Endpoints
tumor, SD, death
DISEASE, TUMOR
Stage 1 primary endpoint was disease control rate (DCR) defined as the proportion of patients with a best tumor response of CR, PR, or SD (DCR = CR + PR + SD) in the intent‐to‐treat population. Responses and SD did not require confirmation. Secondary endpoints included ORR (CR + PR), pharmacokinetics (PK) of abemaciclib, its metabolites and LY3023414, and safety.Stage 2 primary endpoint of progression‐free survival (PFS) was defined as the time from randomization until progression or death from any cause. Secondary endpoints included DCR, clinical benefit rate (CR + PR + SD ≥6 months), ORR, duration of response (time from response until progression or death), and overall survival (OS).