Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy

Study 849-010 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Colorectal Cancer; Advanced Colorectal Cancer
• Intervention / Treatment: Drug: MRTX849; Biological: Cetuximab; Drug: mFOLFOX6 Regimen; Drug: FOLFIRI Regimen

• Study Type: Interventional
• Enrollment (Actual): 461
• Phase: Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

• Study Contact: Name: Mirati Therapeutics Study Locator Services; Phone Number: 1-844-893-5530; Email: miratistudylocator@careboxhealth.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ANZ
    • Research Site
  • Buenos Aires, Argentina, C1061AAS
    • Research Site
  • Buenos Aires, Argentina, CI264 AAA
    • Research Site
  • La Rioja, Argentina, F5300COE
    • Research Site
  • Rio Negro
    • Viedma, Rio Negro, Argentina, R8500ACE
      • Research Site
• Australia
  • Garran, Australia, 2605
    • Research Site
  • New South Wales
    • Waratah, New South Wales, Australia, 2298
      • Research Site
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Research Site
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Research Site
    • Heidelberg, Victoria, Australia, 3084
      • Research Site
    • Melbourne, Victoria, Australia, 3004
      • Research Site
• Austria
  • Wien, Austria, 1090
    • Research Site
  • Wiener Neustadt, Austria, 2700
    • Research Site
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Research Site
• Belgium
  • Brussels, Belgium, 1090
    • Research Site
  • Gent, Belgium, 9000
    • Research Site
  • Yvoir, Belgium, 5530
    • Research Site
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Research Site
• Brazil
  • Curitiba, Brazil, 80520-174
    • Research Site
  • Ijuí, Brazil, 98700-000
    • Research Site
  • Sao Paulo, Brazil, 01509-010
    • Research Site
  • São Paulo, Brazil, 01246
    • Research Site
  • São Paulo, Brazil, 01323-030
    • Research Site
  • São Paulo, Brazil, 04543-000
    • Research Site
  • São Paulo, Brazil, 09060-650
    • Research Site
  • São Paulo, Brazil, 15090-000
    • Research Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Research Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
      • Research Site
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89010-340
      • Research Site
• Canada
  • Toronto, Canada, M5G 2M9
    • Research Site
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Research Site
    • Toronto, Ontario, Canada, M5B 1W8
      • Research Site
  • Quebec
    • Montréal, Quebec, Canada, H1T 2M4
      • Research Site
• China
  • Beijing, China, 100142
    • Research Site
  • Beijing, China, 100021
    • Research Site
  • Shanghai, China, 200032
    • Research Site
  • Shanghai, China, 200025
    • Research Site
  • Shanghai, China, 200123
    • Research Site
  • Shanghai, China, 201620
    • Research Site
  • Tianjin, China, 300060
    • Research Site
  • Xi'an, China, 710068
    • Research Site
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Research Site
    • Hefei, Anhui, China, 230031
      • Research Site
    • Hefei, Anhui, China, 230088
      • Research Site
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Research Site
  • Guang Dong
    • Guangzhou, Guang Dong, China, 510655
      • Research Site
    • Shenzhen, Guang Dong, China, 518036
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  • Guangxi
    • Nanning, Guangxi, China, 530000
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  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Research Site
  • Henan
    • Zhengzhou, Henan, China
      • Research Site
  • Hubei
    • Wuhan, Hubei, China
      • Research Site
  • Hunan
    • Changsha, Hunan, China, 410008
      • Research Site
    • Changsha, Hunan, China, 410013
      • Research Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Research Site
    • Wuxi, Jiangsu, China, 214400
      • Research Site
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Research Site
  • Jilin
    • Changchun, Jilin, China, 130000
      • Research Site
    • Changchun, Jilin, China, 130015
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  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Research Site
    • Shenyang, Liaoning, China, 110101
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  • Pudong
    • Shanghai, Pudong, China, 201321
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  • Shandong
    • Jinan, Shandong, China, 250117
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  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Research Site
    • Neijiang, Sichuan, China, 641100
