A Randomized, Open-label, Single-dose, Dose-escalation, Self-controlled Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YPEG-Filgrastim in Cancer Patients Receiving Chemotherapy

Xiamen Amoytop Biotech Co., Ltd.1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2010年4月最近更新: 2013年2月4日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Xiamen Amoytop Biotech Co., Ltd.
入组人数: 30
试验地点: 1
主要终点: Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study.

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 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
盲法: None

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age: 18～70yrs
•Signed informed consent
•Confirmed malignant tumor patients by histopathological or cytological diagnosis, suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin
•Karnofsky score ≥70
•Life expectancy >3 months
•WBC≥3,500 per cubic milliliter, ANC≥1,500 per cubic milliliter, PLT≥100,000 per cubic milliliter
•Normal coagulation function, no evidences of hemorrhage
•Normal liver, heart, kidney function

排除标准

•Pregnant or lactating females
•Proven active infectious diseases (e.g. viral hepatitis, TB)
•Not adequately controlled infections
•Known hypersensitivity to filgrastim or any other components of the study drug
•Unstable or uncontrolled cardiac disease or hypertension
•Currently participated in any other clinical trials
•Patients with previous or expected to receive systemic radiotherapy
•Evidence of metastatic disease in bone marrow, brain, et al
•Alcoholic or drug abusers
•Other conditions which in the opinion of the investigator preclude enrollment into the study