Spots Global Cancer Trial Database for Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer
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Trial Identification
Brief Title: Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer
Official Title: A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies
Study ID: NCT02219711
Conditions
Interventions
Study Description
Brief 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. 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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University, New York, 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, , Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Korea Veterans Health Service, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Contact Details
Name: Richard Chao, MD
Affiliation: Mirati Therapeutics Inc.
Role: STUDY_DIRECTOR
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