A Trial to Determine the Maximum Tolerated Dose and Evaluate the Safety and Pharmacokinetics of Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel, in Subjects With Advanced Solid Malignancies

Samyang Biopharmaceuticals Corporation1 个研究点分布在 1 个国家目标入组 19 人开始时间: 2010年4月最近更新: 2017年5月5日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 19
试验地点: 1
主要终点: The maximum tolerated dose (MTD) of Docetaxel-PNP

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
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.
•Patient who has a history of resistance, intolerance, or no response to Docetaxel therapy