CTRI/2015/03/005653招募中不适用
A randomized, open label, multi centric, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial manufactured by Sindan Pharma for Actavis LLC, USA and Abraxane 100 mg/vial (Albumin bound Paclitaxel 260 mg/m2) intravenous infusion Abraxis BioScience LLC, New Jersey in patients with metastatic breast cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Actavis LLC
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Cmax, AUC0-t and AUC0-∞
研究概览
简要总结
This study is a randomized, openlabel, two way cross over, bioequivalence study comparing Paclitaxelprotein-bound particles for injectable suspension (albumin-bound) 100 mg/vialmanufactured by Sindan Pharma for Actavis LLC, USA and Abraxane 100 mg/vial (Albumin bound Paclitaxel)intravenous infusion Abraxis BioScience LLC, New Jersey in Patients with metastatic breastcancer. This study will be conducted in multi centre sites in India. Theprimary objective of this study is to show bioequivalence of Paclitaxelprotein-bound particles for injectable suspension (albumin-bound) 100 mg/vialmanufactured by Sindan Pharma for Actavis LLC and Abraxane 100 mg/vial (Albumin bound Paclitaxel)intravenous infusion Abraxis BioScience LLC in patients with metastatic breastcancer.
Secondary objectiveis to summarize the treatment emergent adverse events in patients with metastaticbreast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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
- •i. Female patients aged between
- •60 years of age (inclusive) with histological or cytological confirmation of diagnosis of breast cancer. ii.Female patients with metastatic breast cancer (No known CNS metastasis) after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. If the patient is already receiving Paclitaxel, at least two more cycles of Paclitaxel should be required for completing the course of chemotherapy, for inclusion in the study. iii. Life expectancy of more than 6 months as judged by the Investigator. iv. ECOG (Eastern Cooperative Oncology Group) performance status of 2 or less. v. Adequate renal function defined as Serum Creatinine ≤1.5 times ULN vi. Previous chemotherapy and or radiotherapy should be completed 4 weeks prior to start of first IMP administration for the current study vii. Previous hormonal treatment should be completely washed out prior to start of IMP administration viii. Satisfactory medical assessment done by investigator to ensure that there are no clinically significant and relevant abnormalities (of medical history, physical examination and ECG, clinical or laboratory evaluation (haematology, biochemistry, serology and urinalysis). Patients must have Hemoglobin ≥ 9 gm/dl for inclusion in the study ix. Postmenopausal women with amenorrhea for at least 12 consecutive months x. Female patients of child bearing potential must agree to use one of the following contraceptive measures during and for at least three months after cessation of therapy: a. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy). b. IUD in place for at least 3 months. c. Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study and for 4 days following the last dose. d. Abstinence e. Other birth control methods deemed acceptable by the investigator xi. The patient must understand and be able, willing and likely to fully comply with study procedures and restrictions xii. Patient must have provided signed and dated Informed consent given in written form in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before initiating any study-related procedures.
排除标准
- •i. History or presence of significant current or recurrent disease (other than breast cancer) that could affect the action or disposition of the investigational product, or clinical or laboratory assessments. ii. History or presence of significant current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment (other than breast cancer) or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. iii. Patients requiring any concurrent chemotherapy, hormonal therapy, immunotherapy, therapy with biologicals or radiotherapy for the disease. iv. Patients with medical conditions that preclude administration of chemotherapy [uncontrolled intercurrent 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). v. Patients with liver impairment.
- •serum transaminase levels (alanine transaminase [ALT] and/or aspartate transaminase [AST]) greater than 2.5 times the upper limit of normal (ULN) concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN vi. Patients with absolute neutrophil count of < 1,500 cells/mm3 & platelet < 1,00,000 /mm3 during screening vii. Serum albumin < 3 gm/dl viii. Presence of Left ventricular ejection fraction (LVEF) of <50% as determined by Echocardiography (ECHO)/ Multiple Gated Acquisition scan (MUGA). ix. Previous documented history of QTc prolongation with other medication or patient with congenital QT prolongation or patient with Patients with QTc ≥ 470 ms (where QTc based on Bazett’s correction method) or patient with any other significant cardiac disease. x. Presence of left bundle branch block (LBBB) and with significant atrioventricular block (AV block). xi. Current (within 2 weeks of the start of the study) or regular use of any medication (including over the counter [OTC], herbal or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessment. xii. Clinical illness other than breast cancer, radiotherapy or any major surgery within 4 weeks before the start of the study. xiii. Patients with known CNS metastasis. xiv. Positive urine drug screening, HIV, VDRL/RPR, Hepatitis B & C tests. xv. Patients with severe fluid retention e.g. pleural effusion, pericardial effusion or ascites. xvi. Patients previously been randomized into this study and subsequently withdrawn xvii. Known or suspected intolerance or Hypersensitivity to Paclitaxel or any of the excipients or any other taxane xviii. Patients who have participated in any other clinical study in the preceding 30 days prior to the start of the study. xix. Patients who are pregnant or demonstrating a positive pregnancy screen or are currently breast-feeding or planning to become pregnant during study period. xx. Patient unable to be closely followed for social, Geographic or psychological reasons. xxi. Patients who have taken medication that are either substrates or inhibitor/inducer of CYP3A4/CYP2C8 enzyme < 3 weeks prior to start of IP or require as concomitant medication xxii. Patients with pre-existing sensory neuropathy of a severity > grade 3 as defined in National Cancer Institute Common Toxicity Criteria (CTC).
结局指标
主要结局
Cmax, AUC0-t and AUC0-∞
时间窗: 0.250, 0.500, 0.750, 1.000, 1.500, 2.000, 3.000, 4.000, 6.000, 8.000, 12.000, 24.000, 48.000 72.00 and 96.000
•The study duration for each patient will be of approximately 50 days (14 days of screening+21 days of washout including P-I dosing +15 days of follow up period)
时间窗: 0.250, 0.500, 0.750, 1.000, 1.500, 2.000, 3.000, 4.000, 6.000, 8.000, 12.000, 24.000, 48.000 72.00 and 96.000
次要结局
- To summarize the treatment emergent adverse events in patients(Throughout the study)
研究者
研究点 (9)
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