Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
8
Countries
1
Sites
1
Advanced non-small cell lung cancer with EGFR and/or HER2 mutations
Key facts
- Sponsor
- Bayer AG, Bayer AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Jan 2024 → 8 May 2024
- Decision date (initial)
- 2023-10-04
- 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
Advanced non-small cell lung cancer with EGFR and/or HER2 mutations
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10071975 | EGFR gene mutation | 100000004850 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.1 | PT | 10077483 | Human epidermal growth factor receptor increased | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- -
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 8 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Clinical research ICON, Van Swietenlaan 6, 9728 NZ, Groningen
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 | 2024-01-24 | 2024-05-08 | 2024-01-25 | 2024-02-05 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-04 | Netherlands | Acceptable with conditions 2023-10-04
|
2023-10-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-30 | Netherlands | Acceptable 2023-11-03
|
2023-11-03 |