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Post# of 252311
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Alias Born 01/22/2006

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Sunday, 07/30/2006 5:21:20 PM

Sunday, July 30, 2006 5:21:20 PM

Post# of 252311
Have been reading posts on this board for a few weeks now and find the quality and level of discussion very high! I was wondering if anyone follows UTHR or REX and the currently running IMPACT I&II Ovarian cancer trials?

By my estimation the mean PFS is likely to be 20+ month (in each trial). If one goes by the Successful Front-Line Therapy Patients (SFLT) subset of the Phase 2B trial that had a Placebo averages 10.8 months (ITT Placebo was 10.3 months) that would put the OvaRex arm in the 24+ month range which would be HIGHLY statistically significant.

However, what is puzzling me is the Phase 2B was powered with an assumption of 18 month median TTR in the Placebo arm. I have been looking for some historical data to see which is the more reasonable number and was wondering if anyone has any insight (links would be greatly appreciated)

Basically it is for Stage III/IV patients with complete clinical response to front-line surgery and chemo (platinum based) with elevated CA-125 levels prior to surgery. There is a lot more that is brief summary
The entry criteria for the trial can be found at:
http://www.clinicaltrials.gov/ct/show/NCT00050375

Thanks in advance for any info and for making a useful discussion board!

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