None listed
Conditions
Interventions
Intervention1: Paclitaxel lipid suspension: 175 mg/m2 IV infusion over 3 hours
Control Intervention1: Taxol®
(Paclitaxel Injection of Bristol-Myers Squibb): 175 mg/m2 IV infusion over 3 hours
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To monitor the safety of the patientsTimepoint: throughout the studyperiod | — |
Countries
India
Contacts
Public ContactMr Rajesh CN
Lambda Therapeutics Ltd.
Outcome results
None listed