Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
141
Countries
2
Sites
3
Solid tumor
Key facts
- Sponsor
- 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
- 29 Jun 2023 → 27 Feb 2025
- Decision date (initial)
- 2023-06-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501317-31-00
- WHO UTN
- U1111-1281-9541
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
Bristol-Myers Squibb International Corporation
- Sponsor organisation
- Bristol-Myers Squibb International Corporation
- Address
- Chaussee De La Hulpe 185
- City
- Watermael-Boitsfort
- Postcode
- 1170
- Country
- Belgium
Scientific contact point
- Organisation
- Bristol-Myers Squibb International Corporation
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb International Corporation
- Contact name
- GSM-CT
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 4 | 2 |
| Netherlands | Ended | 3 | 1 |
| Rest of world
Chile, Argentina
|
— | 134 | — |
Investigational sites
Universitair Ziekenhuis Gent
Department of Medical Oncology, Corneel Heymanslaan 10, 9000, Gent
Antwerp University Hospital
Department of Oncology, Drie Eikenstraat 655, 2650, Edegem
Clinical Trial Center Maastricht B.V.
Department of Medical Oncology, Oxfordlaan 70, 6229 EV, Maastricht
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 | 2023-06-29 | 2023-07-17 | 2024-03-15 | ||
| Netherlands | 2023-07-10 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-11985
- Halt date
- 2024-01-11
- Member states concerned
- Netherlands
- Publication date
- 2024-01-25
- Reason
- Reprioritisation of trial
- Explanation
- BMS has decided to pause enrolment for this trial. This decision is not due to any emerging safety concerns or change of the benefit/risk relationship, but to the willingness to review and analyse the data accrued so far to make the best decisions for the development of this asset. Participants who are currently receiving study treatment are permitted to continue until protocol-specified criteria for discontinuation are met. Additionally, any participants who are currently in screening, may proceed with screening and treatment initiation if deemed eligible for the study by the Investigator.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-11984
- Member states concerned
- Belgium
- Publication date
- 2024-01-25
- Reason
- Reprioritisation of trial
- Explanation
- BMS has decided to pause enrolment for this trial. This decision is not due to any emerging safety concerns or change of the benefit/risk relationship, but to the willingness to review and analyse the data accrued so far to make the best decisions for the development of this asset. Participants who are currently receiving study treatment are permitted to continue until protocol-specified criteria for discontinuation are met. Additionally, any participants who are currently in screening, may proceed with screening and treatment initiation if deemed eligible for the study by the Investigator.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-17 | Netherlands | Acceptable 2023-06-12
|
2023-06-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-08-07 | Netherlands | Acceptable 2023-09-18
|
2023-09-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-02 | Netherlands | Acceptable 2023-09-18
|
2024-05-02 |