Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial: Mylanâ??s Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/v
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease or has had a relapse within 6months of adjuvant chemotherapy (Prior therapy should have included anthracycline unless clinically contraindicated) 2. Male and/or non-pregnant, non-lactating females aged 18 years or older but less than 70 years (both inclusive) 3. ECOG performance status of less or equal 2 4. Adequate hemopoietic, renal and liver function. 5. Patients receiving stable concomitant medications are allowed to participate 6. Treated and stable brain metastases
Exclusion criteria
Exclusion criteria: 1. Social Habits (for example) ingestion of alcoholic beverages, caffeine- or xanthine-containing food or beverage. 2. Use of any food (e.g. broccoli, Brussels sprouts, char-grilled meat, star fruit) known to induce or inhibit hepatic enzyme activity must be limited to no more than 2 standard servings. 3. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies except the disease/metastasis under study unless deemed not clinically significant by the Investigator 4. Patients who require a dose reduction to below 260 mg/m2. 5. Received chemotherapy and/ or radiotherapy within the past 30 days of first IMP administration or has not recovered from the side effects of previous therapy or has less than 5 washout periods from previous therapy. The toxicities should not be more than grade 1 at the time of dosing. 6. History of significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure. 7. Known, existing uncontrolled coagulopathy. 8. Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves (e.g. AUCL, AUCINF and Cmax) of unbound and total Paclitaxel Timepoint: Blood samples will be collected at various timepoints from day 1 to day 5 in both periods | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited
Outcome results
None listed