Seel,

What would be the endpoints for phase 2?  I know MTD is endpoint for phase 1, so would phase 2 endpoint be something like tumor reduction by some % of tumor size, complete elimination of the tumor, some pre-defined length of time for dosing (say 3-4 months), etc?

What if K works at reducing tumors for 4 months and then liver problems start.  Would K be sent to the junkheap for rework or would the conclusion be you can only be given it for 3 months max or something to that effect?

TIA