Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
12
Countries
1
Sites
1
Small cell lung carcinoma (SCLC)
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
- 22 Feb 2024 → ongoing
- Decision date (initial)
- 2023-08-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-501818-54-00
- WHO UTN
- U1111-1291-7129
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Small cell lung carcinoma (SCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Amsterdam UMC
Afdeling Geneeskundige Oncologie, De Boelelaan 1117, 1081 HV, Amsterdam
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 | 2024-02-22 | 2024-08-06 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-05 | Netherlands | Acceptable 2023-08-14
|
2023-08-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-16 | Netherlands | Acceptable 2023-08-14
|
2024-01-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-18 | Netherlands | Acceptable 2024-12-05
|
2024-12-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-04 | Netherlands | Acceptable 2026-02-03
|
2026-02-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-26 | Netherlands | Acceptable 2026-05-12
|
2026-05-15 |