RE:Dosage Level?Scarlet is the resident dosage expert, but if I understand it, the 420mg commenced a while back and they had that one neutropenia which means they halt, figure out why, if treatment related they would have fallen back a level. But they said it wasn't and they proceeded with more at 420mg - I believe PL said on the OCT 13th call they needed to do 3 at that level to monitor it. So those 3 were likely done soon after that and would have to do the full cycle over 3 weeks. Add in some time in between and maybe you finished that 420mg full cycle end November.
From there you'd have two possible outcomes. If this level saw the same DLTs in more than one patient you'd stop and move to the 6 person final check off. If you saw no DLTs you'd go up another level to 560 with 3. Same thing, if DLT >2 people, stop and go to the final 6 at one level down I think. IF no DLT or less than one, move them up again to 720 which they show as the max they would do. IF each cycle takes 3 weeks, they could be done roughly (my guess).
420 level - end around now (3rd/4th week of Dec)
560 level - add another 3-5 weeks (end Jan)
720 level - add another 4-6 weeks after that (end Feb)
Maybe add a few more weeks to each end date for data acquisition, follow=-up, report writing,etc..
Purely a guess since I'm not 100% sure on those procedures, but means 420 level would end around end of year or early Jan. 560 level would be end Jan/early Feb, 720 level end Feb/early Mar.
Kd5513 wrote:
I know we are at 2x Docetaxel currently. As we are waiting for news on 1A we are now appraoching 3X levels administered (would be a huge win). If, we get to 3X how long into '22 do we have to run on 3X level before they could say we're good at this level for MTD and release news? Does that align with January news release?