CTRI/2018/08/015506招募中未知
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 Abraxane® 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.
试验速览
- 阶段
- 未知
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Female patient aged between 18 and 60 years of age (both inclusive).
- •2. 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.
- •3. Life expectancy of more than 6 months as judged by the Investigator.
- •4. ECOG PS (Eastern Cooperative Oncology Group performance status) of 0, 1 or 2.
- •5. 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.
- •6. Patient able to understand, willing and likely to comply with study procedures and restrictions.
- •7. Patient has provided signed and dated Informed consent before initiating any study-related procedures.
排除标准
- •1. 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.
- •2. 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).
- •3. 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).
- •4. 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
- •5. 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.
- •6. 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.
- •7. Positive result of urine screen for drugs of abuse (i.e., Amphetamines, Morphine, Benzodiazepines,Marijuana (THC), Cocaine and Barbiturates).
- •8. Patients with positive HIV, HBV, HCV and/or VDRL.
- •9. Known or suspected intolerance or hypersensitivity to Paclitaxel or any of the excipients or any other taxane.
- •10. Patients who have participated in any other clinical study in the preceding 30 days prior to the start of the study.
- •11. Patients who are pregnant or demonstrating a positive pregnancy screen or are currently breast-feeding or planning to become pregnant during study period.
- •12. 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.
- •13. 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).
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