Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
137
Countries
4
Sites
11
BRAF-V600 Mutation-Positive Advanced Solid Tumor or BRAF-V600 Mutation-Positive Melanoma with or without Central Nervous System Metastases
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], Health Care [N] - Environment and Public Health [N06]
- Trial duration
- 15 Feb 2022 → 12 Mar 2026
- Decision date (initial)
- 2024-02-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506310-43-00
- EudraCT number
- 2021-003426-77
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
BRAF-V600 Mutation-Positive Advanced Solid Tumor or BRAF-V600 Mutation-Positive Melanoma with or without Central Nervous System Metastases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10027481 | Metastatic melanoma | 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
4 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 12 | 3 |
| Denmark | Ended | 6 | 1 |
| Poland | Ended | 13 | 3 |
| Spain | Ended | 39 | 4 |
| Rest of world
Brazil, Australia, New Zealand, United Kingdom, Switzerland, Canada, United States
|
— | 67 | — |
Investigational sites
Antwerp University Hospital
Medical oncology, Drie Eikenstraat 655, 2650, Edegem
UZ Leuven
General medical oncology, Herestraat 49, 3000, Leuven
UZ Brussel
Medical oncology, Laarbeeklaan 101, 1090, Jette
Herlev Hospital
Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed, Borgmester Ib Juuls Vej 1, 2730, Herlev
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
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej, Ul. Stanislawa Przybyszewskiego 49, 60-355, Poznan
Clinica Universidad De Navarra
Oncologia, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Hm Sanchinarro
Oncologia, Calle Ona 10, 28050, Madrid
Vall D'hebron Institut De Recerca
Oncologia, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Oncologia, Pio XII Etorbidea 36, 31008, Pamplona
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 | 2022-02-15 | 2022-02-21 | 2025-03-31 | ||
| Denmark | 2022-03-08 | 2022-06-01 | 2025-03-31 | ||
| Spain | 2022-03-29 | 2022-05-11 | 2025-03-31 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-20 | Poland | Acceptable 2024-02-08
|
2024-02-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-31 | Poland | Acceptable 2024-02-08
|
2024-05-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-12 | Poland | Acceptable 2024-09-24
|
2024-09-25 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-09 | Poland | Acceptable 2024-09-24
|
2024-10-09 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-03 | Acceptable 2025-12-02
|
2025-12-05 |