NCT00299390终止2 期
Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy Naive Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 10
- 主要终点
- Response to treatment according to the modRECIST (complete response or partial response)
研究概览
简要总结
The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven Small-cell lung cancer (SCLC)
- •Stage of extensive disease defined by the presence of distant metastases
- •At least 1 unidimensionally measureable lesion
- •WHO performance status 0 to 1
- •No previous SCLC-related chemotherapy
- •No previous SCLC-related surgery
- •No previous radiotherapy (excepting for brain metastasis)
- •Adequate function of major organs and systems
- •Nervous system
- •No Grade 2 or greater peripheral neuropathy
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No arrythmia needing continuous treatment
- •No other uncontrolled concurrent illness
排除标准
- •Superior vena cava syndrome or obstruction of any vital structure
- •Untreated malignant hypercalcemia
- •Pleural effusion as the only manifestation of disease
- •Extensive disease amenable to radiation therapy
- •Symptomatic brain metastases requiring whole brain irradiation
- •Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix
研究组 & 干预措施
Sagopilone
Experimental
干预措施: Sagopilone (BAY86-5302, ZK 219477) (Drug)
结局指标
主要结局
Response to treatment according to the modRECIST (complete response or partial response)
时间窗: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
次要结局
- Duration of complete or partial tumor response(Every 2 cycles until tumor progression i.e. approximately every 6 weeks)
- Number of participants with adverse events(Approximately 30 weeks)
- Time to tumor progression(Every 2 cycles until tumor progression i.e. approximately every 6 weeks)
研究者
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