An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007

Exclusion Criteria

• •1. Have not recovered from unacceptable toxicity associated with previous Oraxol treatment in KX-ORAX-007.
• •2. Are currently receiving other medications intended for the treatment of their malignancy.
• •3. Women who are pregnant or breastfeeding.
• •4. Taking any following prohibited medications:
• •* Strong inhibitors (eg, ketoconazole) or strong 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 strong inducers (eg, rifampin) of CYP2C8 (within 2 weeks prior to the start of dosing in the study).
• •* Strong P-gp inhibitors or inducers.
• •* 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.
• •5. Use of warfarin. Patients 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.
• •6. 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.
• •7. Known allergic reaction or intolerance to study medication components.
• •8. Known allergic reaction or intolerance to contrast media.
• •9. Patients who, in the Investigator's opinion, are not suitable for participation in this study.