Some of our best results have been with Advanced Breast Cancer. That study was done in combination with docetaxel. The only other trial that has used docetaxel as part of the protocol is the 2nd line NSCLC PIIb that will report data 1H12.
Why did they choose docetaxel in the 120 patient registration trial and not the protocol of the Indian 49 patient NSCLC trial?
ABC Protocol Weekly bavituximab infusion of 3 mg/kg combined with up to six 28-day cycles of docetaxel chemotherapy. After treatment phase, weekly bavituximab maintenance is continued until disease progression.
NSCLC Protocol NSCLC had two bavi arms -- one with 3mg/kg (same as above); one with 1mg/kg. The docetaxol schedule changes from a 28 day cycle to a 21 day cycle…
I don't really know what to make of it, but it looks like a slightly more aggressive version of a docetaxel protocol and a bracketed bavi protocol to test both the same bavi dose and a lower dose.
How would results that were comparable to our ABC results fit into our homerun scenario for the registrational NSCLC PIIb trial?
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