A Randomized Phase II Study Of Imetelstat (GRN163L) In Combination With Paclitaxel (With Or Without Bevacizumab) in Patients With Locally Recurrent Or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 54
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone for patients with locally recurrent or metastatic breast cancer who have not received chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.
详细描述
Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Women who are pregnant or breast feeding
- •Locally recurrent disease amenable to resection with curative intent
- •HER-2-positive breast cancer
- •Active central nervous system (CNS) metastatic disease including those patients receiving radiotherapy and/or steroid treatment (within the last 3 months)
- •Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior of first relapse
- •Investigational therapy within 4 weeks of first study drug administration
- •Prior radiation, cytotoxic, or hormonal therapy within 2 weeks of first study drug administration
- •Therapeutic anti-coagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration (low dose anti-coagulant therapy to maintain patency of a vascular access device is allowed)
- •Grade ≥ 2 neuropathy
- •Uncontrolled clinically significant atrial or ventricular arrhythmias (unless pacemaker in place)
- •Severe conduction disturbance including clinically significant QTC prolongation > 450 ms (unless pacemaker in place)
- •Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
- •Clinically relevant active infection
- •Known positive serology for human immunodeficiency virus (HIV)
研究组 & 干预措施
Imetelstat + Paclitaxel (with or without bevacizumab)
干预措施: Imetelstat sodium (Drug)
Imetelstat + Paclitaxel (with or without bevacizumab)
干预措施: Bevacizumab (Drug)
Imetelstat + Paclitaxel (with or without bevacizumab)
干预措施: Paclitaxel (Drug)
Paclitaxel (with or without bevacizumab) alone
干预措施: Bevacizumab (Drug)
Paclitaxel (with or without bevacizumab) alone
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Occurring post randomization through end of study period (9 mos. after the last participant is randomized)
Defined as the time from randomization to documented disease progression, as determined by the investigator's assessment according to RECIST, or death from any cause, whichever occurs first.
次要结局
- Clinical benefit rate(Occurring post randomization through end of study period (9 mos. after the last participant is randomized))
- Objective response(Occurring post randomization through end of study period (9 mos. after the last participant is randomized))