Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
48
Countries
1
Sites
1
Tenosynovial Giant Cell Tumor (TGCT)
Key facts
- Sponsor
- Deciphera Pharmaceuticals Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Dec 2023 → 6 Dec 2025
- Decision date (initial)
- 2023-09-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Tenosynovial Giant Cell Tumor (TGCT)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10018253 | Giant cell tumor of tendon sheath | 10029104 |
| 21.1 | PT | 10010014 | Colony stimulating factor therapy | 100000004865 |
| 21.1 | PT | 10018255 | Giant cell tumour of tendon sheath | 100000004864 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Deciphera Pharmaceuticals Inc.
- Sponsor organisation
- Deciphera Pharmaceuticals Inc.
- Address
- 200 Smith Street
- City
- Waltham
- Postcode
- 02451-0099
- Country
- United States
Scientific contact point
- Organisation
- Deciphera Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Deciphera Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 32 | 1 |
| Rest of world
United States
|
— | 16 | — |
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 |
|---|---|---|---|---|---|
| Hungary | 2023-12-21 | 2025-12-05 | 2023-12-27 | 2025-12-05 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-22 | Hungary | Acceptable 2023-09-13
|
2023-09-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-20 | Hungary | Acceptable 2023-12-11
|
2023-12-20 |