Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
April 22, 2026 updated by: Amgen
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)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
450
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amgen Call Center
- Phone Number: 866-572-6436
- Email: medinfo@amgen.com
Study Locations
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Buenos Aires, Argentina, C1280AEB
- Recruiting
- Hospital Britanico de Buenos Aires
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La Rioja, Argentina, F5300COE
- Recruiting
- Centro Oncologico Riojano Integral
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1093AAS
- Recruiting
- Hospital Universitario Fundacion Favaloro
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CABA, Buenos Aires, Argentina, C1093AAS
- Recruiting
- Instituto Argentino de Diagnóstico y Tratamiento
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CABA, Buenos Aires, Argentina, C1425BGH
- Recruiting
- Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
- Recruiting
- CEMIC
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La Plata, Buenos Aires, Argentina, 1900
- Recruiting
- Sanatorio Britanico de Rosario
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Recruiting
- Instituto de Investigaciones clinicas de Mar del Plata
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Córdoba Province
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Córdoba, Córdoba Province, Argentina, 5000
- Recruiting
- Hospital Italiano de Cordoba
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Córdoba, Córdoba Province, Argentina, X5000JHQ
- Recruiting
- Sanatorio Allende
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Córdoba, Córdoba Province, Argentina, X5004FHP
- Recruiting
- Clínica Universitaria Privada Reina Fabiola
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Río Negro Province
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Viedma, Río Negro Province, Argentina, 8500
- Recruiting
- Clinica Viedma
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- Recruiting
- Exelsus Oncologia Clinica
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Recruiting
- Chris OBrien Lifehouse
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Queensland
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Toowoomba, Queensland, Australia, 4350
- Recruiting
- Toowoomba Hospital
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Woolloongabba, Queensland, Australia, 4102
- Recruiting
- Princess Alexandra Hospital
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South Australia
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Bedford Park, South Australia, Australia, 5042
- Recruiting
- Flinders Medical Centre
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Woodville South, South Australia, Australia, 5011
- Recruiting
- The Queen Elizabeth Hospital
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Recruiting
- Austin Health, Austin Hospital
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Graz, Austria, 8036
- Recruiting
- Medizinische Universitaet Graz
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Linz, Austria, 4010
- Recruiting
- Ordensklinikum Linz Barmherzige Schwestern
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Rankweil, Austria, 6830
- Recruiting
- Landeskrankenhaus Feldkirch
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Vienna, Austria, 1090
- Recruiting
- Universitaetsklinikum Allgemeines Krankenhaus Wien
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Wiener Neustadt, Austria, 2700
- Recruiting
- Krankenhaus Wiener Neustadt
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Brussels, Belgium, B-1070
- Recruiting
- Institut Jules Bordet
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Brussels, Belgium, 1200
- Recruiting
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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Charleroi, Belgium, 6060
- Recruiting
- Grand Hopital de Charleroi - Site des Viviers
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Ghent, Belgium, 9000
- Recruiting
- Universitair Ziekenhuis Gent
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Leuven, Belgium, 3000
- Recruiting
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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Mechelen, Belgium, 2800
- Recruiting
- Algemeen Ziekenhuis Sint Maarten-Emmaus vzw
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Roeselare, Belgium, 8800
- Recruiting
- AZ Delta Campus Rumbeke
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Sint-Niklaas, Belgium, 9100
- Recruiting
- VITAZ Campus Sint-Niklaas Moerland
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Rio de Janeiro, Brazil, 22250-205
- Recruiting
- Oncoclinicas Rio de Janeiro S A
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São Paulo, Brazil, 04014-002
- Recruiting
- Instituto Brasileiro de Controle do Cancer Ibcc
