Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
1
Countries
1
Sites
1
Advanced solid malignancies
Key facts
- Sponsor
- Astrazeneca AB
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Feb 2007 → ongoing
- Decision date (initial)
- 2022-07-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-500685-10-00
- EudraCT number
- 2006-004497-26
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid malignancies
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astrazeneca AB
- Sponsor organisation
- Astrazeneca AB
- Address
- Kvarnbergagatan 12
- City
- Sodertalje
- Postcode
- 151 36
- Country
- Sweden
Scientific contact point
- Organisation
- Astrazeneca AB
- Contact name
- Clinical Trial Information Center
Public contact point
- Organisation
- Astrazeneca AB
- Contact name
- Clinical Trial Information Center
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 1 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Stichting Radboud University Medical Center
Medische Oncologie, Huispostnr. 452, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
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 |
|---|---|---|---|---|---|
| Netherlands | 2007-02-28 | 2007-03-08 | 2008-01-02 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-07-12 | Netherlands | Acceptable 2022-07-28
|
2022-07-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2022-12-09 | Netherlands | Acceptable 2022-07-28
|
2022-12-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-06 | Netherlands | Acceptable 2022-07-28
|
2024-08-06 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-09-19 | Netherlands | Acceptable 2022-07-28
|
2024-09-19 |