EUCTR2012-004331-23-DE进行中（未招募）1 期
A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms Associated With Mineralocorticoid Excess in Asymptomatic, Chemotherapy-Naïve and Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 164
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
- •-Have a histologically or cytologically confirmed adenocarcinoma of the
- •- Have metastatic disease documented by positive bone scan or by computed tomography or magnetic resonance imaging
- •- Have prostate cancer progression documented by prostate specific
- •antigen according to Prostate Cancer Working Group 2 or radiographic
- •progression according to modified RECIST (response evaluation criteria
- •in solid tumors, v1.1) criteria
- •-Be asymptomatic from prostate cancer. A score of 0-1 on BPI-SF
- •Question #3 (worst pain in last 24 hours) will be considered
- •asymptomatic
- •-Be surgically or medically castrated, with testosterone levels of <50
- •ng/dL (<2.0 nmol/L). If the subject is being treated with luteinizing
- •hormone releasing hormone (LHRH) agonists or antagonists (subjects
- •who have not undergone orchiectomy), this therapy must have been
- •initiated at least 4 weeks prior to Day 1, Cycle 1 and must be continued
- •throughout the study
- •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 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •-Has a history of pituitary or adrenal dysfunction
- •-Has an active infection or other medical condition that would
- •contraindicate corticosteroid use
- •-Has any chronic medical condition requiring corticosteroid treatment or
- •has received prior corticosteroid treatment for prostate cancer
- •-Has a pathological finding consistent with small cell carcinoma of the
- •-Has a known brain metastasis
研究者
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已完成
1 期
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