Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
149
Countries
3
Sites
11
Solid Tumor
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Sep 2023 → 13 May 2025
- Decision date (initial)
- 2023-07-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-500930-27-00
- WHO UTN
- U1111-1284-2839
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid Tumor
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Locations
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 16 | 4 |
| Italy | Ended | 12 | 3 |
| Spain | Ended | 20 | 4 |
| Rest of world
Australia, Canada, Argentina, Mexico, Chile, United States
|
— | 101 | — |
Investigational sites
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Curie
Service d’Oncologie médicale 4/Unité d’Investigation Clinique, 26 Rue D Ulm, 75005, Paris
Institut Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Paoli-Calmettes
Hopital de jour médical/Unité d’Evaluation Thérapeutique en Onco-Hématologie (EOTH), 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Istituto Oncologico Veneto
Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, Via Gattamelata 64, 35128, Padova
Humanitas Research Hospital
Operative unit of Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Medical Oncology, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
University Hospital Virgen Del Rocio S.L.
Oncologia Medica, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Ramon Y Cajal
Oncologia Medica, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario 12 De Octubre
Oncologia Medica, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Clinic De Barcelona
ICMHO. Oncologia Medica, Calle Villarroel 170, 08036, 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 | 2023-09-27 | 2023-10-12 | 2024-07-18 | ||
| Italy | 2023-10-12 | 2023-11-07 | 2025-05-12 | ||
| Spain | 2023-09-15 | 2025-05-01 | 2024-09-06 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-16 | Italy | Acceptable 2023-07-10
|
2023-07-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-05 | Italy | Acceptable 2024-03-22
|
2024-03-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-15 | Italy | Acceptable 2024-03-22
|
2024-04-15 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-23 | Italy | Acceptable 2024-03-22
|
2024-09-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-24 | Italy | Acceptable 2024-11-25
|
2024-11-27 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-02-03 | Acceptable 2024-11-25
|
2025-02-03 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-02-06 | Italy | Acceptable 2024-11-25
|
2025-02-06 |