NCT00543231已完成1 期
A Pharmacokinetic and Safety Assessment of G3139 Administered by Subcutaneous Injection to Patients With Solid Tumors
Genta Incorporated2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2005年12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
- 8
- 试验地点
- 2
研究概览
简要总结
Genasense® is currently administered to subjects in clinical studies as a multiple-day continuous intravenous infusion. Subjects are treated on an outpatient basis and carry a pump that delivers the drug through a peripheral or central intravenous line. The route of administration limits the convenience of treatment, and catheter-related complications have been reported. This study is designed to evaluate the pharmacokinetics and safety of G3139 administered by subcutaneuous injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single
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
- •A Confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has failed standard therapy or for which no standard therapy is available. Patients with a history of brain metastasis will be eligible if there is no evidence of cerebral edema or treatment with steroids.
- •Adequate organ function as determined < 7 days prior to starting study medication
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •At least 3 weeks and recovery from effects of major prior surgery or other therapy including radiation therapy, immunotherapy, cytokine, biological, vaccine and chemotherapy
排除标准
- •Significant medical diesese
- •History of leptomeningeal disease
- •Coexisting condition that would require the subject to continue therapy during the treatment phase of the study with a drug known to alter renal function.
- •Use of any investigational drug within 3 weeks prior to starting study medication
- •Known hypersensitivity to phosphorothioate-containing oligonucleotides
- •Pregnancy/Lactation
研究者
研究点 (2)
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