Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
734
Countries
3
Sites
10
Recurrent or metastatic Head and NeckSquamous Cell Carcinoma of the oral cavity,oropharynx, hypopharynx or larynx
Key facts
- Sponsor
- Astrazeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Jul 2023 → ongoing
- Decision date (initial)
- 2023-09-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-501570-18-00
- ClinicalTrials.gov
- NCT05647122
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Recurrent or metastatic Head and NeckSquamous Cell Carcinoma of the oral cavity,oropharynx, hypopharynx or larynx
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10001160 | Adenocarcinoma lung | 10029104 |
| 21.1 | LLT | 10029514 | Non-small cell lung cancer NOS | 10029104 |
| 21.0 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
| 20.0 | LLT | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.0 | PT | 10041826 | Squamous cell carcinoma of lung | 100000004864 |
| 21.0 | PT | 10052358 | Colorectal cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astrazeneca AB
- Sponsor organisation
- Astrazeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- Astrazeneca AB
- Contact name
- Clinical Trial Information Center
Public contact point
- Organisation
- Astrazeneca AB
- Contact name
- Clinical Trial Information Center
Locations
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 38 | 3 |
| Italy | Ongoing, recruitment ended | 60 | 4 |
| Spain | Ongoing, recruitment ended | 47 | 3 |
| Rest of world
Taiwan, China, United States, Korea, Republic of, Canada, Japan, Malaysia, Australia
|
— | 589 | — |
Investigational sites
Centre Hospitalier Regional De Marseille
Centre d'essais en cancérologie de Marseille, 264 Rue Saint Pierre, 13005, Marseille
Institut Gustave Roussy
Department of Medical oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre De Lutte Contre Le Cancer Eugene Marquis
Recherche Clinique en Pneumologie, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
ASST Grande Ospedale Metropolitano Niguarda
Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Oncology, Regione Gonzole 10, 10043, Orbassano
Humanitas Research Hospital
Operative unit of Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Hospital Universitari Vall D Hebron
Servicio de Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
University Hospital Virgen Del Rocio S.L.
Servicio de Oncología, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 | 2023-09-29 | 2023-11-22 | 2026-05-19 | ||
| Italy | 2023-11-29 | 2024-03-19 | 2026-05-19 | ||
| Spain | 2023-07-18 | 2023-11-23 | 2026-05-19 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-28 | Spain | Acceptable 2023-05-05
|
2023-05-17 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2023-05-26 | 2023-09-08 | ||
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2023-05-26 | Acceptable 2023-05-05
|
2023-07-17 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-17 | Spain | Acceptable 2024-02-13
|
2024-02-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-13 | Spain | Acceptable | 2024-04-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-05 | Spain | Acceptable 2024-10-01
|
2024-10-01 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-20 | Spain | Acceptable 2025-02-18
|
2025-02-18 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-04 | Spain | Acceptable 2025-06-03
|
2025-06-03 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-11 | Acceptable 2025-06-03
|
2025-06-11 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-08 | Spain | Acceptable 2025-09-26
|
2025-09-30 |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-09 | Spain | Acceptable 2026-04-17
|
2026-04-21 |