Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Adverse Events
Number of Participants With SAEs
时间窗: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with SAEs
Number of Participants With Adverse Events Leading to Discontinuation
时间窗: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Adverse Events Leading to Discontinuation
Number of Participants With Drug Related Laboratory Abnormalities
时间窗: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Drug Related Laboratory Abnormalities
Number of Participants With Laboratory Abnormalities
时间窗: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Laboratory Abnormalities
次要结局
- Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer(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)
- Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer(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)
- Number of Participants With Best Overall Response Per RECIST Criteria(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)
- Duration of Overall Response as Per RECIST Criteria(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)