NCT02452008进行中（未招募）2 期
Overcoming Drug Resistance in Metastatic Castration-resistant Prostate Cancer With Novel Combination of TGF-β Receptor Inhibitor LY2157299 and Enzalutamide: a Randomized Multi-site Phase II Study
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年5月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Progression free survival in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2) using RECIST 1.1 criteria.
研究概览
简要总结
The primary objective of this study is to compare the progression free survival (PFS) of patients with metastatic castration-resistant prostate cancer treated with enzalutamide in combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).
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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have metastatic castration-resistant prostate cancer
- •Must have had prior abiraterone treatment
- •Life expectancy of greater than 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2
- •Age ≥18 years
- •Have measurable disease
- •Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
- •Ability to take oral medication
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests
- •Must use acceptable form of birth control while on study
- •Ability to understand and willingness to sign a written informed consent document
排除标准
- •Known history or evidence of brain metastases
- •Prior chemotherapy for metastatic disease in castration-resistant prostate cancer
- •Had surgery within 4 weeks prior to the first dose of study drug
- •Had radiation, biological, or other investigational cancer therapy within 2 weeks prior to the first dose of study drug
- •Had second-line hormonal therapy within 2 weeks prior to the first dose of study drug
- •Systemic steroids within 1 weeks prior to the first dose of study drug
- •Had prior enzalutamide, ARN-509, or galeterone therapy
- •Have moderate or severe cardiovascular disease
- •Have a history of a seizure
- •Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements
- •Have a history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythmatosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis)
- •Have known history of infection with HIV, hepatitis B, or hepatitis C
研究组 & 干预措施
Arm 1: Enzalutamide with LY2157299
Experimental
干预措施: Enzalutamide (Drug)
Arm 1: Enzalutamide with LY2157299
Experimental
干预措施: LY2157299 (Drug)
Arm 2: Enzalutamide alone
Experimental
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Progression free survival in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2) using RECIST 1.1 criteria.
时间窗: 4 years
次要结局
- Number of patients experiencing treatment-related toxicities(4 years)
- Tumor marker kinetics (PSA) in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).(4 years)
- Overall survival (OS) in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).(4 years)
研究者
研究点 (4)
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