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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)

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ClinicalTrials.gov Identifier: NCT04793958
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Study Description
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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
Advanced Colorectal Cancer Metastatic Colorectal Cancer Drug: MRTX849 Biological: Cetuximab Drug: mFOLFOX6 Regimen Drug: FOLFIRI Regimen Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 15, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: MRTX849 + Cetuximab Drug: MRTX849
28 Day Cycle

Biological: Cetuximab
28 Day Cycle
Other Name: Erbitux
Active Comparator: mFOLFOX6 or FOLFIRI Drug: mFOLFOX6 Regimen
  • Fluorouracil
  • Oxaliplatin
  • Folinic acid

Drug: FOLFIRI Regimen
  • Fluorouracil
  • Irinotecan
  • Folinic acid


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 30 months ]
    Defined as time from date of randomization to date of death due to any cause.

  2. Progression-free Survival (PFS) [ Time Frame: 30 months ]
    Defined as time from randomization until disease progression or death from any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 30 months ]
    Defined as number of patients with treatment emergent AEs.

  2. Objective Response Rate (ORR) [ Time Frame: 30 months ]
    Defined as the percent of patients documented to have a confirmed CR or PR.

  3. 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.

  4. Patient Reported Outcomes (PROs) [ Time Frame: 30 months ]
    To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).

  5. Quality of Life Assessment [ Time Frame: 30 months ]
    To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Mirati Therapeutics Study Locator Services 1-844-893-5530 miratistudylocator@emergingmed.com

Locations
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United States, Arkansas
Highlands Oncology Group Recruiting
Springdale, Arkansas, United States, 72762
United States, Connecticut
Eastern CT Hematology and Oncology Associates Recruiting
Norwich, Connecticut, United States, 06360
United States, Florida
Comprehensive Hematology Oncology Recruiting
Saint Petersburg, Florida, United States, 33709
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Sponsors and Collaborators
Mirati Therapeutics Inc.
Investigators
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Study Director: Andrew Chi, MD, Ph.D Mirati Therapeutics
More Information
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04793958    
Other Study ID Numbers: 849-010
KRYSTAL-10 ( Other Identifier: Mirati Therapeutics )
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents