NCT00518895已完成3 期
A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)
Genta Incorporated76 个研究点 分布在 7 个国家目标入组 300 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 76
- 主要终点
- Progression-free survival and overall survival
研究概览
简要总结
This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically confirmed diagnosis of melanoma
- •Progressive disease that is not surgically resectable, or metastatic Stage IV
- •Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal
- •No prior chemotherapy
- •Measurable disease
- •ECOG performance status ≤ 1
- •At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
- •Prior immunotherapy allowed
- •Adequate organ function
排除标准
- •Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment
- •Primary ocular or mucosal melanoma
- •Bone-only metastatic disease
- •History or presence of brain metastasis or leptomeningeal disease
- •Significant medical disease other than cancer
- •Organ allograft
研究组 & 干预措施
A
Experimental
Dacarbazine with Genasense
干预措施: dacarbazine plus Genasense (Drug)
B
Active Comparator
Dacarbazine with placebo
干预措施: dacarbazine plus placebo (Drug)
结局指标
主要结局
Progression-free survival and overall survival
时间窗: Every 42 days from date of randomization during protocol therapy
次要结局
- Response rate, durable response rate, duration of response, safety(Response and progression every 42 days from date of randomization during protocol therapy)
研究者
研究点 (76)
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