Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.

Official Title

Open-Label Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Daily Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies

Details

MGCD265 belongs to a new class of drugs with anticancer potential, known as tyrosine kinase inhibitors. MGCD265 was shown to slow down the growth of human cancer cells in mice. Clinical studies are being pursued to evaluate the safety of MGCD265 in cancer patients.

In this study, MGCD265 is orally administered on a daily basis to patients with advanced malignancies.

Keywords

Advanced Cancer MET AXL VEGFR NSCLC HNSCC (Head and neck squamous cell carcinoma) Tumor Safety Phase 1 Solid tumor MGCD265

Eligibility

You can join if…

Open to people ages 18 years and up

  • Advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit, and/or the patient declines to receive standard treatment such as chemotherapy.
  • Evaluable disease;
  • Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy;
  • Recovery from the adverse effects ≤ grade 1;
  • Acceptable ECOG status 0, 1, or 2;
  • Life expectancy greater than 3 months following study entry;
  • Adequate laboratory values;
  • For patients enrolling in the four expansion cohorts:
  • NSCLC patients must meet criteria for MET and/or Axl expression or,
  • HNSCC patients must meet criteria for MET and/or Axl expression or,
  • NSCLC patients must meet criteria for amplification of the MET gene locus,defined MET mutations, or rearrangements involving the AXL or MET gene locus or;
  • Patients with tumor types such as HNSCC, papillary renal carcinoma, gastric adenocarcinoma, and other solid tumors must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus

You CAN'T join if...

  • Uncontrolled concurrent illness;
  • History of cardiovascular illness;
  • QTc > 470 msec (including subjects on medication);
  • Left ventricular ejection fraction (LVEF) < 50%;
  • Immunocompromised subjects;
  • History of bone marrow transplant;
  • Lung tumor lesions with increased likelihood of bleeding;
  • Symptomatic or uncontrolled brain metastases;
  • Unable to swallow oral medications or with pre-existing gastrointestinal disorders.

Locations

  • UC San Diego
    San Diego California 92093 United States
  • UC Irvine Medical Center
    Orange California 92868 United States
  • City of Hope
    Duarte California 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirati Therapeutics Inc.
ID
NCT00697632
Phase
Phase 1
Study Type
Interventional
Last Updated
August 1, 2018