NCT01025206已完成1 期
A Phase I Dose-Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of BI 505, a Human Anti-Intercellular Adhesion Molecule 1 Monoclonal Antibody, in Patients With Relapsed/Refractory Multiple Myeloma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 7
- 主要终点
- Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests
研究概览
简要总结
This is a first in human study which will assess the safety and tolerability of a monoclonal antibody against ICAM-1 in patients with Multiple Myeloma. The tumour response rate will also be measured.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced Myeloma with measurable disease after at least 2 previous regimens.
- •Life expectancy > 3 months.
- •Performance status ECOG < 2.
排除标准
- •Prior antineoplastic therapy within 4 weeks prior to inclusion.
- •No high dose steroids within 7 days prior to screening.
- •Severe other conditions.
研究组 & 干预措施
BI-505
Experimental
干预措施: BI-505 (Biological)
结局指标
主要结局
Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests
时间窗: four weeks
次要结局
未报告次要终点
研究者
研究点 (7)
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