A Phase II Trial of FASN Inhibition by Omeprazole in Combination With Cabazitaxel in Patients With Docetaxel- and Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change Radiographic Response - RECIST 1.1
研究概览
简要总结
The purpose of this research study is to find out what effects (good and bad) omeprazole and cabazitaxel, or omeprazole and docetaxel, has on participants and their condition. Investigators believe omeprazole may help the other medications work.
详细描述
Primary Objective(s): Obtain RECIST Overall Response Rate (ORR) of 29% by adding the fatty acid synthase inhibitor, omeprazole to cabazitaxel. ORR defined by partial response (PR) or complete response (CR) in tumor size and bone metastasis
Secondary Objectives (only at patients treated at Wake Forest Baptist Comprehensive Cancer Center main campus):
- Obtain a prostate specific antigen response rate by adding the fatty acid synthase inhibitor omeprazole to cabazitaxel regimen
- Measure pain using the Patient-Reported Outcomes Measurement Information System (PROMIS) at Baseline, Cycle 5, Cycle 12, and every cycle thereafter.
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
- •Patients must have castrate refractory prostate cancer with prior docetaxel treatment which was used in the castrate refractory setting
- •Cancer Progression as defined by prostate cancer working group 3 (PCWG3) any type- prostate specific antigen only, bone only +nodal, nodal only or new lesions
- •Age 18 or older.
- •ECOG 0, 1, or 2
- •Life expectancy of greater than 2 months
- •Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for three (3) months after study treatment discontinuation.
- •Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
- •Organ & marrow function as defined below: Absolute neutrophil count >1,200/mcL, Platelets >75,000/mcL; total bilirubin = within normal institutional limits; AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal; creatinine <2.5 X institutional upper limit of normal
排除标准
- •Patients may not be receiving any other investigational agents.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to omeprazole or taxane therapy.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Omeprazole Plus Standard of Care for Prostate Cancer Regimen
This intervention will be given on an outpatient basis. Omeprazole, 80 mg twice daily.
干预措施: Omeprazole 80 mg twice daily (Drug)
结局指标
主要结局
Change Radiographic Response - RECIST 1.1
时间窗: Up to approximately 2 years
Response will be defined by RECIST 1.1 as defined by Prostate Cancer Clinical Trials Working Group 3 definition for complete response (CR) - disappearance of all target lesions); partial response (PR) (at least a 30% decrease in the sum of diameters of target lesions); progressive disease (PD) (at least a 20% increase in the sum of diameters or target lesions); stable disease (SD) (neither sufficient shrinkage to qualify for partial response nor sufficient to qualify for progressive disease); or not evaluable (NE).
Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
时间窗: Up to approximately 2 years
Response will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) for complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) or not evaluable (NE).
次要结局
- Prostate Specific Antigen (PSA) Progression(At baseline and up to approximately 2 years)
- Prostate Specific Antigen (PSA) Response(At baseline and up to approximately 2 years)
- Patient Reported Outcome - Pain(At baseline, 12 weeks, and Day 1 of every subsequent cycle (each cycle is 28 days) up to approximately 2 years)