Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maxinum tolerated dose of M2ES
研究概览
简要总结
- MTD and DLT of M2ES
- Pharmacokinetics of M2ES
详细描述
Patients received infusion of M2ES for 120 minutes weekly（d1,d8,d15）by calculated pump and underwent evaluation of vital signs including blood pressure, pulse, respiratory rate, and temperature before treatment, at intervals during infusion, and hourly for 6 hours after infusion. After infusion, patients underwent serial pharmacokinetic sampling. All patients were seen weekly during the study therapy and follow-up and underwent evaluation with physical examination including ECOG performance status, vital signs, and laboratory evaluation with complete blood count with manual differential, chemistry evaluation, prothrombin time/partial thromboplastin time, and urinalysis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years;Genders eligible for study: both;
- •Histologic diagnosis of solid malignancies ;
- •Performance status of 0 or 1;
- •Tumor not amenable to standard curative or palliative therapy;
- •life expectancy beyond 3 months;
- •Ability to give signed informed consent
排除标准
- •Pregnancy or lactation;
- •Had a history of brain metastasis or a primary brain tumor;
- •An active, potentially severe autoimmune disease;
- •Serum creatinine ≥1.5mg/dl or a calculated creatinine clearance <60ml/min; WBC count < 2.0×109/L，hemoglobin < 90g/L，and platelet count < 100×109/L; Total bilirubin value < 2.0 times the upper limit of normal (ULN), ALT level < 2.0 times ULN, AST < 2.0 times ULN;
- •Positive of anti-HIV antibodies;
- •An active infection;
- •had received chemotherapy or immunotherapy within the prior 4 weeks before study entry
- •Participation in a clinical study during the last 28 days
- •QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG
研究组 & 干预措施
PEDylated Recombinant Human Endostatin
PEDylated Recombinant Human Endostatin
干预措施: PEDylated Recombinant Human Endostatin (Drug)
结局指标
主要结局
Maxinum tolerated dose of M2ES
时间窗: one month
To assess the adverse events
次要结局
- DLT of M2ES(one month)
- Pharmacokinetic effect(one month)
- Tumor response rate(one month)
研究者
Li Zhang
Profressor
Sun Yat-sen University