Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
277
Countries
1
Sites
8
Advanced Malignancies
Key facts
- Sponsor
- Invox Pharma Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Feb 2022 → 23 Jan 2025
- Decision date (initial)
- 2024-07-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514777-22-00
- EudraCT number
- 2021-002820-19
- ClinicalTrials.gov
- NCT04648202
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Invox Pharma Limited
- Sponsor organisation
- Invox Pharma Limited
- Address
- Suite 2, First Floor Westworks, 195 Wood Lane First Floor Westworks 195 Wood Lane
- City
- London
- Postcode
- W12 7FQ
- Country
- United Kingdom
Scientific contact point
- Organisation
- Invox Pharma Limited
- Contact name
- invoX Pharma Clinical Trials
Public contact point
- Organisation
- Invox Pharma Limited
- Contact name
- invoX Pharma Clinical Trials
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 113 | 8 |
| Rest of world
Israel, United States
|
— | 164 | — |
Investigational sites
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Germans Trias I Pujol
Oncology, Carretera Canyet 1a Planta, 08916, Badalona
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 | 2022-02-07 | 2022-03-17 | 2024-08-02 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-16 | Spain | Acceptable with conditions 2024-07-18
|
2024-07-18 |