NCT00057395Unknown1 期
A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.
详细描述
Primary Objective:
- Determine response rate (RR; complete and partial response [CR, PR]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies.
Secondary Objective:
- Determine the safety and tolerability of Aroplatin
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
- •Advanced solid malignancies;
- •Amenable to therapy with DACH platinum agents;
- •Measurable disease (RECIST criteria);
- •ECOG performance score of 0-2;
- •Adequate hematopoietic, liver and renal function;
- •Adequate cardiac function (maximum of class II, NYHA);
- •Women of childbearing potential must have a negative urine or serum pregnancy test;
- •Signed written informed consent;
- •Subjects must be willing to be followed during the course of treatment/observation and follow-up.
排除标准
- •No other active malignancies;
- •No prior therapy with oxaliplatin;
- •No known brain metastases;
- •Active, uncontrolled infection or other serious medical illnesses;
- •Not using or have used any investigational therapy during four weeks before start of protocol treatment.
研究者
研究点 (2)
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