Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
261
Countries
6
Sites
14
Advanced or metastatic 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 Aug 2021 → 14 Nov 2025
- Decision date (initial)
- 2024-09-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511503-41-00
- EudraCT number
- 2017-003210-95
- WHO UTN
- U1111-1305-3046
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or metastatic 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 · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 22 | 2 |
| Denmark | Ended | 9 | 1 |
| Germany | Ended | 29 | 4 |
| Poland | Ended | 20 | 2 |
| Spain | Ended | 24 | 4 |
| Sweden | Ended | 8 | 1 |
| Rest of world
Canada, Israel, Korea, Republic of, United States, Japan
|
— | 149 | — |
Investigational sites
UZ Leuven
Medical Oncology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Unité d'Oncologie Médicale, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Universitaetsklinikum Tuebingen AöR
Abteilung Innere Medizin VIII, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
University Hospital Cologne AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
HELIOS Klinikum Berlin-Buch GmbH
Onkologie und Palliativmedizin, Schwanebecker Chaussee 50, Buch, Berlin
Universitaetsmedizin Goettingen
Klinik für Hämatologie und Medizinische Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
The Early-Phase Clinical Trials Unit, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Med Polonia Sp. z o.o.
Limited liability company, Obornicka 262, 60-693, Poznan
Complexo Hospitalario Universitario De Santiago
Servicio de Oncología Médica, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Oncología Médica, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinic De Barcelona
Clinical Trials Unit, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Servicio de Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 | 2021-08-13 | 2025-06-26 | 2021-08-26 | 2024-09-23 | |
| Denmark | 2023-06-27 | 2025-08-28 | 2023-08-07 | 2024-09-23 | |
| Germany | 2021-08-25 | 2025-07-29 | 2021-11-15 | 2024-09-23 | |
| Poland | 2022-02-22 | 2025-11-13 | 2022-05-09 | 2024-09-23 | |
| Spain | 2021-10-14 | 2025-07-22 | 2022-04-06 | 2024-09-23 | |
| Sweden | 2023-03-07 | 2025-07-29 | 2023-03-21 | 2024-09-23 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-28 | Spain | Acceptable with conditions 2024-09-26
|
2024-09-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-09 | Spain | Acceptable with conditions 2024-09-26
|
2024-12-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-28 | Spain | Acceptable 2025-05-23
|
2025-05-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-17 | Acceptable | 2025-06-20 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-23 | Spain | Acceptable | 2025-07-23 |