NCT00035867已完成1 期
Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Telik18 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2002年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 18
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically or cytologically confirmed diagnosis of MDS
- •Adequate liver and kidney function
- •Ineligible for, or refusing, allogeneic bone marrow transplant
- •At least 18 years of age
- •Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry
排除标准
- •Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry
- •Pregnant or lactating women
- •History of allergy to eggs
- •Other investigational drugs within 14 days of study entry
- •Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
- •Concomitant steroids or hormones for the treatment of neoplasms
研究者
研究点 (18)
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