When this study was started I got the impression it was mostly to allow for compassionate use in the EU until they received approval and also It seemed to me like it was going to be a condition of approval that they got that up and running before the EU would approve the drug. While it was started before we received approval in the US, it seemed weird to me that they were going to start another trial that to me sounded like the pivotal phase 2 that was already near completion at the time. All just assumptions on my part. This study doesn't really create much interest on my part. I can't wait to here about the triple combo in pancreatic cancer and hope we get good news at the SU2C televised event next month or before, that would be huge.
thank you earl. for those who don't know, if you go to changes and click OFF "hide non-essential portions...", just in the 7 2012 updates on changes there are many additional cities/countries that have been added. i have often wondered why they started this study (in 6/2011). the primary is safety - so part could be ema as roche announced that they had submitted a maa to the ema in 12/2011, and, of course they were planning the maa submission prior to the 6/2011 study. secondary outcomes are the usual trr, ttr, dor, pfs, and os - all with approximately 2 year time frames. on 6/20/2011, genentech presented the very positive phase ii data that eventually lead to the 1/30/2012 fda approval. however, as earl has pointed out, SINCE APPROVAL Roche has continued to expand the number/location of sites for the mostly eastern european study for a product that has already been approved for the indication for which the study is intended. sorry if this has already been addressed.