RE:RE:Dose Escalation QuestionGot it - so they all escalate, but never higher than the newest patient's dosage. So if we have no Patient #2 yet, the Gettysburg patient is still at the original dosage level. I guess we don't have a way to know if anyone else has enrolled except if the company gives an update. I would have thought it wouldn't be hard to identify possible patients given it's a refractory cancer all-comers. But still don't see it in MD Anderson list.
juniper88 wrote: Patient #2 will go to the next higher dose. Patient # 1 will never go higher than patient #2. Both will continue to go up as the trial proceeds.
Wino115 wrote: Simple question on Patient #1, do they escalate the dosage for each patient or do you keep the dose constant for each patient, so Patient #2 will get the higher dosage while Patient #1 sticks at the original dose level?
From the description, it looks like the former but it's not entierly clear the way it's worded. So Patient #1 if he passed the exam, got a higher dosage for his second round. Patient #2 will start at the same beginning dose and then also escalate. Is that correct?
From the clinical trial site:
" Dose escalation by dose-doubling will be done for the first 2 dose levels, followed by a modified Fibonacci dose escalation scheme (i.e. dose increases of 67%, 50%, 40% and 33%) thereafter for each dose level. Patients in Part 1 will be observed for 21 days post Cycle 1 Day 1 drug administration for dose limiting toxicity (DLT). Dose escalation to the next dose level will proceed following satisfactory review of safety data until the MTD is reached. The MTD is defined as that dose-level at which ≤1 of 6 patients in a cohort develop an emergent DLT."