RE:Dose Escalation Question I think that's right, patient 1 will escalate alongside patient 2. I think there's some strong assumption that the first dose is below the efficacy level of the drug (that might not be true though). It seems to me there would be an aspect of cruelty to keeping the first patient on that dose through all their dosings.
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."