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  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
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    • Hangzhou, Zhejiang, China, 310017
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• Colombia
  • Barranquilla, Colombia, 080020
    • Research Site
  • Bogotá, Colombia, 111511-110411001
    • Research Site
  • Medellín, Colombia, 050034
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  • Santander
    • Floridablanca, Santander, Colombia, 681001
      • Research Site
• Czechia
  • Olomouc, Czechia, 779 00
    • Research Site
  • Prague, Czechia, 128 08
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  • Prague
    • Praha, Prague, Czechia, 150 06
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  • South Moravian
    • Brno, South Moravian, Czechia, 656 53
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    • Brno, South Moravian, Czechia, 656 91
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• Denmark
  • Copenhagen, Denmark, 2100
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  • Odense, Denmark, DK 5000
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  • Vejle, Denmark, 7100
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• Finland
  • Helsinki, Finland, 00290
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  • Tampere, Finland, 33520
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  • Turku, Finland, 20520
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• France
  • Marseille, France, 13005
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  • Paris, France, 75010
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  • Paris, France, 75012
    • Research Site
  • Paris, France, 75013
    • Research Site
  • Pessac, France, 33720
    • Research Site
  • Suresnes, France, 92150
    • Research Site
  • Tours, France, 37044
    • Research Site
  • Bourgogne
    • Dijon, Bourgogne, France, 21079
      • Research Site
  • Bretagne
    • Brest, Bretagne, France, 29200
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  • Doubs
    • Besançon, Doubs, France, 25000
      • Research Site
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59037
      • Research Site
  • Ile-de-France
    • Paris, Ile-de-France, France, 75015
      • Research Site
  • Midi-Pyrenees
    • Toulouse, Midi-Pyrenees, France, 31059
      • Research Site
  • Provence Alpes Cote d'Azure
    • Avignon, Provence Alpes Cote d'Azure, France, 84918
      • Research Site
  • Rhone
    • Bourdeaux, Rhone, France, 33000
      • Research Site
  • Rhone-Alpes
    • Lyon, Rhone-Alpes, France, 69008
      • Research Site
  • Val-de-Marne
    • Villejuif, Val-de-Marne, France, 94805
      • Research Site
• Germany
  • Amberg, Germany, 92224
    • Research Site
  • Berlin, Germany, 10117
    • Research Site
  • Hamburg, Germany, 20246
    • Research Site
  • Herne, Germany, 44625
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  • Monchengladbach, Germany, 41063
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  • München, Germany, 81377
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  • Baden-Wuerttemberg
    • Ulm, Baden-Wuerttemberg, Germany, 89081
      • Research Site
  • Baden-Wurttemberg
    • Reutlingen, Baden-Wurttemberg, Germany
      • Research Site
  • Bayern
    • München, Bayern, Germany, 81737
      • Research Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60488
      • Research Site
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44791
      • Research Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Research Site
• Greece
  • Athens, Greece, 11528
    • Research Site
  • Athens, Greece, 15562
    • Research Site
  • Heraklion, Greece, 71110
    • Research Site
  • Thessaloniki, Greece, 54645
    • Research Site
  • Thessaloníki, Greece, 57001
    • Research Site
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • Research Site
• Hong Kong
  • Central, Hong Kong, 1401-02
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  • Hong Kong, Hong Kong
    • Research Site
• Ireland
  • Dublin, Ireland, D04 Y8V0
    • Research Site
  • Dublin, Ireland, D24 NR0A
    • Research Site
  • Dublin, Ireland, D07 R2WY
    • Research Site
  • Dublin, Ireland, D09V2N0
    • Research Site
• Italy
  • Avellino, Italy, 81300
    • Research Site
  • Biella, Italy, 13875
    • Research Site
  • Cagliari, Italy, 9042
    • Research Site
  • Meldola, Italy, 47014
    • Research Site
  • Milan, Italy, 20141
    • Research Site
  • Milano, Italy, 20162
    • Research Site
  • Naples, Italy, 80131
    • Research Site
  • Padova, Italy, 35128
    • Research Site
  • Pisa, Italy, 56126
    • Research Site
  • Reggio Emilia, Italy, 42100
