Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
21
Countries
1
Sites
5
Recurrent or locally advanced retroperitoneal soft tissue sarcoma
Key facts
- Sponsor
- Cebiotex S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Aug 2024 → 28 Nov 2025
- Decision date (initial)
- 2024-08-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516971-34-00
- EudraCT number
- 2018-001026-25
- ClinicalTrials.gov
- NCT04619056
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Recurrent or locally advanced retroperitoneal soft tissue sarcoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10039491 | Sarcoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cebiotex S.L.
- Sponsor organisation
- Cebiotex S.L.
- Address
- Tech Barcelona Pier 07 Entresuelo, Via Laietana 26 Via Laietana 26
- City
- Barcelona
- Postcode
- 08003
- Country
- Spain
Scientific contact point
- Organisation
- Cebiotex S.L.
- Contact name
- Anna Huguet
Public contact point
- Organisation
- Cebiotex S.L.
- Contact name
- MFAR Clinical Research
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 21 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital De La Santa Creu I Sant Pau
Oncology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
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 | 2024-08-20 | 2025-11-28 | 2024-08-20 | 2024-08-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-06 | Spain | Acceptable with conditions 2024-08-20
|
2024-08-20 |