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

Phase 3Active Not RecruitingNCT04793958

Mirati Therapeutics Inc.461 enrolled

Overview

Study CA239-0006 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

461

Conditions

Advanced Colorectal Cancer Metastatic Colorectal Cancer

Interventions

MRTX849DRUG

28 Day Cycle

CetuximabBIOLOGICAL

28 Day Cycle

mFOLFOX6 RegimenDRUG

* Fluorouracil * Oxaliplatin * Folinic acid

FOLFIRI Regimen

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (419)

Outcomes

Primary Outcomes

Overall Survival (OS)

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

Time frame: 30 months

Progression-free Survival (PFS)

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

Time frame: 30 months

Secondary Outcomes

Adverse Events

Defined as number of patients with treatment emergent AEs.

Time frame: 30 months

Objective Response Rate (ORR)

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

Time frame: 30 months

Duration of Response (DOR)

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.

Time frame: 30 months

Patient Reported Outcomes (PROs)

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

Time frame: 30 months

Quality of Life Assessment

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

Time frame: 30 months

Data from ClinicalTrials.gov

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Alabaster, Alabama, United States

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Bessemer, Alabama, United States

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