Clinical trial • Phase III • Oncology

Clinical trial in Metastatic colorectal cancer

Phase III trial for Metastatic colorectal cancer. 240 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic colorectal cancer
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
31-05-2024
First CTIS Authorization Date
08-07-2024

Trial design

Phase III trial across 26 sites in Denmark, Germany, Italy and others.

Target Sample Size
240

Recruitment

Planned Sample Size
240
Recruitment Window Months
84

Geography

Total Number Of Sites
26
Total Number Of Participants
69

Denmark

Earliest CTIS Part Ii Submission Date
11-04-2023
Latest Decision Or Authorization Date
08-07-2024
Processing Time Days
454
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Rigshospitalet
Department Name
Onkologisk afdeling
Contact Person Name
Kristoffer Staal Rohrberg
Site Name
Herlev og Gentofte Hospital
Department Name
Onkologisk afdeling
Contact Person Name
Rikke Løvendahl Eefsen

Germany

Earliest CTIS Part Ii Submission Date
11-04-2023
Latest Decision Or Authorization Date
09-07-2024
Processing Time Days
455
Number Of Sites
8
Number Of Participants
31

Sites

Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin I
Contact Person Name
Thomas J. Ettrich
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Hämatologie und Onkologie
Contact Person Name
Anke Claudia Reinacher-Schick
Contact Person Email
Anke.Reinacher@rub.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik
Contact Person Name
Gunnar Folprecht
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Gastroenterologie Infektologie u. Hepatologie
Contact Person Name
Christoph Roderburg
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Hämatologie, Onkologie, Palliativmedizin und Rheumatologie
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik III
Contact Person Name
Volker Heinemann
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Hämatologie/Onkologie und Tumorimmunologie
Contact Person Name
Dominik Paul Modest
Contact Person Email
dominik.modest@charite.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Innere Medizin III, Schwerpunkt Häma./Onko./Palliativm.
Contact Person Name
Uwe Martens
Contact Person Email
uwe.martens@slk-kliniken.de

Italy

Earliest CTIS Part Ii Submission Date
11-04-2023
Latest Decision Or Authorization Date
12-07-2024
Processing Time Days
458
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Fase 1
Contact Person Name
Gennaro Daniele
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
S.C. Oncologia Falck
Contact Person Name
Salvatore Siena
Site Name
Istituto Oncologico Veneto
Department Name
Oncologia Medica 1
Contact Person Name
Sara Lonardi
Contact Person Email
sara.lonardi@iov.veneto.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Oncologia Medica 1
Contact Person Name
Filippo De Braud
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Oncologia Medica
Contact Person Name
Fortunato Ciardiello
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Alessandro Passardi

Spain

Earliest CTIS Part Ii Submission Date
11-04-2023
Latest Decision Or Authorization Date
11-07-2024
Processing Time Days
457
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncologia
Contact Person Name
Victor Moreno Garcia
Contact Person Email
victor.moreno@startmadrid.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncologia
Contact Person Name
Susana Rosello Keranen
Contact Person Email
srosello@incliva.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncología
Contact Person Name
Ana Ruiz Casado
Contact Person Email
arcasado@salud.madrid.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncologia
Contact Person Name
Elena Elez Fernandez
Contact Person Email
meelez@vhio.net
Site Name
Hospital Universitario Donostia
Department Name
Oncología
Contact Person Name
Aranzazu Bujedo Martínez
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncología
Contact Person Name
Alfonso Yubero Esteban
Contact Person Email
ayuberoe@salud.aragon.es

Poland

Earliest CTIS Part Ii Submission Date
11-04-2023
Latest Decision Or Authorization Date
24-07-2024
Processing Time Days
470
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Onkologii
Contact Person Name
Piotr Wysocki
Contact Person Email
klinikaonkologii@su.krakow.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej
Contact Person Name
Jacek Mackiewicz
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Ośrodek Badań Klinicznych Wczesnych Faz
Contact Person Name
Natalia Cichowska-Cwalińska
Contact Person Email
obkwf@uck.gda.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oddział Badań Wczesnych Faz
Contact Person Name
Iwona Ługowska
Contact Person Email
iwona.lugowska@pib-nio.pl

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

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