A Phase 1-2 Study of Weekly OGX-011 Plus a Gemcitabine/Platinum-Based Regimen in Patients With Stage IIIB or IV Non Small Cell Lung Cancer
OGX-011 is an experimental drug that has been shown to increase the effectiveness of
commonly used cancer therapies such as chemotherapy, radiation and hormone therapy in
several kinds of cancer types in animals. OGX-011 is being studied in the treatment of
cancer patients in combination with chemotherapy. In humans, OGX-011 in combination with
hormone therapy has been shown to decrease the tissue levels of a protein called clusterin,
which can be overproduced in cancer cells. Clusterin has been found to block cell death and
makes cells more resistant to cancer therapy. Gemcitabine (GEM), cisplatin (CIS) and
carboplatin (CARB) have been approved by Health Canada and the Food and Drug Administration
in the United States for the treatment of patients with lung cancer.
OGX-011 was administered as a 2-hr intravenous (IV) infusion on Days -7, -5, and -3 prior to
Cycle 1, then weekly on Days 1, 8, 15 of each 21-day cycle; GEM was infused IV after OGX-011
on Days 1 and 8; either CIS or CARB was infused IV after GEM on Day 1 of each cycle. Six
cycles of treatment were planned. Most patients received OGX-011 at 640 mg, but 3 patients
received OGX-011 at 480 mg dose; OGX-011 dose groups were combined due to the small number
of patients who received 480 mg.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate of OGX-011 in Combination With Gemcitabine/Platinum-based Regimen
Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR). The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles. CR: disappearance of clinical/radiological evidence of tumor. PR: >= 30% decrease in the sum of the longest diameter of target lesions. SD: did not fulfill the criteria for CR or PR but not progressive disease.
Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death.
Janessa Laskin, M.D.
BCCA, Vancouver Clinic
United States: Food and Drug Administration
|Cancer Centers of the Carolinas||Greenville, South Carolina 29605|
|Mary Crowley Medical Research Center||Dallas, Texas 75246|
|Oregon Health and Science University||Portland, Oregon 97201|
|New York Oncology Hematology||Albany, New York 12208|
|University of Southern California Norris||Los Angeles, California 90033|
|LAC-USC Medical Center||Los Angeles, California 90033|