NCT01137916已完成2 期
Phase II Study to Evaluate Glivec (Imatinib Mesylate) to Induce Progression Arrest in Aggressive Fibromatosis / Desmoid Tumors Not Amenable to Surgical Resection With R0 Intent or Accompanied by Unacceptable Function Loss
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Non-progression rate after 6 months of treatment
研究概览
简要总结
The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological confirmed aggressive fibromatosis (desmoid tumor)
- •Measurable disease according to the RECIST criteria
- •Evidence of relapse or disease progression within the last 6 months (based on RECIST criteria) in computed tomography or magnetic resonance imaging
- •No possibility of complete surgical resection or cases in which surgical therapy leaving a large tissue defect, functional deficit or disfigurement would be required
- •No possibility of curative radiotherapy with acceptable toxicity and/or late morbidity
- •Previous treatment of the tumor region by surgical intervention and/or radiotherapy and/or antihormonal therapy possible
- •Age > or = 18 years
- •WHO PS < or = 1
- •Effective contraception during study medication
- •Signed informed consent form
排除标准
- •Surgical intervention < 4 weeks
- •Prior therapy with imatinib
- •Pregnancy or lactation
- •Severe hepatic dysfunction
- •Known allergic reaction to imatinib or one of its components
- •The following laboratory values: Absolute neutrophil count < 1.5 x 103/mm3, Platelets < 100,000/mm3, Serum creatinine > or = 2.5 mg/dl, SGOT and/or SGPT > 2.5 x ULN (upper limit of normal), Total bilirubin > 1.5 x ULN
- •Participation in another study (four weeks before and during the study)
- •Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
研究组 & 干预措施
drug
Experimental
Imatinib 800 mg
干预措施: Imatinib (Drug)
结局指标
主要结局
Non-progression rate after 6 months of treatment
时间窗: 6 months
次要结局
- Non-progression rate after 12 and 24 months of treatment(12 and 24 months)
- Response rate(12 and 24 months)
- Progression-free survival (PFS) and overall survival (OS)(12 and 24 months)
- Recording of patient quality of life(12 and 24 months)
研究者
Bernd Kasper
PD Dr. med.
Heidelberg University
研究点 (1)
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