Pete - common goals of phII are establishing optim

Pete - common goals of phII are establishing optimal treatment dose and duration, continued monitoring of safety parameters, more targeted tumor mapping/biomarker examination. Endpoints dependent on drug - for some it is progression-free survival, for some it is tumor reduction measurable thru repeat scans, combo of biomarker reduction/tumor reduction/increased overall survival/increased progression free survival...

Given the phI study goals - it looks like ctix will iron the wrinkles out of treatment dose and duration, establish goal  of tumor reduction for solid tumor patients, establish specific tumor markers for reduction, establish safety parameters, prove efficacy. I can't guess what survival goals they will use. Those goals could look like this: PFS6 and OS12 - 6 months progression-free survival and 12 months overall survival. I don't know what their timeline will be on PF and OS.

If patients do fine on average at optimal dose for 3 months with evidence of efficacy then run into liver problems - they will likely design further research around that info. Unlikely that K would be scratched if 3 months of clinically significant efficacious therapy is well tolerated. They might design a treatment holiday for a time and then resume - and that could end up being the established protocol of this drug if it is safely tolerated.