Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 447
- 试验地点
- 2
- 主要终点
- Time to Progression (TTP)
研究概览
简要总结
This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).
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
- •Surgically or medically castrated
- •Bone metastasis
- •Rising PSA
排除标准
- •Opiate use
- •Prior chemotherapy
研究组 & 干预措施
Placebo
Matching placebo oral tablet once daily, with best supportive care
干预措施: Placebo (Drug)
ZD4054 10 mg
ZD4054 10 mg oral tablet once daily, with best supportive care
干预措施: ZD4054 10 mg (Drug)
ZD4054 15 mg
ZD4054 15 mg oral tablet once daily, with best supportive care
干预措施: ZD4054 15 mg (Drug)
结局指标
主要结局
Time to Progression (TTP)
时间窗: Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).
Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.
次要结局
- Time to Death(Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).)
- Change in Total Prostate Specific Antigen (PSA) Over Time(Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).)
- Objective Response Rate (ORR)(For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).)
- Change in Number of Bone Metastases Over Time(Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.)