Friday, February 14, 2014 11:54:27 AM
This is a phase I/II trial with eventually 56 patients, it is still enrolling.
The interim results to be reported on will not contain mOS data
since the trial has not even closed enrollment yet. In addition, the primary
outcomes are for safety (phase I) and Time to Progression (phase II),
with overall survival as the secondary outcome. We do know that biopsy data
is being collected, so that will be valuable for evaluating the MOA.
Also, the trial is testing three levels of bavituximab (0.3, 1.0, and 3.0 mg/kg)
so there will not be very many patients at 3.0 mg/kg, the dose in SUNRISE.
In other words, this is not a trial for comparing bavi + sorafenib to SOC (sorafenib),
since it is a single arm, open label, trial with a relatively small number of patients.
Of course, I am hoping for good results from this trial so that a larger
phase II trial could be done. I just think the expectations for the interim
results are out of proportion from what is likely to be presented.
http://www.clinicaltrials.gov/ct2/show/NCT01264705?term=Bavituximab+OR+Peregrine&recr=Open&rank=4
"By all means let's be open-minded, but not so open-minded that our brains drop out." - Richard Dawkins
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