OncoGenex starts first Phase III trial of custirsen sodium (OGX-011) in mCRPC

OncoGenex has initiated the first of two Phase III trials of custirsen sodium (OGX-011) in the treatment of men with metastatic castrate-resistant prostate cancer (mCPRC).

According to a media release issued by the company earlier today, this randomized, double-blind, controlled, clinical trial — known as the SATURN study — will be conducted at approximately 50 cancer centers and will enroll about 300 patients with mCRPC who have previously responded to first-line docetaxel therapy, but have had subsequent disease progression that involves prostate cancer-related pain despite opioid usage. Patients will be randomized to receive retreatment with either docetaxel + prednisone + custirsen sodium or docetaxel + prednisone + a placebo in a blinded manner.

The primary endpoint of the SATURN trial will be to determine whether durable relief from pain is observed for 12 weeks or more in patients in one or other arm of the study. Additional information about the trial is available on ClinicalTrials.gov or on the company’s web site.

Not all trial sites will be enrolling patients immediately. European trial sites, for example, will only start to enroll patients in the third quarter of 2010.

A second, randomized, double-blind, controlled, Phase III clinical trial is planned that will evaluate the ability of docetaxel + prednisone + custirsen sodium to extend overall survival of patients compared to docetaxel + prednisone + a placebo in men with mCRPC. The timing of this second trial in advanced prostate cancer is still to be announced.

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