NCT00912899终止1 期
A Phase I Open Label Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- To determine the maximum tolerated dose
研究概览
简要总结
This is a phase 1 study to evaluate the safety and determine maximum tolerated dose, safety & tolerability of noscapine HCl in patients with advanced multiple myeloma
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 Multiple Myeloma.
- •Progression after ≥ 2 lines of prior therapy, including at least one steroid, one immunomodulatory agent (iMID), one alkylator, and bortezomib (VELCADE®).
- •ECOG performance status of either 0 or 1.
排除标准
- •Prior chemotherapy with antimicrotubule agents
- •Metastasis involving the brain or spinal cord
- •Clinically significant lung or heart disease
- •Abnormal electrocardiogram
- •Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
- •Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
研究组 & 干预措施
One
Experimental
Noscapine HCl
干预措施: Noscapine HCl (Drug)
结局指标
主要结局
To determine the maximum tolerated dose
时间窗: During the first 28 day treatment cycle
次要结局
- To determine the safety and tolerability in the study population(End of the study treatment)
- To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma(End of the study treatment)
- To evaluate the pharmacokinetics of study drug(End of the study treatment)
研究者
研究点 (4)
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