A Phase II, Open Label, Single Arm Study of i.v. Panobinostat (LBH589) in Patients With Metastatic Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 5
- 主要终点
- Percentage of Participants With Progression-Free Survival (PFS) Rate at 24 Weeks
研究概览
简要总结
This Phase II single dose study was designed to characterize the safety, tolerability, and efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants with hormone refractory prostate cancer.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Panobinostat
Participants with metastatic hormone refractory prostate cancer received 20 milligrams per meter square (mg/m^2) of panobinostat intravenously (i.v.) on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or withdrawal of consent.
干预措施: Panobinostat (Drug)
结局指标
主要结局
Percentage of Participants With Progression-Free Survival (PFS) Rate at 24 Weeks
时间窗: 24 weeks
The PFS rate was defined as the percentage of participants that were alive without documented disease progression at the end of 24 weeks from first study treatment. Disease Progression as per response evaluation criteria in solid tumors (RECIST) criteria: Measurable lesions: If target lesion was lymph node then it had to be at least 2 centimeter (cm) at baseline to assess change in size. Bone lesions: (non-target lesions) appearance of greater than or equal to (\>=) 2 unequivocal new lesions confirmed on a second scan at least 6 weeks later.
次要结局
- Median Progression-free Survival (PFS)(After every cycle up to approximately 2.7 years)
- Overall Survival(Start of study treatment to date of death due to any cause (Up to approximately 2.7 years))
- Percentage of Participants With Tumor Response Rate(Every 12 weeks up to approximately 2.7 years)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From start of the study up to at least 4 weeks following the last dose of study treatment (Up to approximately 2.7 years))
- Percentage of Participants With Duration of Stable Disease (SD) Per RECIST(Every 12 weeks up to approximately 2.7 years)
- Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate at 24 Weeks(24 weeks)
- Percentage of Participants With PSA Progression Rate at 24 Weeks(24 weeks)