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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)

Sponsor
Mirati Therapeutics Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04793958
Collaborator
(none)
420
Enrollment
209
Locations
2
Arms
45.5
Anticipated Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: MRTX849
  • Biological: Cetuximab
  • Drug: mFOLFOX6 Regimen
  • Drug: FOLFIRI Regimen
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Mar 15, 2021
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [30 months]

      Defined as time from date of randomization to date of death due to any cause.

    2. Progression-free Survival (PFS) [30 months]

      Defined as time from randomization until disease progression or death from any cause, whichever occurs first.

    Secondary Outcome Measures

    1. Adverse Events [30 months]

      Defined as number of patients with treatment emergent AEs.

    2. Objective Response Rate (ORR) [30 months]

      Defined as the percent of patients documented to have a confirmed CR or PR.

    3. Duration of Response (DOR) [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.

    4. Patient Reported Outcomes (PROs) [30 months]

      To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).

    5. Quality of Life Assessment [30 months]

      To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Birmingham Alabama United States 35205
    2 Research Site Gilbert Arizona United States 85234
    3 Research Site Goodyear Arizona United States 85338
    4 Research Site Phoenix Arizona United States 85054
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    197 Research Site Kaohsiung Taiwan 807
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    209 Research Site Aberdeen Scotland United Kingdom AB25 2ZN

    Sponsors and Collaborators

    • Mirati Therapeutics Inc.

    Investigators

    • Study Director: Hirak Der-Torossian, MD, Mirati Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mirati Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT04793958
    Other Study ID Numbers:
    • 849-010
    • KRYSTAL-10
    First Posted:
    Mar 11, 2021
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mirati Therapeutics Inc.
    Colorectal Cancer
    Colorectal Cancer Trial
    Colorectal Carcinoma
    Rectal Cancer
    Colon Cancer
    KRAS
    KRAS G12C
    RAS
    Colorectal Adenocarcinoma
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Cetuximab
    Adagrasib

    Study Results

    No Results Posted as of Aug 5, 2022