Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
62
Countries
2
Sites
4
Neoplasms
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Aug 2019 → 10 Jan 2026
- Decision date (initial)
- 2024-07-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513574-21-00
- EudraCT number
- 2018-001924-20
- ClinicalTrials.gov
- NCT03843359
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Neoplasms
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 28 | 2 |
| Spain | Ended | 34 | 2 |
| Rest of world | — | 0 | — |
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 | 2019-08-09 | 2026-01-09 | 2019-08-09 | 2023-05-16 | |
| Spain | 2019-09-11 | 2025-10-28 | 2019-09-23 | 2023-05-16 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-30 | Spain | Acceptable 2024-06-26
|
2024-06-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-22 | Spain | Acceptable 2025-01-22
|
2025-01-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-13 | Spain | Acceptable 2025-11-22
|
2025-11-28 |