A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Percentage of Participants With Prostate-specific Antigen (PSA) Response
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.
详细描述
This is an open-label (all people know the identity of the intervention), multicenter, single arm (only one treatment group) study to evaluate the efficacy and safety of abiraterone acetate in patients with mCRPC. The study will be divided into screening phase (up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of treatment will be 28 days), and follow-up phase. Approximately 80 patients will be enrolled into this study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug) assessments will be conducted in this study. Patients will continue to receive abiraterone acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)
- •Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria
- •Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel
- •Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL
- •Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment
- •Eastern Cooperative Oncology Group Performance Status less than or equal to 2
排除标准
- •Active or uncontrolled autoimmune disease that may require corticosteroid therapy
- •Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- •Uncontrolled hypertension
- •Hemoglobin less than or equal to 9.0 g/dL independent of transfusion
- •Has abnormal liver function tests
- •Surgery or local prostatic intervention within 30 days of the first dose
研究组 & 干预措施
Abiraterone actetate and Prednisolone
干预措施: Abiraterone acetate (Drug)
Abiraterone actetate and Prednisolone
干预措施: Prednisolone (Drug)
结局指标
主要结局
Percentage of Participants With Prostate-specific Antigen (PSA) Response
时间窗: Baseline, Month 4
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
次要结局
- Dehydroepiandrosterone Sulfate (DHEA-S)(Baseline and End-of-Treatment Visit (up to approximately 3 years))
- Overall Survival(Up to 3 Years)
- Time to PSA Progression(Up to 28 Months)
- Serum Testosterone(Baseline and End-of-Treatment Visit (up to approximately 3 years))
- Percentage of Participants With Objective Radiographic Response(Up to 3 Years)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 3 Years)