NCT00543205终止2 期
A Pharmacokinetic Study of Genasense® (Bcl-2 Antisense Oligonucleotide) in Combination With Dacarbazine (DTIC) in Subjects With Advanced Melanoma and Normal or Impaired Hepatic Function
Genta Incorporated0 个研究点目标入组 6 人开始时间: 2005年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 主要终点
- Pharmacokinetics of G3139
研究概览
简要总结
This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic function; n+8 and Cohort II (subjects with moderate hepatic impairment, Child-Pugh classification Grade B; n=8). If, for any reason, the Genasense infusion is interrupted or discontinued prior to completion or the rate of administration of the Genasense infusion is changed, the subject will be replaced.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of malignant melanoma
- •Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
- •ECOG Performance status of 0,1,or 2
- •Adequate venous access
- •Agreement to practice effective methods of birth control
- •Hepatically impaired consistent with Child-Pugh classification Grade B
排除标准
- •Chronic intravascular coagulopathy confirmed by the presence of fibrinogen degradation products, metastases to the liver, or exudative ascites
- •Prior organ allograft
- •Requirement for concomitant anticoagulant therapy (with the exception of 1 mg/day of warfarin for central line prophylaxis) while receiving protocol therapy
- •Known hypersensitive to DTIC
- •Prior treatment with Genasense
结局指标
主要结局
Pharmacokinetics of G3139
时间窗: 6-day period
次要结局
- Safety(30 days post last dose of study medication)
研究者
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