Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
Status: Recruiting
Location: See all (264) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
• Central laboratory detection of KRAS p.G12C mutation.
• Measurable metastatic disease per RECIST v1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
• Adequate organ function.
Locations
United States
Arizona
Ironwood Cancer and Research Centers Scottsdale
RECRUITING
Chandler
California
Providence Saint Jude Medical Center
RECRUITING
Fullerton
City of Hope National Medical Center
RECRUITING
Long Beach
Cancer and Blood Research Center, LLC
RECRUITING
Los Alamitos
California Research Institute
RECRUITING
Los Angeles
Connecticut
Norwalk Hospital
RECRUITING
Norwalk
Florida
Cancer Specialists of North Florida
RECRUITING
Jacksonville
D and H Cancer Research Center
RECRUITING
Margate
Mid Florida Hematology and Oncology Centers PA
RECRUITING
Orange City
Boca Raton Clinical Research Medical Center Inc
RECRUITING
Plantation
Georgia
Georgia Cancer Specialists
RECRUITING
Atlanta
Illinois
Insight Research Institute
RECRUITING
Chicago
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Orchard Healthcare Research Inc
RECRUITING
Skokie
Kentucky
Pikeville Medical Center
RECRUITING
Pikeville
Michigan
Henry Ford Health System
RECRUITING
Detroit
Cancer and Hematology Centers of Western Michigan
RECRUITING
Grand Rapids
Missouri
Saint Louis Cancer Care West County
RECRUITING
Bridgeton
North Carolina
Duke Cancer Center
RECRUITING
Durham
FirstHealth Cancer Center
RECRUITING
Pinehurst
New Jersey
Minniti Center for Medical Oncology and Hematology
RECRUITING
Mickleton
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
South Carolina
Carolina Blood and Cancer Care
COMPLETED
Rock Hill
Tennessee
Tennessee Oncology PLLC
RECRUITING
Nashville
Tennessee Oncology PLLC - Chattanooga
RECRUITING
Nashville
Vanderbilt University Medical Center
RECRUITING
Nashville
Other Locations
Argentina
Hospital Britanico de Buenos Aires
RECRUITING
Buenos Aires
Hospital Universitario Fundacion Favaloro
RECRUITING
Caba
Instituto Argentino de Diagnóstico y Tratamiento
RECRUITING
Caba
Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL
RECRUITING
Caba
Cemic
RECRUITING
Ciudad Autonoma De Buenos Aires
Clinica Universitaria Privada Reina Fabiola
RECRUITING
Córdoba
Hospital Italiano de Córdoba
RECRUITING
Córdoba
Sanatorio Allende
RECRUITING
Córdoba
Sanatorio Británico de Rosario
RECRUITING
La Plata
Centro Oncologico Riojano Integral
RECRUITING
La Rioja
Instituto de Investigaciones clinicas de Mar del Plata
RECRUITING
Mar Del Plata
Exelsus Oncologia Clinica
RECRUITING
San Miguel De Tucumán
Clinica Viedma
RECRUITING
Viedma
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
Chris OBrien Lifehouse
RECRUITING
Camperdown
Austin Health, Austin Hospital
RECRUITING
Heidelberg
Toowoomba Hospital
RECRUITING
Toowoomba
The Queen Elizabeth Hospital
RECRUITING
Woodville South
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Medizinische Universitaet Graz
RECRUITING
Graz
Ordensklinikum Linz Barmherzige Schwestern
RECRUITING
Linz
Landeskrankenhaus Feldkirch
RECRUITING
Rankweil
Universitaetsklinikum Allgemeines Krankenhaus Wien
RECRUITING
Vienna
Belgium
Institut Jules Bordet
RECRUITING
Brussels
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
RECRUITING
Brussels
Grand Hôpital de Charleroi - Site des Viviers
RECRUITING
Charleroi
Universitair Ziekenhuis Gent
RECRUITING
Ghent
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
RECRUITING
Leuven
Algemeen Ziekenhuis Sint-Maarten
RECRUITING
Mechelen
AZ Delta Campus Rumbeke
RECRUITING
Roeselare
Vitaz campus Sint-Niklaas Moerland
RECRUITING
Sint-niklaas
Brazil
Fundacao Pio Xii Barretos
RECRUITING
Barretos
Oncoclinicas Belo Horizonte
RECRUITING
Barretos
Hospital Sirio Libanes
RECRUITING
Brasília
