Phase I/II Study of Ixabepilone in Combination With the Autophagy Inhibitor Hydroxychloroquine for the Treatment of Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Tumor Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help ixabepilone work better by making tumor cells more sensitive to the drug.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone given together with hydroxychloroquine and to see how well they work in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
- The primary objective of this study is to assess the antitumor activity, measured by tumor response rate, in patients who receive this regimen as a third-line treatment. (Phase II)
Secondary
- To measure the duration of response for responding patients.
- To measure the time to progressive disease.
- To measure survival time.
- To characterize the quantitative and qualitative toxicities of this regimen in these patients.
- To develop pharmacodynamic markers for autophagy detection in patient specimens.
- To characterize the effects of hydroxychloroquine on autophagy in patients in vivo.
- To investigate whether the estrogen receptor, progesterone receptor, and/or HER2 status of breast tumors correlates with treatment response.
OUTLINE: This is a multicenter, phase I dose-escalation study of ixabepilone followed by a phase II study.
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
- 18 Years 至 120 Years（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
- 未提供
研究组 & 干预措施
Ixabepilone and hydroxychloroquine
干预措施: hydroxychloroquine (Drug)
Ixabepilone and hydroxychloroquine
干预措施: ixabepilone (Drug)
结局指标
主要结局
Tumor Response Rate
时间窗: 3 years
Overall Complete Response and Partial Response will be considered tumor response. Ixabepilone as a single agent (40 mg/m2 as an intravenous infusion every 3 weeks) was evaluated in a previous (Phase II) study in women with metastatic breast cancer and that the objective tumor response rate was 11.5%. In another(Phase III) study, Ixabepilone in combination with capecitabine resulted in an objective tumor response rate of 35%, compared to that of capecitabine alone (14%). Therefore, in the Phase II portion of the ixabepilone plus hydroxychloroquine combination treatment study, a tumor response rate of less than 15% will be deemed uninteresting. The target tumor response rate will be 35%. Due to uncertainty about the true response rate of ixabepilone plus hydroxychloroquine combination on this patient poupation, we also will consider a response rate of 30% to be encouraging.
次要结局
- Duration of Response(5 years)
- Time to Progressive Disease(5 years)
- Survival Time(5 years)
- Pharmacodynamic Markers for Autophagy Detection(2 years)
- Effects of Hydroxychloroquine on Autophagy(2 years)
- Correlation of Estrogen Receptor, Progesterone Receptor and/or HER2 Status With Treatment Response(5 years)