EUCTR2006-003554-15-SK进行中（未招募）1 期
The histone deacetylase inhibitor (HDAC) valproic acid as second line treatment for hormone refractory metastatic prostate cancer. A phase II. study. - HDAC-VA
ational Cancer Institute0 个研究点目标入组 35 人开始时间: 2006年9月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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
- •1.signed written informed consent
- •2.men aged 18 years or older
- •3.histologically proven metastatic hormone refractory prostatic adenocarcinoma, with progression after standard 1st line chemotherapy (only docetaxel+prednisone). The progression is defined: progression according RECIST criteria or evidence of PSA progression. Minimum evidence of progression is a 25% increase over a reference value of PSA (20ng/mL), provided that the increase is > 5 ng/mL. The first increase in PSA should occur at a minimum of one week from the reference value. This increase should then be confirmed by a second increase in PSA at least 1 week later (Bubley, 1999).
- •4.patients with measurable or non-measurable disease as defined in the RECIST criteria: At least one site of disease must be unidimensionally measurable as follows:
- •X-ray, physical exam > 20 mm } N.B. Most hospitals have spiral CT scanning
- •Spiral CT scan > 10 mm } equipment – check with your radiology department.
- •Non-spiral CT scan> 20 mm }
- •All radiology studies must be performed within 28 days prior to registration
- •5.ECOG PS 0 – 1 at study entry
- •6.at least 4 weeks must have elapsed since the last surgery, radiotherapy and/or chemotherapy before study entry
- •7.complete recovery from prior surgery, and/or reduction of all adverse events to grade 1 from previous systemic therapy or radiotherapy
- •8.no concurent treatment with experimental drugs was allowed.
- •9.no concurrent chemotherapy. Corticosteroids and bisphophonates are permitted if they were admistered more than 2 months before study entry in the same dose and route of application.
- •10.patients with surgical castration or patients without surgical castration must have a serum testosterone level less than 50ng/ml before study entry and to continue on LHRH agonist therapy
- •11.adequate renal function defined as creatinine clearance > 60ml/min
- •12.adequate liver function defined by normal total bilirubin level and ALT, AST < 2,0 ULN
- •13.adequate hematologic function defined by ANC > 1500/mm3, platelet count > 100 000/mm3 and hemoglobin level > 9g/dl.
- •14.normal blood coagulation tests: INR, fibrinogen, PTT, bleeding time
- •15.serum albumin level > 34g/l
- •16.life expectancy more than 3 months
- •17. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- •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
- •1.inability to absorb medication e.g. malabsorption syndrome
- •2.hepatic porphyria
- •3.acute or chronic hepatitis (positivity HbsAg, antiHCV and/or LFT`s see also inclusion criteria)
- •4.hypersensitivity to valproic acid
- •5.personal or familial history of severe drug induced hepatitis
- •6.grade 3-4 infection without neutropenia
- •7.known CNS metastasis
- •8.Any concurrent malignancy other than non-melanoma skin cancer, no other cancer in past 5 years.
- •9.Serious concomitant systemic disorders or diseases incompatible with the study (at the discretion of investigator )
- •10.systemic lupus erythematosis
研究者
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