Posted on November 6, 2012 by Sitemaster
Well, it?s taken a little over 2 years, but OncoGenex has completed enrollment of patients into the randomized, double-blind, Phase III SYNERGY trial, which is designed to assess whether the addition of custirsen (OGX-011) to docetaxel-based chemotherapy can extend the survival of men with metastatic, castration-resistant prostate cancer (mCRPC).
The SYNERGY study is one of two ongoing, pivotal Phase III studies evaluating the potential benefits of treatment with custirsen for men with castration-resistant forms of prostate cancer.
According to a media release from OncoGenex Pharmaceuticals earlier today, the company has enrolled > 1,000 men into the SYNERGY study, at 142 different clinical trials sites (mostly in the USA, Canada, and Europe). The company has stated that survival data are now expected by the end of 2013.
For those who have forgotten, custirsen in combination with docetaxel-based chemotherapy had shown a survival benefit of 6.9 months over docetaxel-based chemotherapy alone in Phase I and Phase II trials involving some 294 patients, and completed several years ago now. Adverse events to custirsen recorded in those trials were relatively mild. The most common adverse events associated with custirsen were flu-like symptoms. However, more serious adverse events associated with custirsen and docetaxel included febrile neutropenia, fever, pleural effusion, and dyspnea, with each of these types of adverse event occurring in some 2 to 4 percent of patients in the Phase II study.
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Filed under: Drugs in development Tagged: | custirsen, mCRPC, OGX-011, Phase III, trial
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