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

Completed · Phase 1

Conditions studied: Advanced Cancer

In brief

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

Key facts

Study ID

NCT00697632

Run by

Mirati Therapeutics Inc.

People needed

180

Starts

2008-06-01

Expected to finish

2019-01-01

Last updated by the study team

2019-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University, Alvin J. Siteman Cancer Center — St Louis, Missouri, United States
• Columbia University, Herbert Irving Comprehensive Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Cross Cancer Institute — Edmonton, Alberta, Canada
• British Columbia Cancer Agency, Vancouver Center — Vancouver, British Columbia, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• National Cancer Center — Gyeonggi-do, South Korea
• Seoul National University Hosptial — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• Yonsei University Health System, Severance Hospital — Seoul, South Korea
• City of Hope — Duarte, California, United States
• UC Irvine Medical Center — Orange, California, United States
• UC San Diego — San Diego, California, United States
• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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