Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
Non small cell lung cancer
Key facts
- Sponsor
- Meander Medical Center
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 7 Nov 2023 → ongoing
- Decision date (initial)
- 2023-08-21
- 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
Non small cell lung cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Meander Medical Center
- Sponsor organisation
- Meander Medical Center
- Address
- P. O. Box 1502
- City
- Amersfoort
- Postcode
- 3800 BM
- Country
- Netherlands
Scientific contact point
- Organisation
- Meander Medical Center
- Contact name
- Judith Herder
Public contact point
- Organisation
- Meander Medical Center
- Contact name
- Department of communication
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Meander Medical Center
Pulmonology, P. O. Box 1502, 3800 BM, Amersfoort
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 | 2023-11-07 | 2023-11-08 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-22 | Netherlands | Acceptable with conditions 2023-08-21
|
2023-08-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-26 | Netherlands | Acceptable 2024-04-25
|
2024-04-25 |