Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
51
Countries
6
Sites
12
Extra-pulmonary neuroendocrine carcinoma (epNEC)
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
- 11 Jan 2024 → ongoing
- Decision date (initial)
- 2023-11-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505870-13-00
- WHO UTN
- U1111-1292-1400
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Extra-pulmonary neuroendocrine carcinoma (epNEC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10057270 | Neuroendocrine carcinoma | 100000004864 |
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
6 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 4 | 2 |
| France | Ongoing, recruitment ended | 7 | 2 |
| Germany | Ongoing, recruitment ended | 7 | 2 |
| Netherlands | Ongoing, recruitment ended | 2 | 1 |
| Spain | Ongoing, recruitment ended | 12 | 3 |
| Sweden | Ongoing, recruitment ended | 3 | 2 |
| Rest of world
Japan, United States
|
— | 16 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Medical Oncology, Drie Eikenstraat 655, 2650, Edegem
Institut Paoli-Calmettes
Service d'oncologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Hospices Civils De Lyon
Pneumologie, 59 Boulevard Pinel, 69500, Bron
Universitaetsklinikum Tuebingen AöR
Innere Medizin VIII - Medizinische Onkologie und Pneumologie, Otfried-Mueller-Strasse 14, Nordstadt, Tuebingen
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Universitair Medisch Centrum Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, 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 |
|---|---|---|---|---|---|
| Belgium | 2024-06-07 | 2024-06-19 | 2026-05-20 | ||
| France | 2024-05-29 | 2024-09-30 | 2026-05-20 | ||
| Germany | 2024-03-07 | 2024-10-16 | 2026-05-20 | ||
| Netherlands | 2025-04-08 | 2025-06-03 | 2026-05-20 | ||
| Spain | 2024-01-11 | 2024-01-22 | 2026-05-20 | ||
| Sweden | 2025-04-08 | 2025-04-30 | 2026-05-20 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-28 | Germany | Acceptable 2023-11-17
|
2023-11-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-29 | Germany | Acceptable 2024-04-22
|
2024-04-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-17 | Germany | Acceptable 2024-09-23
|
2024-09-25 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-10-11 | Acceptable 2024-09-23
|
2024-12-13 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-10-11 | Acceptable 2024-09-23
|
2025-01-15 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-13 | Acceptable | 2025-03-28 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-25 | Germany | Acceptable 2025-07-31
|
2025-07-31 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-16 | Germany | Acceptable 2026-01-27
|
2026-01-27 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-18 | Acceptable | 2026-02-23 |