CTRI/2024/03/064383进行中（未招募）不适用
An open label, multi-center, randomized, two-treatment, two period, two-sequence, two-way cross-over, single dose, Bioequivalence (BE) study with pharmacokinetic (PK) endpoints of Paclitaxel 100mg/vial injectable suspension at a dose of 260 mg/m2 of Anbison Lab, China with ABRAXANE® 100mg/vial for Injectable suspension at a dose of 260 mg/m2 of Celgene Corporation Summit, NJ 07901 in subject with metastatic Breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy.
Anbison Lab. Co., Ltd.12 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年4月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 12
- 主要终点
- Establish the bioequivalence between the Test and the Reference product based on ln-transformed pharmacokinetic parameters Cmax, AUC0-t, and AUC0-inf for unbound and total paclitaxel
研究概览
简要总结
Anbison Lab. has developed the test product Paclitaxel 100 mg/vial injectable suspension similar to that of the reference product ABRAXANE® 100mg/vial for Injectable suspension of Celgene Corporation Summit, NJ 07901 for USFDA regulatory submission.
This study is being conducted to characterize the pharmacokinetic profile of Sponsor’s test product in comparison to the reference product after single intravenous infusion at a dose of 260 mg/m2 in female subjects with Breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy to assess the bioequivalence.
Study is designed as per USFDA OGD recommendation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Willing and able to provide written informed consent prior to any study-related activities being performed and to follow protocol requirements
- •Female subjects aged 18 to 65 years (both inclusive) and having Body Mass Index at least 17 kg per m
- •Subjects with histopathologically or cytologically confirmed breast cancer
- •Subjects with breast cancer after failure of combination chemotherapy for metastatic disease or having relapse within 6 months of adjuvant chemotherapy.
- •(Prior therapy should have included an anthracycline unless clinically contraindicated).
- •Life expectancy of greater than 90 days at the time of enrolment.
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to2
- •Acceptable hematology status a.
- •Hemoglobin greater than or equal to 9 g per dL b.
- •Absolute neutrophil count (ANC) greater than or equal to 1500 cells per micro L c.
- •Platelet count greater than or equal to 1, 00,000 cells per mm3
- •Acceptable liver function: a.
- •Alanine aminotransferase (ALT) less than or equal to2.5 X upper limit of normal (ULN) b.
- •Aspartate aminotransferase (AST) less than or equal to2.5 X ULN c.
- •Bilirubin less than or equal to1.5 X ULN d.
- •Alkaline phosphatase less than or equal to2.5 X ULN
- •Subjects of child-bearing potential with negative serum pregnancy test at screening and negative urine pregnancy test at Day
- •Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during treatment with the investigational product) practicing two acceptable methods of contraception during the study and at least 6 months after the last dose of study medication.
- •Female subjects of non-child bearing potential or who have completed menopause are not required to use effective method of contraception during the study.
- •Hormonal method (including oral, vaginal ring, transdermal patch, implanted or injection) started at least 7 days prior to Day 0 plus one barrier method (cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, female or male condom) b.
- •Intrauterine device (IUD) or intrauterine system placed at least 7 days prior to Day
- •Two barrier method used together (cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, male or female condom) d.
- •Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that subject) plus one additional contraception method (hormonal or barrier method) e.
- •Documented tubal sterilization (tubal ligation or trans cervical tubal occlusion with documentation of occlusion 6 months post-procedure) f.
- •Total abstinence; partial abstinence is not acceptable (no sex or genital contact with a male partner)
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction within past one year.
- •Subject should have recovered from the toxicity or adverse effects of previous radiation, surgery and/or chemotherapy as per investigators assessment before administration of study intervention.
排除标准
- •Known hypersensitivity to Paclitaxel, other taxane products or the components of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) or to any of the excipients.
- •Subjects with history of other malignancy in the past.
- •History or presence of sepsis or pneumonitis.
- •Subjects with ≥ Grade 2 peripheral neuropathy.
- •Presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
- •Subjects with known history or current symptoms of unstable angina or myocardial infarction within the past 6 months prior to screening visit.
- •Subjects with electrocardiographic evidence of acute ischemic or active conduction system abnormalities at screening assessment.
- •Subjects taking any of the inhibitors or inducers of either CYP2C8 or CYP3A
- •Known CNS metastasis.
- •Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •Surgical or other non-healing wounds.
- •Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •Loss of ≥350 ml (1 unit) of blood within 90 days before the first dose of Investigational Product.
- •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.
- •Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents.
- •Exceptions are alopecia (any grade is acceptable) and fatigue (Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V 5.0).
- •Pregnant or lactating women.
结局指标
主要结局
Establish the bioequivalence between the Test and the Reference product based on ln-transformed pharmacokinetic parameters Cmax, AUC0-t, and AUC0-inf for unbound and total paclitaxel
时间窗: Per Period Total 23 blood sample till 120hrs will be collected including pre dose sample.
次要结局
- Assess safety & tolerability of test product compared to reference product by monitoring adverse events.(08 Weeks per patients.)
研究者
Dr Sandeep Singh
CBCC Global Research
研究点 (12)
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