Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
2022年2月16日 更新者：Bristol-Myers Squibb
The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of observed adverse reactions in treated subjects
研究概览
研究类型
介入性
注册 (实际的)
11
阶段
- 阶段2
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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Kanagawa、日本
- Local Institution
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Tochigi、日本、329-0498
- Local Institution
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Chiba
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Kashiwa-shi、Chiba、日本、2778577
- Local Institution
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Ehime
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Matsuyama-shi、Ehime、日本
- Local Institution
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Kagoshima
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Kagoshima-shi、Kagoshima、日本、8900075
- Local Institution
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Kanagawa
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Yokohama、Kanagawa、日本、241-0815
- Local Institution
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Osaka
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Osaka-shi、Osaka、日本、5458586
- Local Institution
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Shizuoka
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Sunto-gun、Shizuoka、日本、4118777
- Local Institution
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Tokyo
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Meguro-ku、Tokyo、日本、1520021
- Local Institution
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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
- 孩子
- 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:
- Subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator
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：紫杉醇
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Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With SAEs
大体时间：From the first infusion to the completion of study. Approximately up to 28 months
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Number of Participants with SAEs
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From the first infusion to the completion of study. Approximately up to 28 months
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Number of Participants With Adverse Events Leading to Discontinuation
大体时间：From the first infusion to the completion of study. Approximately up to 28 months
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Number of Participants with Adverse Events Leading to Discontinuation
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From the first infusion to the completion of study. Approximately up to 28 months
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Number of Participants With Adverse Events
大体时间：From the first infusion to the completion of study. Approximately up to 28 months
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Number of Participants with Adverse Events
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From the first infusion to the completion of study. Approximately up to 28 months
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Number of Participants With Laboratory Abnormalities
大体时间：From the first infusion to the completion of study. Approximately up to 28 months
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Number of Participants with Laboratory Abnormalities
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From the first infusion to the completion of study. Approximately up to 28 months
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Number of Participants With Drug Related Laboratory Abnormalities
大体时间：From the first infusion to the completion of study. Approximately up to 28 months
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Number of Participants with Drug Related Laboratory Abnormalities
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From the first infusion to the completion of study. Approximately up to 28 months
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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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Number of Participants With Best Overall Response Per RECIST Criteria
大体时间：From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
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Best overall response is represented by the number participants who have had complete response, partial response and have stable disease.
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From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
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Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
大体时间：From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
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Best overall response is represented by the number participants who have had complete response, partial response and not completed.
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From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
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Duration of Overall Response as Per RECIST Criteria
大体时间：From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
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DOR is defined as the median time from the first date of Partial Response to the first date of Progressive Disease.
Participants were evaluated for DOR in a separate study (NCT00971867).
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From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
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Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
大体时间：From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
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Best overall response is represented by the number participants who have had complete response, partial response and not completed.
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From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
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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。
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 (实际的)
2006年8月4日
初级完成 (实际的)
2008年11月26日
研究完成 (实际的)
2008年11月26日
研究注册日期
首次提交
2009年9月3日
首先提交符合 QC 标准的
2009年9月3日
首次发布 (估计)
2009年9月4日
研究记录更新
最后更新发布 (实际的)
2022年4月8日
上次提交的符合 QC 标准的更新
2022年2月16日
最后验证
2022年2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.
Paclitaxel的临床试验
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Fujian Cancer HospitalJiangsu Hengrui Pharmaceutical Co., Ltd.; SunWay Biotech Co., LTD.尚未招聘肝转移 | 恶性黑色素瘤