Metastatic Colorectal Cancer Clinical Trial
Official title:
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
| Verified date | March 2024 |
| Source | Mirati Therapeutics Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | La Rioja | |
| Argentina | Research Site | Viedma | Rio Negro |
| Australia | Research Site | Bedford Park | South Australia |
| Australia | Research Site | Clayton | Victoria |
| Australia | Research Site | Garran | |
| Australia | Research Site | Heidelberg | Victoria |
| Australia | Research Site | Melbourne | Victoria |
| Australia | Research Site | Waratah | New South Wales |
| Austria | Research Site | Innsbruck | Tyrol |
| Austria | Research Site | Wien | |
| Austria | Research Site | Wiener Neustadt | |
| Belgium | Research Site | Brussels | |
| Belgium | Research Site | Edegem | Antwerpen |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Yvoir | |
| Brazil | Research Site | Blumenau | Santa Catarina |
| Brazil | Research Site | Curitiba | |
| Brazil | Research Site | Ijuí | |
| Brazil | Research Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Research Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | São Paulo | |
| Brazil | Research Site | São Paulo | |
| Brazil | Research Site | São Paulo | |
| Brazil | Research Site | São Paulo | |
| Brazil | Research Site | São Paulo | |
| Canada | Research Site | Montréal | Quebec |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Bengbu | Anhui |
| China | Research Site | Changchun | Jilin |
| China | Research Site | Changchun | Jilin |
| China | Research Site | Changsha | Hunan |
| China | Research Site | Changsha | Hunan |
| China | Research Site | Chengdu | Sichuan |
| China | Research Site | Fuzhou | Fujian |
| China | Research Site | Guangzhou | Guang Dong |
| China | Research Site | Hangzhou | Zhejiang |
| China | Research Site | Hangzhou | Zhejiang |
| China | Research Site | Harbin | Heilongjiang |
| China | Research Site | Hefei | Anhui |
| China | Research Site | Hefei | Anhui |
| China | Research Site | Jinan | Shandong |
| China | Research Site | Nanchang | Jiangxi |
| China | Research Site | Nanjing | Jiangsu |
| China | Research Site | Nanning | Guangxi |
| China | Research Site | Neijiang | Sichuan |
| China | Research Site | Shanghai | Pudong |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shenyang | Liaoning |
| China | Research Site | Shenyang | Liaoning |
| China | Research Site | Shenzhen | Guang Dong |
| China | Research Site | Tianjin | |
| China | Research Site | Wuhan | Hubei |
| China | Research Site | Wuxi | Jiangsu |
| China | Research Site | Xi'an | |
| China | Research Site | Zhengzhou | Henan |
| Colombia | Research Site | Barranquilla | |
| Colombia | Research Site | Bogotá | |
| Colombia | Research Site | Floridablanca | Santander |
| Colombia | Research Site | Medellín | |
| Czechia | Research Site | Brno | South Moravian |
| Czechia | Research Site | Brno | South Moravian |
| Czechia | Research Site | Olomouc | |
| Czechia | Research Site | Prague | |
| Czechia | Research Site | Praha | Prague |
| Denmark | Research Site | Copenhagen | |
| Denmark | Research Site | Odense | |
| Denmark | Research Site | Vejle | |
| Finland | Research Site | Helsinki | |
| Finland | Research Site | Tampere | |
| Finland | Research Site | Turku | |
| France | Research Site | Avignon | Provence Alpes Cote d'Azure |
| France | Research Site | Besançon | Doubs |
| France | Research Site | Bourdeaux | Rhone |
| France | Research Site | Brest | Bretagne |
| France | Research Site | Dijon | Bourgogne |
| France | Research Site | Lille | Hauts-de-France |
| France | Research Site | Lyon | Rhone-Alpes |
| France | Research Site | Marseille | |
| France | Research Site | Paris | |
| France | Research Site | Paris | |
| France | Research Site | Paris | |
| France | Research Site | Paris | Ile-de-France |
| France | Research Site | Pessac | |
| France | Research Site | Suresnes | |
| France | Research Site | Toulouse | Midi-Pyrenees |
| France | Research Site | Tours | |
| France | Research Site | Villejuif | Val-de-Marne |
| Germany | Research Site | Amberg | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Bochum | Nordrhein-Westfalen |
| Germany | Research Site | Dresden | Sachsen |
| Germany | Research Site | Frankfurt | Hessen |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Herne | |
| Germany | Research Site | Monchengladbach | |
| Germany | Research Site | München | |
| Germany | Research Site | München | Bayern |
| Germany | Research Site | Reutlingen | Baden-Wurttemberg |
| Germany | Research Site | Ulm | Baden-Wuerttemberg |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Heraklion | |
| Greece | Research Site | Larissa | Thessaly |
| Greece | Research Site | Thessaloniki | |
| Greece | Research Site | Thessaloníki | |
| Hong Kong | Research Site | Central | |
| Hong Kong | Research Site | Hong Kong | |
| Ireland | Research Site | Dublin | |
| Ireland | Research Site | Dublin | |
| Ireland | Research Site | Dublin | |
| Ireland | Research Site | Dublin | |
| Italy | Research Site | Avellino | |
| Italy | Research Site | Biella | |
| Italy | Research Site | Cagliari | |
| Italy | Research Site | Candiolo | Torino |
| Italy | Research Site | Lido Di Camaiore | Lucca |
| Italy | Research Site | Meldola | |
| Italy | Research Site | Milan | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Naples | |
| Italy | Research Site | Padova | |
| Italy | Research Site | Pisa | |
| Italy | Research Site | Reggio Emilia | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Turin | |
| Korea, Republic of | Research Site | Anyang-si | Gyeonggi-do |
| Korea, Republic of | Research Site | Busan | |
| Korea, Republic of | Research Site | Busan | |
| Korea, Republic of | Research Site | Daejeon | |
| Korea, Republic of | Research Site | Goyang-si | |
| Korea, Republic of | Research Site | Hwasun | Jeollanam-do |
| Korea, Republic of | Research Site | Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Sowon | |
| Korea, Republic of | Research Site | Yangsan | Gyeongsangnam |
