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

NCT04793958

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT04793958

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 849-010
  • SECONDARY ID: KRYSTAL-10
  • NCT ID: NCT04793958

Conditions

  • Advanced Colorectal Cancer
  • Metastatic Colorectal Cancer

Interventions

DrugSynonymsArms
MRTX849MRTX849 + Cetuximab
CetuximabErbituxMRTX849 + Cetuximab
mFOLFOX6 RegimenmFOLFOX6 or FOLFIRI
FOLFIRI RegimenmFOLFOX6 or FOLFIRI

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
MRTX849 + CetuximabExperimental
  • MRTX849
  • Cetuximab
mFOLFOX6 or FOLFIRIActive Comparator
  • mFOLFOX6 Regimen
  • FOLFIRI Regimen

Eligibility Criteria

        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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:30 months
Safety Issue:
Description:Defined as time from date of randomization to date of death due to any cause.

Secondary Outcome Measures

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

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Mirati Therapeutics Inc.

Trial Keywords

  • Colorectal Cancer
  • Colorectal Cancer Trial
  • Colorectal Carcinoma
  • Rectal Cancer
  • Colon Cancer
  • KRAS
  • KRAS G12C
  • RAS
  • Colorectal Adenocarcinoma

Last Updated

August 16, 2021