The compound, OGX-011, is a second-generation antisense drug designed to specifically inhibit the production of clusterin, a cell-survival protein associated with resistance to standard anticancer treatments.
The clinical trial is designed to assess the safety and efficacy of OGX-011 in combination with docetaxel in women with metastatic or locally advanced breast cancer. OncoGenex is developing OGX-011 in collaboration with Isis Pharmaceuticals.
Increased clusterin expression protects cancer cells from the cytotoxic effects of chemotherapy, leading to treatment resistance. By blocking the production of clusterin, OGX-011 may improve the effectiveness of existing chemotherapies. The primary objective of this study is to assess the objective response rates (reduction in tumor size) when OGX-011 is combined with docetaxel in patients with metastatic or locally recurrent breast cancer. Secondary endpoints include estimation of time to disease progression, overall survival and the effect of OGX-011 on serum clusterin.
Scott Cormack, president and CEO of OncoGenex said: “Based on patient accrual estimates, we look forward to beginning to uncover response data from the first of these phase II trials by the end of 2006 and continuing through 2007.”
Coordinated by the National Cancer Institute of Canada Clinical Trials Group, this multi-center, open-label phase II study will enroll up to 42 patients with carcinoma of the breast who show evidence of metastatic or locally advanced disease, which is not curable with standard treatment. Patients will receive a fixed dose of OGX-011 (640mg) once per week and will also receive docetaxel once every three weeks.