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São Paulo, Brazil, 01246-000
- Recruiting
- Instituto Cancer Sao Paulo Icesp
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São Paulo, Brazil, 04501-000
- Recruiting
- Oncologia Rede D Or
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29308-020
- Recruiting
- Hospital Evangelico de Cachoeiro de Itapemirim
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Federal District
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Brasília, Federal District, Brazil, 70200-730
- Recruiting
- Hospital Sirio Libanes Brasilia
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Piauí
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Teresina, Piauí, Brazil, 64049-200
- Recruiting
- Vencer e Oncoclinica
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brazil, 59075-740
- Recruiting
- Liga Norte-Riograndense Contra O Cancer
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brazil, 98700-000
- Recruiting
- Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
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Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
- Recruiting
- Irmandade da Santa Casa de Misericordia de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
- Recruiting
- Associacao Hospitalar Moinhos de Vento
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Santa Catarina
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Itajaí, Santa Catarina, Brazil, 88301-220
- Recruiting
- Clinica de Neoplasias Litoral
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São Paulo
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Barretos, São Paulo, Brazil, 14784-400
- Recruiting
- Oncoclinicas Belo Horizonte
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Barretos, São Paulo, Brazil, 14784-400
- Recruiting
- Fundacao pio xII Barretos
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São José do Rio Preto, São Paulo, Brazil, 15090-000
- Recruiting
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, Brazil, 01246-000
- Recruiting
- Fundacao Antonio Prudente AC Camargo Cancer Center
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Haskovo, Bulgaria, 6300
- Recruiting
- Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
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Plovdiv, Bulgaria, 4000
- Recruiting
- Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
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Plovdiv, Bulgaria, 4004
- Recruiting
- Complex Oncology Center Plovdiv EOOD
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Sofia, Bulgaria, 1606
- Recruiting
- Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
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Sofia, Bulgaria, 1632
- Recruiting
- Multiprofile Hospital for Active Treatment Serdikamed EOOD
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Recruiting
- Arthur J E Child Comprehensive Cancer Centre
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Ontario
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Brampton, Ontario, Canada, L6R 3J7
- Recruiting
- William Osler Health System - Brampton Civic Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Research Institute Sunnybrook Health Sciences Centre
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Recruiting
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Recruiting
- Saskatoon Cancer Centre
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Santiago, Chile, 7500921
- Recruiting
- Fundacion Arturo Lopez Perez
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Santiago, Chile, 7560907
- Recruiting
- Centro de oncologia de precision Spa
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Santiago, Chile, 8330336
- Recruiting
- Biocinetic servicios medicos limitada
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Valdivia, Chile, 5110683
- Terminated
- Clinical Research Chile SpA
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Cautín
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Temuco, Cautín, Chile, 4800827
- Recruiting
- James Lind Centro de Investigacion del Cancer
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Temuco, Cautín, Chile, 4810218
- Recruiting
- Centro de investigacion y desarrollo oncolgico Spa
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Santiago Metropolitan
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Providencia, Santiago Metropolitan, Chile, 7500587
- Recruiting
- Enroll Spa
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Vitacura, Santiago Metropolitan, Chile, 7650018
- Recruiting
- Clinica Redsalud Vitacura, Instituto del Cancer
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Antioquia
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Medellín, Antioquia, Colombia, 050030
- Recruiting
- Servicios de Salud Ips Suramericana Sas - Ips Sura Industriales
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Rionegro, Antioquia, Colombia, 054040
- Recruiting
- Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
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Cundinamarca
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Bogota, Cundinamarca, Colombia, 111711
- Recruiting
- Instituto Nacional de Cancerologia
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Bogotá, Cundinamarca, Colombia, 110131
- Recruiting
- Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
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Departamento de Córdoba
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Montería, Departamento de Córdoba, Colombia, 230018
- Recruiting
- Instituto Medico de Alta Tecnologia sas - Imat sas
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Santander Department
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Floridablanca, Santander Department, Colombia, 681004
- Recruiting
- Fundacion Oftalmologica de Santander - FOSCAL
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Brno, Czechia, 656 53
- Recruiting
- Masarykuv onkologicky ustav
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Hradec Králové, Czechia, 500 05
- Recruiting
- Fakultni nemocnice Hradec Kralove
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Olomouc, Czechia, 779 00
- Recruiting
- Fakultni nemocnice Olomouc
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Prague, Czechia, 100 34
- Recruiting
- Fakultni nemocnice Kralovske Vinohrady
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Prague, Czechia, 150 06
- Recruiting
- Fakultni nemocnice v Motole
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Prague, Czechia, 180 81
- Recruiting
- Fakultni nemocnice Bulovka
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Aalborg, Denmark, 9000
- Recruiting
- Aalborg Sygehus
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Aarhus N, Denmark, 8200
- Recruiting
- Aarhus University Hospital
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Copenhagen, Denmark, 2100
- Recruiting
- Rigshospitalet
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Odense C, Denmark, 5000
- Recruiting
- Odense University Hospital
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Tallinn, Estonia, 13419
- Recruiting
- North Estonia Medical Centre Foundation
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Clermont-Ferrand, France, 63003
- Recruiting
- Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing
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Créteil, France, 94000
- Recruiting
- Hopital Henri Mondor
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Dijon, France, 21079
- Recruiting
- Centre Hospitalier Universitaire de Dijon - Hopital du Bocage
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Lyon, France, 69008
- Recruiting
- Hopital Prive Jean Mermoz
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Montpellier, France, 34298
- Recruiting
- Institut régional du Cancer Montpellier
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Nice, France, 06189
- Recruiting
- Centre Antoine Lacassagne
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Paris, France, 75015
- Recruiting
- Hôpital Européen Georges Pompidou
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Paris, France, 75475
- Recruiting
- Hopital saint Louis
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Paris, France, 75651
- Recruiting
- Hôpital Pitié-Salpêtrière
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Pessac, France, 33604
- Recruiting
- Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
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Poitiers, France, 86021
- Recruiting
- Centre Hospitalier Universitaire De Poitiers
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Reims, France, 51092
- Recruiting
- Hôpital Robert Debré
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Rennes, France, 35033
- Recruiting
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Saint-Herblain, France, 44805
- Recruiting
- Institut de Cancerologie de l Ouest Rene Gauducheau
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Saint-Priest-en-Jarez, France, 42270
- Recruiting
- Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
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Vandœuvre-lès-Nancy, France, 54519
- Recruiting
- Institut de Cancerologie de Lorraine
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Berlin, Germany, 13353
- Recruiting
- Charite - Universitaetsmedizin Berlin, Campus Virchow
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Chemnitz, Germany, 09116
- Recruiting
- Klinikum Chemnitz gGmbH
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Dresden, Germany, 01307
- Recruiting
- Universitaetsklinikum Dresden
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Essen, Germany, 45147
- Recruiting
- Universitaetsklinikum Essen
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Frankfurt am Main, Germany, 60488
- Recruiting
- UCT Universitaeres Zentrum fuer Tumorerkrankungen Frankfurt
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Hamburg, Germany, 20246
- Recruiting
- Haematologisch Onkologische Praxis Eppendorf
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Ludwigsburg, Germany, 71640
- Recruiting
- Regional Kliniken Holding Klinikum Ludwigsburg
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München, Germany, 81377
- Recruiting
- Klinikum der LMU Muenchen
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Ulm, Germany, 89081
- Recruiting
- Universitaetsklinikum Ulm
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Wolfsburg, Germany, 38440
- Recruiting
- Klinikum der Stadt Wolfsburg
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Athens, Greece, 18547
- Recruiting
- Metropolitan Hospital
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Athens, Greece, 10676
- Recruiting
- General Hospital Evangelismos
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Athens, Greece, 11528
- Recruiting
- Aretaieio Hospital
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Athens, Greece, 15123
- Recruiting
- Hygeia Hospital
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Athens, Greece, 11522
- Recruiting
- Agios Savvas Anticancer Hospital
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Athens, Greece, 11525
- Recruiting
- Athens Medical Center S.A - Psychikon
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Larissa, Greece, 41110
- Recruiting
- University Hospital Of Larissa
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Piraeus, Greece, 18537
- Recruiting
- Metaxa Anticancer Hospital
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Thessaloniki, Greece, 57001
- Recruiting
- European Interbalkan Medical Center
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Thessaloniki, Greece, 546 22
- Recruiting
- Bioclinic of Thessaloniki
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Thessaloniki, Greece, 55236
- Recruiting
- Saint Luke Hospital
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Thessaloniki, Greece, 55236
- Recruiting
- Saint Lukes Hospital SA
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Hong Kong, Hong Kong
- Recruiting
- Queen Mary Hospital, The University of Hong Kong
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Kowloon, Hong Kong
- Recruiting
- Princess Margaret Hospital
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New Territories, Hong Kong
- Recruiting
- Tuen Mun Hospital
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Budapest, Hungary, 1122
- Recruiting
- Orszagos Onkologiai Intezet
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Debrecen, Hungary, 4032
- Recruiting
- Debreceni Egyetem Klinikai Kozpont
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Gyula, Hungary, 5700
- Recruiting
- Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
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Kaposvár, Hungary, 7400
- Recruiting
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Nyíregyháza, Hungary, 4400
- Terminated
- Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház Nyíregyházi Jósa András Tagkórház
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Szolnok, Hungary, 5000
- Recruiting
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
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Brescia, Italy, 25124
- Recruiting
- Istituto Ospedaliero Fondazione Poliambulanza
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Castellana Grotte, Italy, 70013
- Recruiting
- Ente Ospedaliero IRCCS Saverio De Bellis
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Florence, Italy, 50134
- Recruiting
- Azienda Ospedaliero Universitaria Careggi
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Foggia, Italy, 71100
- Recruiting
- Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
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Genova, Italy, 16132
- Recruiting
- Ospedale Policlinico San Martino IRCCS
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Meldola FC, Italy, 47014
- Recruiting
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
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Milan, Italy, 20133
- Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Milan, Italy, 20162
- Recruiting
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Naples, Italy, 80131
- Recruiting
- Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
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Naples, Italy, 80131
- Recruiting
- Istituto Nazionale dei Tumori IRCCS Fondazione Giovanni Pascale
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Padova, Italy, 35128
- Recruiting
- Istituto Oncologico Veneto IRCCS
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Palermo, Italy, 90127
- Recruiting
- Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
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Pesaro, Italy, 61122
- Recruiting
- Azienda Sanitaria Territoriale Pesaro Urbino - Presidio San Salvatore Muraglia
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Pisa, Italy, 56126
- Recruiting
- Azienda Ospedaliero Universitaria Pisana
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Ravenna, Italy, 48121
- Recruiting
- Azienda Unità Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna
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Rozzano MI, Italy, 20089
- Recruiting
- IRCCS Istituto Clinico Humanitas
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San Giovanni Rotondo, Italy, 71013
- Recruiting
- Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza
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Udine, Italy, 33100
- Recruiting
- Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
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Verona, Italy, 37126
- Recruiting
- Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 464-8681
- Recruiting
- Aichi Cancer Center
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Chiba
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Chiba, Chiba, Japan, 260-8717
- Recruiting
- Chiba Cancer Center
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Kashiwa-shi, Chiba, Japan, 277-8577
- Recruiting
- National Cancer Center Hospital East
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Ehime
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Matsuyama, Ehime, Japan, 791-0280
- Recruiting
- National Hospital Organization Shikoku Cancer Center
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Fukuoka
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Fukuoka, Fukuoka, Japan, 811-1395
- Recruiting
- National Hospital Organization Kyushu Cancer Center
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Recruiting
- Hokkaido University Hospital
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Hyōgo
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Akashi-shi, Hyōgo, Japan, 673-8558
- Recruiting
- Hyogo Cancer Center
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Kanagawa
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Kawasaki-shi, Kanagawa, Japan, 216-8511
- Recruiting
- St Marianna University Hospital
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Yokohama, Kanagawa, Japan, 232-0024
- Recruiting
- Yokohama City University Medical Center
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Yokohama, Kanagawa, Japan, 241-8515
- Recruiting
- Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
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Niigata
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Niigata, Niigata, Japan, 951-8566
- Recruiting
- Niigata Cancer Center Hospital
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Osaka
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Hirakata-shi, Osaka, Japan, 573-1191
- Recruiting
- Kansai Medical University Hospital
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Osaka, Osaka, Japan, 540-0006
- Recruiting
- National Hospital Organization Osaka National Hospital
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Suita-shi, Osaka, Japan, 565-0871
- Recruiting
- The University of Osaka Hospital
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Saitama
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Kitaadachi-gun, Saitama, Japan, 362-0806
- Recruiting
- Saitama Cancer Center
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Shizuoka
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Sunto-gun, Shizuoka, Japan, 411-8777
- Recruiting
- Shizuoka Cancer Center
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Tokushima
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Tokushima, Tokushima, Japan, 770-8503
- Recruiting
- Tokushima University Hospital
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Tokyo
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Chuo-ku, Tokyo, Japan, 104-0045
- Recruiting
- National Cancer Center Hospital
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Koto-ku, Tokyo, Japan, 135-8550
- Recruiting
- The Cancer Institute Hospital of Japanese Foundation for Cancer Research
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Mexico City, Mexico, 14080
- Recruiting
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Mexico City
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Benito Juárez, Mexico City, Mexico, 03104
- Recruiting
- Centro Especializado en Investigacion y Tratamiento Oncologicos SC
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Mexico City, Mexico City, Mexico, 03100
- Recruiting
- Health Pharma Professional Research SA de CV
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Recruiting
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Amsterdam, Netherlands, 1066 CX
- Recruiting
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek
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Dordrecht, Netherlands, 3318 AT
- Recruiting
- Albert Schweitzer Ziekenhuis, locatie Dordwijk
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Enschede, Netherlands, 7512 KZ
