Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
48
Countries
1
Sites
4
Non-small cell lung cancer (NSCLC)
Key facts
- Sponsor
- Instituto Oncologico Dr. Rosell S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Jun 2021 → 4 May 2026
- Decision date (initial)
- 2024-07-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509776-41-00
- EudraCT number
- 2020-005151-20
- ClinicalTrials.gov
- NCT04772235
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-small cell lung cancer (NSCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instituto Oncologico Dr. Rosell S.L.
- Sponsor organisation
- Instituto Oncologico Dr. Rosell S.L.
- Address
- Calle De Sabino Arana Num. 5
- City
- Barcelona
- Postcode
- 08028
- Country
- Spain
Scientific contact point
- Organisation
- Instituto Oncologico Dr. Rosell S.L.
- Contact name
- A person designed by the Sponsor
Public contact point
- Organisation
- Instituto Oncologico Dr. Rosell S.L.
- Contact name
- A person designed by the Sponsor
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 48 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
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 |
|---|---|---|---|---|---|
| Spain | 2021-06-30 | 2026-05-04 | 2022-02-11 | 2025-01-31 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-17 | Spain | Acceptable with conditions 2024-07-23
|
2024-07-23 |