A randomized, open label, balanced, multicenter, two-treatment, two-period, two-sequence, two-way crossover, single dose, bioequivalence study with pharmacokinetic endpoints of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) 100 mg/vial at a dose of 260 mg/m2 of Ningbo Shouzheng Medicinal Research Co., Ltd. with ABRAXANE® for Injectable Suspension (albumin-bound) 100 mg/vial at a dose of 260 mg/m2 of Celgene Corporation, Summit, NJ 07901 in Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy under fasting condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- To assess the BE by comparing PK parameters of Paclitaxel Protein-Bound Particles for Injectable Suspension 100mg/vial with ABRAXANE® for Injectable Suspension 100mg/vial in Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy under fasting condition; To assess variability, optimize sample collection time intervals and provide the information for determination of sample size.
研究概览
简要总结
Thisis a randomized, open label, balanced, multicenter, two-treatment, two-period,two-sequence, two-way crossover, single dose, bioequivalence study withpharmacokinetic endpoints of Paclitaxel Protein-Bound Particles for InjectableSuspension (albumin-bound) 100mg/vial in Breast cancer patients afterfailure of combination chemotherapy for metastatic disease or relapse within 6months of adjuvant chemotherapy under fasting condition.
Theprimary objective of study is to assess the bioequivalence by comparing PKparameters and to assess variability, optimize sample collection time intervalsand provide the information for determination of sample size of Pivotal BEstudy. Upon randomization, patients will receive assigned study drug on Day 1(Period 01) and Day 22 (Period 02) based on the randomization schedule (eitherTest (A) or Reference (B)) at a dose of 260mg/m2 intravenously over30minutes under fasting conditions. Statistical analysis will be performed on the pharmacokinetic parametersusing SAS® statistical software. The 90% confidence interval of the relativemean (Geometric mean) of the test to reference formulation for Ln-transformed Cmax,AUC0-t and AUC0-inf should be within 80.00% to 125.00%for unbound and total paclitaxel to establish bioequivalence.
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
- •Willing and able to provide voluntary informed consent and to follow the protocol requirements.
- •2.Females aged 18 to 65 years (both inclusive) having Body Mass Index (BMI) at least 17.00 calculated as weight in kg/height in m
- •Patients with histopathologically /cytologically confirmed metastatic breast cancer
- •Patients with metastatic breast cancer after failure of combination chemotherapy for metastatic disease or have had a relapse within 6 months of adjuvant chemotherapy.
- •(Prior therapy should have included an anthracycline unless clinically contraindicated)
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
- •Life expectancy of at least 6 months at the time of enrolment.
- •Acceptable hematology status: a.Hemoglobin more than or equal to 9.0 g/dL b.Absolute neutrophil count (ANC) more than or equal to 1500 cells/mm3 c.Platelet count more than or equal to 1,00,000 cells/mm3
- •Acceptable liver function: a.Alanine aminotransferase (ALT) less than or equal to 2.5 X ULN b.Aspartate aminotransferase (AST) less than or equal to 2.5 X ULN c.Bilirubin more than or equal to 2 X ULN d.Alkaline phosphatase ≤ 5 X ULN
- •Patients with Creatinine clearance ≥ 60 mL/minute
- •Patients with negative serum pregnancy test at screening and negative urine pregnancy test at Day
- •Patients who agree to use adequate contraception (eg, hormonal, chemical, double-barrier, or abstinence) while in the study and for 3 months after study participation is discontinued.
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •Known hypersensitivity to Paclitaxel or the components of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) or to any of the related drugs (other taxane products).
- •2.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
- •3.Patients taking any of the inhibitors or inducers of either CYP2C8 or CYP3A
- •4.Known CNS metastasis.
- •5.Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •6.Surgical or other non-healing wounds.
- •7.Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •8.Patients with current clinical or laboratory evidence of active infection.
- •9.History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer).
- •10.Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents.
- •Exceptions are alopecia (any grade is acceptable), fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0).
- •11.Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •12.Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of investigational product for the current study.
- •13.Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
- •14.Breastfeeding.
结局指标
主要结局
To assess the BE by comparing PK parameters of Paclitaxel Protein-Bound Particles for Injectable Suspension 100mg/vial with ABRAXANE® for Injectable Suspension 100mg/vial in Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy under fasting condition; To assess variability, optimize sample collection time intervals and provide the information for determination of sample size.
时间窗: The pre-infusion blood sample (00.00) will be drawn within one hour prior to the start of infusion and at 0.08 (5 min), 0.17 (10 min), 0.25 (15 min), 0.33 (20 min), 0.42 (25 min), 0.50 (30 min), 0.58 (35 min), 0.67 (40 min), 0.75 (45 min), 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00 and 120.00 hours after the start of infusion in each period.
次要结局
- To monitor the adverse events and to assess the safety and tolerability in patients(As per Study Requirement)