Eligibility criteria
Participants were required to have advanced cancer; be scheduled to
receive weekly paclitaxel 80mg/m2 as monotherapy or in
combination with other agents; provide written informed consent; age
>/= 18, Eastern Cooperative Oncology Group Performance
Status (ECOG PS) 0 or 1, and have life expectancy of 3 months or more.
Other key inclusion criteria were: adequate bone marrow reserve (Hb
>/= 90g/L, neutrophil count >/=
1.5x109/L, platelet count ≥100 ×
109/L), hepatic reserve (total bilirubin of ≤20 μmol/L
or, for subjects with liver metastasis, ≤30μmol/L; alanine
aminotransferase (ALT) ≤3 × upper limit of normal (ULN) or, for subjects
with liver metastasis, ≤5 × ULN; alkaline phosphatase (ALP) ≤3 × ULN or,
for subjects with liver or bone metastasis, ≤5 × ULN, gamma glutamyl
transferase (GGT) <10 × ULN), and adequate renal function
(calculated creatinine clearance > 50ml/min by
Cockcroft-Gault, or Cr <177 μmol /L), willing to fast 8h prior
and 4 hour post dose, and refrain from alcohol and caffeine. Concomitant
inducers or inhibitors of P-gp or CYP 3A4 or 2C9 were prohibited within
2 weeks of study medicine.