PK analysis
BLOOD
Blood samples for PK analysis of LXI-15029 were collected on day 1 (pre-dose, 20 min, 40 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, and 48 h), cycle 1 day 8 (pre-dose), cycle 1 day 15 (pre-dose), and cycle 1 day 28 (pre-dose, 20 min, 40 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 h). The blood samples were stored at -70°C until testing. The concentration of LXI-15029 in plasma was measured using the validated liquid chromatography-tandem mass spectrometry (LC–MS/MS) method. The concentration–time information of LXI-15029 was summarized based on pre-dose and post-dose data of each patient, to explore the linearity of exposure with single dose and steady-state situations, the time to reach steady state and the predictability of single to multiple doses PK. PK parameters were calculated separately for single and repeated doses using descriptive statistics. PK analysis was performed by Covance Central Laboratory using the validated software Phoenix WinNonlin Version 8.1 (Pharsight, Mountain View, CA). A standard non-compartmental method was used to calculate the peak plasma concentration (C