NCT04862091已完成2 期
A Randomized, Open-Label, Multi-Center, Parallel Controlled Study Comparing the Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer After Oral Administration of Abiraterone Acetate Tablets (I) or ZYTIGA®
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Serum testosterone concentration
研究概览
简要总结
To evaluate whether the efficacy of the abiraterone acetate tablets (I) is comparable to that of the ZYTIGA®) by comparing the serum testosterone concentrations on Day 9 and/or Day 10 after oral administration of the two formulations in patients with metastatic castration-resistant prostate cancer (mCRPC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males, ≥ 18 years old;
- •Histologically or cytologically diagnosed with prostate adenocarcinoma, without neuroendocrine or small cell characteristics, and having metastatic lesions with imaging evidence (such as positive bone scan or metastatic lesions on CT/MRI);
- •Serum testosterone level < 50 ng/dL or 1.7 nmol/L at the screening; subjects who have not undergone bilateral orchidectomy must plan to continue medication throughout the study to maintain therapy with effective GnRH agonist or antagonist;
- •Progression of prostate cancer as confirmed by diagnostic files, meeting one of the conditions for disease progression: 1) Biochemistry evidence of recurrence: continuous 3 rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 2 ng/mL, greater than 50% of the minimum value in 2 rises; 2) Radiographic progression: a clear evidence of new lesion; 2 or more new bone lesions appearing on bone scan; CT or MRI showing lesion progression (RECIST 1.1);
- •ECOG performance status score of ≤ 1;
- •Life expectancy of ≥ 6 months;
- •Major organs are functioning well
排除标准
- •History of pituitary or adrenal dysfunction;
- •Have used flutamide within 4 weeks before the first dose of study treatment, and bicalutamide or nilutamide within 6 weeks before the first dose of study treatment;
- •Prior therapy with CYP17 inhibitors (such as abiraterone acetate, ketoconazole, TAK-700, etc.) or investigational drugs or marketed drugs of new androgen receptor antagonists (such as enzalutamide, apalutamide, SHR3680, ODM-201, and proxalutamide);
- •Have received 5-reductase inhibitors (such as finasteride and dutasteride), estrogen, progesterone, any herbal products (such as saw palmetto) that may decrease PSA levels, and radiotherapy within 4 weeks prior to the start of study medication;
- •Have previously received biotherapy or cytotoxic chemotherapy for mCRPC; patients who have completed docetaxel treatment for at least 1 year before enrollment can participate in screening;
- •Prostate cancer with moderate to severe pain symptoms, with a score of > 3 for Question 3 (the worst pain in the last 24 hours, 0-1 point means asymptomatic, 2-3 points mean mild symptoms) of the Brief Pain Inventory-Short Form (BPI-SF);
- •With contraindications to the use of glucocorticoids, such as uncontrolled persistent infections or other conditions;
- •Chronic diseases that require systemic corticosteroid therapy (> 10 mg/day prednisone or equivalent). Patients who have discontinued the administration or reduced the dose to < 10 mg within 14 days prior to the start of study treatment are eligible;
- •Presence of abdominal fistula, gastrointestinal perforation, abdominal abscess, or other abnormal gastrointestinal function within 6 months before the first dose of study treatment, which may affect drug absorption as judged by the investigator;
- •Presence of active heart disease within 6 months prior to the first dose of study treatment, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, left ventricular ejection fraction < 50%, and severe arrhythmia requiring treatment or New York Heart Association (NYHA) Class III-IV heart failure;
- •Inability to swallow the whole tablet;
- •Other conditions that make the patient unsuitable for the study as judged by the investigator.
研究组 & 干预措施
Abiraterone Acetate Tablets (I)
Experimental
干预措施: Abiraterone Acetate Tablets (I) (Drug)
ZYTIGA®.
Active Comparator
干预措施: ZYTIGA® (Drug)
结局指标
主要结局
Serum testosterone concentration
时间窗: Day 9/Day 10
Blood Sample tested for Serum Testosterone Levels
次要结局
- Cmin, ss(Day 9)
- PSA level(Day 28, Day 56, and Day 84)
- AUC0-τ(Day 9)
- Cav, ss(Day 9)
- Absolute testosterone concentration(Day 9/10, Day 28, Day 56, and Day 84)
- Testosterone inhibition rate(Day 9/10, Day 28, Day 56, and Day 84)
- PSA-50 response rate(Day 28, Day 56, and Day 84)
- Steady-state minimum concentration of abiraterone(Day 9/10, Day 28, Day 56, and Day 84)
- Cmax, ss(Day 9)
研究者
研究点 (1)
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