Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
178
Countries
1
Sites
1
Acute myeloid leukaemia
Key facts
- Sponsor
- Seagen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Jan 2022 → ongoing
- Decision date (initial)
- 2023-09-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506945-42-00
- EudraCT number
- 2019-001917-18
- ClinicalTrials.gov
- NCT04227847
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute myeloid leukaemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10000880 | Acute myeloid leukaemia | 100000004864 |
| 21.1 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Seagen Inc.
- Sponsor organisation
- Seagen Inc.
- Address
- 21823 30th Drive Southeast
- City
- Bothell
- Postcode
- 98021-3907
- Country
- United States
Scientific contact point
- Organisation
- Seagen Inc.
- Contact name
- Seagen Clinical Trial Information
Public contact point
- Organisation
- Seagen Inc.
- Contact name
- Seagen Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 8 | 1 |
| Rest of world
Japan, United States
|
— | 170 | — |
Investigational sites
Universitair Medisch Centrum Utrecht
University Medical Center (UMC) Utrecht Cancer Center, Heidelberglaan 100, 3584 CX, Utrecht
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 |
|---|---|---|---|---|---|
| Netherlands | 2022-01-21 | 2024-02-21 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-21 | Netherlands | Acceptable 2023-09-15
|
2023-09-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-15 | Netherlands | Acceptable 2024-04-25
|
2024-05-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-29 | Netherlands | Acceptable 2024-06-21
|
2024-06-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-30 | Netherlands | Acceptable 2025-06-12
|
2025-06-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-14 | Netherlands | Acceptable | 2025-08-20 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-16 | Netherlands | Acceptable | 2026-01-16 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-24 | Netherlands | Acceptable 2026-03-13
|
2026-03-13 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-01 | Netherlands | Acceptable 2026-03-13
|
2026-04-01 |