NCT02363439已完成1 期
An Extension Study to Evaluate the Long-Term Safety, Tolerability, and Clinical Activity of IMO-8400 in Patients With Relapsed or Refractory Waldenström's Macroglobulinemia Who Completed Study 8400-401
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.
详细描述
Patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (NCT02092909) will continue to receive IMO-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with IMO-8400 have been met.
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
- •Completed 24 weeks of treatment in Protocol 8400-401
排除标准
- •Grade 3 (or higher) adverse event assessed as treatment-related at any time during the course of treatment under Protocol 8400-
- •Has evidence of disease progression under Protocol 8400-
- •Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.
研究组 & 干预措施
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
Experimental
Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
干预措施: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: During receipt of study treatment on the trial.
Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia
次要结局
未报告次要终点
研究者
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