NCT02652234Unknown1 期
A Single-arm, Open-label Study to Investigate the Safety, Tolerability and Pharmacokinetics of Endostar Subcutaneous Injection in Chinese Advanced NSCLC Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- incidence of adverse events
研究概览
简要总结
This is an open-label, single-arm study to assess the safety, tolerability and pharmacokinetics of Endostar subcutaneous injection in Chinese advanced NSCLC patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological/cytological confirmed unresectable stage ⅢB～Ⅳ non-squamous NSCLC
- •ECOG performance status 0-1
- •Life expectancy≥3 months
- •Adequate hematologic function: WBC≥3.0×109/L ,ANC≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L;
- •Adequate hepatic and renal function: ALT≤2.5×ULN, AST≤2.5×ULN, TBIL≤1.5×ULN, creatinine≤1×ULN, creatinine clearance≥50ml/min;
- •Normal coagulation function (PT, APTT, TT, Fbg) ;
- •Patients signed informed consent form;
- •Willingness and capability to comply with protocol requirement and well communicate with investigators.
排除标准
- •With uncontrolled ascites or pleural effusion;
- •Patients receiving a chest or abdominal surgery within 28 days before enrollment; or with not fully healed surgical incision; or expected to receive surgery during the study;
- •History of ischemic or TIA within 6 months before enrollment;
- •Uncontrolled hypertension, hypertensive crisis or hypertensive encephalopathy;
- •Arrhythmias need to be treated; history of coronary artery disease (including angina pectoris and myocardial infarction) or ischemic myocardium; congestive heart-failure NYHA class ≥ II；
- •Serious active infections;
- •History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment;
- •Symptomatic brain or meningeal metastasis;
- •Epileptic seizure need to be treated;
- •HCV, HBV or HIV positive;
- •History of other malignant tumors within 5 years (except curable cervix carcinoma in situ or skin basal cell carcinoma);
- •Known allergies to any excipient in the study drug;
- •Any conditions that may interfere with the patient's participation in the study or have an impact on the assessment of the results of the study;
- •Any conditions that may endanger patient safety or interfere with the patient's compliance;
- •Pregnant and lactating women;
- •The investigators consider the patients unsuitable for this trial
研究组 & 干预措施
Endostar-subcutaneous injection/Chemotherapy
Experimental
干预措施: Endostar (Drug)
Endostar-subcutaneous injection/Chemotherapy
Experimental
干预措施: Chemotherapy (Drug)
结局指标
主要结局
incidence of adverse events
时间窗: until 30 days after the last dose
次要结局
- T1/2(day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks)
- CL(day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks)
- Cmax(day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks)
- AUC(day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks)
- Tmax(day1, day2 of cycle1;day1,day2,day4,day13,day14,day15,day16,day17 of cycle2; day2,day13,day14,day15 of cycle3; up to 9 weeks)
研究者
研究点 (1)
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