Status:
COMPLETED
Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 be...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00697632
Start Date
June 1 2008
End Date
January 1 2019
Last Update
February 12 2019
Active Locations (19)
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1
City of Hope
Duarte, California, United States, 91010
2
UC Irvine Medical Center
Orange, California, United States, 92868
3
UC San Diego
San Diego, California, United States, 92093
4
University of Chicago
Chicago, Illinois, United States, 60637