EUCTR2007-001891-35-FR进行中（未招募）1 期
A randomized, double-blind phase II trial to assess the efficacy and safety of bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with castration-refractory metastatic prostate cancer without any clinical symptom related to disease progression.
AstraZeneca SAS0 个研究点目标入组 90 人开始时间: 2007年5月10日最近更新:
适应症
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
- 90
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.Provision of written informed consent prior any study-related procedures.
- •2.Male aged 18 years and over.
- •3.Previously confirmed histological diagnosis of adenocarcinoma of the prostate.
- •4.Evidence of metastases (including bone, lymph nodes, or other site) radiologically or histologically documented.
- •5.Despite a serum testosterone =1.73 nmol/L (50 ng/dL) proving castration, evidence of biochemical progression of prostate cancer, documented by a rise in PSA that meets all the following criteria:
- •3 consecutive dosages of PSA, each of them showing an increase of the PSA value compared to the previous dosage (see Figure 2, criterion 1).
- •NB: If the third PSA value is lower than the second PSA value then a fourth PSA assessment is required and the PSA value should be higher than the second PSA value (see Figure 2, criterion 2).
- •2 weeks minimum time interval between sampling.
- •All PSA values must be =5 ng/mL and should have been assessed in the same laboratory using the same PSA assay.
- •6.World Health Organisation (WHO) performance status 0 – 2 (see Appendix C).
- •7.No prior cytotoxic chemotherapy for the treatment of prostate cancer.
- •8.No clinical symptom related to disease progression: no bone pain related to bone metastasis, no change in the urinary symptoms during the last 6 months.
- •9.Withdrawal of antiandrogens, within 4 weeks of randomisation to the study (at the exception of luteinising hormone-releasing hormone (LHRH) analogue, LHRH analogue must be maintained) or within 6 weeks of randomisation to the study for bicalutamide. Continued elevation of the PSA can be demonstrated during the washout times provided above.
- •Biphosphonate therapy is allowed if the first dose was administered more than 30 days before Visit 1.
- •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.No metastatic prostate cancer or no resistance to castration or symptomatic prostate cancer.
- •2.Radiotherapy or surgery or antiandrogens (except LHRH analogue) or bilateral orchiectomy within the 30 days preceding Visit 1. Incompletely healed surgical incision.
- •3.Concomitant anticancer therapy other than surgical castration or continuous medical castration.
- •4.Biology.
- •Serum bilirubin >1.5x the upper limit of reference range (ULRR)
- •Serum creatinine >1.5 x ULRR or creatinine clearance < 50 mL/minute (calculated by Cockcroft-Gault formula.)
- •Potassium, <4.0 mmol/L despite supplementation; or above the CTCAE grade 1 upper limit.
- •Magnesium below the normal range despite supplementation, or above the CTCAE grade 1 upper limit.
- •Serum calcium above the CTCAE grade 1 upper limit. In cases where the serum calcium is below the normal range, 2 options would be available: 1) the calcium adjusted for albumin is to be obtained and substituted for the measured serum value. Exclusion is to then be based on the adjusted for albumin values falling below the normal limit. 2) Determine the ionized calcium levels. Exclusion is then to be based if these ionized calcium levels are out of normal range despite supplementation.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 ´ ULRR or alkaline phosphatase (ALP) >2.5 x ULRR, or > 5 x ULRR if judged by the investigator to be related to liver metastases.
- •5.Cardiovascular history.
- •Clinical significant cardiovascular event (eg. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease =2 [See Appendix G]) within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- •History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia or uncontrolled atrial fibrillation), which is symptomatic or requires treatment (CTCAE grade 3), symptomatic despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled on medication are permitted.
- •Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 millimeter of mercury [mmHg] or diastolic blood pressure greater than 100 mmHg).
- •Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
- •QTc prolongation with other medications that required discontinuation of that medication.
- •Presence of left bundle branch block (LBBB).
- •QTc with Bazett’s formula unmeasurable or =480 msec or greater on screening ECG (see Appendix D for Bazett’s formula).
- •Note: If a patient has QTc interval =480 msec on screening ECG, the screen ECG may be repeated twice [at least 24 hours apart]. The average QTc from the three screening ECGs must be <480 msec in order for the patient to be eligible for the study.
- •7.Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes (see Appendix E for the lists of medications in Table 1 & Table 2) or induce CYP3A4 function (see Section 3.7).
- •8.Known severe hypersensitivity to study treatments and to their excipients.
- •9.Human Immunodeficiency Virus (HIV) positive.
- •10.In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, (eg, currently unstable or uncompensated respiratory, cardiac, hepatic or renal disease) or evidence of any o
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