A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense
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
- 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
- 是
入选标准
- •Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
- •ECOG Performance Status of 0, 1, or 2
- •Life expectancy of at least 12 weeks
- •Adequate venous access
- •Agreement to practice effective method of birth control
排除标准
- •Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy
- •Significant medical disease
- •Known hypersensitivity to phosphorothioate-containing oligonucleotides
- •Known hypersensitivity to DTIC
- •Pregnancy/Lactation
研究组 & 干预措施
Group 1
Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2
干预措施: Genasense® (G3139, oblimersen sodium) (Drug)
Group 1
Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2
干预措施: DTIC alone; then Genasense followed by DTIC (Drug)
Group 2
Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
干预措施: Genasense® (G3139, oblimersen sodium) (Drug)
Group 2
Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
干预措施: Genasense followed by DTIC; then DTIC alone (Drug)