Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
309
Countries
5
Sites
26
Metastatic Colorectal Cancer
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
- 1 Oct 2021 → ongoing
- Decision date (initial)
- 2024-07-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505163-37-00
- EudraCT number
- 2021-001207-33
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic Colorectal Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10052362 | Metastatic colorectal cancer | 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 · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 3 | 2 |
| Germany | Ongoing, recruiting | 31 | 8 |
| Italy | Ongoing, recruiting | 20 | 6 |
| Poland | Ongoing, recruiting | 3 | 4 |
| Spain | Ongoing, recruiting | 12 | 6 |
| Rest of world
Korea, Republic of, Australia, United States, Canada, Taiwan, United Kingdom
|
— | 240 | — |
Investigational sites
Rigshospitalet
Onkologisk afdeling, Blegdamsvej 9, 2100, Copenhagen Oe
Herlev og Gentofte Hospital
Onkologisk afdeling, Borgmester Ib Juuls Vej 1, 2730, Herlev
Charite Universitaetsmedizin Berlin KöR
Hämatologie/Onkologie und Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
Katholisches Klinikum Bochum gGmbH
Hämatologie und Onkologie, Gudrunstrasse 56, Grumme, Bochum
Universitaetsklinikum Duesseldorf AöR
Klinik für Gastroenterologie Infektologie u. Hepatologie, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin I, Albert-Einstein-Allee 23, Eselsberg, Ulm
Asklepios Kliniken Hamburg GmbH
Hämatologie, Onkologie, Palliativmedizin und Rheumatologie, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
SLK-Kliniken Heilbronn GmbH
Innere Medizin III, Schwerpunkt Häma./Onko./Palliativm., Am Gesundbrunnen 20-26, Neckargartach, Heilbronn
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Oncologia Medica, Via Sergio Pansini 5, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Fase 1, Largo Francesco Vito 1, 00168, Rome
ASST Grande Ospedale Metropolitano Niguarda
S.C. Oncologia Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Istituto Oncologico Veneto
Oncologia Medica 1, Via Gattamelata 64, 35128, Padova
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddział Badań Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Onkologii, Ul. Mikolaja Kopernika 50, 31-501, Cracow
Hospital Universitari Vall D Hebron
Oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinico Universitario De Valencia
Oncologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Puerta De Hierro De Majadahonda
Oncología, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Clinico Universitario Lozano Blesa
Oncología, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Donostia
Oncología, Pasealeku Doct. Begiristain 109, 20014, Donostia
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 |
|---|---|---|---|---|---|
| Denmark | 2023-12-01 | 2023-12-08 | |||
| Germany | 2025-06-17 | 2025-06-17 | |||
| Italy | 2021-10-01 | 2021-10-06 | |||
| Poland | 2023-09-11 | 2023-12-04 | |||
| Spain | 2021-10-19 | 2021-12-09 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-31 | Denmark | Acceptable 2024-07-07
|
2024-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-22 | Denmark | Acceptable 2024-10-31
|
2024-10-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-25 | Denmark | Acceptable 2025-02-26
|
2025-02-26 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-02 | Denmark | Acceptable 2025-02-26
|
2025-04-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-09 | Denmark | Acceptable | 2025-05-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-26 | Denmark | Acceptable 2025-07-31
|
2025-07-31 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-21 | Denmark | Acceptable 2026-02-03
|
2026-02-04 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-19 | Denmark | Acceptable 2026-05-19
|
2026-05-19 |