JPRN-jRCT2031220508已完成2 期
Phase II Trial of Endocrine therapy for patients with Metastatic extramammary Paget's disease ExpRessing Androgen-Receptor using Darolutamide with/without LH-RH agonist. - EMPERAR Trial
akamura Yoshio0 个研究点目标入组 40 人开始时间: 2022年12月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically diagnosed extramammary Paget's disease
- •2) Locally advanced or recurrent/metastatic disease for which curative surgery or radiotherapy is not indicated
- •3) Androgen receptor expressing tumor cells confirmed by immunohistochemical staining performed by a central laboratory
- •4) ECOG Performance Status of 0 or 1
- •5) Laboratory examination within 14 days prior to enrollment meets the given criteria
- •6) Legally adult at the date of consent
- •7) One or more measurable diseases as defined in the RECIST Guidelines Version 1.1 on clinical and imaging findings within 14 days prior to enrollment
- •8) Female patients of childbearing potential who have agreed to use double contraception for at least 28 days after the last dose of the study drug from the time of consent and agreed not to breastfeed for at least 28 days after the last dose of the study drug from the date of consent
- •9) Male patients who have agreed to use double contraception for at least 90 days after the last dose of the study drug from the date of consent
- •10) Patients who have given written consent to participate in this study
排除标准
- •1) Patients who have received the following prior therapies
- •- Androgen receptor inhibitors
- •- CYP 17 enzyme inhibitors
- •- Luteinizing hormone-releasing hormone preparations
- •2) Patients who used estrogen or 5-alpha reductase inhibitors within 28 days prior to enrollment
- •3) Patients who received systemic corticosteroids of 10 mg/day or more of prednisolone equivalent within 28 days prior to enrollment
- •4) Patients who received radiotherapy, excluding irradiation of non-target lesions for symptomatic relief of pain associated with bone metastases, within 12 weeks prior to enrollment
- •5) Patients with severe or poorly controlled complications or infections
- •6) Patients with complications which are determined to be inappropriate to enroll by the investigator or subinvestigator
- •7) Patients with known hypersensitivity to the investigational drug or its components
- •8) Patients who have received any anti-cancer agent within 28 days prior to enrollment in this study
- •9) Previous pleurodesis or pericardial adhesionwithin 28 days prior to enrollment
- •10) Surgery with general anethesia within 28 days prior to enrollment
- •11) Surgery with local or surface anesthesia within 14 days prior to enrollment
- •12) Patients who received radiopharmaceuticals, excluding the use for laboratory and diagnostic purposes, within 8 weeks prior to enrollment
- •13) Patients with a history of stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, or congestive heart failure of New York Heart Association Class III or IV within 6 months prior to enrollment
- •14) Patients with poorly controlled hypertension
- •15) Patients with gastrointestinal disorders that are expected to significantly impair absorption of the investigational drug or patients who have difficulty taking the investigational drug
- •16) Patients with active viral hepatitis, active human immunodeficiency virus infection, or chronic liver disease
- •17) Patients who are not expected to survive for at least 3 months from the date of consent
- •18) Patients with moderate or severe ascites or pleural effusion
- •19) Metastasis to the central nervous system
- •20) Uncontrolled tumor-related pain.
- •21) Avtive double cancer
- •22) Pregnant, lactating or patients with a positive pregnancy test
- •23) Patients participating in clinical trials using any other investigational drugs or medical devices within 30 days prior to enrollment
研究者
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