2023-510298-33-00招募中2 期
A Phase 2 Open-label Extension Study for Subjects with Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 251
- 试验地点
- 61
- 主要终点
- Not Applicable
研究概览
简要总结
The objective of the study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide (as assessed by the investigator) from their participation in an enzalutamide clinical study sponsored by Astellas or Medivation/Pfizer (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open-label extension
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •IRB/IEC approved written Informed Consent and privacy language as per national regulations [e.g., Health Insurance Portability and Accountability Act authorization for the United States sites] must be obtained from the subject prior to any study-related procedures.
- •Subject must currently be receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator’s assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
- •Subjects are able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator’s assessment a change is needed to the subject’s regimen approval (e.g., dose change in androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
- •Subject is able to swallow enzalutamide capsules and comply with study requirements.
- •Subject and his female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective† and 1 must be a barrier method‡ throughout the study and for 3 months after final enzalutamide administration. Two acceptable forms of birth control include: ‡ Condom (barrier method of contraception), AND † In addition to a condom, 1 of the following acceptable forms of contraception is required: ● Established use of oral, injected or implanted hormonal methods of contraception ● Placement of an intrauterine device or intrauterine system ● Tubal ligation ● Vasectomy or other surgical castration prior to initial screening
- •Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
排除标准
- •Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from.
- •Subject requires treatment with or plans to use any of the following: ● New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment (e.g., ADT). ● Investigational therapy other than enzalutamide.
- •Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
- •Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.
结局指标
主要结局
Not Applicable
Not Applicable
次要结局
未报告次要终点
研究者
Head of Clinical Trial Unit Regulatory Affairs
Scientific
Astellas Pharma Global Development Inc.
研究点 (61)
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