CTRI/2020/09/028155已完成不适用
A randomized, multicenter, single dose, two-treatment, two-period, crossover, bioequivalence study of Mylan’s Paclitaxel protein bound particles for Injectable Suspension (albumin-bound) and Abraxis Bioscience’s Abraxane® for Injectable Suspension in 110 breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 17
- 主要终点
- Comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves (e.g. AUCL, AUCINF and Cmax) of unbound and total Paclitaxel
研究概览
简要总结
Abioequivalence study with Paclitaxel injection in Metastatic breast cancerpatients with the following objective:
To investigatethe bioequivalence of Mylan’s Paclitaxel protein bound particles for injectablesuspension to Abraxane® following a single, intravenous injection of 260 mg/m2(1 × 100 mg) administered in breast cancer patients after failure ofcombination chemotherapy for metastatic disease or relapse within 6 months ofadjuvant chemotherapy.
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
- All
入选标准
- •1.Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease or has had a relapse within 6months of adjuvant chemotherapy (Prior therapy should have included anthracycline unless clinically contraindicated) 2.Male and/or non-pregnant, non-lactating females aged 18 years or older but less than 70 years (both inclusive)
- •ECOG performance status of less or equal 2 4.Adequate hemopoietic, renal and liver function.
- •5.Patients receiving stable concomitant medications are allowed to participate 6.Treated and stable brain metastases.
排除标准
- •1.Social Habits (for example) ingestion of alcoholic beverages, caffeine- or xanthine-containing food or beverage.
- •2.Use of any food (e.g. broccoli, Brussels sprouts, char-grilled meat, star fruit) known to induce or inhibit hepatic enzyme activity must be limited to no more than 2 standard servings.
- •History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies except the disease/metastasis under study unless deemed not clinically significant by the Investigator 4.Patients who require a dose reduction to below 260 mg/m
- •5.Received chemotherapy and/ or radiotherapy within the past 30 days of first IMP administration or has not recovered from the side effects of previous therapy or has less than 5 washout periods from previous therapy.
- •The toxicities should not be more than grade 1 at the time of dosing.
- •6.History of significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
- •7.Known, existing uncontrolled coagulopathy.
- •8.Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention.
结局指标
主要结局
Comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves (e.g. AUCL, AUCINF and Cmax) of unbound and total Paclitaxel
时间窗: Blood samples will be collected at various timepoints from day 1 to day 5 in both periods
次要结局
- Not applicable(Not applicable)
研究者
研究点 (17)
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