OncoGenex completes enrollment of patients to Phase III trial of custirsen in mCRPC

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.

6 Responses

  1. I know this is probably good, but I just wish there were more drugs in the mill that extend life more than just a couple to 7 months. Progress seems so little.

  2. It’s not probably good. It is good. For decades, there were no (0) drugs that showed significant survival benefit. Now there are several: Zytiga, Xtandi, Provenge, and others that at least show an average of 4+ months. For many, the survival benefit is years.

    It will be interesting to see how the sequencing (or the combination) of these drugs, and others, will increase the survival benefit.

    I appreciate what you are saying, but the number of new drugs for prostate cancer in just the last 4-5 years is amazing. I imagine it is tough to prove survival benefit through all the hoops companies have to go through.

  3. Just want to survive long enough for a cure. Maybe one of the vaccines that’s being worked on can give me enough time, if it’s in God’s plan.

  4. My husband died at just 54 while on this trial. For just [4 or 5?] weeks. He was relatively active and well when it began.

  5. Can anyone tell me how toxic it is. I have had docetaxel a year ago and now they want me to do it again with OGX-011 added.

  6. Dear Mike:

    Go to this link and look at slides 13 and 14.

    The only major difference I can see (from the Phase II trial data) between docetaxel alone and docetaxel + OGX-011 is an increased impact on lymphocyte levels for the combination.

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