Hospital Evangelico de Cachoeiro de Itapemirim
RECRUITING
Cachoeiro De Itapemirim
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
RECRUITING
Ijuí
Clinica de Neoplasias Litoral
RECRUITING
Itajaí
Liga Norte-Riograndense Contra O Cancer
RECRUITING
Natal
Associação Hospitalar Moinhos de Vento
RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericordia de Porto Alegre
RECRUITING
Porto Alegre
Oncoclinicas Rio de Janeiro S A
RECRUITING
Rio De Janeiro
Hospital de Base de Sao Jose do Rio Preto
RECRUITING
São José Do Rio Preto
Fundacao Antonio Prudente AC Camargo Cancer Center
RECRUITING
São Paulo
Instituto Brasileiro de Controle do Cancer Ibcc
RECRUITING
São Paulo
Instituto Cancer Sao Paulo Icesp
RECRUITING
São Paulo
Oncologia Rede D Or
RECRUITING
São Paulo
Vencer e Oncoclinica
RECRUITING
Teresina
Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
RECRUITING
Haskovo
Complex Oncology Center Plovdiv EOOD
RECRUITING
Plovdiv
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
RECRUITING
Plovdiv
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
RECRUITING
Sofia
Multiprofile Hospital for Active Treatment Serdika EOOD
RECRUITING
Sofia
Canada
Allan Blair Cancer Centre
RECRUITING
Regina
Saskatoon Cancer Centre
RECRUITING
Saskatoon
Chile
Enroll SpA
RECRUITING
Providencia
Biocinetic servicios medicos limitada
RECRUITING
Santiago
Centro de oncologia de precision Spa
RECRUITING
Santiago
Fundacion Arturo Lopez Perez
RECRUITING
Santiago
Centro de investigacion y desarrollo oncolgico Spa
RECRUITING
Temuco
James Lind Centro de Investigacion del Cancer
RECRUITING
Temuco
Clinical Research Chile SpA
RECRUITING
Valdivia
Clinica Redsalud Vitacura, Instituto del Cancer
RECRUITING
Vitacura
Colombia
Instituto Nacional de Cancerologia
RECRUITING
Bogota
Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
RECRUITING
Bogotá
Fundacion Oftalmologica de Santander - Foscal
RECRUITING
Floridablanca
Servicios de Salud Ips Suramericana Sas - Ips Sura Industriales
RECRUITING
Medellín
Instituto Medico de Alta Tecnologia sas - Imat sas
RECRUITING
Montería
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
RECRUITING
Rionegro
Denmark
Aalborg Sygehus
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus N
Rigshospitalet
RECRUITING
Copenhagen
Odense University Hospital
RECRUITING
Odense C
Estonia
North Estonia Medical Centre Foundation
RECRUITING
Tallinn
France
Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing
RECRUITING
Clermont-ferrand
Hopital Henri Mondor
RECRUITING
Créteil
Centre Hospitalier Universitaire de Dijon - Hopital du Bocage
RECRUITING
Dijon
Hopital Prive Jean Mermoz
RECRUITING
Lyon
Institut regional du Cancer Montpellier
RECRUITING
Montpellier
Centre Antoine Lacassagne
RECRUITING
Nice
Hopital Europeen Georges Pompidou
RECRUITING
Paris
Hopital Pitie-Salpetriere
RECRUITING
Paris
Hopital Saint Louis
RECRUITING
Paris
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
RECRUITING
Pessac
Centre Hospitalier Universitaire de Poitiers
RECRUITING
Poitiers
Hopital Robert Debre
RECRUITING
Reims
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
RECRUITING
Rennes
Institut de Cancerologie de l Ouest Rene Gauducheau
RECRUITING
Saint-herblain
Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord
RECRUITING
Saint-priest-en-jarez
Institut de Cancerologie de Lorraine - Alexis Vautrin
RECRUITING
Vandœuvre-lès-nancy
Germany
Charite - Universitaetsmedizin Berlin, Campus Virchow
RECRUITING
Berlin
Klinikum Chemnitz gGmbH
RECRUITING
Chemnitz
Universitaetsklinikum Dresden
RECRUITING
Dresden
Universitaetsklinikum Essen
RECRUITING
Essen
UCT Universitaeres Zentrum fuer Tumorerkrankungen Frankfurt
RECRUITING
Frankfurt Am Main
Haematologisch Onkologische Praxis Eppendorf
RECRUITING
Hamburg
Regional Kliniken Holding Klinikum Ludwigsburg
RECRUITING
Ludwigsburg
