NCT00554229已完成3 期
A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 896
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.
- This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.
- ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases.
- All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy.
- Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
- No patients will be deprived of standard prostate cancer therapy.
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
- •Patients who answer TRUE to the following criteria may be eligible to participate in this trial.
- •Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases)
- •Increasing Prostate Specific Antigen (PSA) over a one month period
- •No pain, or mild pain from prostate cancer
- •Currently receiving treatment with surgical or medical castration
排除标准
- •Patients who answer TRUE to the following may NOT eligible to participate in this trial.
- •Currently using opiates based pain killers)
- •Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
- •Suffering from heart failure or had a myocardial infarction within last 6 months
- •A history of epilepsy or seizures
研究组 & 干预措施
ZD4054
Experimental
ZD4054 10 mg oral tablet once daily
干预措施: ZD4054 (Drug)
Placebo
Placebo Comparator
Matching Placebo, oral tablets once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: From date of randomization until date of death, assessed up to 32 months
Median time (in months) from randomisation until death using the Kaplan-Meier method
次要结局
- Progression Free Survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months)
- Time to Use of Opiates(From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months)
- Incidence of Skeletal Related Events(From date of randomization until occurrence of a skeletal related event, assessed up to 31 months)
- Bone Metastases Formation(Patients were assessed every 12 weeks)
- Health Related Quality of Life(Patients were assessed at every visit)
- Time to Prostate-specific Antigen (PSA) Progression(Patients were assessed every 12 weeks)
- Time to Pain Progression(Patients were assessed every 12 weeks)
- Time to Initiation of Chemotherapy(Patients were assessed every 12 weeks)
- Pharmacokinetic Characteristics of ZD4054(PK samples were performed at randomisation, Week 4, Week 8 and Week 12)
研究者
研究点 (1)
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