2.3 Subjects, treatment and sample collection.
The patients were enrolled at Sun Yat-sen University Cancer Center.
According to the Helsinki Declaration, the design and monitoring of
clinical studies were consistent with the ethical principles of Good
Clinical Practice. The key inclusion and exclusion criteria are listed
in Table S1. Each eligible study subject was required to read, sign and
date a consent form prior to inclusion in the study. A single oral dose
(60 mg) of ningetinib capsules was administered every 24 h to patients
with NSCLC (n = 5, aged 28.5–45.9 years old, body weight of 51.9–73.8
kg, height of 158–188 cm) from day 1 to day 28. In another clinical
trial, a single oral dose of ningetinib capsules and 250 mg of gefitinib
tablets were daily administered to the patients with NSCLC (n = 4, aged
47–76 years old, body weight of 55.2–68.6 kg, height of 149–170.5 cm)
for 28 days. On the first and 28th days, venous blood samples were
collected within 1 h before administration and 0.5, 1, 2, 3, 4, 5, 8, 12
and 24 h in tubes containing EDTA-2K. All the blood samples were
centrifuged at 4 °C at 2000 rpm for 10 min. The plasma samples were
stored at approximately -70 °C until analysis.