EUCTR2011-004155-39-FR进行中（未招募）1 期
Phase Ib / II study of BAY 1000394 in combination with cisplatin / etoposide or carboplatin / etoposide as first-line therapy in subjects with extensive disease small cell lung cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •Male or female subjects aged equal or above 18 years
- •Histologically or cytologically confirmed, extensive disease SCLC
- •At least 1 solid tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1. Subjects with non-measurable disease according to RECIST 1.1 can be included in the Phase Ib part of the study
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Life expectancy of at least 12 weeks
- •Serum sodium equal or above 130 mmol/L
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •Prior systemic anticancer therapy
- •Prior radiotherapy (local palliative radiotherapy is permitted)
- •History of cardiac disease: congestive heart failure > NYHA Class II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months prior to study entry), myocardial infarction within the past 3 months prior to study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- •Moderate or severe hepatic impairment, ie Child-Pugh class B or C
- •Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
研究者
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