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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months
研究概览
简要总结
This randomized, double-blind phase II trial is 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. The study is blinded, and subjects will be randomised (1:1 ratio) to either ZD6474 300 mg or placebo. The blinded design ensures robust, unbiased data collection and assessment. Placebo control is necessary to ensure a robust assessment of PSA PFS, and is acceptable in this subject population where all subjects will also received bicalutamide 150 mg o.d. Subjects will continue study treatment until they reach objective biological disease progression or unacceptable toxicity or withdrawal of consent or until end of trial (which event occurs first). The end of study is fixed 12 months after the last randomised patient's first dose of study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males presented with a confirmed histological diagnosis of adenocarcinoma of the prostate with evidence of metastases (including bone, lymph nodes, or other site) radiologically or histologically documented and 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 .
排除标准
- •Radiotherapy or surgery or antiandrogens (except LHRH analogue) or bilateral orchiectomy within the 30 days preceding Visit
- •Incompletely healed surgical incision.
- •Concomitant anticancer therapy other than surgical castration or continuous medical castration.
- •Biology restriction.
- •Clinical significant cardiovascular event or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- •History of arrhythmia 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
- •ECG /QTc prolongation
- •Presence of left bundle branch block (LBBB).
研究组 & 干预措施
2
Bicalutamide 150mg + placebo
干预措施: Bicalutamide (Drug)
1
Bicalutamide 150mg + ZD6474 300mg
干预措施: ZD6474 (Vandetanib) (Drug)
1
Bicalutamide 150mg + ZD6474 300mg
干预措施: Bicalutamide (Drug)
2
Bicalutamide 150mg + placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months
时间窗: 4 months
To assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set). PSA progression free rate defined as the number of participants with : * After decline from baseline: a 25% increase above the nadir * No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL)
次要结局
- Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression)(4 months)
- Progression Rate From the Radionuclide Bone Scanning(4 months)
- Overall Survival (OS)(End of study (July 2011))
- Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms)(4 months)
- Number of Circulating Tumour Cells (CTC) (in Patients Included in Ile de France Centres Only)(4 months)
- Number of Circulating Endothelial Cells (CEC) of Tumour Blood Cells (in Patients Included in Ile de France Centres Only)(4 months)
- PSA Response Rate(4 months)
- Number of Patients With CECs, CTCs and Gene Signature Profile of CTCs(4 months)