Klinikum der LMU Muenchen
RECRUITING
München
Universitaetsklinikum Ulm
RECRUITING
Ulm
Klinikum der Stadt Wolfsburg
RECRUITING
Wolfsburg
Greece
Agios Savvas Anticancer Hospital
RECRUITING
Athens
Aretaieio Hospital
RECRUITING
Athens
General Hospital Evangelismos
RECRUITING
Athens
Hygeia Hospital
RECRUITING
Athens
Metropolitan Hospital
RECRUITING
Athens
University Hospital of Larissa
RECRUITING
Larissa
Metaxa Anticancer Hospital
RECRUITING
Piraeus
Agios Loukas Clinic
RECRUITING
Thessaloniki
Bioclinic of Thessaloniki
RECRUITING
Thessaloniki
European Interbalkan Medical Center
RECRUITING
Thessaloniki
Saint Lukes Hospital SA
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital, The University of Hong Kong
RECRUITING
Hong Kong
Princess Margaret Hospital
RECRUITING
Kowloon
Tuen Mun Hospital
RECRUITING
New Territories
Hungary
Orszagos Onkologiai Intezet
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
RECRUITING
Gyula
Somogy Varmegyei Kaposi Mor Oktato Korhaz
RECRUITING
Kaposvár
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
RECRUITING
Nyíregyháza
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
RECRUITING
Szolnok
Italy
Istituto Ospedaliero Fondazione Poliambulanza
RECRUITING
Brescia
Ente Ospedaliero IRCCS Saverio De Bellis
RECRUITING
Castellana Grotte
Azienda Ospedaliero Universitaria Careggi
RECRUITING
Florence
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
RECRUITING
Foggia
Ospedale Policlinico San Martino IRCCS
RECRUITING
Genova
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
RECRUITING
Meldola Fc
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
RECRUITING
Napoli
Istituto Oncologico Veneto IRCCS
RECRUITING
Padua
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
RECRUITING
Palermo
Azienda Sanitaria Territoriale Pesaro Urbino - Presidio San Salvatore Muraglia
RECRUITING
Pesaro
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Azienda Unità Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna
RECRUITING
Ravenna
IRCCS Istituto Clinico Humanitas
RECRUITING
Rozzano Mi
Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo Fg
Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
RECRUITING
Udine
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
RECRUITING
Verona
Japan
Hyogo Cancer Center
RECRUITING
Akashi-shi
Chiba Cancer Center
RECRUITING
Chiba
National Cancer Center Hospital
RECRUITING
Chuo-ku
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Kansai Medical University Hospital
RECRUITING
Hirakata-shi
National Cancer Center Hospital East
RECRUITING
Kashiwa-shi
St Marianna University Hospital
RECRUITING
Kawasaki-shi
Saitama Cancer Center
RECRUITING
Kitaadachi-gun
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
RECRUITING
Koto-ku
National Hospital Organization Shikoku Cancer Center
RECRUITING
Matsuyama
Aichi Cancer Center
RECRUITING
Nagoya
Niigata Cancer Center Hospital
RECRUITING
Niigata
National Hospital Organization Osaka National Hospital
RECRUITING
Osaka
Hokkaido University Hospital
RECRUITING
Sapporo
The University of Osaka Hospital
RECRUITING
Suita-shi
Shizuoka Cancer Center
RECRUITING
Sunto-gun
Tokushima University Hospital
RECRUITING
Tokushima
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
RECRUITING
Yokohama
Yokohama City University Medical Center
RECRUITING
Yokohama
Mexico
Centro Especializado en Investigacion y Tratamiento Oncologicos SC
RECRUITING
Benito Juárez
Health Pharma Professional Research SA de CV
RECRUITING
Mexico City
Hospital Universitario Dr Jose Eleuterio Gonzalez
RECRUITING
Monterrey
Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Medisch Spectrum Twente
RECRUITING
Enschede
Maastricht Universitair Medisch Centrum
RECRUITING
Maastricht
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Poland
Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia
RECRUITING
