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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:August 2014
End Date:September 2019
Contact:Mirati Therapeutics Study Locator Services
Email:miratistudylocator@emergingmed.com
Phone:1-844-893-5530

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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.

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.

Inclusion Criteria:

- Metastatic or unresectable solid tumor malignancy

- Standard treatment is not available

- Adequate bone marrow and organ function

Exclusion Criteria:

- History of a significant cardiovascular illness

- Prolonged corrected QT (QTc) interval

- Left ventricular ejection fraction < 40%

- Symptomatic or uncontrolled brain metastases

- Other active cancer
We found this trial at
38
sites
303 East Superior Street
Chicago, Illinois 60611
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Albuquerque, NM
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Austin, Texas 78705
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Birmingham, Alabama 35294
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Birmingham, AL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Denver, Colorado 80218
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Detroit, Michigan 48202
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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2620 W Faidley Ave
Grand Island, Nebraska 68803
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Greenville, South Carolina 29607
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New Orleans, Louisiana 70121
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Ocala, Florida 34471
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Omaha, NE
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Roanoke, VA
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Rockville, Maryland 20850
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4921 Parkview Place
Saint Louis, Missouri 63110
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Salt Lake City, Utah 84112
Phone: 801-587-4744
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San Diego, California 92093
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San Francisco, California 94143
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Santa Monica, California 90403
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Sarasota, Florida 34232
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Sayre, Pennsylvania 18840
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Tyler, Texas 75702
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Vancouver, Washington 98684
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Whittier, California 90603
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