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iwfal

01/18/15 9:49 PM

#186286 RE: honestabe13 #186285

are IST's supposed to spend the big bucks before they get indications from smaller, less complex trials?



38 patients in a single arm trial? C'mon. If they wanted 'an indication' they could have run a 10 to 15 person trial. Any single arm trial of greater than about 15, or maybe 20 worst case, for one cancer indication is probably being run for other reasons than to find efficacy. (I.e. They should already know MTD pretty well and with 38 patients they could have run a more perceptive RCT)

And BTW 5% response rate when the single arm is a combo with a known oncologic agent almost shouts "the new agent does nothing"?

Finally, to make it clear, I think part of the reason people are fooled by the category "Stable Disease" is the name is misleading. It just means all those patients whose tumors haven't (yet) grown enough to qualify as progression plus all those who didn't have a response. It does NOT mean the tumor hasn't grown.