Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
36
Countries
1
Sites
1
Lymphoma
Key facts
- Sponsor
- Hutchmed Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Sep 2019 → 26 Feb 2025
- Decision date (initial)
- 2024-11-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515123-11-00
- EudraCT number
- 2018-004807-38
- ClinicalTrials.gov
- NCT03779113
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10025632 | Malignant lymphoma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hutchmed Ltd.
- Sponsor organisation
- Hutchmed Ltd.
- Address
- Building 4, 720 Cailun Road, China (Shanghai) Pilot Free Trade Zone 720 Cailun Road China (Shanghai) Pilot Free Trade Zone
- City
- Shanghai
- Postcode
- 201203
- Country
- China
Scientific contact point
- Organisation
- Hutchmed Ltd.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Hutchmed Ltd.
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 14 | 1 |
| Rest of world
United States
|
— | 22 | — |
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 |
|---|---|---|---|---|---|
| Poland | 2019-09-05 | 2019-11-04 | 2023-09-11 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | Poland | Acceptable 2024-11-05
|
2024-11-11 |