NCT00704158已完成1 期
A Phase I/II Study of CR011-vcMMAE in Patients With Locally Advanced or Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 9
- 主要终点
- To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients
研究概览
简要总结
This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial to further evaluate the safety and efficacy of CR011-vcMMAE.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with confirmed breast cancer
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- •Locally advanced or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer, as follows:
- •At least one regimen must have been for locally advanced or metastatic disease
- •Subject must have received an anthracycline, a taxane, and capecitabine in any combination unless the subject was intolerant to or not a candidate for any of these agents
- •Hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or immunotherapy do not count as one of the 2 regimens
- •Subjects with HER2/neu overexpressing tumors must have been treated with trastuzumab except in situations where the subject was intolerant to or not a candidate for trastuzumab
- •Documented progressive disease within 6 months of the last regimen
- •Adequate bone marrow, renal and liver function
- •Signed informed consent
排除标准
- •Chemotherapy, radiation, hormonal therapy, or bevacizumab within two weeks, or trastuzumab or investigational therapy within three weeks before treatment start
- •Neuropathy > NCI-CTCAE Grade 1
- •Active brain metastases.
- •New York Heart Association class III or IV heart disease
- •Unstable angina
- •Uncontrolled arrhythmia
- •A marked baseline prolongation of QT/QTc interval
- •Pregnant or breast-feeding women, and women of childbearing age and potential who are not willing to use effective contraception
结局指标
主要结局
To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients
时间窗: throughout the study
To determine the MTD of CR011-vcMMAE in breast cancer patients
时间窗: throughout the study
次要结局
- Evaluation of efficacy (progression-free survival rate at 12 weeks, objective response rate, time to response, duration of response and time to progression)(throughout the study)
研究者
研究点 (9)
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