EUCTR2006-001539-23-AT进行中（未招募）不适用
Does imatinib therapy lead to an increased uptake of low molecular weight substances into solid tumor metastasis in patients with hormone refractory prostate cancer? - PET_ONKO
department of clinical pharmacology0 个研究点目标入组 10 人开始时间: 2006年5月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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
- Male
入选标准
- •Age: >18 years old
- •Laboratory analysis: adequate organ functions is required and defined as platelet count >100,000/mm3, absolute neutrophil count >1,500/mm3, serum bilirubin <1.5 mg/dL, AST and ALT <2x the upper limit of normal, serum creatinine clearance >40 mL/min, or serum creatinine less than 1.5x the upper limit of normal, hemoglobin >10. No presence of any clinically relevant abnormal value, which the investigator considers may affect the validity of the study
- •Physical examination: no co-morbidities in terms of symptomatic congestive heart failure, unstable angina or recent myocardial infarction, and oxygen-dependent lung disease, no clinically relevant abnormal findings which could interfere with the objectives of the present study
- •serum testosterone level (<50 ng/dL)
- •No history of hypersensitivity or anaphylaxis to the study medication
- •No medication during two weeks before the start of the study, which the investigator considers may affect the validity of the study
- •No participation in the evaluation of any drug during two weeks before the start of the study and no participation in studies with radiotracer injection within 1 year before the start of the study
- •No chemotherapy or radiation therapy within the last 30 days and systemic radioisotope therapy within the last 90 days
- •No history of drug or alcohol (>60g/day) abuse
- •Ability to comprehend the full nature and purpose of the study, including possible risks and side effects and signature of informed consent prior to inclusion in the study
- •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
- •Age: <18 years old
- •Any abnormality found as part of the screening or in any of the laboratory tests performed that the investigators considers as clinically significant
- •Laboratory values out of the range of: absolute neutrophil count <1,500/mm3, platelet count <100,000/mm3, serum bilirubin >1.5 mg/dL, AST and ALT >2x the upper limit of normal, serum creatinine clearance <40 mL/min, or serum creatinine less than 1.5x the upper limit of normal, hemoglobin< 10. The presence of any clinically relevant abnormal value, which the investigator considers may affect the validity of the study
- •Co-morbidities in terms of symptomatic congestive heart failure, unstable angina or recent myocardial infarction, and oxygen-dependent lung disease
- •Serum testosterone level (>50 ng/dL)
- •Any medication during two weeks before the start of the study, which the investigator considers may affect the validity of the study
- •Chemotherapy or radiation therapy within the last 30 days and systemic radioisotope therapy within the last 90 days
- •Participation in the evaluation of any drug within two weeks before the start of the study or participation in studies with radiotracer injection within 1 year before the start of the study
- •History of drug or alcohol abuse
- •Inability to comprehend the full nature and purpose of the study or unwillingness to sign the informed consent
- •Life expectancy > 3 months
- •Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for >5 years.
研究者
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