OncoGenex Pharmaceuticals has just announced today that the company is “ready to proceed with two Phase 3 trial designs” for its investigational drug OGX-011, “one in first-line and one in second-line treatment of advanced prostate cancer.”
This announcement follows agreement with the U.S. Food and Drug Administration (FDA) allowing modifications to the study population of a previously reviewed Phase 3 trial.
According to Scott Cormack, the president and CEO of OncoGenex, “The trial for first-line treatment evaluates overall survival benefit for OGX-011 while the trial for second-line treatment evaluates for a durable pain palliation benefit.” However, the company’s media release implies that the implementation and timing of these two trials may be “subject to the receipt of additional funding.”
The revised “first-line” Phase III trial will be a randomized, controlled, international study, enrolling 800 men with metastatic, castaration-resistant prostate cancer (CRPC) who are in need of first-line chemotherapy. Patients will be randomized to receive treatment with either OGX-011 + docetaxel + prednisone or docetaxel + prednisone alone. The primary endpoint of the study will be overall survival. It is expected that approximately 80 sites, primarily in the United States and Canada, will participate in this study.
The media release from OncoGenex did not provide information about the projected start date for the first-line chemotherapy trial, and it provided no additional information about the size, structure, or timing for the second-line chemotherapy study. Yhe “New” Prostate Cancer InfoLink assumes that this additional information will become available once the company has raised the funds necessary to implement two relatively large, Phase III clinical trials.
Filed under: Drugs in development, Management, Treatment
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I have prostate cancer spread to the lymph nodes. How do I apply for the clinical trial?
Dear Mr. Monroe:
Unfortunately you would not be eligible for this trial unless you have: (a) evident metastatic prostate cancer (as opposed to lymph node-positive disease) and (b) you have already received docetaxel-based chemotherapy and have progressive disease after such treatment.