A Phase I Study of AEG35156 in Combination With Docetaxel in Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Response and progression using RECIST criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug.
PURPOSE: This phase I trial is studying the side effects and best dose of AEG35156 when given together with docetaxel in treating patients with solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and define the recommended phase II dose of AEG35156 in combination with docetaxel in patients with solid tumors.
Secondary
- Determine the qualitative and quantitative toxicities of AEG35156 and docetaxel and define duration and reversibility of those toxicities.
- Determine the pharmacokinetic profile of this regimen.
- Assess, preliminarily, the antitumor activity of this regimen in patients with measurable disease.
- Assess the pharmacodynamic effects of AEG35156 administration on X-linked inhibitor of apoptosis protein (XIAP) levels and apoptosis in peripheral blood mononuclear cells and, in selected patients, in tumor tissue.
- Evaluate M30/M65 cytokeratin 18 level, a marker of apoptosis/necrosis of epithelial tumors, in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AEG35156 plus docetaxel
干预措施: AEG35156 (Drug)
AEG35156 plus docetaxel
干预措施: docetaxel (Drug)
结局指标
主要结局
Response and progression using RECIST criteria
时间窗: Every 6 weeks
Response duration measured from the time complete response or partial response (whichever is first recorded) is documented until the first date that recurrent or progressive disease is objectively documented
时间窗: Every 3 months
After completion of protocol therapy, patients with PR/CR ongoing assessed q3 months until relapse.
Safety and toxicity evaluated according to the NCI CTCAE version 3.0
时间窗: Every 3 weeks
Pharmacokinetics
时间窗: cycle 1 and 2
Stable disease duration measured from the time of start of therapy until the criteria for progression are met
时间窗: Every 3 months
After completion of protocol therapy, patients with ongoing SD assess q 3months until progression.
次要结局
未报告次要终点