A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,494
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.
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 compared with docetaxel.
All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.
Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further 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
- Triple (Participant, Care Provider, Investigator)
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 metastasis)
- •Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
- •Currently receiving treatment with surgical or medical castration
排除标准
- •Patients who answer TRUE to the following ARE NOT eligible to participate in this trial.
- •Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial.
- •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
Placebo + Docetaxel
placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
干预措施: Docetaxel (Drug)
Placebo + Docetaxel
placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
干预措施: Placebo (Drug)
ZD4054 + Docetaxel
ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
干预措施: Docetaxel (Drug)
ZD4054 + Docetaxel
ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
干预措施: ZD4054 (Drug)
结局指标
主要结局
Overall Survival
时间窗: Patients were followed for survival up to 40 months
Median time (in months) from randomisation until death using the Kaplan-Meier method.
次要结局
- Progression Free Survival(Patients were followed for progression up to 40 months)
- Incidence of Skeletal Related Events(While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months))
- Time to Prostate-specific Antigen (PSA) Progression(While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months))
- Time to Pain Progression(While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months))
- Pain Response(While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months))
- Health Related Quality of Life(While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months))
- PSA Response(While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months))