NCT00940758已完成1 期
Phase I and Pharmacokinetic Study of Biweekly PEP02 (Liposome Irinotecan) in Patients With Metastatic Colorectal Cancer Refractory to First-line Oxaliplatin-based Chemotherapy
PharmaEngine1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2009年6月最近更新:
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
- 18
- 试验地点
- 1
- 主要终点
- To establish the MTD
研究概览
简要总结
The purpose of this study is to evaluate the dose-limiting toxicity (DLT), toxicity profile, maximum tolerated dose (MTD) and characterize the pharmacokinetics of biweekly PEP02 treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histopathologically confirmed metastatic colorectal cancer
- •Documented disease progression after first-line chemotherapy containing oxaliplatin
- •Both genders, age 18 years
- •ECOG performance status 0 or 1
- •Adequate organ and marrow function
- •Written informed consent to participate in the study
排除标准
- •Have received irinotecan treatment
- •With active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
- •With clinically significant gastrointestinal disorder (e.g. bleeding, inflammation, obstruction, including partial or complete obstruction secondary to peritoneal carcinomatosis, or diarrhea > grade 1)
- •With uncontrolled intercurrent illness that could limit study compliance considered to be ineligible for the study by the investigators including, but NOT limited to, any of the following:ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia psychiatric illness or social situation that would preclude study compliance
- •With other primary malignancies, except those remain disease-free for 3 or more years after curative treatment.
- •Prior chemotherapy within 3 weeks
- •Major surgery or radiotherapy within 4 weeks
- •Prior participation in any investigational drug study within 3 weeks
- •History of allergic reaction to liposome product
- •Pregnant or breastfeeding (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative)
研究组 & 干预措施
PEP02
Experimental
干预措施: PEP02 (Drug)
结局指标
主要结局
To establish the MTD
时间窗: 3 years
To evaluate the DLT and the toxicity profile
时间窗: 3 years
To characterize the pharmacokinetics of biweekly PEP02 in patients with metastatic colorectal cancer who failed to first-line oxaliplatin-based chemotherapy
时间窗: 3 years
次要结局
- To collect data for preliminary evaluation of tumor response(3 years)
- To explore the association of the pharmacogenetics of PEP02 including UGT1A family - UGT1A1 and UGT1A9 with pharmacokinetic parameters and toxicity(3 years)
研究者
研究点 (1)
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