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

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

California

San Diego
University of California San Diego
Status: Active
Contact: Lyudmila Alexandrovna Bazhenova
Phone: 858-822-5354
Email: cancercto@ucsd.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Name Not Available

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Contact: James W. Mier
Phone: 617-667-9925
Email: jmier@bidmc.harvard.edu
Dana-Farber Cancer Institute
Status: Active
Contact: Rebecca Suk Heist
Phone: 877-726-5130
Email: rheist@partners.org
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Rebecca Suk Heist
Phone: 877-726-5130
Email: rheist@partners.org

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Ajjai Shivaram Alva
Phone: 734-647-8903

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Richard C. Lauer
Phone: 505-272-6972
Email: rlauer@salud.unm.edu

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Contact: Sanjay Goel
Phone: 718-904-2730
Email: aecc@aecom.yu.edu
Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Contact: Gary K. Schwartz
Phone: 212-305-8615
Email: gks2123@cumc.columbia.edu

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Shubham Pant
Phone: 713-563-0193ext0

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Theresa Werner
Email: theresa.werner@hci.utah.edu

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Contact: Keith D. Eaton
Phone: 800-804-8824
Email: kdeaton@u.washington.edu

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Christos Kyriakopoulos
Phone: 608-263-0786
Email: ckyriako@medicine.wisc.edu

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Mirati Therapeutics

Trial IDs

Primary ID 516-001
Secondary IDs NCI-2014-01866
Clinicaltrials.gov ID NCT02219711