NCT01022671已完成2 期
Single-Arm, Open-label, Multicenter, Phase 2 Clinical Trial to Assess the Efficacy and Safety of Single-Agent Camtobell Inj.(Belotecan) Administered on A Weekly Schedule in Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Previously Treated With Chemotherapy
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
- 52
- 主要终点
- Objective Response Rate
研究概览
简要总结
A phase II study is conducted to determine the efficacy and safety of a single agent Camtobell inj.(belotecan) on a weekly schedule in locally advanced or metastatic non-small cell lung cancer patients previously treated with chemotherapy. The usefulness of the this regimen is evaluated by response rate, median survival time, progression free survival and duration of response.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 Years and older
- •Histologically or cytologically confirmed locally advanced or metastatic NSCLC(Stage IIIB or IV)
- •≥ one measureable or evaluable lesion, <25% of the bone marrow had been irradiated
- •prior platinum based chemotherapy
- •ECOG PS ≤ 2
- •Life expectancy > 3 months
- •Adequate organ function:
- •hematology: ANC ≥ 1.5×109/L, Platelet ≥ 100×109/L, hemoglobin ≥ 9.0g/dL
- •hepatic: total bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.0×ULN, ALP ≤2.0×ULN
- •renal: serum creatinine ≤ 1.5×ULN
- •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
研究组 & 干预措施
Belotecan
Experimental
Single arm
干预措施: Belotecan (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: every 2 cyc
次要结局
- Overall Survival(6 months after Last patient out)
- Progression Free survival(6 months after Last patient out)
- Adverse event(every visit)
研究者
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