CTRI/2019/02/017445已完成未知
A randomized, open label, balanced, multicenter, two-treatment, two-period, two-sequence, two-way crossover, single dose, bioequivalence study with pharmacokinetic endpoints of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) 100 mg/vial at a dose of 260 mg/m2 of Ningbo Shouzheng Medicinal Research Co., Ltd. with ABRAXANE® for Injectable Suspension (albumin-bound) 100 mg/vial at a dose of 260 mg/m2 of Celgene Corporation, Summit, NJ 07901 in Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy under fasting condition - CO180006
ingbo Shouzheng Medicinal Research Co Ltd0 个研究点目标入组 18 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 18
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. Willing and able to provide voluntary informed consent and to follow the protocol requirements.
- •2.Females aged 18 to 65 years (both inclusive) having Body Mass Index (BMI) at least 17.00 calculated as weight in kg/height in m2.
- •3. Patients with histopathologically /cytologically confirmed metastatic breast cancer
- •4. Patients with metastatic breast cancer after failure of combination chemotherapy for metastatic disease or have had a relapse within 6 months of adjuvant chemotherapy. (Prior therapy should have included an anthracycline unless clinically contraindicated)
- •5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- •6. Life expectancy of at least 6 months at the time of enrolment.
- •7. Acceptable hematology status:
- •a.Hemoglobin more than or equal to 9.0 g/dL
- •b.Absolute neutrophil count (ANC) more than or equal to 1500 cells/mm3
- •c.Platelet count more than or equal to 1,00,000 cells/mm3
- •8. Acceptable liver function:
- •a.Alanine aminotransferase (ALT) less than or equal to 2.5 X ULN
- •b.Aspartate aminotransferase (AST) less than or equal to 2.5 X ULN
- •c.Bilirubin more than or equal to 2 X ULN
- •d.Alkaline phosphatase <= 5 X ULN
- •9. Patients with Creatinine clearance >= 60 mL/minute
- •10. Patients with negative serum pregnancy test at screening and negative urine pregnancy test at Day 0.
- •11. Patients who agree to use adequate contraception (eg, hormonal, chemical, double-barrier, or abstinence) while in the study and for 3 months after study participation is discontinued.
- •12. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •1. Known hypersensitivity to Paclitaxel or the components of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) or to any of the related drugs (other taxane products).
- •2.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
- •3.Patients taking any of the inhibitors or inducers of either CYP2C8 or CYP3A4.
- •4.Known CNS metastasis.
- •5.Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •6.Surgical or other non-healing wounds.
- •7.Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •8.Patients with current clinical or laboratory evidence of active infection.
- •9.History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer).
- •10.Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0).
- •11.Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •12.Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of investigational product for the current study.
- •13.Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
- •14.Breastfeeding.
研究者
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