RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FittingObviously I meant several phase IIa, so testing on many types of cancer at the same time. The same idea as their basket trial, but really more like a phase IIa, so the first part of a larger trial that could lead to approval. Obviously to get that from the FDA they would need excellent efficacy early on. This is just a guess on my part, but if early efficacy would relly be excellent with clear tumor shrinkage, I think this path would be possible. That being said, if the MTD is really relatively high and they see efficacy at lower doses, they will need to test what is the best way to use the drug. They would have to chose between a dose close to MTD for a few cycles to hammer the tumors, or a lower, but still efficacious dose, for many more cycles to keep the progression and proliferation in check for the longer run.
jfm1330 wrote: If the results would really be very good, then the FDA could allow a trial design to speed up the whole approval process with a surrogate endpoint like objective response rate, also called overall response rate where phase Ib would become more a phase IIa or multiple phase IIb, but that is wishful thinking at this point.