NCT03244358终止2 期
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple negative breast
详细描述
This is a phase II,single center,prospective, single arm clinical trials. The objective is to evaluate the efficacy and safetyof Epalrestat in the treatment of metastatic triple negative breast.Primary endpoint is 16-week clinical benefit rate (CBR).
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female ≥ 18 years, ≤70 years.
- •Minimum life expectancy 16 weeks
- •Histologicalconfirmation of hormone receptor negative and HER2 negative breast cancer(IHC:ER -, PR-) on primary tumour at diagnosis/on biopsy of metastasis
- •Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection
- •ECOG 0-2 with no deterioration over previous 2 weeks Measurable disease
- •Adequate bone marrow and organ function
- •Availability of archival tumour sample or fresh biopsy Informed consent
- •Normal organ function
排除标准
- •Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days prior to study treatment
- •Last dose of palliative radiotherapy <7 days prior to study treatment
- •Rapidly progressive visceral disease not suitable for further therapy
- •Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for ≥ 4 weeks study treatment
- •Major surgery (excluding placement of vascular access) within 4 weeks before study treatment
- •Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV
- •With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
- •Elevated ALP in absence of bone metastasis
- •Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
- •Participation in another study with investigational product during last 30 days
- •Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
研究组 & 干预措施
Epalrestat
Experimental
Epalrestat added to standard treatment
干预措施: Epalrestat (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 30 months
the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(30 months)
- Overall Survival(3 years)
研究者
Zhong-yu Yuan
professer
Sun Yat-sen University
研究点 (1)
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