Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer

March 2, 2023 updated by: Mirati Therapeutics Inc.

A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies

MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles.

During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations.

Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed.

During the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon the following cancer diagnosis:

Non-small cell lung cancer with genetic alterations in MET, AXL, RET, TRK, DDR2, KDR, PDGFRA, KIT or CBL.

Head and neck squamous cell carcinoma with genetic alterations in MET.

Clear cell renal cell carcinoma refractory to angiogenesis inhibitors.

Metastatic prostate cancer with bone metastases.

Other cancer diagnosis having a selected genetic alteration in MGCD516 target RTKs.

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Cheongju-si, Korea, Republic of
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Hospital
      • Goyang-si, Korea, Republic of
        • National Cancer Center
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of
        • Korea Veterans Health Service
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • California
      • San Diego, California, United States, 92093
        • University of California, San Diego
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • Santa Monica, California, United States, 90403
        • Sarcoma Oncology Research Center
      • Whittier, California, United States, 90602
        • Innovative Clinical Research Institute
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Michael & Dianne Bienes Comprehensive Cancer Center
      • Ocala, Florida, United States, 34471
        • Florida Cancer Affiliates
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology,
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University Center for Advanced Medicine
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • CHI Health St Francis, Saint Francis Cancer Treatment Center
      • Omaha, Nebraska, United States, 68130
        • Oncology Hematology West PC, Nebraska Cancer Specialists
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10032
        • Columbia University
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care, Inc.
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinical Research
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • St. Francis Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Oncology-Austin Midtown
      • Dallas, Texas, United States, 75251
        • Mary Crowley Cancer Research Center
      • Houston, Texas, United States, 77030
        • University of Texas, MD Anderson Cancer Center
      • Tyler, Texas, United States, 75702
        • Texas Oncology-Tyler
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • The Huntsman Cancer Institute
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc., Blue Ridge Cancer Care
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, P.C.
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Metastatic or unresectable solid tumor malignancy
  • Standard treatment is not available
  • Adequate bone marrow and organ function

Exclusion Criteria:

  • History of a significant cardiovascular illness
  • Prolonged corrected QT (QTc) interval
  • Left ventricular ejection fraction < 40%
  • Symptomatic or uncontrolled brain metastases
  • Other active cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MGCD516
MGCD516 oral capsule, administered in escalating doses in Phase 1, beginning with daily dosing and exploring other regimens as necessary, in 21 or 28 days cycles
Drug: MGCD516
MGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water.
Other Names:
  • Sitravatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Type of dose limiting adverse event
Time Frame: Up to 3 weeks on treatment
Up to 3 weeks on treatment
Area under the plasma concentration versus time curve (AUC) of MGCD516
Time Frame: Up to 72 hours
Up to 72 hours
Peak Plasma Concentration (Cmax) of MGCD516
Time Frame: Up to 72 hours
Up to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kind of metabolites of MGCD516 in blood plasma
Time Frame: Up to 9 weeks on treatment
Up to 9 weeks on treatment
Concentration of selected marker proteins in blood plasma
Time Frame: Up to 9 weeks on treatment
Proteins include VEGF A, soluble VEGF-R2 and soluble MET
Up to 9 weeks on treatment
Percent of patients having objective disease response to treatment
Time Frame: Up to 1 year on treatment
Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Up to 1 year on treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mirati Therapeutics Inc.

Investigators

  • Study Director: Richard Chao, MD, Mirati Therapeutics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

April 27, 2022

Study Completion (Actual)

April 27, 2022

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 516-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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