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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04793958
Other study ID # CA239-0006
Secondary ID KRYSTAL-10CA239-
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 15, 2021
Est. completion date February 28, 2026

Study information

Verified date June 2024
Source Mirati Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 461
Est. completion date February 28, 2026
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue. - Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment. Exclusion Criteria: - Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510). - Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab). - Active brain metastasis

Study Design


Intervention

Drug:
MRTX849
28 Day Cycle
Biological:
Cetuximab
28 Day Cycle
Drug:
mFOLFOX6 Regimen
Fluorouracil Oxaliplatin Folinic acid
FOLFIRI Regimen
Fluorouracil Irinotecan Folinic acid

Locations

Country Name City State
Argentina Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo Buenos Aires
Argentina Instituto Medico Especializado Alexander Fleming Buenos Aires
Argentina CIPREC - Centro de Investigacion y Prevencion Cardiovascular Caba
Argentina CORI Centro Oncologico Riojano Integral La Rioja
Argentina Hospital Nossa Senhora da Conceicao Porto Alegre
Argentina Clinica Viedma Viedma
Australia Flinders Medical Centre Bedford Park
Australia Monash Health Clayton
Australia Canberra Region Cancer Centre Garran
Australia Austin Health Heidelberg
Australia The Alfred Melbourne
Australia Calvary Mater Newcastle Hospital Waratah
Austria Medizinische Universitat Innsbruck Innsbruck
Austria Medizinische Universitat Wien Wien
Austria Landesklinikum Wiener Neustadt Wiener Neustadt
Belgium Universitair Ziekenhuis Brussel Brussel
Belgium Universitair Ziekenhuis Antwerpen Edegem
Belgium Universitair Ziekenhuis Gent Gent
Belgium Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne Yvoir
Brazil Centro de Ensino e Pesquisa da Clinica de Oncologia Reichow Blumenau Santa Catarina
Brazil Instituto de Oncologia do Parana - IOP Oncoville Curitiba
Brazil ONCOSITE - Centro de Pesquisa Clinica Em Oncologia Ltda. Ijui Rio Grande Do Sul
Brazil A.C. Camargo Cancer Center Liberdade
Brazil Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande Do Sul
Brazil CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia Santo Andre
Brazil Hospital de Base - Sao Jose do Rio Preto Sao Jose do Rio Preto
Brazil Instituto do Cancer do Estado de Sao Paulo (ICESP) Sao Paolo
Brazil A Beneficencia Portuguesa de Sao Paulo - Unidade Mirante Sao Paulo
Brazil OncoStar - Rede Dor Sao Paulo
Canada Hopital Maisonneuve-Rosemont Montreal Quebec
Canada Ottawa Hospital - General Campus Ottawa Ontario
Canada Princess Margaret Cancer Centre Toronto Ontario
Canada St. Michaels Hospital - Toronto Toronto Ontario
Colombia Clinica de la Costa Barranquilla
Colombia Instituto Nacional de Cancerologia Bogota
Colombia Fundacion Oftalmologica de Santander - FOSCAL Floridablanca
Colombia Hospital Pablo Tobon Uribe Medellin
Czechia Fakultni Nemocnice u sv. Anny v Brne Brno
Czechia Masarykuv Onkologicky Ustav Brno
Czechia Fakultni Nemocnice Olomouc Olomouc
Czechia Fakultni nemocnice v Motole Praha 5
Denmark Rigshospitalet Copenhagen
Denmark Odense Universitetshospital Odense
Denmark Sygehus Lillebaelt - Vejle Sygehus Vejle
Finland Helsingin ja Uudenmaan Sairaanhoitopiirin - Syopakeskus Helsinki
Finland Tampereen Yliopistollinen Sairaala (TAYS) Tampere
Finland Turun Yliopistollinen Keskussairaala - Kantasairaala Turku
France Institut Sainte Catherine Avignon Cedex 9
France Centre Hospitalier Regional et Universitaire de Besancon - Saint-Jacques Besancon
France Institut Bergonie Bordeaux
France Hopital Morvan Brest
France Centre Georges Francois Leclerc Dijon cedex
France Hopital Huriez Lille
France Centre Leon Berard Lyon
France Hopital de la Timone Marseille Cedex 5
France Hopital Europeen Georges-Pompidou Paris
France Hopital Saint-Louis Paris
France Hopital Universitaire Pitie Salpetriere Paris
France Hopital Saint-Antoine Paris Cedex 12
France Centre Hospitalier Universitaire de Bordeaux Pessac
France Hopital Foch Suresnes
France Centre Hospitalier Universitaire de Toulouse Toulouse cedex 9
France Hopital Bretonneau Tours Cedex 9
France Gustave Roussy Villejuif
Germany Klinikum St. Marien Amberg Amberg
Germany Charite Campus Mitte (SEE Charite - Universitatsmedizin Berlin) Berlin
Germany Medizinische Universitatsklinik Ruhr-Universitat-Bochum Bochum
Germany Universitatsklinikum Carl Gustav Carus Dresden Dresden
Germany Krankenhaus Nordwest Frankfurt am Main
Germany Facharztzentrum Eppendorf Hamburg
Germany Marien Hospital Herne - Universitatsklinikum der Ruhr-Universitat Bochum Herne
Germany Kliniken Maria Hilf Monchengladbach
Germany LMU Klinikum - Campus Grohadern Munchen
Germany Munchen Klinik Neuperlach Munchen
Germany Kreiskliniken Reutlingen - Klinikum am Steinenberg Reutlingen
Germany Universitatsklinikum Ulm Ulm
Greece "General Hospital of Athens "Alexandra"" Athens
Greece Metropolitan General Cholargos
Greece Local Institution - 010-238 Heraklion
Greece University General Hospital of Larissa Larissa
Greece Euromedica General Clinic - Thessaloniki Thessaloniki
Greece Interbalkan Medical Center of Thessaloniki Thessaloniki
Hong Kong Humanity & Health Clinical Trial Centre Central
Hong Kong Hong Kong Integrated Oncology Centre Hong Kong
Ireland Beaumont Hospital - Dublin Dublin
Ireland Mater Misericordiae University Hospital Dublin
Ireland Mater Private - Dublin Dublin
Ireland St. Vincents University Hospital Dublin
Ireland Tallaght University Hospital Dublin
Italy Azienda Ospedaliera San Giuseppe Moscati - Avellino Avellino
Italy Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi Biella
Italy Azienda Ospedaliero - Universitaria di Cagliari Cagliari
Italy Istituto di Candiolo - Fondazione del Piemonte per lOncologia Candiolo
Italy Azienda Unita Sanitaria Locale Toscana Nord Ovest Lido di Camaiore
Italy "Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST" Meldola
Italy Istituto Europeo di Oncologia Milan
Italy Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milano
Italy Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Napoli
Italy Istituto Oncologico Veneto - IRCCS Padova
Italy Azienda Ospedaliero-Universitaria Pisana Pisa
Italy Azienda Unita Sanitaria Locale di Reggio Emilia Reggio Emilia
Italy Istituto Nazionale Tumori Regina Elena Roma
Italy Azienda Ospedaliera Ordine Mauriziano di Torino Torino
Korea, Republic of Hallym University Sacred Heart Hospital Anyang-si
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of National Cancer Center - Korea Goyang-si
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun-gun
Korea, Republic of Cha Bundang Medical Center Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of The Catholic University of Korea - Seoul St. Marys Hospital Seoul
Korea, Republic of Catholic University of Korea Saint Vincents Hospital Suwon-Si
Korea, Republic of Pusan National University Yangsan Hospital Yangsan-si
Malaysia Hospital Sultan Ismail Johor Bahru Johor
Malaysia Hospital Wanita Dan Kanak-Kanak Sabah Kota Kinabalu Sabah
Malaysia Hospital Kuala Lumpur Kuala Lumpur
Malaysia Pusat Perubatan Universiti Malaya Kuala Lumpur
Malaysia Beacon Hospital Sdn Bhd. Petaling Jaya Selangor
Malaysia Institut Kanser Negara Putrajaya
Mexico CLIMERS Clinical Medical Research Colonia Centro Orizaba Veracruz
Mexico PanAmerican Clinical Research Mexico - Cuernavaca Cuernavaca Morelos
Mexico "Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"" Guadalajara Jalisco
Mexico Consultores en Oncologia Mexico S. de R.L. de C.V. Guadalajara Jalisco
Mexico Instituto Nacional de Cancerologia - Mexico Mexico City Distrito Federal
Mexico Unidad de Medicina Especializada SMA SC San Juan del Rio Queretaro
Mexico Centro de Estudio y Prevencion del Cancer Tuxtla Gutierrez Chiapas
Netherlands Amsterdam Universitair Medische Centra (UMC) - Locatie Vrije Universiteit Medisch Centrum Amsterdam
Netherlands Antoni Van Leeuwenhoek Ziekenhuis Amsterdam
Netherlands Radboud Universitair Medisch Centrum Nijmegen
Netherlands St. Antonius Ziekenhuis - Ziekenhuis Nieuwegein Utrecht
Poland Copernicus Podmiot Leczniczy - Wojewodzkie Centrum Onkologii Gdansk
Poland Europejskie Centrum Zdrowia Otwock Otwock
Poland Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie - Wawelska Warszawa
Poland Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji (MSWiA) w Warszawie Warszawa
Portugal Unidade Local de Saude de Braga, E. P. E (Hospital de Braga) Braga
Portugal The Champalimaud Centre for the Unknown Lisbon
Portugal Unidade Local de Saude de Santa Maria, E. P. E. - Hospital de Santa Maria Lisbon
Portugal Instituto Portugues de Oncologia do Porto Francisco Gentil Porto
Portugal Unidade Local de Saude de Santo Antonio, E. P. E - Hospital Geral de Santo Antonio Porto
Puerto Rico Fundacion de Investigacion de Diego Clinical Research San Juan
Puerto Rico Hospital Espanol Auxilio Mutuo San Juan
Puerto Rico PanOncology Trials - Rio Piedras Medical Center San Juan
Romania Spitalul Jude?ean de Urgen?a dr. Constantin Opri? Baia Mare Baia Mare
Romania Hyperclinica MedLife Policlinica de Diagnostic Rapid Turnului Brasov Bra?ov
Romania Institutul Clinic Fundeni Bucharest
Romania Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Romania Medisprof Cluj-Napoca
Romania Centrul de Oncologie Sf Nectarie Craiova
Romania Ovidius Clinical Hospital Ovidiu
Romania SC OncoMed SRL Timisoara
Singapore Icon Cancer Centre Farrer Park Singapore
Singapore National Cancer Centre Singapore Singapore
