A Biomarker Study of STA9090 in Castration-Resistant Prostate Cancer (CRPC) With Assessment of Androgen Receptor Pathway Signaling
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- To assess AR transcriptional activity based on expression of a series of AR regulated genes, in baseline and on therapy tumor biopsies in CRPC patients treated with STA- 9090 +/-dutasteride.
研究概览
简要总结
In this research study, the investigators are looking to determine the safety and efficacy of an investigational drug, STA9090 alone and in combination with dutasteride for the treatment of castrate resistant prostate cancer. STA9090 may cause the growth of cancer to slow down or shrink by targeting proteins required for the cancer to grow. The investigators are also looking to determine whether the use of dutasteride to lower male hormone levels will enhance the effect of STA9090 in the treatment of castrate resistant prostate cancer.
详细描述
Subjects will have a tumor biopsy before treatment begins. Subjects who are randomized to Arm A will receive infusions of STA9090 on days 1, 8, and 15 of a 28 day cycle. Subjects randomized on Arm B will receive daily oral dutasteride for 2 weeks prior to beginning STA9090 treatment. They will continue to receive dutasteride while on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adenocarcinoma of the prostate
- •Progressive castration resistant disease
- •Metastatic disease
- •Normal organ and marrow function
排除标准
- •History of current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass
- •Current treatment with the following antiarrhythmic drugs: flecainide, moricizine or propafenone
- •New York Heart Association class II/III/IV congestive heart failure
- •Current or prior radiation therapy to the left hemithorax
- •Treatment with chronic immunosuppressants
- •Uncontrolled intercurrent illness
- •Poor venous access for study drug administration
- •Venous thromboembolism in the past 6 months
研究组 & 干预措施
STA9090 with Dutasteride
STA9090 with Dutasteride
干预措施: STA9090 with Dutasteride (Drug)
STA9090
STA9090
干预措施: STA9090 (Drug)
结局指标
主要结局
To assess AR transcriptional activity based on expression of a series of AR regulated genes, in baseline and on therapy tumor biopsies in CRPC patients treated with STA- 9090 +/-dutasteride.
时间窗: 2 years
The primary objective is to determine whether STA-9090, or the combination with dutasteride further suppresses AR transcriptional activity. AR transcriptional activity will be assessed based on expression of a series of AR regulated genes, in baseline and on therapy tumor biopsies in CRPC patients treated with STA-9090 +/- dutasteride.
次要结局
- To evaluate progression-free survival (PFS) of men with CRPC treated with STA9090 with or without dutasteride(2 years)
- To determine the response rate of measurable disease if present (RECIST)(2 years)
- To assess the safety and tolerability of STA9090 in men the CRPC(2 years)
- To evaluate the overall survival of men with metastatic CRPC treated with STA9090 alone or in combination with dutasteride(2 years)
研究者
Toni Choueiri, MD
Overall Investigator
Dana-Farber Cancer Institute