NCT00080015已完成2 期
A Phase II Open Label Study Investigating the Activity of Diflomotecan (BN80915) Administered at the Fixed Dose of 7mg as a 20 Minute Intravenous Infusion Once Every 3 Weeks in Patients With Sensitive Small Cell Lung Cancer (SCLC) Who Have Failed First-line Treatment With a Platinum Based Regimen.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 9
- 主要终点
- Overall objective response rate (tumour assessments should be performed every 6 weeks)
研究概览
简要总结
This is a Phase II, open-label, multicenter, single-arm, exploratory "proof of concept" study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive disease after first-line treatment with a platinum-based regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Documented small cell lung cancer (SCLC)
- •Measurable disease
- •One line of previous chemotherapy, including any platinum analogue, and excluding any camptothecin analogues, with objective response and relapsed no less than 3 months
排除标准
- •Uncontrollable brain metastasis
- •Treated with an investigational drug within 30 days
结局指标
主要结局
Overall objective response rate (tumour assessments should be performed every 6 weeks)
次要结局
- Time to tumour progression
- Time to treatment failure
- Duration of overall response
- Overall complete response, partial response and stable disease
- Time to response
- Six month and one year survival rates
- Median survival
- Best overall response
- Overall objective response rate
研究者
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