since the ph II trial is over for gem + nab wouldnt you think that the triple trial with nab + gem + hh would have been stopped by now since it has been running for long enough time since they have the nab + gem baseline? infi trial was stopped due to futility. just a question.
big, i think i understand what you are asking, but i'm not sure what you know at this time. you probably already know all of this. yes, the phase 2 (gem+nab-pac (abraxane) is over and the results were very good. in addition, dr von hoff has a phiii (800+ patients) and results are expected to be good and are due by the end of the year. i have been talking about all of this for two years.
sorry to bore you with the repeats. first, the infinity (ipi-926 hh inhibitor) trial in comb with gemcitabine failure has nothing to do with the vis/gem study, because vis and ipi have different mechanisms (but dr. von hoff did wonder why it failed). the fact that they have continued to recruit is positive. i have looked at all of the changed for the triple comb trial in clinical trials . gov and found that as of 3/26/12 sidney kimmel is still listed a recruiting and t-gen (dr von hoff) is active, not recruiting (meaning still treating and evaluating). the triple comb trial is open-label (both researchers and patients know they are getting the real treatment, and no comparator is used.
read under bold "further study details..." you will see a two-year time frame ending this dec., but just before "Eligibility" is the statement: "Patients may continue on treatment regimen until they experience progressive disease or unacceptable toxicity, require palliative radiotherapy, withdraw consent or the physician feels it is not longer in their best interest to continue on treatment."
they have also spent a ton of money on all of this work, but the fact that they are continuing to recruit and treat (according to the information provided above from clinical trials . gov) would indicate that they are getting results that are at least encouraging. it says that they are still recruiting at kimmel, but it has been two years, so if true i'm surprised they haven't expanded access.