An Open-Label, Single-Arm, Multiple Center Extension Study to Evaluate One Year of Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With YONSA™ 500 mg (4 x 125 mg qd) With Methylprednisolone (4 mg Bid)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Number of Subjects With Adverse Events
研究概览
简要总结
This is an open-label, single-arm, multi-center extension study to evaluate safety in patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid). Patients will have successfully completed an 84-day treatment with abiraterone acetate in a previous trial. Results from the final visit of the previous study will be used to determine patient's eligibility for this study. Patients in this study will be eligible to receive open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of serum testosterone and PSA levels will be monitored. Disease progression will be assessed by PCWG2 criteria.
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
- •Successful completion of 84 days of treatment with YONSA in Churchill Pharmaceuticals clinical trial, CHL-AA-201
- •Last dose of YONSA or Zytiga within 45 days prior to treatment in this study
- •Written informed consent obtained prior to any study-related procedure being performed
- •Has in the investigator's opinion, the potential to gain clinical benefit with YONSA treatment
- •Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level <50 ng/dL at screening
- •Life expectancy of at least 9 months at screening
- •Subject is willing and able to comply with all protocol requirements assessments
- •Agrees to protocol-defined use of effective contraception.
排除标准
- •Serious concurrent illness, including psychiatric illness, that would interfere with study participation
- •Inability to swallow tablets whole
- •Known hypersensitivity to YONSA, methylprednisolone, or any excipients in study medications
- •Moderate to severe hepatic impairment (Child-Pugh Classes B and C)
研究组 & 干预措施
YONSA with Methylprednisolone
Aberaterone Acetate 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)
干预措施: abiraterone acetate with Methylprednisolone (Drug)
结局指标
主要结局
Number of Subjects With Adverse Events
时间窗: one year
Adverse events
次要结局
- Proportion of Subjects With Disease Progression(one year)
- Testosterone Levels(Baseline and 360 days)
- Prostate Specific Antigen Levels(One year)
- Testosterone Complete Suppression(360 days)
- Percentage of Subjects With Prostate Specific Antigen - 50 Response(360 days)