Last updated on July 2019

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


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02219711

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University of Alabama

Birmingham, AL United States
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Florida Cancer Specialists

Sarasota, FL United States
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Northwestern University

Chicago, IL United States
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University of Michigan

Ann Arbor, MI United States
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Henry Ford Health System

Detroit, MI United States
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Columbia University

New York, NY United States
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St. Francis Cancer Center

Greenville, SC United States
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The Huntsman Cancer Institute

Salt Lake City, UT United States
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Virginia Cancer Specialists

Fairfax, VA United States
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University of Wisconsin

Madison, WI United States
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Maryland Oncology Hematology,

Rockville, MD United States
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Oncology Hematology Care, Inc.

Cincinnati, OH United States
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Texas Oncology-Tyler

Tyler, TX United States
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National Cancer Center

Goyang-si, Korea, Republic of
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Sarcoma Oncology Research Center

Santa Monica, CA United States
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Ochsner Clinic Foundation

New Orleans, LA United States
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