Singapore National University Hospital - Singapore Singapore
Singapore Oncocare Cancer Centre Singapore
Singapore Raffles Hospital Singapore
Spain Complejo Hospitalario Universitario A Coruna A Coruna
Spain Hospital Germans Trias i Pujol Badalona
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitari Vall dHebron Barcelona
Spain Hospital Universitario Reina Sofia Cordoba
Spain Hospital Duran i Reynals LHospitalet de Llobregat
Spain Hospital Clinico San Carlos Madrid
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario La Paz Madrid
Spain Clinica Universidad de Navarra - Pamplona Pamplona
Spain Hospital de Sabadell Sabadell
Spain Hospital Universitario Marques de Valdecilla Santander
Spain Consorci Hospital General Universitari de Valencia Valencia
Spain Hospital Clinico Universitario de Valencia Valencia
Taiwan Changhua Christian Hospital Changhua City
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Chi Mei Hospital - Liouying Tainan City
Taiwan National Taiwan University Hospital Taipei City
Taiwan Chang Gung Memorial Hospital - Linkou Branch Taoyuan
Thailand Mahidol University Bang Phlat
Thailand Faculty of Medicine Ramathibodi Hospital Bangkok
Thailand Maharaj Nakorn Chiang Mai Hospital Chiang Mai
Thailand Holistic Center For Cancer Study and Care Hat Yai
Thailand King Chulalongkorn Memorial Hospital Khlong Toey
Ukraine Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical Oncological Dispensary Sumy
United Kingdom NHS Grampian Aberdeen
United Kingdom University Hospital Birmingham NHS Foundation Trust Birmingham
United Kingdom Cambridge University Hospitals NHS Foundation Trust Cambridge
United Kingdom University Hospitals Dorset NHS Foundation Trust Dorset
United Kingdom NHS Greater Glasgow and Clyde Glasgow
United Kingdom Maidstone and Tunbridge Wells NHS Trust Kent
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds
United Kingdom The Royal Marsden NHS Foundation Trust London
United Kingdom University College London Hospitals NHS Foundation Trust London
United Kingdom The Christie NHS Foundation Trust Manchester
United Kingdom East and North Hertfordshire NHS Trust Middlesex
United States Emory University Atlanta Georgia
United States UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center Aurora Colorado
United States Comprehensive Blood and Cancer Center - Bakersfield Bakersfield California
United States University of Maryland Baltimore Maryland
United States SCRI - Hematology Oncology Clinic - Baton Rouge Baton Rouge Louisiana
United States New Jersey Cancer Care Belleville New Jersey
United States Alabama Oncology - St. Vincents Birmingham Birmingham Alabama
United States Massachusetts General Hospital Boston Massachusetts
United States Greco-Hainesworth Tennessee Oncology Centers for Research - Chattanooga-Memorial Plaza Chattanooga Tennessee
United States USOR - Oncology Hematology Care - West Cincinnati Ohio
United States Dallas Veterans Affairs Medical Center Dallas Texas
United States USOR - Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center Dallas Texas
United States USOR - Rocky Mountain Cancer Centers - Denver - Midtown Denver Colorado
United States Henry Ford Hospital Detroit Michigan
United States Astera Cancer Care - East Brunswick East Brunswick New Jersey
United States Providence Regional Cancer Partnership Everett Washington
United States Inova Medical Group - Hematology Oncology - Arlington Fairfax Virginia
United States Summit Medical Group - Florham Park Campus Florham Park New Jersey
United States SCRI - Florida Cancer Specialists - South Region Research Office Fort Myers Florida
United States Hematology Oncology Associates of Fredericksburg Fredericksburg Virginia
United States University of California San Francisco - Fresno Center for Medical Education and Research Fresno California
United States Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton Fullerton California
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States Southeastern Medical Oncology Center - Goldsboro Goldsboro North Carolina
United States City of Hope Phoenix Goodyear Arizona
United States Bon Secours Hematology and Oncology Greenville South Carolina
United States Millennium Physicians - North Houston Houston Texas
United States Oncology Consultants - Texas Medical Center Houston Texas
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Franciscan Physician Network Oncology & Hematology Specialists Indianapolis Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Local Institution - 010-999 Irving Texas
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Comprehensive Cancer Centers of Nevada - Central Valley - Twain Las Vegas Nevada
United States Southeast Nebraska Cancer Center - 68th Street Location Lincoln Nebraska
