Originally posted by What A Gas
OK, so I emailed Leslie.
My question was:
' .... Of the 14 patients enrolled how many of the 4 NOT evaluable patients were in fact the additional enrollments referred to in the ann of 11-Sep-2018? ....'
The relevant part of Leslie's prompt reply contained:
' .... your question, the patients are considered non evaluable when they couldn’t make the day 56 scans and it was across all the dose levels. Their data was collected for other study parameters .... '
Although not directly answering my question it is pretty clear to me that the 4 not evaluable patients were NOT part of the additional recruitments. Further, it is now unclear to me whether the 14 patients referred to included these additional patients or not (assuming any such patients were, indeed, ever enrolled.)
Therefore, I humbly apologise for previously insisting that those 4 non evaluable patients were 'additional' (as in the sense of the 11-09-2018 ann).
My nett conclusion is that 14 patients were enrolled to be 'potentially' evaluated for top line results, of which 4 did not last the 56 day journey (for whatever reason), leaving 10 to meet the evaluation criteria. It is for others wiser than I to attach significance, if any, to this apparent fact.
Looking at the trial on ClinicalTrials.gov it says number of participants is 18, yet on the recent announcement it is 14. Why do these numbers not tally? Trials are supposed to be updated to reflect changes in key criteria, even in October the trial was reporting trial numbers as 18. I may have missed an update in regards to trial numbers earlier, but it appears from comments here another 4 were added more recently to the trial so are not evaluable in this announcement. I wonder when/if we will here any reports on the most recent 4, perhaps in a more detailed summary of the phase1b? To be honest, the number of patients in the trial and what happened to them is murky at this point and that is not confidence inducing.
The word that concerns me is "best" in the following sentence - "in particular the five patients whose best response showed more than 30% decrease intheir tumour size from baseline scans". We know from the outcome measures quoted in the trial description that tumour size was to be evaluated beyond the 56 days during long term maintenance. Given the first cohort started treatment in August last year they have at least nine months of meaningful data on tumour size post treatment. I read the "best" as that was as good as it got and the tumours have increased since.
It would have been nice if the phase1/b had produced a clear cut better than standard treatment result that could have been presented without ambiguity. But no Christmas presents this year.
It will be sometime till we have clarity, I have no option other than to wait it out and hope.
(20min delay)
