questions re phase 3 trial, page-2

Hi Mrdog,

To answer your first question, second and third line patients are those who have colorectal cancer which has progressed after treatment (the first or second line chemotherapy)

Secondly irinotecan-naïve does indeed mean patients who have not previously been treated with irinotecan. This is important, as patients who have, and have progressed, are likely to have cancers which have potentially mutated to resist treatment with irinotecan.

To answer the third question, I don't know about the distribution of patients, but the randomisation method would consider patient treatment site, and it is unlikely that there will be any statistically significant difference in survivals between control and treatment groups due based solely on differing geography. There are certainly Australian patients, as about six months ago I had to field a question regarding one (nothing remotely interesting or market sensitive).

All else said and done, I'm feeling quite positive regarding the trial at this point.