Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04793958|
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : September 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Colorectal Cancer Metastatic Colorectal Cancer||Drug: MRTX849 Biological: Cetuximab Drug: mFOLFOX6 Regimen Drug: FOLFIRI Regimen||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 15, 2021|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||December 30, 2024|
|Experimental: MRTX849 + Cetuximab||
28 Day Cycle
28 Day Cycle
Other Name: Erbitux
|Active Comparator: mFOLFOX6 or FOLFIRI||
Drug: mFOLFOX6 Regimen
Drug: FOLFIRI Regimen
- Overall Survival (OS) [ Time Frame: 30 months ]Defined as time from date of randomization to date of death due to any cause.
- Progression-free Survival (PFS) [ Time Frame: 30 months ]Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
- Adverse Events [ Time Frame: 30 months ]Defined as number of patients with treatment emergent AEs.
- Objective Response Rate (ORR) [ Time Frame: 30 months ]Defined as the percent of patients documented to have a confirmed CR or PR.
- Duration of Response (DOR) [ Time Frame: 30 months ]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.
- Patient Reported Outcomes (PROs) [ Time Frame: 30 months ]To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).
- Quality of Life Assessment [ Time Frame: 30 months ]To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793958
|Contact: Mirati Therapeutics Study Locator Servicesemail@example.com|
|Study Director:||Hirak Der-Torossian, MD||Mirati Therapeutics|