A Randomized, Open-Label, Two Period, Two-Treatment, Two Sequence, Single-Dose, Crossover, Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound) of Panacea Biotec, India with ABRAXANE® (Paclitaxel Protein-bound Particles for Injectable Suspension) (albumin-bound) manufactured for Celgene Corporation, Summit, NJ in Patients with Metastatic Breast Cancer under Fasting Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 19
- 主要终点
- Pharmacokinetic parameters: AUCt, AUCi, Kel, Cmax,Tmax,Kel, tHalf .
研究概览
简要总结
This study is to evaluate the bioequivalence of Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound) of Panacea Biotec Ltd, India with ABRAXANE® (Paclitaxel Protein-bound Particles for Injectable Suspension) (albumin-bound) of manufactured for Celgene Corporation, Summit, NJ in patients with Metastatic Breast Cancer under fasting conditions. Expected study duration of clinical part is at least 26 days from the day of check-in of first period. Two consecutive treatment cycles will be used for the two treatment periods. The two arms of the crossover study will be conducted on two of the days when the patients are scheduled to receive their usual therapy so that the treatment regimen is not altered or delayed. Pharmacokinetic parameters Cmax, AUCt, AUCi, Tmax, Kel and tHalf will be calculated using professional software.
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 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female patients 18 to 70 years of age (both inclusive) having breast cancer who a.
- •Has histologically confirmed diagnosis of breast cancer.
- •Has metastatic breast cancer c.
- •Has 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.
- •2.Body surface area (BSA) that is within 1.2 to 2.2 m2 3.Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •4.Patient has adequate hematological, renal, and hepatic function.
排除标准
- •1.Patients with a history of other malignancies 2.Patients who have previously received a taxane within the 30 days prior to randomization.
- •3.Patients who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies Grade 1 or higher by CTCAE, with the exception of alopecia.
- •4.Prior chemotherapy must be completed at least 30 days prior to randomization (42 days for mitomycin C or nitrosoureas).
- •Prior immunotherapy, prior antitumor hormonal therapy, and prior radiotherapy must be completed at least 14 days prior to randomization.
- •5.Patient had major surgery within 30 days prior to randomization, or patient has not recovered from prior major surgery.
- •6.Sensory / Peripheral neuropathy of Grade 2 or higher by CTCAE version 4.03 at Screening.
- •7.Abnormal ECG : QTc>470 msec in female patients at screening and randomization.
- •8.Patients with known brain metastases.
结局指标
主要结局
Pharmacokinetic parameters: AUCt, AUCi, Kel, Cmax,Tmax,Kel, tHalf .
时间窗: Period 1 and 2: | 0.167, 0.333, 0.50, 0.833, 1.000, 1.500, 2.000, 3.000, 4.000, 5.000, 6.000, 8.000, 10.000, 16.000, 24.000, 48.000, 72.000, 96.000 and 120.000 hours after start of infusion
次要结局
- NA(NA)