NCT01497873已完成2 期
A Phase IIb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Relapsed Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 14
- 主要终点
- Objectives Response Rate(ORR, %)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.
详细描述
A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell inj.) or Topotecan in Patients with Relapsed Small Cell Lung Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •At least 18 years of age
- •Histological or cytological diagnosis of SCLC
- •Limited disease (LD) or Extensive disease (ED) at time of study entry
- •Recurrent or progressive SCLC ≥ 90 days of duration of response for firstline therapy
- •Measurable disease defined by RECIST criteria
- •ECOG Performance Status of 0, 1, or 2
- •Life expectancy ≥ 3 months
- •Adequate bone marrow, Renal, Hepatic reserve:
- •absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/mm3 platelet count ≥ 100,000 cells/ mm3 hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 mm3 Alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤ 2.0 X ULN Alkaline Phosphatase (ALP) ≤ 2.0 X ULN Serum creatinine ≤ 1.5mg/dL or calculated creatinine clearance > 60mL/min
- •Signed a written informed consent
排除标准
- •Active infection
- •Symptomatic brain lesion
- •Any other type of cancer during the previous 5 years
- •Severe concurrent diseases
- •Prior anticancer therapy within 4 weeks before enroll
- •Active pregnancy test and Pregnant or nursing women
- •Participation in any investigational drug study within 28 days prior to study entry
研究组 & 干预措施
Belotecan
Experimental
Camtobell Injection
干预措施: Belotecan (Drug)
Topotecan
Active Comparator
Hycamtin Injection
干预措施: Topotecan (Drug)
结局指标
主要结局
Objectives Response Rate(ORR, %)
时间窗: Up to 18weeks
The response rate was defined as the test subject who had a complete response (CR) or a partial response (PR) as determined by the 'tumor response evaluation' criteria specified in the research protocol
次要结局
- Overall Survival(OS)(7years)
- Progression Free survival(PFS)(Up to 18weeks)
研究者
研究点 (14)
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