| Malaysia | Research Site | Johor Bahru | |
| Malaysia | Research Site | Kota Kinabalu | Sabah |
| Malaysia | Research Site | Kuala Lumpur | Selangor |
| Malaysia | Research Site | Kuala Lumpur | Selangor |
| Malaysia | Research Site | Petaling Jaya | Selangor |
| Malaysia | Research Site | Putrajaya | |
| Mexico | Research Site | Cuernavaca | Morelos |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | Mexico City | |
| Mexico | Research Site | San Juan Del Río | Queretaro |
| Mexico | Research Site | Tuxtla Gutiérrez | Chiapas |
| Mexico | Research Site | Veracruz | |
| Netherlands | Research Site | Amsterdam | Noor-Holland |
| Netherlands | Research Site | Amsterdam | Noord-Holland |
| Netherlands | Research Site | Nieuwegein | Utrecht |
| Netherlands | Research Site | Nijmegen | Gelderland |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Otwock | |
| Poland | Research Site | Warsaw | |
| Poland | Research Site | Warsaw | |
| Portugal | Research Site | Braga | |
| Portugal | Research Site | Lisboa | |
| Portugal | Research Site | Lisbon | |
| Portugal | Research Site | Porto | |
| Portugal | Research Site | Porto | |
| Puerto Rico | Research Site | San Juan | |
| Puerto Rico | Research Site | San Juan | |
| Romania | Research Site | Baia Mare | |
| Romania | Research Site | Brasov | |
| Romania | Research Site | Bucuresti | |
| Romania | Research Site | Cluj-Napoca | |
| Romania | Research Site | Cluj-Napoca | |
| Romania | Research Site | Craiova | |
| Romania | Research Site | Ovidiu | Constanta |
| Romania | Research Site | Timisoara | |
| Singapore | Research Site | Singapore | |
| Singapore | Research Site | Singapore | |
| Singapore | Research Site | Singapore | |
| Singapore | Research Site | Singapore | |
| Singapore | Research Site | Singapore | |
| Spain | Research Site | A Coruña | |
| Spain | Research Site | Badalona | Barcelona |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Córdoba | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Pamplona | |
| Spain | Research Site | Sabadell | |
| Spain | Research Site | Santander | |
| Spain | Research Site | Valencia | |
| Spain | Research Site | Valencia | |
| Taiwan | Research Site | Changhua | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taoyuan | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Chiang Mai | |
| Thailand | Research Site | Hat Yai | |
| United Kingdom | Research Site | Aberdeen | Scotland |
| United Kingdom | Research Site | Birmingham | England |
| United Kingdom | Research Site | Bournemouth | Dorset |
| United Kingdom | Research Site | Cambridge | England |
| United Kingdom | Research Site | Glasgow | Scotland |
| United Kingdom | Research Site | Leeds | England |
| United Kingdom | Research Site | London | England |
| United Kingdom | Research Site | London | England |
| United Kingdom | Research Site | Maidstone | England |
| United Kingdom | Research Site | Manchester | England |
| United Kingdom | Research Site | Middlesex | England |
| United Kingdom | Research Site | Sutton | England |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Baton Rouge | Louisiana |
| United States | Research Site | Belleville | New Jersey |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Chattanooga | Tennessee |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clovis | California |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Everett | Washington |
| United States | Research Site | Fairfax | Virginia |
| United States | Research Site | Florham Park | New Jersey |
| United States | Research Site | Fort Myers | Florida |
| United States | Research Site | Fredericksburg | Virginia |
| United States | Research Site | Fullerton | California |
| United States | Research Site | Gilbert | Arizona |
| United States | Research Site | Goodyear | Arizona |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | North Carolina |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lincoln | Nebraska |
| United States | Research Site | Longview | Texas |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Morgantown | West Virginia |
| United States | Research Site | Naperville | Illinois |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Brunswick | New Jersey |
| United States | Research Site | New York | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | Norwich | Connecticut |
| United States | Research Site | Ocala | Florida |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Port Jefferson Station | New York |
| United States | Research Site | Redlands | California |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rochester | Minnesota |
| United States | Research Site | Saint Paul | Minnesota |
| United States | Research Site | Saint Petersburg | Florida |
| United States | Research Site | Saint Petersburg | Florida |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Francisco | California |
| United States | Research Site | Santa Monica | California |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Somerset | New Jersey |
| United States | Research Site | Sparta | North Carolina |
| United States | Research Site | Springdale | Arkansas |
| United States | Research Site | Springfield | Missouri |
| United States | Research Site | Sylmar | California |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tallahassee | Florida |
| United States | Research Site | Temple | Texas |
| United States | Research Site | Torrance | California |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Vancouver | Washington |
| United States | Research Site | West Palm Beach | Florida |
| United States | Research Site | Weston | Florida |
| United States | Research Site | Whittier | California |
| United States | Research Site | Zion | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Mirati Therapeutics Inc. |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, 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, United Kingdom,
| 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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