Pharmacokinetics
pre‐dose
For patients receiving abemaciclib, PK samples were collected on Cycle 1 Day 1 approximately 2 h after dosing and pre‐dosed on Day 1 of Cycles 2, 3, and 4. During the safety lead‐in, PK samples were collected pre‐dose on Cycle 1 Days 1 and 14, and at 0.5‐, 1‐, 2‐, 4‐, 6‐, and 8‐h post‐dose. Pharmacokinetics samples were analyzed for galunisertib, abemaciclib, and its metabolites (LSN2839567 [M2] and LSN3106726 [M20]) (QFor the safety lead‐in, non‐compartmental analysis methods were used to compute standard PK parameters of abemaciclib, M2, M20, and galunisertib. For Stage 1, average concentrations of abemaciclib, M2, M20, and LY3023414 were reported at each planned PK sampling time.