A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
2019年2月28日 更新者：Janssen Research & Development, LLC
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.
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
82
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Abiraterone actetate and Prednisolone
|
Type=exact number, unit=mg, number=250, form=tablet, route=oral.
Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.
其他名称：
Type=exact number, unit=mg, number=5, form=tablet, route=oral.
Patients will receive 1 tablet of prednisolone twice daily.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Prostate-specific Antigen (PSA) Response
大体时间：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.
|
Baseline, Month 4
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival
大体时间：Up to 3 Years
|
Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason.
|
Up to 3 Years
|
|
Time to PSA Progression
大体时间：Up to 28 Months
|
Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria.
For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL).
For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.
|
Up to 28 Months
|
|
Percentage of Participants With Objective Radiographic Response
大体时间：Up to 3 Years
|
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0.
The CR is disappearance of all lesions.
The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
|
Up to 3 Years
|
|
Serum Testosterone
大体时间：Baseline and End-of-Treatment Visit (up to approximately 3 years)
|
Median serum testosterone concentration was reported at baseline and End-of-Treatment visit.
|
Baseline and End-of-Treatment Visit (up to approximately 3 years)
|
|
Dehydroepiandrosterone Sulfate (DHEA-S)
大体时间：Baseline and End-of-Treatment Visit (up to approximately 3 years)
|
Median DHEA-S concentration was reported at baseline and End-of-Treatment visit.
|
Baseline and End-of-Treatment Visit (up to approximately 3 years)
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Up to 3 Years
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
Up to 3 Years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年8月30日
初级完成 (实际的)
2013年1月24日
研究完成 (实际的)
2018年3月6日
研究注册日期
首次提交
2012年9月12日
首先提交符合 QC 标准的
2012年9月14日
首次发布 (估计)
2012年9月17日
研究记录更新
最后更新发布 (实际的)
2019年3月15日
上次提交的符合 QC 标准的更新
2019年2月28日
最后验证
2019年2月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- CR100009
- 212082PCR2007 (其他标识符：Janssen Research & Development, LLC)
药物和器械信息、研究文件
研究美国 FDA 监管的设备产品
不
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