A Phase I/II Trial of AN-152 [AEZS-108) in Castration- and Taxane-Resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Clinical benefit defined as non-progression with no dose-limiting toxicity or other toxicity requiring termination of treatment
研究概览
简要总结
This is a research study for advanced prostate cancer. An experimental drug called AN-152 (also known as AEZS-108) will be used. The purpose of this study is to test the safety, tolerability and benefits of an experimental drug called AN-152.
The participants tumor will be tested for expression of this receptor (using an old biopsy). If the participants cancer does not have this receptor, participants will not be eligible to participant in this study.
AN-152 (AEZS-108) is administered intravenously (IV) over 2 hours and will be given at the specified dose every 3 weeks. Premedication with dexamethasone 8mg is recommended.
Participants will continue treatment until death, disease progression, unacceptable toxicity, participants refusal, treatment delay >3 weeks, or the completion of 6 cycles. Continuation beyond 6 cycles is left at the discretion of the study doctor.
The study is planned to last 2 years. Up to 55 (up to 18 for the Phase I portion, up to 37 for the Phase II portion).
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
Arm I
Patients receive doxorubicin-GnRH agonist conjugate AEZS-108 intravenously (IV) over 2 hours once every 21 days (21 days = 1 cycle). Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm I
Patients receive doxorubicin-GnRH agonist conjugate AEZS-108 intravenously (IV) over 2 hours once every 21 days (21 days = 1 cycle). Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
Arm I
Patients receive doxorubicin-GnRH agonist conjugate AEZS-108 intravenously (IV) over 2 hours once every 21 days (21 days = 1 cycle). Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: doxorubicin-GnRH agonist conjugate AEZS-108 (Drug)
结局指标
主要结局
Clinical benefit defined as non-progression with no dose-limiting toxicity or other toxicity requiring termination of treatment
时间窗: At 3 months up to 24 months
次要结局
- Response for patients with measurable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST)(At 3 months up to 24 months)
- To assess the prostate specific antigen (PSA) response rate in patients treated with AN-152(At 3 months up to 24 months)
- Time to PSA progression(Up to 24 months)
- Overall survival(Up to 2 years)
- Time to overall disease progression(Up to 24 months)
- Number of participants with adverse events as a measure of safety and tolerability(At 3 weeks up to 72 weeks)