NCT01837095已完成1 期
A Phase I Dose Escalation Study of POL6326 With Eribulin in Patients With Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer
Polyphor Ltd.12 个研究点 分布在 2 个国家目标入组 54 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 12
- 主要终点
- Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer
研究概览
简要总结
POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin. Different doses and dosing frequencies will be investigated
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive cancer of the breast.
- •Presence of at least one measurable lesion per RECIST 1.1 criteria
- •Stage IV disease by AJCC criteria (7th edition).
- •HER2 negative (IHC 0,1 or FISH HER2:CEP17 ratio < 2.0)
- •Must have had treatment with at least 2 but no more than 3 previous regimens in the metastatic setting. Previous treatment must have included an anthracycline and taxane in either the adjuvant or metastatic setting.
- •At least 21 days from the completion of any previous cytotoxic chemotherapy or biological therapy at time of initiation of POL
- •ECOG performance status < 2
排除标准
- •Previously received eribulin.
- •Peripheral neuropathy > Grade
- •Receipt of any other investigational agent within the 28 days prior to Day
- •Receipt of colony stimulating factor filgrastim, pegfilgrastim, or sargramostim within 14 days prior to Day
- •Radiation therapy within the 14 days prior to Day
- •Severe concurrent illness or psychiatric illness/social situation that would limit compliance with study requirements.
- •History of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- •Pregnant or breastfeeding.
- •Known HIV positivity on combination antiretroviral therapy; these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
研究组 & 干预措施
POL6326
Experimental
POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin
干预措施: POL6326 (Drug)
结局指标
主要结局
Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer
时间窗: 6 months
Incidence and severity of adverse events and serious adverse events of the combination of POL6326 and eribulin when compared to the adverse event profile of eribulin alone
次要结局
- Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer(12-24 months)
研究者
研究点 (12)
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