A randomized, multicenter, single dose, two-treatment, two-period, crossover, bioequivalence study of Mylanâ??s Paclitaxel protein bound particles for Injectable Suspension (albumin-bound) and Abraxis Bioscienceâ??s AbraxaneÂ® for Injectable Suspension in 110 breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy

Mylan Laboratories Limited0 个研究点目标入组 111 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•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)
•3. 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

•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.
•3. 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/m2.
•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.

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