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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04793958
Registration number
NCT04793958
Ethics application status
Date submitted
2/03/2021
Date registered
11/03/2021
Date last updated
15/03/2024
Titles & IDs
Public title
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
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Scientific 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
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Secondary ID [1]
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0
KRYSTAL-10
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Secondary ID [2]
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849-010
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Colorectal Cancer
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Metastatic Colorectal Cancer
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0
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Condition category
Condition code
Cancer
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0
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - MRTX849
Other interventions - Cetuximab
Treatment: Drugs - mFOLFOX6 Regimen
Treatment: Drugs - FOLFIRI Regimen
Experimental: MRTX849 + Cetuximab -
Active Comparator: mFOLFOX6 or FOLFIRI -
Treatment: Drugs: MRTX849
28 Day Cycle
Other interventions: Cetuximab
28 Day Cycle
Treatment: Drugs: mFOLFOX6 Regimen
Fluorouracil
Oxaliplatin
Folinic acid
Treatment: Drugs: FOLFIRI Regimen
Fluorouracil
Irinotecan
Folinic acid
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
0
0
Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Defined as time from date of randomization to date of death due to any cause.
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Timepoint [1]
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30 months
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Primary outcome [2]
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Progression-free Survival (PFS)
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Assessment method [2]
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Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
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Timepoint [2]
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30 months
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Secondary outcome [1]
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Adverse Events
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Assessment method [1]
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Defined as number of patients with treatment emergent AEs.
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Timepoint [1]
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30 months
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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Defined as the percent of patients documented to have a confirmed CR or PR.
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Timepoint [2]
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30 months
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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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.
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Timepoint [3]
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30 months
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Secondary outcome [4]
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Patient Reported Outcomes (PROs)
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Assessment method [4]
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To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).
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Timepoint [4]
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30 months
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Secondary outcome [5]
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Quality of Life Assessment
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Assessment method [5]
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To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
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Timepoint [5]
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30 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/02/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
461
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Research Site - Waratah
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Research Site - Bedford Park
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Research Site - Garran
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2298 - Waratah
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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3004 - Melbourne
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Recruitment postcode(s) [6]
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2605 - Garran
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Recruitment outside Australia
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Korea, Republic of
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Gyeongsangnam
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Busan
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Seoul
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Putrajaya
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Morelos
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Queretaro
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Mexico
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Lisbon
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Porto
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San Juan
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Romania
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Constanta
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Romania
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Cluj-Napoca
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Romania
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Timisoara
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Barcelona
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A Coruña
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Córdoba
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Madrid
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Pamplona
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Spain
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Spain
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Spain
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Kaohsiung
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Taipei
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Taoyuan
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Bangkok
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Thailand
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Hat Yai
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United Kingdom
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Dorset
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England
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United Kingdom
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Scotland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Mirati Therapeutics Inc.
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04793958
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Public notes
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Contacts
Principal investigator
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Hirak Der-Torossian, MD
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Address
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Mirati Therapeutics
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04793958
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