临床试验/NCT01019577

NCT01019577已完成2 期

Phase II Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

R-Pharm0 个研究点目标入组 54 人开始时间: 2005年10月最近更新: 2017年1月30日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 54
主要终点: To assess the tumor response using RECIST Criteria to determine the best overall response and response rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.

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: 20 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Women aged 20 years or older
•Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination

排除标准

•Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥ 2

研究组 & 干预措施

Ixabepilone

Experimental

干预措施: Ixabepilone (Drug)

结局指标

主要结局

To assess the tumor response using RECIST Criteria to determine the best overall response and response rate

时间窗: For a maximum of 9 3-week cycles or until unacceptable toxicity

次要结局

To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria(Every cycle)
To evaluate the duration of achieved responses(For a maximum of 9 3-week cycles or until unacceptable toxicity)
To evaluate time to progression (TTP)(For a maximum of 9 3-week cycles or until unacceptable toxicity)

研究者

发起方

R-Pharm

申办方类型

Industry

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未知

2 期

A phase II study of ixabepilone (BMS-247550) in patients with metastatic breast cancer previously treated with an Anthracycline and who are Taxane resistantMetastatic breast cancer

JPRN-jRCT2080220193Bristol-Myers K.K.54