NCT00313248已完成2 期
Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 65
- 主要终点
- Response to treatment with ZK-Epo after 6 cycles
研究概览
简要总结
The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.
详细描述
This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Metastatic breast cancer (meaning the cancer has spread beyond its original location)
- •At least one measurable lesion by CT or MRI
- •Progression of disease following previous therapy for breast cancer
- •Have received previous treatment with anthracyclines (e.g. doxorubicin[Adriamycin or Doxil] or epirubicin [Ellence]), taxanes (paclitaxel [Taxol or Abraxane] or docetaxel [taxotere]) for your breast cancer
- •Not be pregnant
- •Additional criteria to be determined at screening visit.
排除标准
- •More than 3 previous chemotherapy regimens
- •More than one treatment with non cytotoxic agents for breast cancer therapy (e.g. herceptin [trastuzumab] or Avastin [bevacizumab)
- •Prior treatment with epothilones (e.g. Ixabepilone)
- •Symptomatic brain metastases
- •Additional criteria to be determined at screening visit
研究组 & 干预措施
Arm 1
Experimental
干预措施: Sagopilone (ZK 219477) (Drug)
Arm 2
Experimental
干预措施: Sagopilone (ZK 219477) (Drug)
结局指标
主要结局
Response to treatment with ZK-Epo after 6 cycles
时间窗: complete or partial response after 2 to 6 courses of therapy.
次要结局
- Safety and tolerability of ZK-Epo(time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.)
研究者
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