Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer
概览
- 阶段
- 2 期
- 干预措施
- Paclitaxel
- 疾病 / 适应症
- Breast Cancer
- 发起方
- Bristol-Myers Squibb
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Adverse Events
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of continued administration of paclitaxel given weekly in subjects considered to need to continue treatment after completion of the preceding "Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with Advanced Breast Cancer (Protocol No. CA139-371)"
研究者
入排标准
入选标准
- •Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study
排除标准
- 未提供
研究组 & 干预措施
Paclitaxel
干预措施: Paclitaxel
结局指标
主要结局
Number of Participants Experiencing Adverse Events
时间窗: From first dose to end of follow-up period (up to approximately 33 months)
This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively)
Number of Participants Experiencing Laboratory Tests Abnormalities
时间窗: From first dose to end of follow-up period (up to approximately 33 months)
This outcome describes the number of participants experiencing laboratory test abnormalities. The following laboratory test categories were analyzed: * Enzyme investigations * Hematology investigations * Hepatobiliary investigations * Lipid investigations * Protein and chemistry analyses * Renal and urinary tract investigations * Water, electrolytes and mineral investigation. Laboratory test abnormalities were graded according to the NCI Common Toxicity Criteria version 2 (JCOG Version), resulting in a score from Grade 0 (Normal) to Grade 5 (Death due to toxicity). Only laboratory test abnormalities with a Grade 3 or higher are reported
次要结局
- Overall Response Rate (ORR)(From first dose to end of follow-up period (up to approximately 33 months))
- Duration of Response (DOR)(From first date of Partial Response (in study NCT01023204) to first date of Progressive Disease (in study NCT01023204 or NCT00971945) (up to approximately 37 months))