United States Norris Comprehensive Cancer Center Los Angeles California
United States Samuel Oschin Comprehensive Cancer Institute Los Angeles California
United States Sylvester Comprehensive Cancer Center Miami Florida
United States Froedtert Clinical Cancer Center Milwaukee Wisconsin
United States Minnesota Oncology - Edina Clinic Minneapolis Minnesota
United States West Virginia University Health Sciences Campus Morgantown West Virginia
United States Edward Hospital - Main Campus Naperville Illinois
United States Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Icahn School of Medicine at Mount Sinai New York New York
United States Memorial Sloan Kettering Cancer Center - New York New York New York
United States Perlmutter Cancer Center - 34th Street New York New York
United States City of Hope Atlanta Newnan Georgia
United States Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut
United States Florida Cancer Affiliates - Ocala - Main Ocala Florida
United States Mercy Clinic Oncology and Hematology - Coletta Oklahoma City Oklahoma
United States Stephenson Cancer Center Oklahoma City Oklahoma
United States Nebraska Cancer Specialists - Midwest Cancer Center - Legacy Omaha Nebraska
United States AdventHealth Cancer Institute Orlando Florida
United States Orlando Health Orlando Florida
United States Mayo Clinic Hospital - Phoenix Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Local Institution - 010-563 Redlands California
United States Massey Cancer Center Richmond Virginia
United States Virginia Cancer Institute - West End Richmond Virginia
United States Mayo Clinic - Rochester Rochester Minnesota
United States HealthPartners Cancer Research Center - Cancer Center at Regions Hospital Saint Louis Park Minnesota
United States Comprehensive Hematology Oncology LLC - Park Street Clinic Saint Petersburg Florida
United States SCRI - Florida Cancer Specialists - North Region Research Office Saint Petersburg Florida
United States Utah Cancer Specialists Salt Lake City Utah
United States Texas Oncology - San Antonio Medical Center San Antonio Texas
United States Sharp Memorial Hospital San Diego California
United States California Pacific Medical Center Research Institute San Francisco California
United States UCLA Health - Santa Monica Parkside Cancer Care Santa Monica California
United States Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location Seattle Washington
United States New York Cancer & Blood Specialists - Eastchester Cancer Care Center Shirley New York
United States Highlands Oncology Group - Springdale Springdale Arkansas
United States Mercy Research - Smith Glynn Callaway Springfield Missouri
United States Olive View - University of California Los Angeles Medical Center Sylmar California
United States MultiCare Institute for Research & Innovation Tacoma Washington
United States SCRI - Florida Cancer Specialists - Panhandle Research Office Tallahassee Florida
United States Baylor Scott & White Medical Center - Temple Temple Texas
United States Torrance Memorial Physician Network - Cancer Care and Infusion Center Torrance California
United States Oklahoma Cancer Specialists and Research Institute (OCSRI) - Tulsa Tulsa Oklahoma
United States Texas Oncology - Northeast Texas Cancer and Research Institute - Tyler Tyler Texas
United States USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center Vancouver Washington
United States SCRI - Florida Cancer Specialists - East Region Research Office West Palm Beach Florida
United States Cleveland Clinic Florida Weston Florida
United States PIH Health Whittier California
United States City of Hope Chicago Zion Illinois

Sponsors (1)

Lead Sponsor Collaborator
Mirati Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Colombia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Ireland,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Romania,  Singapore,  Spain,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) Defined as time from date of randomization to date of death due to any cause. 30 months
Primary Progression-free Survival (PFS) Defined as time from randomization until disease progression or death from any cause, whichever occurs first. 30 months
Secondary Adverse Events Defined as number of patients with treatment emergent AEs. 30 months
Secondary Objective Response Rate (ORR) Defined as the percent of patients documented to have a confirmed CR or PR. 30 months
Secondary Duration of Response (DOR) Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first. 30 months
Secondary Patient Reported Outcomes (PROs) To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30). 30 months
Secondary Quality of Life Assessment To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L). 30 months
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