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Exelixis, Inc. Message Board

  • erniewerner erniewerner Feb 19, 2011 10:02 AM Flag

    Prostate Cancer Clinical Trials Working Group

    The following link is to the FDA sponsored "FDA Public Workshop on Clinical Trial Endpoints in Prostate Cancer" held in June 2004

    The next article is the 2008 publication of the recommendations of the Prostate Cancer Clinical Trials Working Group (PCWG2). Their recommendations are slanted more toward phase 2 trial design rather than endpoints for pivotal trials, but it is still a good starting reference. The group chose Dr. Scher as the corresponding author and it is not coincidental that he is collaborating with EXEL on the design of the first pivotal trial using a proposed pain/bone scan endpoint.

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    • Great find Earnie, Thanks for the post.

      Color me an optimist, but my read of the results was that the bar that was set for success fell pretty short of what is being achieved to date with CABO.

      Is that your impression?

      "Results The Prostate Cancer Clinical Trials Working Group (PCWG2) recommends a two-objective paradigm: (1) controlling, relieving, or eliminating disease manifestations that are present when treatment is initiated and (2) preventing or delaying disease manifestations expected to occur."

      Below confirms rational for unblinding the data.

      "Conclusion PCWG2 recommends increasing emphasis on time-to-event end points (ie, failure to progress) as decision aids in proceeding from phase II to phase III trials. Recommendations will evolve as data are generated on the utility of intermediate end points to predict clinical benefit."

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