EUCTR2006-004566-13-DE进行中（未招募）不适用
An open-label, randomised, phase II study in subjects with extensive disease, small cell lung cancer (ED-SCLC) after an initial response (complete response or partial response) to platinum-based therapy to determine the effect of EMD 273066 following low-dose cyclophosphamide on disease progression and survival versus best supportive care alone.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Signed written informed consent
- •- >18 years of age
- •- Histologically documented SCLC
- •- Radiologically demonstrated extensive-stage disease by thoracic and abdominal CT or MRI scan prior to induction chemotherapy.
- •- Received 4 cycles of platium-based, first-line chemotherapy (12-14) weeks) without thoracic irradiation.
- •- Experienced a response to platium-based first-line chemotherapy (CR or PR according to RECIST shown after second and fourth course of induction chemotherapy compared to findings prior to induction therapy.
- •- Confirmatory CT or MRI scan
- •- Negative CT of the head.
- •- Be enrolled and begin treatment 3-5 weeks after last infusion of platium-based, first-line chemotherapy.
- •- Life expectancy > 4 months
- •-ECOG performance status < 2 at study entry
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Thoracic radiotherapy, surgery (excluding prior diagnostic biopsyI or any investigational drug in the 30 days before the start of treatment in this study.
- •- ECG with evidence of active clinically significant cardiac disease within 4 weeks prior to starting study treatment.
- •- Uncontrolled CHF New York Heart Association Grade 2-4 or echocardiogram with a left ventricular ejection fraction < 45%
- •- History or repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular or other clinically significant arrhytmias.
- •- Uncontrolled hypertension
- •- Evidence of active brain metastases.
研究者
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