Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
112
Countries
2
Sites
12
Advanced Malignant Tumors
Key facts
- Sponsor
- Bristol Myers Squibb International Corporation, Bristol Myers Squibb International Corporation
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Oct 2022 → 17 Aug 2024
- Decision date (initial)
- 2024-01-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508280-69-00
- EudraCT number
- 2021-006872-17
- WHO UTN
- U1111-1270-3670
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Malignant Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol Myers Squibb International Corporation
- Sponsor organisation
- Bristol Myers Squibb International Corporation
- Address
- Terhulpsesteenweg 185
- City
- Watermaal-Bosvoorde
- Postcode
- 1170
- Country
- Belgium
Scientific contact point
- Organisation
- Bristol Myers Squibb International Corporation
- Contact name
- Head of the GSM-CT
Public contact point
- Organisation
- Bristol Myers Squibb International Corporation
- Contact name
- Head of the GSM-CT
Bristol Myers Squibb International Corporation
- Sponsor organisation
- Bristol Myers Squibb International Corporation
- Address
- Terhulpsesteenweg 185
- City
- Watermaal-Bosvoorde
- Postcode
- 1170
- Country
- Belgium
Locations
2 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 12 | 3 |
| Spain | Ended | 15 | 9 |
| Rest of world
United States, Korea, Republic of, Japan, Argentina
|
— | 85 | — |
Investigational sites
UZ Brussel
Medical Oncology, Laarbeeklaan 101, 1090, Jette
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Clinica Universidad De Navarra
Medical Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Virgen De La Victoria
Medical Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Hm Nou Delfos
Medical Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Hospital Quironsalud Barcelona
Medical Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Clinica Universidad De Navarra
Medical Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, 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 | 2022-12-22 | 2022-12-22 | 2023-12-31 | ||
| Spain | 2022-10-07 | 2022-10-07 | 2023-12-31 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-08 | Belgium | Acceptable 2024-01-08
|
2024-01-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-15 | Belgium | Acceptable 2024-01-08
|
2024-01-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-03-14 | Belgium | Acceptable 2024-01-08
|
2024-03-14 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-03-29 | Belgium | Acceptable 2024-01-08
|
2024-03-29 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-04-25 | Belgium | Acceptable 2024-01-08
|
2024-04-25 |