A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration Resistant Prostate Cancer Patients Who Are Chemotherapy-Naïve
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Percentage of participants achieving Prostate-Specific Antigen (PSA) response up to 12 weeks
研究概览
简要总结
The purpose of this study is to investigate safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not received prior chemotherapy (treatment of disease, usually cancer, by chemical agents).
详细描述
This is a multi-center (conducted in more than one center), open-label (all people know the identity of the intervention), single-arm study to investigate safety and efficacy of abiraterone. The study consists of 3 phases: Screening phase (consists of 14 days before study commences on Day -1); Treatment phase (consists of 28-daily dosing cycles wherein abiraterone 1000 milligram [mg] once daily along with 5 mg prednisolone twice daily will be given until disease progression or unacceptable toxicity is observed); and Follow-up phase (up to 5 years or until survival after the first dose of study drug). Abiraterone will be orally administered daily as at least 1 hour before the meal or 2 hours after the meal. Dose reduction will be allowed at the Investigator's discretion but not lower than 500 mg per day. Participants will discontinue study treatment at disease progression unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from abiraterone. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 12 weeks of therapy. Participants' safety will be monitored throughout the study.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •In-patients or out-patients with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- •Have surgically or medically castrated, with testosterone levels of less than 50 nanogram per deciliter
- •Have prostate-specific antigen (PSA) level of at least 5 nanogram per milliliter
- •Be under PSA progression according to Prostate-Specific Antigen Working Group (PSAWG) eligibility criteria or objective progression by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria for participants with measurable disease after androgen deprivation
- •Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
排除标准
- •Has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels or any systemic corticosteroid within 4 weeks prior to Cycle 1 Day 1 or has received ketoconazole for prostate cancer
- •Has received radiotherapy, chemotherapy (including estramustine) or immunotherapy (including provenge) within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1
- •Has had surgery or local prostatic intervention within 4 weeks prior to Cycle 1 Day
- •In addition, any clinically relevant sequel from the surgery must have resolved prior to Cycle 1 Day 1
- •Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart Association (NYHA) Class 3 to 4 heart disease or cardiac ejection fraction measurement of less than 50 percent within 6 months prior to Cycle 1 Day 1
- •Has uncontrolled hypertension (systolic blood pressure greater than or equal to 160 millimeter of mercury or diastolic blood pressure greater than or equal to 95 millimeter of mercury)
研究组 & 干预措施
Abiraterone plus Prednisolone
Abiraterone 1000 milligram (mg) oral tablets will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
干预措施: Prednisolone (Drug)
Abiraterone plus Prednisolone
Abiraterone 1000 milligram (mg) oral tablets will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
干预措施: Abiraterone (Drug)
结局指标
主要结局
Percentage of participants achieving Prostate-Specific Antigen (PSA) response up to 12 weeks
时间窗: Baseline up to 12 weeks
The PSA response will be evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline up to 12 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.
次要结局
- Percentage of participants with Radiographic Objective Response(Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years)
- Duration of Prostate-Specific Antigen (PSA) response(Baseline and Day 1 of each cycle up to 5 years)
- Percentage of participants achieving Prostate-Specific Antigen (PSA) response(Baseline and Day 1 of each cycle up to 5 years)
- Clinical benefit(Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle up to 5 years)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score(Baseline, Day 1, 8, 15 and 22 of Cycle 1 and 2, and thereafter Day 1 and 15 of all cycles up to 5 years)
- Decline in Serum Prostate-Specific Antigen (PSA)(Baseline and Day 1 of each cycle up to 5 years)
- Overall survival(Every 3 months until death or up to 5 years)
- Prostate-Specific Antigen based Progression-free Survival (PSA-PFS)(Baseline and Day 1 of each cycle until first documented disease progression or up to 5 years)
- Radiographic Progression-free Survival (RAD-PFS)(Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years)
- Percentage of participants with Circulating Tumor Cell (CTC) conversion(Day 1 of Cycle 2, 3, and 4)