NL-OMON53607尚未招募2 期
A Phase 2 Open-label Extension Study for Subjects with Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study - 9785-CL-0123
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •* 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
排除标准
- •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 either 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
- •3. Subject is currently participating in an investigator-initiated
- •interventional trial and receiving enzalutamide.
研究者
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