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OncoGenex Pharmaceuticals, Inc. Message Board

  • mr_ssssamsa mr_ssssamsa Feb 19, 2011 6:08 PM Flag

    Trial timelines on clinicaltrials.gov

    In looking at the timeframes on clinicaltrials.gov for the P2 and P3 trials that are currently in progress, I noticed that the estimated primary completion date for the randomized P2 trial for OGX-427 in prostate cancer is March 2011:

    Estimated Enrollment: 72
    Study Start Date: September 2010
    Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

    Even though the primary endpoint is the proportion of patients without disease progression after 12 weeks, it's hard to believe they could enroll the patients that quickly. Does anyone have any thoughts on how seriously we should take the estimated primary completion dates on clinicaltrials.gov?

    By comparison, here are the timeframes provided on clinicaltrials.gov for the other trials:

    SYNERGY TRIAL FOR OGX-011:
    Estimated Enrollment: 800
    Study Start Date: October 2010
    Estimated Study Completion Date: January 2014
    Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

    SATURN TRIAL FOR OGX-011:
    Estimated Enrollment: 292
    Study Start Date: March 2010
    Estimated Study Completion Date: June 2013
    Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

    Phase 1 bladder trial for OGX-427:
    Estimated Enrollment: 36
    Study Start Date: July 2009
    Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)

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