Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
493
Countries
1
Sites
4
QT interval prolongation
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 May 2015 → 18 Mar 2025
- Decision date (initial)
- 2023-09-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505006-41-00
- EudraCT number
- 2014-002233-66
- ClinicalTrials.gov
- NCT02264678
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
QT interval prolongation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10028997 | Neoplasm malignant | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- Laura Taylor
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- Laura Taylor
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 100 | 4 |
| Rest of world
Korea, Republic of, United States, United Kingdom
|
— | 393 | — |
Investigational sites
Institut Gustave Roussy
Medical oncology, 39 Rue Camille Desmoulins, 94805, Villejuif Cedex
Institut Bergonie
Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Centre Leon Berard
Medical oncology, 28 Rue Laennec, 69008, Lyon
Institut De Cancerologie De L Ouest
Medical oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
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 | 2015-05-11 | 2025-03-18 | 2015-05-11 | 2024-08-20 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-10 | France | Acceptable 2023-08-31
|
2023-09-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-01 | France | Acceptable 2024-06-10
|
2024-06-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-02 | France | Acceptable 2025-01-31
|
2025-02-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-20 | France | Acceptable 2025-04-16
|
2025-04-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-06 | France | Acceptable 2025-06-26
|
2025-07-01 |