non-small cell lung cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
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
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 45 | 2 |
| Spain | Ended | 31 | 2 |
| Rest of world
United Kingdom, United States
|
— | 38 | — |
Investigational sites
Centre Hospitalier Regional De Marseille
Centre d’Essais Précoces en Cancérologie de Marseille (CEPCM), 264 Rue Saint Pierre, 13005, Marseille
Oncopole Claudius Regaud
Departement d’oncologie medicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
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 | 2020-02-14 | 2020-04-24 | 2025-01-21 | ||
| Spain | 2020-11-26 | 2026-04-10 | 2021-04-07 | 2025-01-21 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-03 | Spain | Acceptable 2024-10-24
|
2024-10-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-14 | Spain | Acceptable 2025-06-26
|
2025-06-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-06 | Spain | Acceptable 2025-06-26
|
2025-11-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-13 | Spain | Acceptable 2026-05-04
|
2026-05-05 |