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Wednesday, June 08, 2016 6:07:29 PM
The data show excellent safety results
The data also show that 10% of patients had a 20% decrease in CA-125 and 15% had stable disease for 3 months.
As part of the 1B, when there was excellent safety but little response, the k dose was doubled and K was given 4x weekly, along with maximal Doxorubicin dose, but there was still no change in patient response.
Does the trial proceed? No. Was safety demonstrated- of course. Was efficacy one of the aims of the 1B part of the 1B/2 study? No, safety was the endpoint.
Nonetheless such data would not be good enough to proceed K p2 ovarian CA trial.
They can show safety but they will also have to demonstrate some efficacy. How much, I do not know. But it has to be
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