Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
40
Countries
2
Sites
10
Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Key facts
- Sponsor
- Merck Healthcare KGaA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Jan 2024 → 21 Aug 2024
- Decision date (initial)
- 2023-11-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Healthcare KGaA
- Sponsor organisation
- Merck Healthcare KGaA
- Address
- Frankfurter Strasse 250
- City
- Darmstadt
- Postcode
- 64293
- Country
- Germany
Scientific contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Public contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Locations
2 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 6 | 5 |
| Spain | Ended | 6 | 5 |
| Rest of world
Korea, Republic of, United States, Taiwan, Israel
|
— | 28 | — |
Investigational sites
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Medical Oncologist, Corneel Heymanslaan 10, 9000, Gent
Algemeen Ziekenhuis Groeninge
Medical Oncology, President Kennedylaan 4, 8500, Kortrijk
Vitaz
Medical Oncology, Moerlandstraat 1, 9100, Sint-Niklaas
Hopital De Libramont
Oncology, Avenue De Houffalize 35, 6800, Libramont-Chevigny
Institut Catala D'oncologia
Oncology, Avinguda De Franca S/n, 17007, Girona
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Lucus Augusti
Oncology, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, 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 | 2024-01-18 | 2024-02-26 | 2024-06-24 | ||
| Spain | 2024-02-26 | 2024-02-26 | 2024-06-24 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-10 | Belgium | Acceptable 2023-11-27
|
2023-11-27 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2023-12-11 | Acceptable 2023-11-27
|
2024-02-02 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-21 | Belgium | Acceptable 2024-05-13
|
2024-05-17 |