NCT00600054已完成2 期
Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma
YM BioSciences24 个研究点 分布在 3 个国家目标入组 44 人开始时间: 2007年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 24
- 主要终点
- To determine the objective response rate
研究概览
简要总结
This is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their disease. Patients must be diagnosed with radiologically verified recurrent diffuse intrinsic pontine glioma that is measurable in at least two dimensions. Patients are eligible without histologic confirmation. Treatment regimen will consist of two phases-induction and consolidation.
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Patients with recurrent, diffuse intrinsic pontine gliomas
- •Patients should have had 2 of the following 3 neurological symptoms: cranial nerve deficit, long tract signs, ataxia and a onset prior to initial diagnosis < 6 months.
- •Evidence of disease progression
- •Have a Lansky or Karnofsky Performance Status of > 40
- •Be between the age >3 years to < 18 years of age
- •Have a tumor that is measurable radiologically
- •For female patients of childbearing age: presence of a negative pregnancy test within 7 days prior to day
- •Use of effective contraception
- •Adequate hematological, renal, and hepatic function
排除标准
- •A history of prior use of EGFR-targeting agents (monoclonal antibodies, tyrosine kinase inhibitors)
- •More than one line of treatment
- •Patients with disseminated disease are not eligible
- •Had radiation therapy completed within 12 weeks of enrollment
- •Previous chemotherapy completed < 2 weeks prior to enrollment
- •If female, is pregnant or lactating
- •Has other existing serious medical conditions
- •Has any condition, therapy, or medical condition, which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives
- •Is currently taking or planning to take other investigational drugs during the study
- •Known contraindications against antibodies
结局指标
主要结局
To determine the objective response rate
时间窗: To determine response rate on week 18
次要结局
- To evaluate the safety profile of single agent nimotuzumab in this population(safety will be evaluated after each study drug administration)
研究者
研究点 (24)
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