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Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Mirati Therapeutics Inc.
Information provided by (Responsible Party):
Mirati Therapeutics Inc. Identifier:
First received: May 14, 2008
Last updated: January 17, 2017
Last verified: January 2017
In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.

Condition Intervention Phase
Advanced Cancer
Drug: MGCD265
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Mirati Therapeutics Inc.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 1 year [Anticipated] ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 1 year [Anticipated] ]
  • Pharmacodynamics [ Time Frame: 1 year [Anticipated] ]
  • Clinical response [ Time Frame: 1 year [Anticipated] ]

Estimated Enrollment: 150
Study Start Date: June 2008
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MGCD265
Oral daily administration without interruption

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00697632

Contact: Mirati Therapeutics Study Locator Services 1-844-356-0895 (toll-free)

United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
UC San Diego Recruiting
San Diego, California, United States, 92093
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University, Alvin J. Siteman Cancer Center Recruiting
St. Louis, Missouri, United States, 63110
United States, New York
Columbia University, Herbert Irving Comprehensive Cancer Center Recruiting
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
University of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency, Vancouver Center Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T IE2
Korea, Republic of
National Cancer Center Recruiting
Gyeonggi-do, Korea, Republic of, 410-769
Seoul National University Hosptial Recruiting
Seoul, Korea, Republic of, 110-744
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Yonsei University Health System, Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Byoung Chul Cho         
Sponsors and Collaborators
Mirati Therapeutics Inc.
  More Information

Responsible Party: Mirati Therapeutics Inc. Identifier: NCT00697632     History of Changes
Other Study ID Numbers: 265-101
Study First Received: May 14, 2008
Last Updated: January 17, 2017

Keywords provided by Mirati Therapeutics Inc.:
HNSCC (Head and neck squamous cell carcinoma)
Phase 1
Solid tumor processed this record on May 25, 2017