    • Research Site
  • Roma, Italy, 00144
    • Research Site
  • Turin, Italy, 10128
    • Research Site
  • Lucca
    • Lido Di Camaiore, Lucca, Italy, 55041
      • Research Site
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Research Site
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Research Site
  • Busan, Korea, Republic of, 49201
    • Research Site
  • Daejeon, Korea, Republic of, 35015
    • Research Site
  • Goyang-si, Korea, Republic of, 10408
    • Research Site
  • Seoul, Korea, Republic of, 05505
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Research Site
  • Seoul, Korea, Republic of, 02841
    • Research Site
  • Seoul, Korea, Republic of, 06351
    • Research Site
  • Seoul, Korea, Republic of, 06591
    • Research Site
  • Seoul, Korea, Republic of, 037722
    • Research Site
  • Sŏwŏn, Korea, Republic of, 16247
    • Research Site
  • Gyeonggi-do
    • Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
      • Research Site
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • Research Site
  • Gyeongsangnam
    • Yangsan, Gyeongsangnam, Korea, Republic of, 50612
      • Research Site
  • Jeollanam-do
    • Hwasun, Jeollanam-do, Korea, Republic of, 58128
      • Research Site
• Malaysia
  • Johor Bahru, Malaysia, 81100
    • Research Site
  • Putrajaya, Malaysia, 62250
    • Research Site
  • Sabah
    • Kota Kinabalu, Sabah, Malaysia, 88996
      • Research Site
  • Selangor
    • Kuala Lumpur, Selangor, Malaysia, 50586
      • Research Site
    • Kuala Lumpur, Selangor, Malaysia, 59100
      • Research Site
    • Petaling Jaya, Selangor, Malaysia, 46050
      • Research Site
• Mexico
  • Mexico City, Mexico, 14080
    • Research Site
  • Veracruz, Mexico, 94300
    • Research Site
  • Chiapas
    • Tuxtla Gutiérrez, Chiapas, Mexico, 29038
      • Research Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Research Site
    • Guadalajara, Jalisco, Mexico, 44670
      • Research Site
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62290
      • Research Site
  • Queretaro
    • San Juan Del Río, Queretaro, Mexico, 76800
      • Research Site
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Research Site
  • Noor-Holland
    • Amsterdam, Noor-Holland, Netherlands, 1081
      • Research Site
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066 CX
      • Research Site
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • Research Site
• Poland
  • Gdańsk, Poland, 80-219
    • Research Site
  • Otwock, Poland, 05-400
    • Research Site
  • Warsaw, Poland, 02-034
    • Research Site
  • Warsaw, Poland, 02-507
    • Research Site
• Portugal
  • Braga, Portugal, 4710-243
    • Research Site
  • Lisboa, Portugal, 1400-038
    • Research Site
  • Lisbon, Portugal, 1649-035
    • Research Site
  • Porto, Portugal, 4099-001
    • Research Site
  • Porto, Portugal, 4200-072
    • Research Site
• Puerto Rico
  • San Juan, Puerto Rico, 00935
    • Research Site
  • San Juan, Puerto Rico
    • Research Site
• Romania
  • Baia Mare, Romania, 430031
    • Research Site
  • Braşov, Romania, 500152
    • Research Site
  • Bucuresti, Romania, 022328
    • Research Site
  • Cluj-Napoca, Romania, 400015
    • Research Site
  • Cluj-Napoca, Romania, 400641
    • Research Site
  • Craiova, Romania, 200746
    • Research Site
  • Timişoara, Romania, 300239
    • Research Site
  • Constanta
    • Ovidiu, Constanta, Romania, 905900
      • Research Site
• Singapore
  • Singapore, Singapore, 188770
    • Research Site
  • Singapore, Singapore, 169610
    • Research Site
  • Singapore, Singapore, 217562
    • Research Site
  • Singapore, Singapore, 258499
    • Research Site
  • Singapore, Singapore, 119074
    • Research Site
• Spain
  • A Coruña, Spain, 15006
    • Research Site
  • Barcelona, Spain, 08035
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 08908
    • Research Site
  • Córdoba, Spain, 14004
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  • Madrid, Spain, 28046
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  • Madrid, Spain, 28041
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  • Madrid, Spain, 28040
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  • Madrid, Spain, 28007
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  • Pamplona, Spain, 31008
    • Research Site
  • Sabadell, Spain, 08208
    • Research Site
  • Santander, Spain, 39008
    • Research Site
  • Valencia, Spain, 46010
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  • Valencia, Spain, 46014
    • Research Site
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Research Site
• Taiwan
  • Changhua, Taiwan, 500
