Info
Phase I Clinical Trials
Often the initial phase of human experimentation
When to perform:
Novel drug or combination & promising preclinical data
Primary objectives:
Identify drug tox, MTD, & schedule & RP2D
Secondary objectives:
Describe pharmacology (PK/PD), biomarkers, & response rate
Population:
Typically adv CA w/no std tx options left, good PS & end-organ fxn, heterogeneous tumor types, may select pts based on genetic abnormality (basket trial)
Starting dose:
Dose chosen to treat first cohort based on animal studies, commonly 1/10 of mouse LD10 or STD10 (dose resulting in death or severe tox of 10% of mice)