NCT01118689已完成1 期
A Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent MLN0128 in Subjects With Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
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
- 39
- 主要终点
- determine the dose limiting toxicities
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of MLN0128 in patients with Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
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
- •Age ≥18 years, including males and females;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
- •Life expectancy of ≥3 months;
- •Does not have diabetes and has normal fasting serum glucose and fasting triglycerides ≤ 300 mg/dL
- •For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration;
- •Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
- •Ability to swallow oral medications;
- •Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures;
排除标准
- •Have received prior cancer therapy or other investigational therapy within 2 weeks prior to the first administration of study drug.
- •Known impaired cardiac function or clinically significant cardiac disease
- •HIV infection;
- •Failed to recover from the reversible effects of prior anticancer therapies:
- •Pregnancy (positive serum or urine pregnancy test) or breast feeding;
- •Malabsorption due to prior gastrointestinal (GI) surgery, GI disease;
研究组 & 干预措施
MLN0128
Experimental
干预措施: MLN0128 (Drug)
结局指标
主要结局
determine the dose limiting toxicities
时间窗: 28-days
次要结局
未报告次要终点
研究者
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