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Advanced CancerPhase 1NCT02219711

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

A Phase 1 study testing MGCD516 in people with Advanced Cancer, run by Mirati Therapeutics Inc. at 43 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
MGCD516
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
193 participants
Where
43 sitesin 2 countries
Study dates
Aug 2014to 27 Apr 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

United States37 sites

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87102

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705

  • University of Alabama

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75251

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Holy Cross Michael & Dianne Bienes Comprehensive Cancer Center

    Fort Lauderdale, Florida, 33308

  • CHI Health St Francis, Saint Francis Cancer Treatment Center

    Grand Island, Nebraska, 68803

  • St. Francis Cancer Center

    Greenville, South Carolina, 29607

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University

    New York, New York, 10032

  • Florida Cancer Affiliates

    Ocala, Florida, 34471

  • Oncology Hematology West PC, Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Oncology and Hematology Associates of Southwest Virginia, Inc., Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Maryland Oncology Hematology,

    Rockville, Maryland, 20850

  • The Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of California, San Diego

    San Diego, California, 92093

  • University of California, San Francisco

    San Francisco, California, 94143

  • Sarcoma Oncology Research Center

    Santa Monica, California, 90403

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • Guthrie Clinical Research

    Sayre, Pennsylvania, 18840

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Washington University Center for Advanced Medicine

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

  • Innovative Clinical Research Institute

    Whittier, California, 90602

Other trials in United States

South Korea6 sites

  • Chungbuk National University Hospital

    Cheongju-si

  • Keimyung University Dongsan Hospital

    Daegu

  • National Cancer Center

    Goyang-si

  • Korea Veterans Health Service

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Advanced Cancer
Being tested
MGCD516
Keywords
MGCD516, MET, AXL, RET, TRK, NTRK, DDR2, KDR, VEGFR, PDGFRA, KIT, Tyrosine kinase inhibitor, NSCLC, Non-small cell lung cancer, Head and neck cancer, Renal cell carcinoma, Prostate cancer, Phase 1, CBL, Sitravatinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Carcinoma, Renal Cell, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MGCD516Drug

    Also called Sitravatinib

    MGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water.

Study groups in NCT02219711
Study groupRoleWhat they receive
MGCD516ExperimentalMGCD516 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
Receives: Drug: MGCD516

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Type of dose limiting adverse event

    Measured: Up to 3 weeks on treatment

  2. Area under the plasma concentration versus time curve (AUC) of MGCD516

    Measured: Up to 72 hours

  3. Peak Plasma Concentration (Cmax) of MGCD516

    Measured: Up to 72 hours

Secondary outcomes (3)

  1. Kind of metabolites of MGCD516 in blood plasma

    Measured: Up to 9 weeks on treatment

  2. Concentration of selected marker proteins in blood plasma

    Proteins include VEGF A, soluble VEGF-R2 and soluble MET

    Measured: Up to 9 weeks on treatment

  3. Percent of patients having objective disease response to treatment

    Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Measured: Up to 1 year on treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completion27 Apr 2022
  4. Study completion27 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02219711
Sponsor's protocol ID
516-001
Status last verified
Mar 2023
First submitted
14 Aug 2014
Last updated
6 Mar 2023
Results posted
No
Data monitoring committee
No

Publications

  • Bazhenova L, Kim DW, Cho BC, Goel S, Heist R, Werner TL, Eaton KD, Wang JS, Pant S, Adkins DR, Blakely CM, Yan X, Neuteboom S, Christensen JG, Chao R, Bauer T. Sitravatinib in patients with solid tumors selected by molecular alterations: results from a Phase Ib study. Future Oncol. 2024 Dec;20(39):3213-3227. doi: 10.1080/14796694.2024.2418285. Epub 2024 Nov 8.

    PubMed 39513224

  • Pant S, Cho BC, Kyriakopoulos CE, Spira A, Tannir N, Werner TL, Yan X, Neuteboom S, Chao R, Goel S. Targeting multiple receptor tyrosine kinases with sitravatinib: A Phase 1b study in advanced renal cell carcinoma and castrate-resistant prostate cancer. Invest New Drugs. 2024 Oct;42(5):547-558. doi: 10.1007/s10637-024-01465-9. Epub 2024 Aug 21.

    PubMed 39168901

  • Bauer T, Cho BC, Heist R, Bazhenova L, Werner T, Goel S, Kim DW, Adkins D, Carvajal RD, Alva A, Eaton K, Wang J, Liu Y, Yan X, Christensen J, Neuteboom S, Chao R, Pant S. First-in-human phase 1/1b study to evaluate sitravatinib in patients with advanced solid tumors. Invest New Drugs. 2022 Oct;40(5):990-1000. doi: 10.1007/s10637-022-01274-y. Epub 2022 Jun 29.

    PubMed 35767205

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MGCD516 in people with Advanced Cancer, run by Mirati Therapeutics Inc. at 43 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Type of dose limiting adverse event (time frame: Up to 3 weeks on treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02219711, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.

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