A Randomized, Open Label, Multi Center, Two Treatment,Two Period, Two Sequence, Single Dose, Crossover,Bioequivalence Study of Paclitaxel Protein-Bound Particlesfor Injectable Suspension (Albumin-Bound), 100 mg/vialmanufactured by Teva Pharmachemie, The Netherlands, forTeva Pharmaceuticals USA, and AbraxaneÂ® for InjectableSuspension (paclitaxel protein-bound particles for injectablesuspension)(albumin-bound), 100 mg/vial manufactured byAbraxis BioScience LLC, USA for Celgene Corporation,USA in Patients with Metastatic Breast Cancer.

Teva Pharmaceuticals USA20 个研究点分布在 1 个国家目标入组 66 人开始时间: 2018年9月15日最近更新: 2018年11月21日

试验速览

阶段: 不适用
状态: 招募中
发起方: Teva Pharmaceuticals USA
入组人数: 66
试验地点: 20
主要终点: To demonstrate the

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the proposed study is to assess the bioequivalence of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), 100 mg/vial manufactured by Teva Pharmachemie, The Netherlands, for Teva Pharmaceuticals USA and AbraxaneÂ® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(albuminbound), 100 mg/vial manufactured by Abraxis BioScience LLC, USA for Celgene Corporation, USA in patients with metastatic breast cancer.

The objectives of this proposed trial are as below:

To demonstrate the bioequivalence between Test product (Albumin bound Paclitaxel) and Reference product (ABRAXANEÂ®) in patients with Metastatic Breast Cancer.

To monitor safety

To determine other pharmacokinetic data

A total of 66 patients will be randomized in the study to establish bioequivalence

Analytical Method:

Unbound and total paclitaxel concentration in plasma will be measured using a validated bio-analytical method and according to the bio-analytical laboratoryâ€™s standard operating procedures and applicable regulatory

principles. Unbound paclitaxel concentration in plasma will be measured till 24 hours and total paclitaxel up to 72 hours after start of infusion.

Due to the sensitivity of Paclitaxel to ultraviolet (UV) light, the blood sample collection, sample transfer, sample separation, sample segregation and sample processing procedure will be done under yellow monochromatic light.

Sample collection, processing details and storage of plasma samples at study site will be provided in procedure manual for sample collection.

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 60.00 Year(s)（—）
性别: Female

入选标准

•Female patient aged between 18 and 60 years of age (both inclusive).
•Patient with confirmed (histological or cytological) diagnosis of metastatic (NO known CNS metastasis) breast cancer or relapse within 6 months of adjuvant chemotherapy that included anthracycline unless clinically contraindicated.
•Life expectancy of more than 6 months as judged by the Investigator.
•ECOG PS (Eastern Cooperative Oncology Group performance status) of 0, 1 or
•Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide,absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 30 days prior to study drug administration, during study and 30 days after the last dose of study drug.
•Patient able to understand, willing and likely to comply with study procedures and restrictions.
•Patient has provided signed and dated Informed consent before initiating any study-related procedures.

排除标准

•History or presence of significant coexisting disease or surgery (within 4 weeks prior to start of therapy) that could affect the action or disposition of the investigational product, or clinical or laboratory assessments.
•Patients requiring any concurrent chemotherapy, hormonal therapy, immunotherapy, therapy with biologicals or radiotherapy for the disease (any previous aforementioned treatments within 4 weeks of period 1 dosing).
•Patients with medical conditions that preclude administration of chemotherapy [uncontrolled inter-current illness like unstable angina, myocardial infarction (within 6 months prior to study entry), congestive heart failure, serious cardiac arrhythmias, uncontrolled diabetes, autoimmune disease, or any uncontrolled systemic disease (e.g. recurrent pleural effusion / ascites, active infections, patients with immune deficiency disorders) or patients already on immunosuppressive drugs] or any other significant co-morbid conditions as determined by the investigator(s).
•Clinical significant abnormal laboratory values.
•Bone marrow Function WBC greater than 3000/ microL Absolute Neutrophil Count less than 1500/ microL Platelet count less than 100,000/ microL Haemoglobin less than 9.0 g/dl Renal Function Serum Creatinine greater than 1.5 times ULN Hepatic Function AST greater than 2.5 times ULN ALT greater than 2.5 times ULN Alkaline Phosphatase greater than 2.5 times ULN Serum Albumin less than 3.0 gm/dL
•Left ventricular ejection fraction (LVEF) of less than 50% as determined by Echocardiography (ECHO).
•History or presence of QTc prolongation (QTc greater than or equal to 470 ms, based on bazettâ€™s correction method), left bundle branch block (LBBB), significant atrioventricular block (AV block) or any other significant cardiac disease.
•Current (within 2 weeks of period 1 dosing) or regular use of any medication (including over the counter [OTC], herbal or homeopathic preparations) that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessment.
•Positive result of urine screen for drugs of abuse (i.e., Amphetamines, Morphine, Benzodiazepines,Marijuana (THC), Cocaine and Barbiturates).
•Patients with positive HIV, HBV, HCV and/or VDRL.
•Known or suspected intolerance or hypersensitivity to Paclitaxel or any of the excipients or any other taxane.
•Patients who have participated in any other clinical study in the preceding 30 days prior to the start of the study.
•Patients who are pregnant or demonstrating a positive pregnancy screen or are currently breast-feeding or planning to become pregnant during study period.
•Patients who have taken medication that are either substrates or inhibitor/inducer of CYP3A4/CYP2C8 enzyme less than 4 weeks prior to start of IMP or require as concomitant medication.
•Patients with pre-existing sensory neuropathy of a severity greater than or equal to 3 grade as defined in National Cancer Institute Common Toxicity Criteria (CTC).