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MRTX849 in Patients With Cancer Having a KRAS G12C Mutation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03785249
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : October 29, 2019
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Brief Summary:
Evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors that have a KRAS G12C mutation.

Condition or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease Drug: MRTX849 Phase 1 Phase 2

Detailed Description:
Evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally-available small molecule inhibitor of KRAS G12C.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: Phase 1 Dose Exploration
Dose escalation of MRTX849 to determine maximum tolerated dose
Drug: MRTX849
MRTX849 will be administered orally once daily in a continuous regimen

Experimental: Phase 1b Expansion
Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens
Drug: MRTX849
MRTX849 will be administered orally once daily in a continuous regimen

Experimental: Phase 2
Separate cohorts of patients stratified by histological diagnosis for evaluation of clinical activity of MRTX849
Drug: MRTX849
MRTX849 will be administered orally once daily in a continuous regimen

Primary Outcome Measures :
  1. Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation [ Time Frame: 20 months ]
    Number of participants with treatment related adverse events

  2. Evaluate the pharmacokinetics of MRTX849 [ Time Frame: 20 months ]
    Blood plasma concentration

Secondary Outcome Measures :
  1. Establish maximum tolerated dose [ Time Frame: 12 months ]
    Number of participants with dose limiting toxicity

  2. Evaluate clinical activity of MRTX849 [ Time Frame: 20 months ]
    Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
  • Unresectable or metastatic disease
  • Standard treatment is not available or patient declines
  • Adequate organ function

Exclusion Criteria:

  • Active brain metastases
  • History of intestinal disease or major gastric surgery or inability to swallow oral medications
  • Other active cancer

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 identifier (NCT number): NCT03785249

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Contact: Mirati Therapeutics Study Locator Services 1-844-893-5530

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United States, California
University of California San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
University of California, Irvine Recruiting
Orange, California, United States, 92868
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Medical Center Recruiting
Detroit, Michigan, United States, 48377
United States, New York
Perlmutter Cancer Center Recruiting
New York, New York, United States, 10016
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Tennessee
Tennessee Oncology/The Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75231
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Mirati Therapeutics Inc.
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Study Chair: Isan Chen Mirati Therapeutics

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Responsible Party: Mirati Therapeutics Inc. Identifier: NCT03785249     History of Changes
Other Study ID Numbers: 849-001
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Colon Cancer
Metastatic Cancer
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes