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mojojojo

02/24/12 4:30 PM

#75783 RE: freethemice #75779

As a side note, good PFS and OS numbers for second-line NSCLC trials are around 4 and 7 months. So for the bavi trial, the PFS number has already been determined and the median OS could be triggered at any time.
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Thurly

02/28/12 10:38 AM

#75832 RE: freethemice #75779

UPDATED

From what I'm reading, the trial remains blinded until the patients complete the monotherapy portion of the protocol.

http://clinicaltrials.gov/ct2/show/NCT01138163?term=bavituximab+NSCLC&rank=4
All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.

It wouldn't make any sense to give the placebo during the monotherapy period if the trial were already unblinded, would it?

It also means that they are going to collect PFS data from the double-blind portion of the trial, yes?