Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
40
Countries
1
Sites
1
Active CNS leukemia.
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 May 2023 → 12 Dec 2023
- Decision date (initial)
- 2023-07-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503580-42-00
- EudraCT number
- 2022-003740-27
- WHO UTN
- U1111-1287-5269
- ClinicalTrials.gov
- NCT05038800
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Active CNS leukemia.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10009015 | Chronic myeloid leukemia | 10029104 |
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Mei Chen
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Mei Chen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 15 | 1 |
| Rest of world
Israel, United States
|
— | 25 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Spain | 2023-05-16 | 2023-06-01 | 2023-08-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-29 | Spain | Acceptable 2023-07-05
|
2023-07-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-31 | Spain | Acceptable 2023-11-20
|
2023-11-20 |