An Open-label Extension (OLE), Expanded Access Study, to Assess Long-term Safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) With Methylprednisolone (4mg Bid) in Patients Who Completed Study Number CHL-AA-201
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
An Open-label extension (OLE), expanded access study, to assess long-term safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid) in patients who completed study number CHL-AA-201.
详细描述
An Open-label extension (OLE), expanded access study, to assess long-term safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid) in patients who completed study number CHL-AA-201. An exploratory endpoint of Improved safety from switching from Zytiga (aberaterone Acetate 1000mg(4 x 250 mg qd) to SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) will also be ascertained..
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
- •Written informed consent obtained prior to any study-related procedure being performed
- •Previous, uninterrupted enrollment and treatment in trial number CHL-AA-201.
排除标准
- •Progressive disease as ascertained by the investigator using standard-of-care evaluations.
- •CHL-AA-201 D84 blood counts of the following:
- •Absolute neutrophil count > 1500/µL
- •Platelets > 100,000/µL
- •Hemoglobin > 9 g/dL
- •CHL-AA-201 D84 chemistry values of the following:
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x Upper Limit of Normal (ULN)
- •Total bilirubin < 1.5 x ULN
- •Creatinine< 1.5 x ULN
- •Albumin > 3.0 g/dL
- •Potassium > 3.5 mmol/L
研究组 & 干预措施
SoluMatrix™ Abiraterone Acetate
SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid)
干预措施: SoluMatrix™ Abiraterone Acetate (Drug)
SoluMatrix™ Abiraterone Acetate
SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid)
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: Month 9
Safety as determined by adverse events deemed related to experimental treatment.
次要结局
- Change in incidence of Treatment-Emergent Adverse Events in relation to Core Study(Month 9)