- Recruiting
- Medisch Spectrum Twente
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Groningen, Netherlands, 9728 NT
- Recruiting
- Martini Ziekenhuis
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Maastricht, Netherlands, 6229 HX
- Recruiting
- Maastricht Universitair Medisch Centrum
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Utrecht, Netherlands, 3584 CX
- Recruiting
- Universitair Medisch Centrum Utrecht
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Gdynia, Poland, 81-519
- Recruiting
- Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia
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Kielce, Poland, 25-734
- Recruiting
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
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Lodz, Poland, 93-513
- Recruiting
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
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Opole, Poland, 45-061
- Recruiting
- SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu
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Poznan, Poland, 61-866
- Recruiting
- Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie
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Warsaw, Poland, 02-034
- Recruiting
- Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
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Warsaw, Poland, 02-507
- Recruiting
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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Warsaw, Poland, 04-141
- Recruiting
- Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
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Almada, Portugal, 2801-951
- Recruiting
- Unidade Local de Saude de Almada-Seixal, EPE - Hospital Garcia de Orta
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Coimbra, Portugal, 3004-561
- Recruiting
- Unidade Local de Saude de Coimbra, EPE
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Coimbra, Portugal, 3001-651
- Recruiting
- Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
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Lisbon, Portugal, 1400-038
- Recruiting
- Fundacao Champalimaud
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Lisbon, Portugal, 1500-650
- Recruiting
- Hospital da Luz, SA
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Lisbon, Portugal, 1350-352
- Recruiting
- Hospital Cuf Tejo
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Lisbon, Portugal, 1649-035
- Recruiting
- Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
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Matosinhos Municipality, Portugal, 4464-513
- Recruiting
- Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
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Santa Maria da Feira, Portugal, 4520-211
- Recruiting
- Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao
-
-
-
-
-
Bucharest, Romania, 022328
- Recruiting
- Institutul Clinic Fundeni
-
Bucharest, Romania, 022338
- Recruiting
- Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
-
Cluj-Napoca, Romania, 400015
- Recruiting
- Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
-
Craiova, Romania, 200542
- Recruiting
- Centrul de Oncologie Sf Nectarie SRL
-
Iași, Romania, 700483
- Recruiting
- Institutul Regional de Oncologie Iasi
-
Ploieşti, Romania, 100337
- Recruiting
- Spitalul Municipal Ploiesti
-
Timișoara, Romania, 300239
- Recruiting
- SC Oncomed SRL
-
-
-
-
-
Goyang-si, Gyeonggi-do, South Korea, 10408
- Recruiting
- National Cancer Center
-
Seoul, South Korea, 03080
- Recruiting
- Seoul National University Hospital
-
Seoul, South Korea, 06351
- Recruiting
- Samsung Medical Center
-
Seoul, South Korea, 02841
- Recruiting
- Korea University Anam Hospital
-
Seoul, South Korea, 03722
- Recruiting
- Severance Hospital Yonsei University Health System
-
Seoul, South Korea, 06591
- Recruiting
- The Catholic University of Korea Seoul St Marys Hospital
-
Seoul, South Korea, 138-736
- Recruiting
- Asan Medical Center
-
Seoul, South Korea, 08308
- Terminated
- Korea University Guro Hospital
-
-
-
-
-
Madrid, Spain, 28041
- Recruiting
- Hospital Universitario 12 de Octubre
-
Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz
-
Madrid, Spain, 28009
- Recruiting
- Hospital General Universitario Gregorio Marañon
-
-
Andalusia
-
Córdoba, Andalusia, Spain, 14004
- Recruiting
- Hospital Universitario Reina Sofía
-
Granada, Andalusia, Spain, 18014
- Recruiting
- Hospital Universitario Virgen de las Nieves
-
Málaga, Andalusia, Spain, 29010
- Recruiting
- Hospital Regional Universitario de Malaga
-
Seville, Andalusia, Spain, 41013
- Recruiting
- Hospital Universitario Virgen del Rocio
-
-
Aragon
-
Zaragoza, Aragon, Spain, 50009
- Recruiting
- Hospital Universitario Miguel Servet
-
-
Cantabria
-
Santander, Cantabria, Spain, 39008
- Recruiting
- Hospital Universitario Marqués de Valdecilla
-
-
Castille and León
-
Burgos, Castille and León, Spain, 09006
