EUCTR2008-000688-41-IT进行中(未招募)不适用
IMATINIB MESYLATE IN ADVANCED LOW GRADE SOLID TUMORS EXPRESSING IMATINIB MESYLATE TARGETS - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histological diagnosis of low grade malignant tumor (ie: solitary fibrous malignant tumor,
- •hemangioendothelioma, myoepithelioma)
- •2. Biomolecular or immunohistochemical evidence of overexpression/activation of any of the
- •following Imatinib mesylate targets:
- •3. Measurable disease
- •4. Unfeasible radical surgical resection of local disease, or surgery unaccepted by the patient, or
- •amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction,
- •and/or metastatic disease. Debulking surgery before enrolment is allowed. In this case,
- •enrolment should occur at least one month after surgery
- •5. Performance status (ECOG) 0, 1, 2 or 3
- •6. Adequate organ function, defined as the following: total bilirubin <2.5 x ULN, SGOT and
- •SGPT <2,5 x UNL (or <5 x ULN if hepatic metastases are present), creatinine <1.5 x ULN.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous treatment with any other investigational or not investigational agents within 28 days of
- •first day of study drug dosing.
- •2. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e.,
- •congestive heart failure, myocardial infarction within 6 months of study)
- •3. Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or
- •active uncontrolled infection).
- •4. Known brain metastasis.
- •5. Known diagnosis of human immunodeficiency virus (HIV) infection.
研究者
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