NCT00094159已完成1 期
Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Pharmacokinetic Profiles of Weekly Intravenous Administrations of SNS-595 in Patients With Advanced Malignancies
Sunesis Pharmaceuticals4 个研究点 分布在 1 个国家开始时间: 2004年10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
- 试验地点
- 4
研究概览
简要总结
The purpose of this study is to determine whether SNS-595 given intravenously weekly for 3 weeks is safe.
详细描述
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood) and determining the dose and dose schedule for the next phase of studies with SNS-595.
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
- •Must give written informed consent
- •18 years of age
- •Advanced solid malignant tumors
- •Tumor can be measured and evaluated
- •Blood tests are within standard limits
- •Normal blood coagulation
- •ECOG Performance Status equal to 0 or 1
- •Hemoglobin > or = to 9.0 g/dL
- •Absolute Neutrophil Count > or = to 1,500
- •Platelets > or = to 100,000
- •Calculated or measured creatinine clearance < 50 mL/min
- •Serum creatinine < or = 1.5 times the upper limit of normal (ULN)
- •AST, ALT, Alkaline Phosphatase < 3 times ULN except if there is hepatic involvement then AST, ALT, and Alkaline Phosphatase < or = to 5 times ULN
- •Total Bilirubin < or = to 2 mg/dL
排除标准
- •Prior exposure to SNS-595
- •Pregnant or breastfeeding.
- •Women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
- •Heart attack, stroke/TIA or other blood clotting event (deep vein thrombosis or pulmonary embolus) within 6 months before the screen visit.
- •Requires kidney dialysis (hemodialysis or peritoneal).
- •Known bleeding disorder (i.e., hemophilia, von Willebrand Disease, coagulopathy, etc.).
- •Received an investigational agent or prior chemotherapy or immunotherapy within 28 days before first dose of SNS-595
- •Receiving therapeutic anticoagulation therapy (coumadin, heparin, etc.).
- •Currently receiving corticosteroids (inhaled steroids for breathing diseases are allowed) or seizure medications.
- •Any medical, psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety and or compliance with study procedures.
研究者
研究点 (4)
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