NCT02274610已完成1 期
Phase I Trial to Compare Pharmacokinetics and Safety of Docetaxel PNP With Taxotere in Subjects With Advanced Solid Tumor
Samyang Biopharmaceuticals Corporation0 个研究点目标入组 18 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- Pharmacokinetics of DocetaxelPNP and Taxotere in terms of Area Under the Curve (AUC)
研究概览
简要总结
Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax
详细描述
Comparison of pharmacokinetic parameters (T1/2β, CL, Vdss) Safety as measured by adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ages more than 18 years old
- •Patient should voluntarily sign a written informed consent before study entry
- •Patient historically or cytologically confirmed diagnosis of advanced solid tumor and patient with measurable disease or evaluable disease by RECIST criteria
- •Progressive disease with development of new lesions or an increase in preexisting lesions or standard therapy in order to provide clinical benefit does not exist or is no longer effective
- •Previous anti-cancer therapies must be completed before 21days of first study dose and Patient must have recovered from any previous therapy
- •Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •Patient has a life expectancy of at least 3 months
- •Baseline studies for determining eligibility must be completed within 14 days of first study dose and patient has a adequate organ function including the following:
- •Hb ≥ 10g/dl
- •ANC ≥ 1.5 X 109/L
- •Platelet count ≥ 100 X 109/L
- •Serum total bilirubin ≤ 1.5 mg/dL
- •Serum AST and ALT ≤ 2.5 X UNL
- •Serum ALP ≤ 2.5ⅹUNL
- •Serum creatinine ≤ 1.5 X UNL
排除标准
- •Patient has had a major surgery except tumor ablation within 2 weeks before screening visit
- •Patient has a brain metastasis with neurologic symptom
- •Patient has a sensory neuropathy or motor neuropathy ≥ grade 2 by NCI-CTCAE
- •Patient has any serious concurrent disease such as:
- •Any medical or psychiatric condition that, in the opinion of the investigator, would prohibit the understanding and giving of informed consent Severe cardiovascular disease (e.g. ischemic heart disease requiring medication or myocardial infraction within the past six months, grade 3-4 congestive heart failure defined by the New York Heart Association criteria) Active un controlled infection.
- •Patient has hypersensitivity to the Investigational product or their excipients
- •Patient has participated in any other clinical trial within 4 weeks before screening visit
- •Woman is pregnant or breast feeding
- •Subjects who are of childbearing potential who do not use a medically acceptable method of birth control or do not agree to continue use of this method throughout the trial (screening, treatment period, and 3 weeks from the last done). A negative pregnancy test (urine or serum) should be documented within 14 days prior to initiation of trial medication for women of childbearing potential who have not been amenorrheic for at least 12 months prior to registration into the trial or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). Medically acceptable methods include:
- •Barrier method with spermicide
- •Intrauterine device
- •Complete abstinence, etc.
研究组 & 干预措施
Group A
Experimental
Period 1: Docetaxel-PNP / Washout: 3 weeks / Period 2: Taxotere
干预措施: Docetaxel-PNP (Drug)
Group A
Experimental
Period 1: Docetaxel-PNP / Washout: 3 weeks / Period 2: Taxotere
干预措施: Taxotere (Drug)
Group B
Experimental
Period 1: Taxotere / Washout: 3 weeks / Period 2: Docetaxel-PNP
干预措施: Docetaxel-PNP (Drug)
Group B
Experimental
Period 1: Taxotere / Washout: 3 weeks / Period 2: Docetaxel-PNP
干预措施: Taxotere (Drug)
结局指标
主要结局
Pharmacokinetics of DocetaxelPNP and Taxotere in terms of Area Under the Curve (AUC)
时间窗: 3 months
次要结局
- Number of participants with Adverse Events(3 months)
- Elimination Half Life (T1/2) of DocetaxelPNP and Taxotere(3 months)
- Clearance (CL) of DocetaxelPNP and Taxotere(3 months)
- Volume of Distribution at steady state (Vdss) of DocetaxelPNP and Taxotere(3 months)
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