Intervention: Paclitaxel
Trial phase: Phase 1
ATC code: L01CD01 | L01CD51
SMILES: CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Eligibility criteria:
Inclusion Criteria:

Signed written informed consent
Women ≥18 years of age on day of consent
Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
Measurable disease as per RECIST v1.1 criteria

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

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
Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 3 months
Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days
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
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
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.
Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 96 hours before dosing.

Exclusion Criteria:

Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
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
Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
Known CNS metastasis, including leptomeningeal involvement
Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
Are currently receiving other medications intended for the treatment of their malignancy
Women who are pregnant or breastfeeding
Taking prohibited medications:
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.
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
Known allergic reaction or intolerance to study medication components
Known allergic reaction or intolerance to contrast media
Subjects who, in the Investigator's opinion, are not suitable for participation in this study