NCT00002138已完成1 期
A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Twice Weekly for 21 Days.
Daiichi Pharmaceuticals1 个研究点 分布在 1 个国家开始时间: 2001年8月31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
- 试验地点
- 1
研究概览
简要总结
To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.
详细描述
Patients receive intravenous DS-4152 by infusion twice weekly for 21 days, followed by 2 weeks of rest; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Patients must have:
- •Kaposi's sarcoma plus HIV infection OR metastatic solid tumor.
- •Life expectancy of at least 12 weeks.
- •NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks.
- •Recovered from toxicity of any prior anticancer therapy.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Leukemia or lymphoma.
- •Current gastrointestinal bleeding by stool guaiac.
- •Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors.
- •Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics.
- •Acute intercurrent infection other than genital herpes.
- •Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy.
- •Concurrent Medication:
- •Other anticancer therapy.
- •Other investigational agents.
- •Patients with the following prior conditions are excluded:
- •History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease.
- •History of myocardial infarction within past 6 months.
- •Prior Medication:
- •Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C).
- •Investigational agents within the past 4 weeks.
研究者
研究点 (1)
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