Please see the two depictions of the patient protocol below which have raised a number of quesions for me. Admittedly, I may be a little slow when it comes to things like this but maybe some of you can help me out:
1.) Both protocols below indicate the phase 1a will take 28 weeks. Was that just an unrealistic hope or do they count weeks differently since they did not update the second chart to include more weeks which clearly have been chewed up at this point?
2.) Notice we now have a whole new level on the second slide - 745 mg. If this level was found to be safe, would yet another new level be added? How many can they add before they say it is time to stop even if no SAE's ever occur.
3.) While it appears they had no SAE's at the 420 level and that this is likely the fallback level for the MTD if SAE's are seen at the 540 level, if they had seen some at 420, could they just declare the 300 level as the MTD or would they need to go back and test some more patients. They surely could not declare it the MTD just based on one patient, right? Prehaps this is a moot point, however, as I suspect they do have multiple patients at the 420 level.
4.) Do they have to have at least 15 patients in the trial before it ends? If so, what does that mean for how long the trial might yet last? Can they knock out the extra patients very quickly?
5.) Why did the original slide have 3 patients at the 200 and 300 level but then they only apparently tested one patient each at those levels?
