Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
113
Countries
6
Sites
9
advanced solid tumors
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Jun 2022 → 6 Feb 2026
- Decision date (initial)
- 2024-08-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511352-41-00
- EudraCT number
- 2019-001173-84
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
advanced solid tumors
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
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
- City
- Barcelona
- Postcode
- 08174
- Country
- Spain
Locations
6 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 14 | 1 |
| France | Ended | 16 | 3 |
| Germany | Ended | 5 | 1 |
| Hungary | Ended | 7 | 1 |
| Netherlands | Ended | 2 | 1 |
| Spain | Ended | 9 | 2 |
| Rest of world
Australia, United States, Japan, Singapore, United Kingdom
|
— | 60 | — |
Investigational sites
Institut Bergonie
Early Phase Trials and Sarcoma Units, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Département d'Innovation Thérapeutique et d’Essais Précoces - DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Goethe University Frankfurt
Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Central Hospital Of Northern Pest Military Hospital
Central Hospital of Northern Pest – Military Hospital, Podmaniczky Utca 109, 1062, Budapest VI
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 | 2022-06-13 | 2025-06-16 | 2022-06-22 | 2024-04-19 | |
| France | 2022-10-12 | 2025-07-03 | 2022-10-26 | 2024-04-19 | |
| Germany | 2023-02-06 | 2025-07-16 | 2023-03-20 | 2024-04-19 | |
| Hungary | 2022-12-09 | 2025-06-17 | 2023-01-24 | 2024-04-19 | |
| Netherlands | 2023-01-09 | 2024-07-24 | 2023-02-23 | 2024-04-19 | |
| Spain | 2022-08-19 | 2025-06-20 | 2022-10-03 | 2024-04-19 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-23 | Belgium | Acceptable with conditions 2024-08-26
|
2024-08-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-09 | Belgium | Acceptable with conditions 2024-08-26
|
2024-12-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-14 | Belgium | Acceptable with conditions 2025-06-03
|
2025-06-03 |