Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
171
Countries
5
Sites
14
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]
- Trial duration
- 6 Mar 2020 → 3 Oct 2025
- Decision date (initial)
- 2023-12-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503749-76-00
- EudraCT number
- 2019-004022-25
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 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
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
5 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 32 | 2 |
| Denmark | Ended | 12 | 2 |
| Netherlands | Ended | 21 | 2 |
| Poland | Ended | 30 | 2 |
| Spain | Ended | 67 | 6 |
| Rest of world
Canada
|
— | 9 | — |
Investigational sites
Katholieke Universiteit te Leuven
Oncology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Rigshospitalet
Fase I Enheden - Onkologi, Blegdamsvej 9, 2100, Copenhagen Oe
Herlev Hospital
Afdeling for kræftbehandling, Borgmester Ib Juuls Vej 1, 2730, Herlev
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medische oncologie, Plesmanlaan 121, 1066 CX, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Interne Oncologie, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddział Badań Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Clinica Universidad De Navarra
Oncología, Avenue Pio XII 36, 31008, Pamplona
Hospital Clinic De Barcelona
Oncología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Clinica Universidad De Navarra
Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Consorci Mar Parc De Salut De Barcelona
Oncología, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncología, Avenida De Los Reyes Catolicos 2, 28040, 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 |
|---|---|---|---|---|---|
| Belgium | 2020-04-17 | 2025-06-17 | 2020-05-07 | 2024-05-29 | |
| Denmark | 2020-03-06 | 2024-07-29 | 2020-04-23 | 2024-05-29 | |
| Netherlands | 2020-06-25 | 2024-09-19 | 2020-07-09 | 2024-05-29 | |
| Poland | 2020-04-28 | 2024-12-19 | 2020-05-18 | 2024-05-29 | |
| Spain | 2020-04-08 | 2025-10-02 | 2020-05-04 | 2024-05-29 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-14 | Belgium | Acceptable 2023-12-19
|
2023-12-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-22 | Belgium | Acceptable with conditions 2024-05-22
|
2024-05-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-14 | Belgium | Acceptable 2025-01-15
|
2025-01-15 |