Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer
NCT ID: NCT02219711
Last Updated: 2023-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
193 participants
INTERVENTIONAL
2014-08-31
2022-04-27
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
MGCD516
MGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water.
Interventions
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MGCD516
MGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Standard treatment is not available
* Adequate bone marrow and organ function
Exclusion Criteria
* Prolonged corrected QT (QTc) interval
* Left ventricular ejection fraction \< 40%
* Symptomatic or uncontrolled brain metastases
* Other active cancer
18 Years
ALL
No
Sponsors
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Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Chao, MD
Role: STUDY_DIRECTOR
Mirati Therapeutics Inc.
Locations
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University of Alabama
Birmingham, Alabama, United States
University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Sarcoma Oncology Research Center
Santa Monica, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Holy Cross Michael & Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, United States
Florida Cancer Affiliates
Ocala, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Maryland Oncology Hematology,
Rockville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University Center for Advanced Medicine
St Louis, Missouri, United States
CHI Health St Francis, Saint Francis Cancer Treatment Center
Grand Island, Nebraska, United States
Oncology Hematology West PC, Nebraska Cancer Specialists
Omaha, Nebraska, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Guthrie Clinical Research
Sayre, Pennsylvania, United States
St. Francis Cancer Center
Greenville, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology-Austin Midtown
Austin, Texas, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology-Tyler
Tyler, Texas, United States
The Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., Blue Ridge Cancer Care
Roanoke, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Chungbuk National University Hospital
Cheongju-si, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Korea Veterans Health Service
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Countries
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References
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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.
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.
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.
Other Identifiers
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516-001
Identifier Type: -
Identifier Source: org_study_id
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