A new phase 3, registration trial has been announced by OncoGenex Pharmaceuticals, Inc. of its investigational drug custirsen sodium (OGX-011/TV-1011). The trial, for men with metastatic castrate resistant prostate cancer (mCRPC) is referred to as the Prostate Cancer SATURN Trial.
This randomized, controlled, trial will include approximately 50 cancer centers and is planned to enroll approximately 300 men with mCRPC who have previously responded to first-line docetaxel therapy, but subsequently have disease progression that involves prostate cancer-related pain despite opioid usage.
The subject men will be randomized to receive treatment with docetaxel/prednisone plus OGX-011/ TV-1011 or docetaxel/prednisone plus placebo in a blinded manner. The primary endpoint of this trial will be durable pain palliation for 12 weeks or more in the men treated with docetaxel/prednisone plus OGX-011/ TV-1011 compared to docetaxel/prednisone plus placebo.
The Principal Investigators for the SATURN trial are Dr. Tomasz Beer at the Oregon Health & Science University Knight Cancer Institute for the United States, Dr. Sebastien Hotte at Juravinski Cancer Centre in Hamilton, Ontario for Canada and