Analysis of endpoints
PD
PATHOLOGY
Exploratory aims of the study are to conduct genomic analysis from tissue and pharmacokinetic studies during maintenance therapy. Descriptive statistics will be obtained (no interventions yielding comparison of participant groups). As such, no formal power analysis will be performed related to the exploratory endpoints. Priority for tissue studies 1) pathology, 2) molecular profiling, 3) pharmacology, 4) PDX modeling. Given the small study population, clinical data will be presented as median with range and categorical variables presented as proportions (%). All PK and PD samples will be batched until further analysis.