EUCTR2007-002370-64-AT进行中（未招募）不适用
Multi-center, randomized, double-blind phase II study of sorafenib or placebo with best supportive care after failure of deocetaxol in metastatic hormone-refractory prostate cancer
Austrian Prostate Study Group (AUPSG)0 个研究点目标入组 50 人开始时间: 2007年6月13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
- 50
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
- •1Age = 18 years
- •2Histologically / cytologically proven adenocarcinoma of the prostate
- •3Metastatic disease with documented clinical (imaging) progression of an existing lesion (RECIST), appearance of a new lesion, or bone scan showing new skeletal lesions following docetaxel application. Biochemical (PSA) progression alone is not sufficient to document progression.
- •4One prior chemotherapy with a total dose of 450 mg/m2 docetaxel.
- •5Prior surgery and/or radiation therapy (to less or equal than 25% of the bone marrow only) are allowed. At least 4 weeks must have elapsed since the completion of surgery/radiation therapy and the patient must have recovered from side-effects.
- •6Disease progression after prior hormonal therapy and subsequent cytotoxic chemotherapy with a total dose of 450mg/m2 docetaxel
- •7Patients should have progressive disease defined as PSA progression documented by 2 consecutive rises in PSA values over a previous reference value taken at least one week apart or measurable disease progression according to the modRECIST criteria.
- •8PSA at time of study entry = 5 ng/ml within 1 week prior to randomization.
- •9Castrate level of testosterone (? 0.5 ng/ml). Patients with medical castration with LH-RH analogue must continue LH-RH analogue.
- •10Anti-androgen treatment with Flutamide, Bicalutamide or Nilutamide should be withdrawn at least 6 weeks prior to the start of chemotherapy.
- •11Continuation of bisphosphonates allowed.
- •12ECOG PF 0-2
- •13Life expectancy > 12 weeks
- •14Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •Hemoglobin > 9.0 g/dl
- •Absolute neutrophil count (ANC) >1,500/mm3
- •Platelet count = 100,000/µl
- •Total bilirubin < 1.5 times the upper limit of normal (ULN)
- •ALT and AST < 2.5 x ULN (< 5 ULN for patients with liver involvement)
- •PT-INR/PTT < 1.5 x ULN (Patients who receive anticoagulation therapy with an agent will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists)
- •Serum creatinine < 1.5 x ULN (in case of limit values of serum creatinine, creatinine clearance calculated by Cockroft-Gault method should be = 60 ml/min)
- •15Signed informed consent must be obtained prior to any study specific procedures.
- •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
- •1Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
- •2History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
- •3History of HIV infection or chronic hepatitis B or C
- •4Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- •5Clinically symptomatic brain or meningeal metastasis
- •6Patients with seizure disorder requiring medication (such as anti-epileptics)
- •7Evidence of painful and/or destructive bone metastases for which radiation therapy, initiation of bisphosphonates or bone-seeking radionucleides are considered necessary by the treating physician. Other bone metastases are allowed.
- •8History of organ allograft
- •9Patients with evidence or history of bleeding diasthesis
- •10Patients undergoing renal dialysis
- •11More than 1 prior anticancer chemotherapy or immunotherapy during or within 4 weeks of the study entry
- •12Prior isotope therapy (e.g. strontium, samarium)
- •13Radiotherapy during study or within 3 weeks of start of study drug
- •14Major surgery within 4 weeks of start of study
- •15Autologous bone marrow transplant or stem cell rescue within 4 months of study
- •16Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- •17Prior exposure to the study drug or licensed angiogenesis-inhibitors.
- •18Prior use of inhibitors of Ras/Raf-, MEK, AKT kinase and mTOR-signaling pathway or farnesyl transferase inhibitors
- •19Concomitant treatment with ketoconazole, itraconazole, ritonavir, rifampicin.
- •20Childbearing potential: men enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
- •21Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
- •22Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •23Patients unable to swallow oral medications
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