Comparison of paclitaxel albumin-bound nanoparticles serum level with its original serum brand, Abraxane? in patients with metastatic breast cancer
Not Applicable
Recruiting
- Conditions
- bioequivalence, pharmacokinetics.
- Registration Number
- IRCT20130603013572N6
- Lead Sponsor
- ano Daru pharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 18
Inclusion Criteria
Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy
hemoglobin = 9 g/dl
Female patients should be nonpregnant and non-lactating
ANC = 1,500/mm3
platelet count = 100,000/mm3
serum creatinine ? 2 mg/dl
serum bilirubin ? 1.5 mg/d
Hepatic transaminases should be less than threefold of the upper limit of normal.
Exclusion Criteria
-Use of drugs or supplements known to influence the expression and function of CYP3A4 and/or CYP2C8
- Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with the drug
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method