Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies
- Registration Number
- NCT00697632
- Lead Sponsor
- Mirati Therapeutics Inc.
- Brief Summary
In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
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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.
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Evaluable disease;
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Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy;
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Recovery from the adverse effects ≤ grade 1;
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Acceptable ECOG status 0, 1, or 2;
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Life expectancy greater than 3 months following study entry;
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Adequate laboratory values;
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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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 MGCD265 -
- Primary Outcome Measures
Name Time Method Safety and tolerability 1 year [Anticipated]
- Secondary Outcome Measures
Name Time Method Pharmacodynamics 1 year [Anticipated] Clinical response 1 year [Anticipated] Pharmacokinetics 1 year [Anticipated]
Trial Locations
- Locations (19)
National Cancer Center
🇰🇷Gyeonggi-do, Korea, Republic of
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
British Columbia Cancer Agency, Vancouver Center
🇨🇦Vancouver, British Columbia, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
University of Chicago
🇺🇸Chicago, Illinois, United States
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
City of Hope
🇺🇸Duarte, California, United States
UC San Diego
🇺🇸San Diego, California, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Washington University, Alvin J. Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
UC Irvine Medical Center
🇺🇸Orange, California, United States
Columbia University, Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Texas, MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hosptial
🇰🇷Seoul, Korea, Republic of