Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
378
Countries
3
Sites
18
Gastroesophageal Junction (GEJ) Adenocarcinoma
Key facts
- Sponsor
- Astellas Pharma Global Development Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Jun 2024 → ongoing
- Decision date (initial)
- 2024-01-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504514-29-00
- ClinicalTrials.gov
- NCT05365581
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Gastroesophageal Junction (GEJ) Adenocarcinoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astellas Pharma Global Development Inc.
- Sponsor organisation
- Astellas Pharma Global Development Inc.
- Address
- 1 Astellas Way
- City
- Northbrook
- Postcode
- 60062-6111
- Country
- United States
Scientific contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- Head of Clinical Trial Unit Regulatory Affairs
Public contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- Head of Clinical Trial Unit Regulatory Affairs
Locations
3 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 43 | 6 |
| Italy | Ongoing, recruiting | 31 | 5 |
| Spain | Ongoing, recruiting | 26 | 7 |
| Rest of world
United States, Korea, Republic of, China, Japan
|
— | 278 | — |
Investigational sites
Institut Paoli-Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Institut De Cancerologie De L Ouest
Medical Oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Centre Hospitalier Universitaire De Poitiers
Gastro-Enterology and Medical Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Institut Universitaire Du Cancer Toulouse-Oncopole
Clinical Research Unit, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Gustave Roussy
Medical Oncology/Phase 1 Depertment, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Centro Ricerche Cliniche Di Verona S.r.l.
UOC Oncologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
European Institute Of Oncology S.r.l.
Division of Early Drug Development, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Oncologico Veneto
UOC Oncology 1, Via Gattamelata 64, 35128, Padova
ASST Grande Ospedale Metropolitano Niguarda
Department of Oncology and Hematology-Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Humanitas Research Hospital
Department of Oncology and Hematology-Oncology, Via Alessandro Manzoni 56, 20089, Rozzano
Hospital Universitari Vall D Hebron
Medical Oncology service, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Hm Nou Delfos
Medical Oncology service, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital General Universitario De Elche
Medical Oncology service, Edificio 2, Camino De La Almazara 11, Elche
Hospital Universitario Miguel Servet
Medical Oncology service, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
University Clinical Hospital Virgen De La Arrixaca
Medical Oncology service, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Institut Catala D'oncologia
Medical Oncology service, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital De La Santa Creu I Sant Pau
Medical Oncology service, Carrer De San Quinti 89, 08041, 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 |
|---|---|---|---|---|---|
| France | 2024-06-18 | 2024-06-18 | |||
| Italy | 2024-08-01 | 2024-08-01 | |||
| Spain | 2025-06-18 | 2025-06-18 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-07 | Italy | Acceptable with conditions 2024-01-24
|
2024-01-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-20 | Italy | Acceptable 2024-04-11
|
2024-04-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-21 | Italy | Acceptable 2024-11-11
|
2024-11-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-17 | Italy | Acceptable | 2025-02-17 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-20 | Acceptable | 2025-03-12 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-01-04 | 2025-03-31 | ||
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-04-16 | Italy | Acceptable 2025-06-16
|
2025-06-17 |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-11-04 | Italy | Acceptable 2026-01-15
|
2026-01-20 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-10 | Italy | Acceptable 2026-01-15
|
2026-02-10 |