I presume in a double-blind trial, the researchers only learn which arm each of the patients are on at the end of the trial... ie progression free survival of 40 patients out of 390 - a criteria that I cringe at every time I think about it :( .
In Phase II, back-calculating from ACL's graphs, the equivalent point in the trial would be around 8.3 mths after commencement of treatment. That was when 40/390 would still have PFS. At 8.3 mths, we had PFS of 18% for HA-I and 5% for irino. Taking the spread of starting points into account, the trial end would be around Q2 (Q1 if recruitment had been at consistent rate).
Except that PhII was HA-I vs irinotecan alone. This is FOLF(HA)IRI vs FOLFIRI. PFS for irino alone was 2.4mths. Median PFS for FOLFIRI can be around 7mths. See
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC497044/
Therefore maybe Q4 2013 for PhIII end-point?
The only dampened indication of a successful trial before then will be if the %PFS of all patients is looking higher than FOLFIRI would alone.
That's my take on it anyway.
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