Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
4
Glioblastoma
Key facts
- Sponsor
- Cantex Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 May 2024 → 30 Apr 2026
- Decision date (initial)
- 2024-05-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512954-96-00
- EudraCT number
- 2022-002801-36
- ClinicalTrials.gov
- NCT05635734
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glioblastoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cantex Pharmaceuticals Inc.
- Sponsor organisation
- Cantex Pharmaceuticals Inc.
- Address
- 1792 Bell Tower Lane Suite 222
- City
- Weston
- Postcode
- 33326-3682
- Country
- United States
Scientific contact point
- Organisation
- Cantex Pharmaceuticals Inc.
- Contact name
- A Person designated by the Sponsor
Public contact point
- Organisation
- Cantex Pharmaceuticals Inc.
- Contact name
- A Person designated by the Sponsor
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 32 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Clinic De Barcelona
Onología Médica, Calle Villarroel 170, 08036, Barcelona
Hospital Del Mar
Oncología Médica, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Ramon Y Cajal
Oncología Médica, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, 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 | 2024-05-14 | 2026-04-30 | 2024-05-14 | 2025-05-16 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-06 | Spain | Acceptable 2024-05-14
|
2024-05-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-11 | Spain | Acceptable 2024-11-11
|
2024-11-11 |