- Recruiting
- Hospital Universitario de Burgos
-
-
Catalonia
-
Badalona, Catalonia, Spain, 08916
- Recruiting
- Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
-
Barcelona, Catalonia, Spain, 08041
- Recruiting
- Hospital De La Santa Creu I Sant Pau
-
Barcelona, Catalonia, Spain, 08035
- Recruiting
- Hospital Universitari Vall D Hebron
-
L'Hospitalet de Llobregat, Catalonia, Spain, 08908
- Recruiting
- Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
-
-
Galicia
-
Ourense, Galicia, Spain, 32005
- Recruiting
- Complexo Hospitalario Universitario de Ourense
-
-
Navarre
-
Pamplona, Navarre, Spain, 31008
- Recruiting
- Hospital Universitario de Navarra
-
-
Principality of Asturias
-
Oviedo, Principality of Asturias, Spain, 33011
- Recruiting
- Hospital Universitario Central de Asturias
-
-
Valencia
-
Elche, Valencia, Spain, 03203
- Recruiting
- Hospital General Universitario de Elche
-
Valencia, Valencia, Spain, 46014
- Recruiting
- Hospital General Universitario de Valencia
-
Valencia, Valencia, Spain, 46010
- Recruiting
- Hospital Clínico Universitario de Valencia
-
-
-
-
-
Stockholm, Sweden, 118 83
- Recruiting
- Soedersjukhuset
-
-
-
-
-
Zurich, Switzerland, 8091
- Recruiting
- UniversitaetsSpital Zuerich
-
-
-
-
-
Taichung, Taiwan, 40705
- Recruiting
- Taichung Veterans General Hospital
-
Taichung, Taiwan, 40447
- Recruiting
- China Medical University Hospital
-
Taipei, Taiwan, 11217
- Recruiting
- Taipei Veterans General Hospital
-
Taoyuan District, Taiwan, 33305
- Recruiting
- Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
-
-
-
-
-
Bangkok, Thailand, 10700
- Recruiting
- Siriraj Hospital
-
-
-
-
-
Adana, Turkey (Türkiye), 01370
- Recruiting
- Adana Sehir Egitim ve Arastirma Hastanesi
-
Ankara, Turkey (Türkiye), 06800
- Recruiting
- Ankara Bilkent Sehir Hastanesi
-
Ankara, Turkey (Türkiye), 06560
- Recruiting
- Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
-
Ankara, Turkey (Türkiye), 06230
- Recruiting
- Hacettepe Universitesi Tip Fakultesi Hastanesi
-
Ankara, Turkey (Türkiye), 06590
- Recruiting
- Ankara Universitesi Tip Fakultesi Hastanesi
-
Edirne, Turkey (Türkiye), 22030
- Recruiting
- Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
-
Istanbul, Turkey (Türkiye), 34214
- Recruiting
- Bagcilar Medipol Mega Universite Hastanesi
-
Istanbul, Turkey (Türkiye), 34093
- Recruiting
- Bezmialem Vakif Universitesi Hastanesi
-
Istanbul, Turkey (Türkiye), 34865
- Recruiting
- Kartal Dr Lutfi Kirdar sehir Hastanesi
-
Istanbul, Turkey (Türkiye), 34662
- Completed
- Acibadem Altunizade Hastanesi
-
Izmir, Turkey (Türkiye), 35100
- Recruiting
- Ege Universitesi Tip Fakultesi Hastanesi
-
Konya, Turkey (Türkiye), 42080
- Recruiting
- Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
-
Malatya, Turkey (Türkiye), 44280
- Recruiting
- Inonu Universitesi Turgut Ozal Tip Merkezi
-
-
-
-
-
Birmingham, United Kingdom, B15 2TH
- Recruiting
- Queen Elizabeth Hospital Birmingham
-
Glasgow, United Kingdom, G12 0YN
- Recruiting
- Beatson West Of Scotland Cancer Centre
-
London, United Kingdom, SW3 6JJ
- Recruiting
- Royal Marsden Hospital
-
London, United Kingdom, NW3 2QG
- Recruiting
- Royal Free Hospital
-
London, United Kingdom, SE1 9RT
- Recruiting
- Guys Hospital
-
London, United Kingdom, W1G 6AD
- Terminated
- Sarah Cannon Research Institute UK
-
Maidstone, United Kingdom, ME16 9QQ
- Recruiting
- Maidstone Hospital
-
Northwood, United Kingdom, HA6 2RN
- Recruiting
- Mount Vernon Cancer Centre
-
Sheffield, United Kingdom, S10 2SJ
- Recruiting
- Weston Park Hospital
-
Sutton, United Kingdom, SM2 5PT
- Recruiting
- Royal Marsden Hospital - Sutton
-
-
-
-
Arizona
-
Chandler, Arizona, United States, 85224
- Recruiting
- Ironwood Cancer and Research Centers Scottsdale
-
-
California
-
Fullerton, California, United States, 92835
- Recruiting
- Providence Saint Jude Medical Center
-
Long Beach, California, United States, 90813
- Recruiting
- City of Hope National Medical Center
-
Los Alamitos, California, United States, 90720
- Recruiting
- Cancer and Blood Research Center, LLC
-
Los Angeles, California, United States, 90027
- Recruiting
- California Research Institute
-
-
Connecticut
-
Norwalk, Connecticut, United States, 06856
- Terminated
- Norwalk Hospital
-
-
Florida
-
Jacksonville, Florida, United States, 32256
- Recruiting
- Cancer Specialists of North Florida - Southpoint
-
Margate, Florida, United States, 33063
- Recruiting
- D and H Cancer Research Center
-
Orange City, Florida, United States, 32763
- Terminated
- Mid Florida Hematology and Oncology Centers PA
-
Plantation, Florida, United States, 33322
- Terminated
- Boca Raton Clinical Research Medical Center Inc
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- Recruiting
- Georgia Cancer Specialists
-
-
Illinois
-
Chicago, Illinois, United States, 60616
- Recruiting
- Insight Research Institute
-
Hinsdale, Illinois, United States, 60521
- Terminated
- Hope and Healing Cancer Services
-
