Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
49
Countries
4
Sites
9
Advanced solid tumors
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2023-11-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10080676 | Microsatellite instability | 10010331 |
| 22.0 | PT | 10078672 | DNA mismatch repair protein gene mutation | 100000004850 |
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Head of CTRM Clinical Trial Regulatory Management, Product Development Regulatory
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Head of CTRM Clinical Trial Regulatory Management, Product Development Regulatory
Locations
4 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Not authorised | 8 | 1 |
| Denmark | Not authorised | 8 | 1 |
| France | Not authorised | 10 | 2 |
| Spain | Not authorised | 20 | 5 |
| Rest of world
Canada, United Kingdom, United States
|
— | 3 | — |
Investigational sites
Rigshospitalet
Rigshospitalet; Fase 1 Enhed - Onkologi, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Medical Oncology - DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospital Universitari Vall D Hebron
Servicio de Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Clinica Universidad De Navarra
Servicio de Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
Servicio de Oncología, Avenue Pio XII 36, 31008, Pamplona
Hospital Clinico Universitario De Valencia
Servicio de Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Hm Sanchinarro
Servicio de Oncología, Calle Ona 10, 28050, Madrid
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-21 | Denmark | Not acceptable 2023-11-20
|
2023-11-21 |