Clinical Trial - NCT02219711

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

Recruiting

Sponsor: Mirati Therapeutics Inc.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02219711

Protocol Info

Short Description: Phase 1/1b of MGCD516 in Advanced Solid Tumors
Long Description: A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies
MGH Status: Open
Sponsor: Methylgene
Disease Program: Phase I

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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.
Condition Title Intervention Phase
Advanced Cancer MGCD516 Phase 1
Study Type Interventional
Official Title A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies

Primary Outcome Measures

Type of dose limiting adverse event [Time Frame: Up to 3 weeks on treatment] [Designated as safety issue: ]

Area under the plasma concentration versus time curve (AUC) of MGCD516 [Time Frame: Up to 72 hours] [Designated as safety issue: ]

Peak Plasma Concentration (Cmax) of MGCD516 [Time Frame: Up to 72 hours] [Designated as safety issue: ]


Secondary Outcome Measures

Kind of metabolites of MGCD516 in blood plasma [Time Frame: Up to 9 weeks on treatment] [Designated as safety issue: ]

Concentration of selected marker proteins in blood plasma [Time Frame: Up to 9 weeks on treatment] [Designated as safety issue: ]

Percent of patients having objective disease response to treatment [Time Frame: Up to 1 year on treatment] [Designated as safety issue: ]

Estimated Enrollment: 260
Study Start Date: August 2014
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: December 2019
Arms Assigned Interventions

Experimental: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
Drug:MGCD516
MGCD516 capsules will be taken with water.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02219711

Locations

  • United States, Alabama
    • University of Alabama Birmingham, Alabama, United States, 35294
  • United States, California
    • University of California, San Diego San Diego, California, United States, 92093
    • University of California, San Francisco San Francisco, California, United States, 94143
    • Sarcoma Oncology Research Center Santa Monica, California, United States, 90403
    • Innovative Clinical Research Institute Whittier, California, United States, 90602
  • United States, Colorado
    • Rocky Mountain Cancer Center Denver, Colorado, United States, 80218
  • United States, Florida
    • Holy Cross Michael & Dianne Bienes Comprehensive Cancer Center Fort Lauderdale, Florida, United States, 33308
    • Florida Cancer Affiliates Ocala, Florida, United States, 34471
    • Florida Cancer Specialists Sarasota, Florida, United States, 34232
  • United States, Illinois
    • Northwestern University Chicago, Illinois, United States, 60611
    • Rush University Medical Center Chicago, Illinois, United States, 60612
  • United States, Louisiana
    • Ochsner Clinic Foundation New Orleans, Louisiana, United States, 70121
  • United States, Maryland
    • Maryland Oncology Hematology, Rockville, Maryland, United States, 20850
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • University of Michigan Ann Arbor, Michigan, United States, 48109
    • Henry Ford Health System Detroit, Michigan, United States, 48202
  • United States, Missouri
    • Washington University Center for Advanced Medicine Saint Louis, Missouri, United States, 63110
  • United States, Nebraska
    • CHI Health St Francis, Saint Francis Cancer Treatment Center Grand Island, Nebraska, United States, 68803
    • Oncology Hematology West PC, Nebraska Cancer Specialists Omaha, Nebraska, United States, 68130
  • United States, New Mexico
    • University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico, United States, 87102
  • United States, New York
    • Montefiore Medical Center Bronx, New York, United States, 10467
    • Roswell Park Cancer Institute Buffalo, New York, United States, 14263
    • Columbia University New York, New York, United States, 10032
  • United States, Ohio
    • Oncology Hematology Care, Inc. Cincinnati, Ohio, United States, 45242
  • United States, Pennsylvania
    • Guthrie Clinical Research Sayre, Pennsylvania, United States, 18840
  • United States, South Carolina
    • St. Francis Cancer Center Greenville, South Carolina, United States, 29607
  • United States, Tennessee
    • Sarah Cannon Research Institute Nashville, Tennessee, United States, 37203
  • United States, Texas
    • Texas Oncology-Austin Midtown Austin, Texas, United States, 78705
    • Mary Crowley Cancer Research Center Dallas, Texas, United States, 75251
    • University of Texas, MD Anderson Cancer Center Houston, Texas, United States, 77030
    • Texas Oncology-Tyler Tyler, Texas, United States, 75702
  • United States, Utah
    • The Huntsman Cancer Institute Salt Lake City, Utah, United States, 84112
  • United States, Virginia
    • Virginia Cancer Specialists Fairfax, Virginia, United States, 22031
    • Oncology and Hematology Associates of Southwest Virginia, Inc., Blue Ridge Cancer Care Roanoke, Virginia, United States, 24014
  • United States, Washington
    • Seattle Cancer Care Alliance Seattle, Washington, United States, 98109
    • Northwest Cancer Specialists, P.C. Vancouver, Washington, United States, 98684
  • United States, Wisconsin
    • University of Wisconsin Madison, Wisconsin, United States, 53792
  • Korea, Republic of,
    • 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,

Sponsors and Collaborators

Mirati Therapeutics Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02219711
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Mirati Therapeutics Inc.:

MGCD516

MET

AXL

RET

TRK

NTRK

DDR2

KDR

VEGFR

PDGFRA

KIT

Tyrosine kinase inhibitor

NSCLC

Non-small cell lung cancer

Head and neck cancer

Renal cell carcinoma

Prostate cancer

Phase 1

CBL

Additional relevant MeSH terms:

Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019