Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
50
Countries
3
Sites
8
head and neck squamous cell carcinoma (HNSCC)
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
- 16 Jun 2022 → ongoing
- Decision date (initial)
- 2024-08-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512799-36-00
- EudraCT number
- 2021-003473-59
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
head and neck squamous cell carcinoma (HNSCC)
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
3 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 10 | 3 |
| Romania | Ongoing, recruitment ended | 2 | 2 |
| Spain | Ended | 9 | 3 |
| Rest of world
Japan, Moldova, Republic of, Malaysia, United States, United Kingdom, Thailand, Mexico
|
— | 29 | — |
Investigational sites
Centr Georges Francois Leclerc
Oncologie Médicale, 1 Rue Professeur Marion, 21000, Dijon
Institut Curie
Département Oncologie Médicale, 26 Rue D Ulm, 75005, Paris
Oncopole Claudius Regaud
IUCT-O, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncology, Soseaua Fundeni 252, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department of Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Hospital Universitari Vall D Hebron
Oncology Department, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico San Carlos
Servicio de Oncología Médica, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Institut Catala D'oncologia
Institut Català d'Oncologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| France | 2022-06-16 | 2026-04-27 | 2024-08-21 | 2024-08-21 | |
| Romania | 2023-07-10 | 2024-01-23 | 2024-07-29 | ||
| Spain | 2024-07-23 | 2026-05-11 | 2024-07-23 | 2024-07-23 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-31 | Spain | Acceptable 2024-07-23
|
2024-07-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-30 | Spain | Acceptable 2025-08-01
|
2025-08-01 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-05 | Spain | Acceptable 2025-08-01
|
2025-09-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-10 | Spain | Acceptable | 2025-09-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-22 | Acceptable | 2025-11-21 |