S0916, A Phase II, Window Trial of the Anti-CCR2 Antibody MLN1202 in Patients With Bone Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 47
- 主要终点
- uNTX Response Rate at 43 Days
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such MLN1202, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well MLN1202 works in treating patients with bone metastases.
详细描述
OBJECTIVES:
Primary
- To assess the urinary n-telopeptide (uNTX) response to anti-CCR2 monoclonal antibody MLN1202 in patients with bone metastases.
Secondary
- To assess the feasibility of performing cross-disease site trials within the Southwest Oncology Group.
- To explore the effect of anti-CCR2 monoclonal antibody MLN1202 on markers of tumor cell proliferation, monocytes/macrophage trafficking, and osteoclast maturation.
- To estimate allele frequencies of defined SNPs occurring in the CCL2 and CCR2 genes in these patients.
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
treatment
MLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle
干预措施: laboratory biomarker analysis (Other)
treatment
MLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle
干预措施: anti-CCR2 monoclonal antibody MLN1202 (Drug)
treatment
MLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle
干预措施: polymorphism analysis (Genetic)
结局指标
主要结局
uNTX Response Rate at 43 Days
时间窗: 43 days
Urinary n-telopeptide (uNTX) response is defined as a 25% reduction from baseline levels. Patients with missing response data were included as non-responders.
次要结局
未报告次要终点