NCT00287846已完成1 期
Multicentric Phase I/II Study Evaluating the Efficacy and Toxicity of Imatinib in Adult Patients With Aggressive Fibromatosis That Cannot be Treated by Surgery or Curative Radiotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 40
- 试验地点
- 23
- 主要终点
- Non-progression rate
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis.
详细描述
OBJECTIVES:
Primary
- Determine the non-progression rate in patients with recurrent or refractory aggressive fibromatosis after 3 months of treatment with imatinib mesylate.
Secondary
- Determine the non-progression rate in patients after being treated with this drug for 12 months.
- Determine the toxic effects of this drug in these patients.
- Determine the tolerance to this drug in these patients.
- Determine the response rate in patients treated with this drug
- Determine progression free and overall survival of patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
- Correlate clinical, biological, and genomic markers with response and long-term stable disease in patients treated with this drug.
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
Imatinib
Experimental
400 to 800 mg/day for a maximal 12 months study duration.
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
Non-progression rate
时间窗: 3 months
次要结局
- Non-progression rate(12 months)
- Response rate(5 years)
- Overall survival(the time between the inclusion date and the death whathever the cause)
- Quality of life(5 years)
- Correlation of clinical, biological, and genomic markers with response and long-term stable disease(5 years)
- Toxic effects(12 months)
- Tolerance(12 months)
- Progression-free survival(the time between the inclusion date and the progression date)
研究者
研究点 (23)
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