EUCTR2016-001694-32-BE进行中（未招募）1 期
A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study - Protocol 9785-CL-0123
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Subject is eligible for the study if all of the following apply:
- •1.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.
- •2.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.
- •3.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.
- •4.Subject is able to swallow enzalutamide capsules and comply with study requirements.
- •5.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
- •?Barrier methods of contraception: occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •?Tubal ligation
- •?Vasectomy or other surgical castration prior to initial screening.
- •6.Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
- •7.Subject agrees not to participate in another interventional study while on treatment.
- •Waivers to the inclusion criteria will NOT be allowed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 720
排除标准
- •Subject will be excluded from participation if any of the following apply:
- •1.Subject met any of the discontinuation criteria or progressed on the current enzalutamide clinical study in which they are enrolling from.
- •2.Subject requires treatment with or plans to use a strong CYP3A4 inducers or strong CYP2C8 inhibitors and using any narrow therapeutic index drugs that are metabolized by CYP3A4, CYP2C9) and CYP2C19 or investigational agents.
- •?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
- •?Investigational therapy other than enzalutamide
- •3.Subject is participating in an investigator-initiated interventional trial and receiving enzalutamide.
- •4.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.
- •Waivers to the exclusion criteria will NOT be allowed.
研究者
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