Non-small Cell Lung Cancer Clinical Trial
Official title:
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
This clinical study will help determine if giving OGX-011 (custirsen sodium) in combination with gemcitabine (GEM) and cisplatin (CIS) or carboplatin (CARB) is a safe and effective treatment for patients with lung cancer. This study will help to assess the safety and anti-tumor effect of OGX-011 when given to patients in combination with GEM and CIS/CARB.
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
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