A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 873
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.
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
- •Histologically or cytologically confirmed adenocarcinoma of the prostate.
- •Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
- •Progressive disease based on PSA progression, RECIST, or positive bone scan.
- •ECOG 0 or 1.
排除标准
- •Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting.
- •Chemotherapy within 3 weeks.
- •Impending complications from bone metastases.
- •Ongoing urinary obstruction.
- •Cardiac dysfunction, QTc >470 msec.
- •CNS involvement.
研究组 & 干预措施
A
Treatment Arm A - sunitinib + prednisone
干预措施: Prednisone (Drug)
A
Treatment Arm A - sunitinib + prednisone
干预措施: sunitinib (Drug)
B
Treatment Arm B - placebo + prednisone
干预措施: Placebo (Drug)
B
Treatment Arm B - placebo + prednisone
干预措施: Prednisone (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Baseline up to 32 months
OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus \[-\] date of randomization plus \[+\] 1) divided (/) 30.4.
次要结局
- Change From Baseline in Pain Severity(Day 1 through Day 7 every 28 days (every cycle) up to 29 months)
- Progression-Free Survival (PFS)(Baseline, every 8 weeks up to 123 weeks)
- Percent of Participants With Objective Response (OR)(Baseline, every 8 weeks up to 123 weeks)
- Duration of Response (DR)(Baseline, every 8 weeks up to 123 weeks)
- Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)(Baseline, every 4 weeks up to 123 weeks)
- Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score(Baseline, every 4 weeks up to 123 weeks)