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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 1 Interventional 18 Years and older Mirati Therapeutics Inc. 516-001
NCT02219711
Enrolling patients

Study Design:


Principal Investigator

Assistant Clinical Professor
Division of Hematology/Oncology
Department of Medicine

Clinical Research Coordinator

UCSF Helen Diller Family Comprehensive Cancer Center
415) 353-9712 Phone
(415) 353-9721 Fax

Trial 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.

Eligibility

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

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.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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