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

Completed · Phase 1

Conditions studied: Advanced Cancer

In brief

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.

Key facts

Study ID

NCT02219711

Run by

Mirati Therapeutics Inc.

People needed

193

Starts

2014-08-01

Expected to finish

2022-04-27

Last updated by the study team

2023-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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