NCT01630018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 Recurrent or Refractory Ovarian 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
- 141
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of belotecan or topotecan in patients with recurrent or refractory ovarian cancer (AOC).
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 Recurrent or Refractory Ovarian 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
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Histological or cytological diagnosis of AOC
- •Stable disease (SD) or progression at time of study entry Recurrent or progressive AOC ≥ 90 days of duration of response for first-line 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/μL
- •platelet count ≥ 100,000 cells/μL
- •hemoglobin ≥ 9 g/dL
- •Total bilirubin ≤ 1.5 X ULN
- •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 except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix 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
Topotecan
Active Comparator
Topotecan
干预措施: Topotecan (Drug)
Camtobell
Active Comparator
Belotecan
干预措施: Belotecan (Drug)
结局指标
主要结局
Objective response rate
时间窗: approximately 21 days(every 1 Cycle)
次要结局
- Overall Survival(up to 4 years)
- Progression Free survival(up tp 4 years)
研究者
研究点 (1)
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