NCT00928525已完成2 期
Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
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
- 35
- 试验地点
- 7
- 主要终点
- Tumor response will be evaluated by different imaging techniques
研究概览
简要总结
The purpose of this study is to determine whether Imatinib Mesylate is active in diseases - such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived growth factor (PDGF) both in its isoform alpha and beta
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of DT or CDS.
- •Biomolecular or immunohistochemical evidence of Imatinib mesylate target (KIT, PDGFRα PDGFRβ activation and/or presence of PDGFα or PDGFβ)
- •Measurable or evaluable disease
- •Surgical resection of local disease unfeasible radically (or unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction) and/or metastatic disease.
- •ECOG Performance status 0, 1, 2 or 3
- •Adequate bone marrow, liver and renal function
- •Female patients of child-bearing potential must have negative pregnancy test.
- •Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.
- •Written, voluntary, informed consent.
排除标准
- •Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing
- •Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer or cervical carcinoma in situ.
- •Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
- •Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
- •Known brain metastasis.
- •Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- •Known diagnosis of human immunodeficiency virus (HIV) infection.
- •Previous radiotherapy to >/=25% of the bone marrow or within the previous 2 months on target lesion.
- •Major surgery within 2 weeks prior to study entry.
- •Expected non-compliance to medical regimens (e.g. psychiatric diseases).
研究组 & 干预措施
Imatinib Mesylate
Experimental
Patients affected by Desmoid Tumor and Chondrosarcoma will receive Imatinib Mesylate 800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months
干预措施: Imatinib Mesylate (Drug)
结局指标
主要结局
Tumor response will be evaluated by different imaging techniques
时间窗: every three months
次要结局
未报告次要终点
研究者
研究点 (7)
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