A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer
2014年11月3日 更新者：Bayer
Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)
The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their lung cancer
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
26
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Berlin、德国、12200
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Hamburg、德国、21075
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Baden-Württemberg
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Gerlingen、Baden-Württemberg、德国、70839
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Löwenstein、Baden-Württemberg、德国、74245
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Bayern
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München、Bayern、德国、80336
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München、Bayern、德国、81675
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Hessen
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Frankfurt、Hessen、德国、65929
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Wiesbaden、Hessen、德国、65199
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Nordrhein-Westfalen
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Essen、Nordrhein-Westfalen、德国、45147
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Rheinland-Pfalz
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Mainz、Rheinland-Pfalz、德国、55131
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Small-cell lung cancer
- Stage of extensive disease
- Adequate function of major organs and systems
- Use of highly effective birth control methods in females of child-bearing potential
Exclusion Criteria:
- Prior chemotherapy for small-cell lung cancer
- Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases
- Superior vena cava syndrome or obstruction of any vital structure
- Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation
- Known allergy or hypersensitivity to platinum-containing drugs
- Pregnancy or breast-feeding
- Use of any investigational drug within 4 weeks before start of the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Sagopilone and cisplatin
The study drug sagopilone was administered in combination with a fixed dose of cisplatin
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Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID
75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin
大体时间：Phase 1: Baseline up to 3 month of treatment
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Phase 1: Baseline up to 3 month of treatment
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Phase 2: Efficacy measure
大体时间：Phase 2: every 6 weeks after start of treatment
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Phase 2: every 6 weeks after start of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Phase 1: PK of Sagopilone + Cisplatin
大体时间：Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion
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Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion
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Phase 2: Duration of CR or PR
大体时间：every 6 weeks after start of treatment
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Duration of complete response (CR) or partial response (PR) as 'overall response', defined as time between first date that the measurement criteria for CR or PR as 'overall response' are met and first date that recurrence or overall response of (progressive disease) PD is documented.
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every 6 weeks after start of treatment
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Phase 2: TTP
大体时间：every 6 weeks after start of treatment
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Time to tumor progression (TTP) is defined as the time from the date of treatment assignment to the first observation of disease progression or to the last date of a definite assessment (not status unknown), if the patient is progression-free until that assessment.
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every 6 weeks after start of treatment
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Phase 2: PFS
大体时间：every 6 weeks after start of treatment
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Progression free survival (PFS) is defined as the time from date of treatment assignment to the first observation of disease progression or death of any cause or to the last date of a definite assessment (not status unknown), if the patient was progression-free until that assessment
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every 6 weeks after start of treatment
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Phase 2: OS
大体时间：every 3 months after start of treatment
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Overall survival (OS) is defined as the time from date of treatment assignment until death from any cause or until the last date the patient is known to be alive
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every 3 months after start of treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年7月1日
初级完成 (实际的)
2009年3月1日
研究完成 (实际的)
2009年8月1日
研究注册日期
首次提交
2006年7月27日
首先提交符合 QC 标准的
2006年8月1日
首次发布 (估计)
2006年8月2日
研究记录更新
最后更新发布 (估计)
2014年11月4日
上次提交的符合 QC 标准的更新
2014年11月3日
最后验证
2014年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Sagopilone (BAY86-5302, ZK 219477)的临床试验
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H. Lee Moffitt Cancer Center and Research InstituteBayer完全的