Yes, it is going to take some time to get results
Post# of 154109
(Total Views: 365)
Posted On: 07/12/2019 6:57:00 PM
Re: ClosetInvestor #4810
Yes, it is going to take some time to get results on 5 people. The biggest hurdle seems like enrollment. If I was NP, I wouldn't say 'soon' every again with that. I would just work hard to get the first person injected and they announce. I suspect that will be what he will do.
Anyway, with phase 1 safety 3+3, they start will start with 3 people at 350mg, then the evaluation period between 1-3 cycles; We don't know the protocol for the number of cycles in the evaluation period, but I have posted a survey of experts, most say 2 is best. If all is good during this period, they will escalate dose to 500mg and enroll 3 more.
They will be doing ctc numbers every 21 days, but I suspect they would like to see at least 2 after baseline. So 4 cycles or 84 days is my most likely guess to get good data on 5 people.
But after 6 cycles they would have ctc numbers on patients starting out with 350mg, 500mg, 700mg, which could possible give strong results assuming the higher dose yields a bigger drop in ctc numbers.
Now if the evaluation period is only 1 cycle instead of 2, then shortens this time. So the number of cycles for the evaluation will play a big role.
We could add that question to the TNBC list.
How many (21 day) cycles with the evaluation period be?
Anyway, with phase 1 safety 3+3, they start will start with 3 people at 350mg, then the evaluation period between 1-3 cycles; We don't know the protocol for the number of cycles in the evaluation period, but I have posted a survey of experts, most say 2 is best. If all is good during this period, they will escalate dose to 500mg and enroll 3 more.
They will be doing ctc numbers every 21 days, but I suspect they would like to see at least 2 after baseline. So 4 cycles or 84 days is my most likely guess to get good data on 5 people.
But after 6 cycles they would have ctc numbers on patients starting out with 350mg, 500mg, 700mg, which could possible give strong results assuming the higher dose yields a bigger drop in ctc numbers.
Now if the evaluation period is only 1 cycle instead of 2, then shortens this time. So the number of cycles for the evaluation will play a big role.
We could add that question to the TNBC list.
How many (21 day) cycles with the evaluation period be?
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