The original "Special Protocol Agreement" called for 80 in stage one and up to 400 in stage two. We have been told that 167 are enrolled in stage one and will be evaluated separately for H&N and Mets. So when enrollment resumes should we now expect the maximum enrollment to be 313 for the two patient groups or might this be expanded? Prior to the trial halt we may have been approaching an enrollment rate of 25 to 30 per month?? Thoughts anyone...
The most likely number for stage II when it originally designed was 200, but that number dropped as the PII trials had patients continued to do well. Since the PIIIa are doing even better than expected, this number will drop further. If they decide to go with just the mets becaause the survival differential is even bigger for the whole trial, the number will drop further. I think we are looking at a 6-8 month enrollment for the PIIIb.
I interpreted Brad's unblinding remark - early Dec or January as meaning that January would mean we were seeing longer PFS, i.e., better results. So I hope for Jan. But other questions lurk:
IF we concentrate on mets only in our next trial will we have to enol different groups of H&N mets only and breast ca mets only and lung ca mets only in order to pursue the golden ring of being a broadly applicable mets effective therapy? And if we do how many of each group to reach approvable levels? Or will we only need a H&N mets only group and seek approval in that specific indication? (It wouldn't be a multi billion dollar market.)
If this goes the way of all the past posts I have tried to post on the MB then you will never see this.
I too have been entertaining thoughts along this same line. It seems logical to me that the longer Phase III (A) goes unblinded the fewer patients we should need for the Phase III (B) trial/s. Phase (B) is a conformation trial proving results are consistent with Phase (A) but (B) having an end point of OS.
While it is very frustrating waiting for information about where the trial/s are going to proceed, I lean toward time is our friend.