Replies to post #44698 on Innovation Pharmaceuticals Inc (IPIX)

[govorchin]

i printed out all 34 pages of updates. looks like original phase 1 completion date was oct 2013 page 6.

gov

[noretreat]

The Kevetrin trial will continue to recruit because it is always assumed that another cohort will be necessary. Even if there is a DLT at this dosage level, there will still be an expanded cohort to establish MTD...so they need to continuously recruit. Here is one explanation of a phase 1 design:

Conventional phase 1 study design

... three patients are required for the initial cohort size. Treatment may be escalated to the next higher dose level if no dose-limiting toxicity (DLT) occurs; however, if one drug-related DLT occurs in these three patients, the cohort is expanded to six patients to verify that the toxicity rate has reached 33% (i.e., two of six or fewer patients). When the toxicity rate reaches 33% in a cohort, the next lower dose level will be called the RP2D (so long as the toxicity rate is less than 33%) and the cohort will be expanded to 6 to 15 patients total to establish the preliminary safety profile of the study agent.

The new dates for study completion are 6 months later than the previous dates at clinicaltrials.gov . They pretty much HAD to update this because the original study completion date was this month. I would expect the April, 2014 date to turn out to be a bit optimistic as well.

On a related topic, all this searching for MTD/DLT in Boston reminds me there is one other DLT Boston is certainly getting...Go Cardinals!