Skokie, Illinois, United States, 60076
- Terminated
- Orchard Healthcare Research Inc
-
-
Kentucky
-
Pikeville, Kentucky, United States, 41501
- Recruiting
- Pikeville Medical Center
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Health System
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- Cancer and Hematology Centers of Western Michigan
-
-
Missouri
-
Bridgeton, Missouri, United States, 63044
- Recruiting
- Saint Louis Cancer Care West County
-
-
New Jersey
-
Mickleton, New Jersey, United States, 08056
- Recruiting
- Minniti Center for Medical Oncology and Hematology
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke Cancer Center
-
Pinehurst, North Carolina, United States, 28374
- Recruiting
- FirstHealth Cancer Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Thomas Jefferson University
-
-
South Carolina
-
Rock Hill, South Carolina, United States, 29732
- Completed
- Carolina Blood and Cancer Care
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University Medical Center
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Tennessee Oncology, PLLC
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Tennessee Oncology PLLC - Chattanooga
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Active, untreated brain metastases.
- Leptomeningeal disease
- Previous treatment with a KRAS p.G12C inhibitor
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
Immediate-release solid dosage form administered orally.
Other Names:
Administered via IV infusion Q2W.
Other Names:
|
|
Active Comparator: Arm B: FOLFIRI with or Without Bevacizumab-awwb
Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.
|
Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
Administered via IV infusion Q2W.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame: Up to Approximately 3 Years
|
Up to Approximately 3 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
Pre-dose (Ctrough) Concentrations of Sotorasib
Time Frame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
|
Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
|
|
|
Maximum Plasma Concentration (Cmax) of Sotorasib
Time Frame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
|
Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
|
|
|
Objective Response Rate (ORR) per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
Objective Response (OR) per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
Duration of Response (DOR) per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
Disease Control Rate (DCR) per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
Time to Response (TTR) per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
Depth of Response per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Depth of response is measured as the percentage of tumor shrinkage calculated as the best percentage change from baseline in lesion sum diameters.
|
Up to Approximately 5 Years
|
|
Time to Early Tumor Shrinkage (ETS) per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
PFS Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
ORR Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
DOR Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
DCR Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
TTR Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
Depth of Response Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
Time to ETS Based on Investigator's Assessment per RECIST v1.1
Time Frame: Up to Approximately 5 Years
|
Up to Approximately 5 Years
|
|
|
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to Approximately 5 Years
|
An AE is defined as any untoward medical occurrence in participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.
|
Up to Approximately 5 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: MD, Amgen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2024
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
August 31, 2031
Study Registration Dates
First Submitted
January 15, 2024
First Submitted That Met QC Criteria
February 8, 2024
First Posted (Actual)
February 12, 2024
Study Record Updates
Last Update Posted (Actual)
April 24, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Neoplasms
- Colorectal Neoplasms
- Amino Acids, Peptides, and Proteins
- Proteins
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Bevacizumab
- Panitumumab
- sotorasib
Other Study ID Numbers
- 20210081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities.
There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).
In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling.
Requests are reviewed by a committee of internal advisors.
If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision.
Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.
This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications.
Further details are available at the URL below.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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