    • Research Site
  • Kaohsiung, Taiwan, 807
    • Research Site
  • Taichung, Taiwan, 407
    • Research Site
  • Tainan, Taiwan, 736
    • Research Site
  • Tainan, Taiwan, 704
    • Research Site
  • Taipei, Taiwan, 100
    • Research Site
  • Taoyuan, Taiwan, 333
    • Research Site
• Thailand
  • Bangkok, Thailand, 10400
    • Research Site
  • Bangkok, Thailand, 10700
    • Research Site
  • Bangkok, Thailand, 10110
    • Research Site
  • Chiang Mai, Thailand, 50200
    • Research Site
  • Hat Yai, Thailand, 90110
    • Research Site
• United Kingdom
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Research Site
  • England
    • Birmingham, England, United Kingdom, B91 2PP
      • Research Site
    • Cambridge, England, United Kingdom, CB2 0QQ
      • Research Site
    • Leeds, England, United Kingdom, LS9 7TF
      • Research Site
    • London, England, United Kingdom, NW1 2BD
      • Research Site
    • London, England, United Kingdom, SW3 6JJ
      • Research Site
    • Maidstone, England, United Kingdom, ME16 9QQ
      • Research Site
    • Manchester, England, United Kingdom, M20 4BX
      • Research Site
    • Middlesex, England, United Kingdom, HA6 2RN
      • Research Site
    • Sutton, England, United Kingdom, SM2 5PT
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  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Research Site
    • Glasgow, Scotland, United Kingdom, G12 0YN
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• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Research Site
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Research Site
    • Goodyear, Arizona, United States, 85338
      • Research Site
    • Phoenix, Arizona, United States, 85054
      • Research Site
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Research Site
  • California
    • Bakersfield, California, United States, 93309
      • Research Site
    • Clovis, California, United States, 93611
      • Research Site
    • Fullerton, California, United States, 92835
      • Research Site
    • Los Angeles, California, United States, 90048
      • Research Site
    • Los Angeles, California, United States, 90033
      • Research Site
    • Redlands, California, United States, 92373
      • Research Site
    • San Diego, California, United States, 92123
      • Research Site
    • San Francisco, California, United States, 94115
      • Research Site
    • Santa Monica, California, United States, 90404
      • Research Site
    • Sylmar, California, United States, 91342
      • Research Site
    • Torrance, California, United States, 90505
      • Research Site
    • Whittier, California, United States, 90602
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  • Colorado
    • Denver, Colorado, United States, 80218
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  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Research Site
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Research Site
    • Jacksonville, Florida, United States, 32224
      • Research Site
    • Ocala, Florida, United States, 34471
      • Research Site
    • Orlando, Florida, United States, 32804
      • Research Site
    • Orlando, Florida, United States, 32806
      • Research Site
    • Saint Petersburg, Florida, United States, 33709
      • Research Site
    • Saint Petersburg, Florida, United States, 33705
      • Research Site
    • Tallahassee, Florida, United States, 32308
      • Research Site
    • West Palm Beach, Florida, United States, 33401
      • Research Site
    • Weston, Florida, United States, 33331
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  • Illinois
    • Naperville, Illinois, United States, 60540
      • Research Site
    • Zion, Illinois, United States, 60099
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Research Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Research Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
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  • Massachusetts
    • Boston, Massachusetts, United States, 02114
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  • Michigan
    • Detroit, Michigan, United States, 48202
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  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Research Site
    • Rochester, Minnesota, United States, 55905
      • Research Site
    • Saint Paul, Minnesota, United States, 55101
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  • Missouri
    • Springfield, Missouri, United States, 65804
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Research Site
    • Omaha, Nebraska, United States, 68130
