NCT01302041已完成2 期
A Phase 2, Open-label, Single-arm, Efficacy and Safety Study of Enzalutamide (MDV3100) in Patients With Hormone-naïve Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 12
- 主要终点
- Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25
研究概览
简要总结
To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)
- •Asymptomatic from prostate cancer
- •Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening
- •PSA ≥ 2 ng/mL at screening
排除标准
- •Has previously or is currently receiving:
- •Hormonal therapy with intent to treat prostate cancer
- •Systemic glucocorticoids
- •Chemotherapy with the intent to treat prostate cancer
- •Opiate analgesics for pain from prostate cancer
- •Radiation therapy for treatment of the primary tumor or metastases
- •Has history of known or suspected brain or skull metastases or leptomeningeal disease
- •Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack
- •Clinically significant cardiovascular disease
研究组 & 干预措施
Enzalutamide
Experimental
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25
时间窗: Baseline and Week 25
A PSA response was defined as a decline from Baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 25 for any reason were treated as non-responders.
次要结局
- Percent Change From Baseline in Estradiol(Baseline and Weeks 25 and 49)
- Percent Change From Baseline in Luteinizing Hormone (LH)(Baseline and Weeks 25 and 49)
- Percent Change From Baseline in Prolactin(Baseline and Weeks 25 and 49)
- Percent Change From Baseline in Total Testosterone(Baseline and Weeks 25 and 49)
- Percent Change From Baseline in Sex Hormone-Binding Globulin (SHBG)(Baseline and Weeks 25 and 49)
- Percent Change From Baseline in Androstenedione(Baseline and Weeks 25 and 49)
- Percent Change From Baseline in Dehydroepiandrosterone (DHEA)(Baseline and Weeks 25 and 49)
- Percent Change From Baseline in Dihydrotestosterone (DHT)(Baseline and Week 25 and 49)
- Percent Change From Baseline in Follicle-Stimulating Hormone (FSH)(Baseline and Weeks 25 and 49)
- Percent Change From Baseline in Free Testosterone(Baseline and Weeks 25 and 49)
- Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)(Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25)
- Percentage of Participants With a PSA Response at Weeks 49, 97 and 169(Baseline and Weeks 49, 97 and 169)
- Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level(Baseline and Weeks 25, 49, 97 and 169)
- Number of Participants With Adverse Events(From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052))
- Percent Change From Baseline in PSA(Baseline and Weeks 25, 49, 97, 169 and Week 265 (End of Study))
- Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)(Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25)
- Percentage of Participants With PSA ≤ 4 ng/ml(Weeks 25, 49, 97 and 169)
- Percentage of Participants With PSA ≤ 0.1 ng/ml(Weeks 25, 49, 97 and 169)
- Time to PSA Response(From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052))
- Time to PSA Decline ≥ 90%(From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052))
- Time to PSA ≤ 4 ng/ml(From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052))
- Maximum Decline From Baseline in PSA(Baseline to Week 25 and from Baseline up to the EOS date of 27 Apr 2017; median duration of treatment of 1666.0 days (range of 52-2052))
- Time to PSA ≤ 0.1 ng/ml(From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052))
- Time to PSA Progression(From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052))
- PSA Doubling Time(From Baseline to Week 25)
研究者
研究点 (12)
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