Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
22
Countries
3
Sites
6
Advanced Gastrointestinal Stromal Tumor
Key facts
- Sponsor
- Deciphera Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Jun 2024 → ongoing
- Decision date (initial)
- 2023-08-28
- 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
Advanced Gastrointestinal Stromal Tumor
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10051066 | Gastrointestinal stromal tumour | 100000004864 |
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
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 6 | 1 |
| Netherlands | Ongoing, recruitment ended | 6 | 1 |
| Spain | Ongoing, recruitment ended | 10 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
U.O. Oncologia Medica, Regione Gonzole 10, 10043, Orbassano
Leids Universitair Medisch Centrum (LUMC)
Oncology, Albinusdreef 2, 2333 ZA, Leiden
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Fundacion Instituto Valenciano De Oncologia
Medical Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Fundacion Para La Investigacion Biomedica Hospital Clinico San Carlos
Medical Oncology, Calle Del Profesor Martin Lagos, 28040, Madrid
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| Italy | 2024-06-25 | 2025-02-21 | 2025-06-26 | ||
| Netherlands | 2024-07-29 | 2025-02-13 | 2025-06-26 | ||
| Spain | 2024-07-03 | 2024-07-17 | 2025-06-26 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-17 | Spain | Acceptable 2023-08-22
|
2023-08-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-30 | Spain | Acceptable 2024-02-21
|
2024-02-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-29 | Spain | Acceptable 2025-02-04
|
2025-02-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-02 | Spain | Acceptable 2025-11-13
|
2025-11-17 |