A MULTICENTER OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, SINGLE-DOSE, CROSSOVER BIOEQUIVALENCE STUDY OF PACLIALL(PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION MANUFACTURED BY PANACEA BIOTEC LTD., INDIA) WITH ABRAXANE® (PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION MANUFACTURED FOR CELGENE CORPORATION,USA) IN BREAST CANCER PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- The 90% confidence interval for the Test/Reference (T/R) ratios of log transformed least square means of Cmax, AUC0→t and AUC0→∞ of total and free paclitaxel.
研究概览
简要总结
Subjects with locally invasive or metastatic breast cancer will be enrolled after satisfying the inclusion/exclusion criteria.
Screening procedures will be performed within 8 days prior to administration of study medication**.** Spiral CT scan or MRI, if already undertaken within 28 days prior to administration of study medication shall be valid for the study and need not be repeated**.** (For details refer section 8). xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Day 0 –The day of patient’s admission in cycles 1 and 2
Day 1-The day of administration of the IMP
Protocol treatment period is for 2 cycles. Patients will be randomized to receive 260 mg/m2 of Paclitaxel protein bound particles for injectable suspension of the test or reference product intravenously as a 30-min infusion on cycle 1 day 1 followed 3 weeks later in cycle 2 day 1 by the alternate treatment.
Subjects entering the trial would be admitted at least 12 h before administration of the study drug and would be discharged approximately 48h after dosing. Patients will be observed for longer period if clinically indicated and would be discharged only if found to be hemodynamically stable as judged by the investigator.
Subjects will visit the site for 72 h, 96 h and 120 h PK samples in both the cycles/periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •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 –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 × 109/L (1,500 cells/mm3) (ii)Platelets ≥ 100 × 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) ≤ 1.5 × upper limit of normal range (ULN) (ii)Total bilirubin within normal range (iii)Creatiine within normal range (iv)Alkaline phosphatase ≤ 5 ï‚´ ULN 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 ≤Grade 1 before administration of study drug.
排除标准
- 未提供
结局指标
主要结局
The 90% confidence interval for the Test/Reference (T/R) ratios of log transformed least square means of Cmax, AUC0→t and AUC0→∞ of total and free paclitaxel.
时间窗: 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.
次要结局
- Comparative incidence and severity of clinical and laboratory adverse events (AEs).(Comparative incidence and severity of clinical and laboratory adverse events (AEs).)