Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
68
Countries
4
Sites
12
Metastatic pancreatic ductal adenocarcinoma (mPDAC)
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, 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
- 28 Jan 2025 → 19 Jun 2025
- Decision date (initial)
- 2024-08-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508998-85-00
- WHO UTN
- U1111-1300-7624
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic pancreatic ductal adenocarcinoma (mPDAC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10033599 | Pancreatic adenocarcinoma metastatic | 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
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
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
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
4 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 10 | 2 |
| France | Ended | 10 | 3 |
| Germany | Ended | 14 | 4 |
| Spain | Ended | 14 | 3 |
| Rest of world
United States, Japan
|
— | 20 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
NA, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Department of General Medical Oncology, Herestraat 49, 3000, Leuven
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Centre De Lutte Contre Le Cancer Eugene Marquis
Oncologie Médicale, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Institut Gustave Roussy
Département d'Innovation Thérapeutique et des Essais Précoses (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik II, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Heidelberg AöR
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Universitaetsklinikum Essen AöR
Brückeninstitut für Experimentelle Tumortherapie, Hufelandstrasse 55, Holsterhausen, Essen
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Hospital Clinic De Barcelona
Oncología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Ramon Y Cajal
Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
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 | 2025-01-28 | 2025-02-20 | |||
| France | 2025-02-25 | ||||
| Germany | 2025-02-18 | 2025-02-27 | |||
| Spain | 2025-03-14 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-28 | Belgium | Acceptable with conditions 2024-08-05
|
2024-08-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-20 | Belgium | Acceptable with conditions 2024-12-16
|
2024-12-16 |