An open label, balanced, randomized, two period, two treatment, two sequence, and two way crossover study to evaluate safety and pharmacokinetic comparison of intravenous infusion of paclitaxel Lipid Suspension and Taxol® in patients with Metastatic Breast Cancer
Trial Snapshot
- Phase
- Phase 1
- Locations
- 4
- Primary Endpoint
- To characterise the pharmacokinetic profile of paclitaxel with two formulations for intravenous infusion of paclitaxel in patients of metastatic breast cancer.
Study Overview
Brief Summary
This study is to characterize the pharmacokinetic profile of paclitaxel with two formulations for intravenous infusion of paclitaxel in 16 Indian patients of metastatic breast cancer. Secondary objective is to monitor the safety of the Indian patients who are exposed to the investigational products.The investigational hypothesis is that the new formulation for paclitaxel infusion manufactured by Intas Pharmaceuticals Ltd. is bioequivalent to Taxol i.e. 90% confidence intervals for In-transformed pharmacokinetic parameters Cmax and AUC0-t falls within the acceptance range of 80.00-125.00 percentage for paclitaxel.Both interventions will be given at the interval of 21 days.After completion of study (two cycles) additional two cycles of paclitaxel injection will be administered to the patients for completing the compassionate use of a total four treatment cycles for each Indian patient.The first patient is expected to be enrolled in 2nd week of August.
Study Design
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility 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
- •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.
Outcomes
Primary Outcomes
To characterise the pharmacokinetic profile of paclitaxel with two formulations for intravenous infusion of paclitaxel in patients of metastatic breast cancer.
Time Frame: Multiple time points
Secondary Outcomes
- To monitor the safety of the patients(throughout the studyperiod)