A clinical trial to study the pharmacokinetic comparison of two formulations for Intravenous Infusion of Paclitaxel in Indain Patients with Metastatic Breast Cancer.
- Registration Number
- CTRI/2009/091/000441
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Female & > or =18 years and < 65 years of age and having a body mass index (BMI) at least 17 calculated as weight in kg/(height in meter)2 with histopathologically/cytologically confirmed metastatic breast cancer, Eastern Cooperative Oncology Group (ECOG) performance status < or = 2, adequate bone marrow, renal and hepatic functions, recovery from any toxic effects incurred from previous chemotherapy as judged by the investiagator and with life expectancy of at least 3 months.
-The patient must have given written, personally signed and dated, informed consent to participate in the study before initiating any study related procedures.
-For patient with child bearing potential: Patient should not be pregnant or nursing, having negative pregnancy test at screening, and must be using effective form of birth control measure during and for 1 month after study participation.
-History of hypersensitivity to paclitaxel injection or other drugs containing polyoxyethylated castor oil. Like cyclosporine or teniposide
-Any cardiac conditions
-History of drug addiction within last 1 year
-History of brain metastasis
-Preexisting motor or sensory neurotoxicity of severity > or = grade 2 as defined by NCI criteria
-Serum bilirubin > 2 times ULN, or if SGOT and/or SGPT > 2 times ULN
-The neutrophil count < 1,500 cells/mm3 and platelet count < 100,000 cells/mm3
-HIV infection
-Any other condition that in investigators judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
-Donation of blood (1 unit of 350 ml) within 90 days prior to receiving the first dose of study medicine
-Known existing uncontrolled coagulopathy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterise the pharmacokinetic profile of paclitaxel with two formulations for intravenous infusion of paclitaxel in patients of metastatic breast cancer.Timepoint: Multiple time points
- Secondary Outcome Measures
Name Time Method To monitor the safety of the patientsTimepoint: throughout the studyperiod