Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
42
Countries
1
Sites
2
- Locally advanced or metastatic solid tumors - Cholangiocarcinoma - Skeletal chondrosarcoma - Low-grade glioma - Any other solid tumor harboring an IDH mutation
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
- 9 Feb 2021 → 28 Feb 2025
- Decision date (initial)
- 2024-09-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516370-30-00
- EudraCT number
- 2020-003729-44
- ClinicalTrials.gov
- NCT04762602
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
- Locally advanced or metastatic solid tumors - Cholangiocarcinoma - Skeletal chondrosarcoma - Low-grade glioma - Any other solid tumor harboring an IDH mutation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 27.0 | PT | 10008593 | Cholangiocarcinoma | 100000004864 |
| 20.0 | PT | 10018338 | Glioma | 100000004864 |
| 21.1 | PT | 10008734 | Chondrosarcoma | 100000004864 |
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
- William Schelman
Public contact point
- Organisation
- Hutchmed Ltd.
- Contact name
- William Schelman
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 24 | 2 |
| Rest of world
United States
|
— | 18 | — |
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 | 2021-02-09 | 2025-02-27 | 2021-03-26 | 2023-08-08 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-02 | Spain | Acceptable with conditions 2024-09-04
|
2024-09-04 |