Health Condition 1: null- Breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Conditions
Interventions
Intervention1: PacliALL (Paclitaxel protein-bound particles for injectable suspension) manufactured by Panacea Biotec Ltd., India: PacliALL [Paclitaxel (protein-bound particles) for injectable suspens
Sponsors
Panacea Biotec Ltd
Accutest Research laboratories
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female, non-pregnant and non-lactating patients between 18 and 65 years of age (both inclusive). If patient is of child bearing potential, as evident by regular menstrual periods, she must have a negative serum pregnancy test at screening and negative urine pregnancy test on the day of admission of each period and if sexually active should agree to utilize contraception considered adequate and appropriate by the investigator. 2.Histologically or cytologically confirmed breast cancer 3.Breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated 4.ER/PR â??ve or ER/PR status unknown (defined as no histo-pathological evidence for confirmation of ER/PR status). 5.Patient has no other malignancy within the past 5 years except non-melanoma skin cancer, cervical intraepithelial neoplasia [CIN], or in situ cervical cancer [CIS]. 6.Eastern Cooperative Oncology Group (ECOG)3 performance status of 0, 1 or 2 (refer annexure III) 7.Patiens who are suitable candidates for single agent paclitaxel treatment 8.Hematology levels at baseline of: (i)ANC >= 1.5 Ã? 109/L (1,500 cells/mm3) (ii)Platelets >= 100 Ã? 109/L (100,000 cells/mm3) (iii)Hb >= 100 g/L (10 g/dL) 9.Adequate organ function at baseline as defined by: (i)AST (SGOT), ALT (SGPT) (ii)Total bilirubin within normal range (iii)Creatiine within normal range (iv)Alkaline phosphatase 10.Expected survival of > 12 week 11.Patient is available for and able to comply with the study-specific blood sampling requirements for pharmacokinetic evaluations. 12.Patient must have recovered from all toxicities of prior treatments to NCI-CTCAE v4.0
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 90% confidence interval for the Test/Reference (T/R) ratios of log transformed least square means of Cmax, AUC0â??t and AUC0â??â?? of total and free paclitaxel.Timepoint: Blood samples (6 ml each) for pharmacokinetic assessment will be collected at the following time points in Cycle/Period 1 and Cycle/Period 2: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 h after starting the infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparative incidence and severity of clinical and laboratory adverse events (AEs).Timepoint: Comparative incidence and severity of clinical and laboratory adverse events (AEs). | — |
Countries
India
Contacts
Public ContactDr Lalitendu Mohanty
Panacea Biotec Limited
Outcome results
None listed