A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients

Inclusion Criteria

• •1. Signed written informed consent
• •2. Women ≥18 years of age on day of consent
• •3. Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
• •4. Measurable disease as per RECIST v1.1 criteria
• •5. Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) maintain:
• •* Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
• •* Platelet count ≥100 x 10\^9/L
• •* Hemoglobin (Hgb) ≥9 g/dL
• •6. Adequate liver function
• •* Total bilirubin of ≤1.5 mg/dL
• •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) or ≤5 x ULN if liver metastasis is present
• •* Alkaline phosphatase (ALP) ≤3 x ULN or ≤5 x ULN if bone metastasis is present
• •* Gamma glutamyl transferase (GGT) \<10 x ULN
• •7. Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
• •8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •9. Life expectancy of at least 3 months
• •10. Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days
• •11. Willing to abstain from alcohol consumption for 3 days before the first dose of study drug through the completion of the second inpatient PK sampling period
• •12. Willing to refrain from caffeine consumption for 12 hours before each inpatient dosing period through the completion of protocol-specified PK sampling for that week
• •13. Subjects must be postmenopausal (\>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of assigned study treatment.
• •14. Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 96 hours before dosing.