A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients
Condition: Breastcancer
MeSH terms: Breast Neoplasms
Intervention: Oraxol
Intervention description: HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules
Intervention MeSH terms: Paclitaxel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; paclitaxel

Summary:

      This is a multicenter, open-label, single-arm PK study in patients for whom paclitaxel
      treatment is indicated.
    

Eligibility criteria:

        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.

        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 prohibited medications:

         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