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This is helpful, I finally understand the 3+3 stru

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Post# of 154134
(Total Views: 1212)
Posted On: 03/21/2019 3:59:22 PM
Posted By: BlackDoggie
Re: trding #1193
This is helpful, I finally understand the 3+3 structure. However, it now appears to me that they may only have to dose 9 patients in the 1b if there are no toxic responses, is that correct? If I recall, the original protocol called for 18 patients in the 1b, but I don’t see that figure on clinicaltrials.gov now. If so, very real possibility that the 3+3 speeds up the time to get to 700mg and P2, since we don’t expect to see toxic effects...

Also, on a related note, I hear there have been discussions about the half life and induction period from the mono trial, and potentially strategies for optimizing response rates. Apologies, but I haven’t read back very far on this board, so I don’t know what I’ve missed. If there has been some discovery there - which would align with NP’s statements in the video on Monday about being excited to share discoveries from the mono trial - could that potentially be the cause of the delay in dosing for TNBC? I.e. waiting to make sure they understand what was happening in the mono trial so they make sure they optimize TNBC the first time?

Again, sorry if this has already been discussed. My sense has been that the delay in dosing for TNBC always related to getting the trial right, but I’d feel better if I had a reasonable theory around what exactly they’re trying to get right!


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