A PK Study of Oraxol in Breast Cancer Patients

Exclusion Criteria

• •1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
• •2. If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment
• •3. Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
• •4. Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
• •5. Known CNS metastasis, including leptomeningeal involvement
• •6. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
• •7. Are currently receiving other medications intended for the treatment of their malignancy
• •8. Women who are pregnant or breastfeeding
• •9. Taking any of the following prohibited medications:
• •* Strong inhibitors (eg, ketoconazole) or inducers (eg, rifampin or St. John's Wort) of CYP3A4 (within 2 weeks prior to the start of dosing in the study)
• •* Strong inhibitors (eg, gemfibrozil) or inducers (eg, rifampin) of CYP2C8 (within 2 weeks prior to the start of dosing in the study)
• •* Strong P-gp inhibitors or inducers. Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication ≥1 week before dosing and remain off that medication through the end of study treatment.
• •* An oral medication with a narrow therapeutic index known to be a P-gp substrate (eg,digoxin, dabigatran) within 24 hours prior to start of dosing in the study
• •10. Use of warfarin. Subjects receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the Investigator, may be enrolled in the study provided they are switched to low molecular weight heparin at least 7 days prior to receiving study treatment.
• •11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements
• •12. Known allergic reaction or intolerance to study medication components
• •13. Known allergic reaction or intolerance to contrast media
• •14. Subjects who, in the Investigator's opinion, are not suitable for participation in this study