Multicenter, Randomized, Open Label Study Evaluating an Anti Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) Monoclonal Antibody, AVE1642, Administered Every 4 Weeks in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Clinical benefit defined as a confirmed complete response (CR) or a confirmed partial response (PR) or a stable disease (SD)lasting at least 24 weeks (6 cycles)
研究概览
简要总结
The purpose of this study is to evaluate the clinical activity of AVE1642 in combination with fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of "complete response", "partial response" and "stabilization of the disease".
The additional objectives are to evaluate the safety profile of AVE1642 in combination with fulvestrant and of fulvestrant alone, to assess the rate of patients without disease progression at 6 months and the overall progression-free survival time. An evaluation of the pharmacokinetics and pharmacodynamics interactions between AVE1642 and fulvestrant will also be performed.
The biological activity of treatment will be assessed on tumor biopsies, when possible The potential immunogenicity of AVE1642 will be studied
详细描述
The study treatment will be administered until disease progression, unacceptable toxicity or patient willingness to discontinue.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women
- •Aromatase inhibitor as the last hormonal treatment
- •Breast adenocarcinoma with positive hormone receptor
- •Measurable disease as per RECIST definition
排除标准
- •ECOG performance status (PS) > 2
- •Prior exposure to fulvestrant or to an anti IGF-1R compound
- •No evidence of hormonosensitivity
- •HER 2-neu positive tumor
- •More than one prior regimen of chemotherapy for metastatic disease
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Arm A
干预措施: AVE1642 (Drug)
Arm A
干预措施: Fulvestrant (Drug)
Arm B
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Clinical benefit defined as a confirmed complete response (CR) or a confirmed partial response (PR) or a stable disease (SD)lasting at least 24 weeks (6 cycles)
时间窗: 6 cycles
次要结局
- Progression Free rate(at 6 months)
- Safety (TEAEs, hematology, biochemistry parameters)(study period)