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89169
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  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • Research Site
    • Florham Park, New Jersey, United States, 07932
      • Research Site
    • New Brunswick, New Jersey, United States, 08903
      • Research Site
    • Somerset, New Jersey, United States, 08873-5002
      • Research Site
  • New York
    • New York, New York, United States, 10016
      • Research Site
    • New York, New York, United States, 10065
      • Research Site
    • New York, New York, United States, 10029
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    • Port Jefferson Station, New York, United States, 11776
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  • North Carolina
    • Jacksonville, North Carolina, United States, 28546
      • Research Site
    • Sparta, North Carolina, United States, 28675
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  • Ohio
    • Cincinnati, Ohio, United States, 45211
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73120
      • Research Site
    • Tulsa, Oklahoma, United States, 74146
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  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
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    • Nashville, Tennessee, United States, 37203
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  • Texas
    • Dallas, Texas, United States, 75246
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    • Dallas, Texas, United States, 75216
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    • Houston, Texas, United States, 77030
      • Research Site
    • Houston, Texas, United States, 77090
      • Research Site
    • Longview, Texas, United States, 75601
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    • San Antonio, Texas, United States, 78240
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    • Temple, Texas, United States, 76508
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  • Utah
    • Salt Lake City, Utah, United States, 84106
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  • Virginia
    • Fairfax, Virginia, United States, 22031
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    • Fredericksburg, Virginia, United States, 24408
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    • Richmond, Virginia, United States, 23230
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    • Richmond, Virginia, United States, 23298
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  • Washington
    • Everett, Washington, United States, 98201
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    • Seattle, Washington, United States, 98109
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    • Tacoma, Washington, United States, 98405
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    • Vancouver, Washington, United States, 98684
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  • West Virginia
    • Morgantown, West Virginia, United States, 26506
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  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRTX849 + Cetuximab	Drug: MRTX849; 28 Day Cycle; Biological: Cetuximab; 28 Day Cycle; Other Names: Erbitux
Active Comparator: mFOLFOX6 or FOLFIRI	Drug: mFOLFOX6 Regimen; Fluorouracil; Oxaliplatin; Folinic acid; Drug: FOLFIRI Regimen; Fluorouracil; Irinotecan; Folinic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	Defined as time from randomization until disease progression or death from any cause, whichever occurs first.	30 months
Overall Survival (OS)	Defined as time from date of randomization to date of death due to any cause.	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adverse Events	Defined as number of patients with treatment emergent AEs.	30 months
Objective Response Rate (ORR)	Defined as the percent of patients documented to have a confirmed CR or PR.	30 months
Patient Reported Outcomes (PROs)	To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).	30 months
Quality of Life Assessment	To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).	30 months

Collaborators and Investigators

• Sponsor: Mirati Therapeutics Inc.
• Investigators: Study Director: Hirak Der-Torossian, MD, Mirati Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal Cancer; KRAS G12C; Rectal Cancer; Colon Cancer; Colorectal Carcinoma; KRAS; RAS; Colorectal Adenocarcinoma; Colorectal Cancer Trial
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab; Adagrasib
• Other Study ID Numbers: 849-010; KRYSTAL-10 (Other Identifier: Mirati Therapeutics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No