A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
This is a study for children with cancer with no curative treatment options. The investigators will be giving eribulin, a new chemotherapy agent, for the first time to children. This study is designed to determine a safe dose the investigators can give to children in larger studies. The investigators will be monitoring the children on this study for the safety of the treatment and levels of eribulin in the blood after treatment. The investigators will also study the effect of the agent on the cancer.
详细描述
This is a phase I study of eribulin, a novel tubulin inhibitor in children with relapsed and refractory solid tumors including lymphoma. Dose escalation will be performed in a classic 3+3 design starting with 75% of the adult maximum tolerated dose (MTD). Pharmacokinetics will be done on each patient. Primary endpoint will be the pediatric MTD.
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
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≤ 21 years of age at the time of study enrollment
- •Diagnosis: refractory or recurrent solid tumors, including lymphomas, except those with CNS tumors or known CNS metastases
- •Disease Status: measurable or evaluable disease
- •Adequate organ function as defined in protocol
排除标准
- •Pregnant or breastfeeding
研究组 & 干预措施
Eribulin
All patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients.
干预措施: Eribulin mesylate (Drug)
结局指标
主要结局
Maximum tolerated dose
时间窗: 1 year
The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects
次要结局
- Pharmacokinetics of eribulin in children with cancer(8 days after first dose)
- Tumor expression of BRCP and ABCB1(1 year)
- Tumor response(2 years)