EUCTR2009-015116-17-IT进行中（未招募）1 期
Phase II study with pharmacokinetic and pharmacodynamic evaluations of metronomic chemotherapy with oral Vinorelbine and Dexamethasone in advanced castraction-resistant prostate cancer patients - ProMet-3
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ARCO
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
- •-Diagnosis of metastatic or locally advanced castration-resistant prostate adenocarcinoma,
- •-Failure of previous docetaxel-based chemotherapy or patient unable to receive chemotherapy with docetaxel
- •-Increasing PSA serum levels in three consecutive measuraments at least 1 week apart
- •-PSA serum value ≥ 2 ng/mL
- •-Serum Testosterone < 50 ng/dL (< 1.7 mmol/L)
- •-ECOG PS ≤ 2
- •-Life expectancy ≥ 3 months
- •-Adequate renal function (serum creatinine level < 1.25 upper normal limit)
- •-Adequate liver function (serum total bilirubin level < 1.5 upper normal limit, aspartate aminotransferasi and alanine aminotransferasi < 3 upper limit)
- •-Adequate bone marrow function (leukocytes > 3000/ mL, platelets > 100000/mL, haemoglobin level > 10 g/dL)
- •-Interruption of antiandrogen therapy at least 4-8 weeks before enrollment, without biochemical response at time of suspension, in the absence of clinical or instrumental evidence of disease progression
- •-Written informed consent
- •Are the trial subjects under 18? yes
- •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
- •-Uncontrolled metabolic diseases or active infections
- •-One of the following condition in the 12 months before the enrollment:
- •- Miocardial infarction
- •- Severe or unstable angina
- •- Congestive heart failure
- •- Pulmonary embolism, stroke, transient ischemic attack
- •- Cardiac arrhythmias
- •- QT interval > 450 msec
- •- Coronary or periferic arterial bypass
- •-Uncontrolledi hyperthension
- •-Anticoaugulant treatment
- •-Brain metastases
- •-Second malignancies, except skin basal cell carcinoma
研究者
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