EUCTR2011-006205-95-IT进行中（未招募）不适用
Toremifene in desmoid tumor: prospective clinical trial and identification of potential molecular targets - Toremifene in desmoid tumor
ISTITUTO NAZIONALE PER LA CURA TUMORI0 个研究点开始时间: 2012年8月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Adult patients (age > 18 years) with primary or locally recurrent, sporadic or FAP associated, desmoid fibromatosis. - Histologically documented diagnosis of DF. - At least one measurable site of disease at CT or MRI scans, which has not been previously embolised or irradiated. - Progressive disease demonstrated at contrast-enhanced MRI or CT scan by Response Evaluation Criteria in Solid Tumors (RECIST). - Radiologic or clinical evidence of PD in the previous 6 months. Radiologic PD will be defined according to RECIST. - ECOG Performance status: 0-2. - Prior hormonal therapy, chemotherapy, or molecular targeted therapies are allowed - Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L. - Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug. - Life expectancy of at least 6 months. - Written, voluntary, informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •- Previous history of deep vein thrombosis. - Evidence of prolonged QTc >480 msec (using Bazetts correction, for which the formula is: QTc = QT/vRR) or history of familial long QT syndrome. - Previous arrhythmia. - Clinically significant bradycardia. - Endometrial hyperplasia. - Hepatic insufficiency. - Other concurrent hormonal therapy, including hormonal contraceptives. - Patient has received any other investigational agents within 28 days of first day of study drug dosing. - Female patients who are pregnant or breast-feeding. - Patient has a severe and/or uncontrolled medical disease. - Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. - Patient received chemotherapy within 4 weeks prior to study entry. - Patient had a major surgery within 2 weeks prior to study entry.
研究者
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Unknown
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