Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
2
Sites
5
solid tumour harbouring G12C mutation
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Aug 2021 → 22 Oct 2025
- Decision date (initial)
- 2024-06-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512805-18-00
- EudraCT number
- 2021-000460-29
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
solid tumour harbouring G12C mutation
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 19 | 4 |
| Spain | Ended | 6 | 1 |
| Rest of world
Japan, United States, United Kingdom
|
— | 7 | — |
Investigational sites
UZ Leuven
Digestive Oncology Department, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Route 52 - 1st Floor, Corneel Heymanslaan 10, 9000, Gent
Institut Jules Bordet
Oncology department, Mijlenmeersstraat 90, 1070, Anderlecht
Antwerp University Hospital
Oncology department, Drie Eikenstraat 655, 2650, Edegem
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 |
|---|---|---|---|---|---|
| Belgium | 2021-08-03 | 2025-03-15 | 2021-09-09 | ||
| Spain | 2022-01-11 | 2025-10-22 | 2022-03-28 | 2023-06-20 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-07 | Belgium | Acceptable 2024-06-24
|
2024-06-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-31 | Acceptable 2025-05-13
|
2025-06-13 |