Gdynia
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
RECRUITING
Kielce
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
RECRUITING
Lodz
SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu
RECRUITING
Opole
Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie
RECRUITING
Poznan
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
RECRUITING
Warsaw
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Portugal
Unidade Local de Saude de Almada-Seixal, EPE - Hospital Garcia de Orta
RECRUITING
Almada
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
RECRUITING
Coimbra
Unidade Local de Saude de Coimbra, EPE
RECRUITING
Coimbra
Fundacao Champalimaud
RECRUITING
Lisbon
Hospital Cuf Tejo
RECRUITING
Lisbon
Hospital da Luz, SA
RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
RECRUITING
Lisbon
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
RECRUITING
Matosinhos Municipality
Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao
RECRUITING
Santa Maria Da Feira
Republic of Korea
National Cancer Center
RECRUITING
Goyang-si, Gyeonggi-do
Asan Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea Seoul St Marys Hospital
RECRUITING
Seoul
Romania
Institutul Clinic Fundeni
RECRUITING
Bucharest
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
RECRUITING
Bucharest
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
RECRUITING
Cluj-napoca
Centrul de Oncologie Sf Nectarie SRL
RECRUITING
Craiova
Institutul Regional de Oncologie Iasi
RECRUITING
Iași
Spitalul Municipal Ploiesti
RECRUITING
Ploieşti
SC Oncomed SRL
RECRUITING
Timișoara
Spain
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Universitario de Burgos
RECRUITING
Burgos
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital General Universitario de Elche
RECRUITING
Elche
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Complexo Hospitalario Universitario de Ourense
RECRUITING
Ourense
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Hospital General Universitario de Valencia
RECRUITING
Valencia
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Sweden
Soedersjukhuset
RECRUITING
Stockholm
Switzerland
Universitaetsspital Zuerich
RECRUITING
Zurich
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
Taipei Veterans General Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
RECRUITING
Taoyuan District
Thailand
Siriraj Hospital
RECRUITING
Bangkok
Turkey
Adana Sehir Egitim ve Arastirma Hastanesi
RECRUITING
Adana
Ankara Bilkent Sehir Hastanesi
RECRUITING
Ankara
Ankara Universitesi Tip Fakultesi Hastanesi
RECRUITING
Ankara
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
RECRUITING
Ankara
Hacettepe Universitesi Tip Fakultesi Hastanesi
RECRUITING
Ankara
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
RECRUITING
Edirne
Acibadem Altunizade Hastanesi
RECRUITING
Istanbul
Bagcilar Medipol Mega Universite Hastanesi
RECRUITING
Istanbul
Bezmialem Vakif Universitesi Hastanesi
RECRUITING
Istanbul
Ege Universitesi Tip Fakultesi Hastanesi
RECRUITING
Izmir
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
RECRUITING
Konya
Inonu Universitesi Turgut Ozal Tip Merkezi
RECRUITING
Malatya
United Kingdom
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
Royal Free Hospital
RECRUITING
London
Sarah Cannon Research Institute UK
RECRUITING
London
Maidstone Hospital
RECRUITING
Maidstone
Mount Vernon Cancer Centre
RECRUITING
Northwood
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2024-07-17
Estimated Completion Date: 2031-08-31
Participants
Target number of participants: 450
Treatments
Experimental: Arm A: Sotorasib + Panitumumab + FOLFIRI
Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
Active_comparator: Arm B: FOLFIRI with or Without Bevacizumab-awwb
Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.
Related Therapeutic Areas
Sponsors
Leads: Amgen