Pharmacokinetics
delirium, pneumonitis, neutropenia, fatigue, toxicity, anemia, anorexia
PNEUMONITIS, ORAL MUCOSITIS, NEUTROPENIA, FEBRILE NEUTROPENIA, LYMPHOCYTOPENIA, THROMBOCYTOPENIA, ANOREXIA, ANEMIA, HYPERGLYCEMIA, LEUKOCYTOSIS
A total of 14 patients were evaluated for PK during Cycle 1. All patients were treated with 3 mg daily of sapanisertib. Descriptive statistics of the mean PK parameters on Cycle1 Day 1 and Day 8 are summarized in Table Descriptive statistics of the mean sapanisertib PK parameters in Cycle 1 Day 1 (Day 1) and Cycle 1 Day 8 (Day 8).Further exploratory analysis was undertaken to evaluate the relationship between sapanisertib systemic clearance and toxicity. AEs were classified as hematological and non‐hematological. The subjects with hematologic AEs experienced anemia, neutropenia, febrile neutropenia, thrombocytopenia, lymphocytopenia, or leukocytosis. Six of 11 patients (54.5%) had at least one grade ≥3 non‐hematologic AE: fatigue, anorexia, delirium, hyperglycemia, high blood bilirubin level, oral mucositis, pneumonitis, and others. No significant correlation was found between systemic sapanisertib exposure and hematologic toxicity after drug administration on either Cycle 1 Day 1 or Day 8 (Table The correlation analysis of sapanisertib clearance and toxicity.