An Open-Label, Phase I, Randomized Pharmacokinetic Study of Dietary Effects on Abiraterone Acetate Drug Levels in Patients With Metastatic Castration-Resistant Prostate Cancer (DEAL)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC)0-24 measurement
研究概览
简要总结
This randomized pilot phase I trial studies the side effects of dietary fat levels and abiraterone acetate uptake in patients with metastatic hormone-resistant prostate cancer. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Eating a low or high fat diet may increase the uptake of abiraterone acetate.
详细描述
PRIMARY OBJECTIVES:
I. To assess the dietary effects of a low fat and high fat diet at a low abiraterone acetate dose (250 mg) on drug levels compared to standard dose administered in a fasting condition.
SECONDARY OBJECTIVES:
I. To potentially guide decisions in the future to use low dose abiraterone in a fed state and decrease overall cost.
II. To evaluate the potential relationship between esterase activity and abiraterone metabolism in an exploratory analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Histologically confirmed adenocarcinoma of the prostate
- •About to initiate or currently being treated with abiraterone acetate 1000 mg orally once daily
- •Clinically able to receive abiraterone acetate in the opinion of the investigator in accordance with standard prescribing practices
- •Ability to consume a low fat and high fat diet
- •Expected duration of continuous abiraterone therapy > 8 weeks
- •Signed and dated informed consent
排除标准
- •Patients taking medications that strongly inhibit or induce cytochrome P450 (CYP)3A4 within 28 days prior to the start of the study will be excluded
研究组 & 干预措施
Arm I (abiraterone acetate, low then high fat breakfast)
Patients receive standard dose abiraterone acetate PO QD (held on days 2, 3, 9, and 10), and low-dose abiraterone acetate PO QD on days 3 and 10. Patients eat a low fat breakfast on day 3 and a high fat breakfast on day 10.
干预措施: abiraterone acetate (Drug)
Arm I (abiraterone acetate, low then high fat breakfast)
Patients receive standard dose abiraterone acetate PO QD (held on days 2, 3, 9, and 10), and low-dose abiraterone acetate PO QD on days 3 and 10. Patients eat a low fat breakfast on day 3 and a high fat breakfast on day 10.
干预措施: dietary intervention (Dietary Supplement)
Arm I (abiraterone acetate, low then high fat breakfast)
Patients receive standard dose abiraterone acetate PO QD (held on days 2, 3, 9, and 10), and low-dose abiraterone acetate PO QD on days 3 and 10. Patients eat a low fat breakfast on day 3 and a high fat breakfast on day 10.
干预措施: pharmacological study (Other)
Arm I (abiraterone acetate, low then high fat breakfast)
Patients receive standard dose abiraterone acetate PO QD (held on days 2, 3, 9, and 10), and low-dose abiraterone acetate PO QD on days 3 and 10. Patients eat a low fat breakfast on day 3 and a high fat breakfast on day 10.
干预措施: questionnaire administration (Other)
Arm I (abiraterone acetate, low then high fat breakfast)
Patients receive standard dose abiraterone acetate PO QD (held on days 2, 3, 9, and 10), and low-dose abiraterone acetate PO QD on days 3 and 10. Patients eat a low fat breakfast on day 3 and a high fat breakfast on day 10.
干预措施: laboratory biomarker analysis (Other)
Arm II (abiraterone acetate, high then low fat breakfast)
Patients receive abiraterone acetate as in Arm I. Patients eat a high fat breakfast on day 3, and a low fat breakfast on day 10.
干预措施: abiraterone acetate (Drug)
Arm II (abiraterone acetate, high then low fat breakfast)
Patients receive abiraterone acetate as in Arm I. Patients eat a high fat breakfast on day 3, and a low fat breakfast on day 10.
干预措施: dietary intervention (Dietary Supplement)
Arm II (abiraterone acetate, high then low fat breakfast)
Patients receive abiraterone acetate as in Arm I. Patients eat a high fat breakfast on day 3, and a low fat breakfast on day 10.
干预措施: pharmacological study (Other)
Arm II (abiraterone acetate, high then low fat breakfast)
Patients receive abiraterone acetate as in Arm I. Patients eat a high fat breakfast on day 3, and a low fat breakfast on day 10.
干预措施: questionnaire administration (Other)
Arm II (abiraterone acetate, high then low fat breakfast)
Patients receive abiraterone acetate as in Arm I. Patients eat a high fat breakfast on day 3, and a low fat breakfast on day 10.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Area under the curve (AUC)0-24 measurement
时间窗: Up to 24 hours (day 1)
The cross-over difference (log\[AUC0-24(low fat)\] - log\[AUC0-24(high fat)\]) of each patient will be computed and graphically illustrated. The cross-over difference will be estimated and reported with 95% confidence interval. Hills-Armitage approach will be used to adjust for the period effect for the estimation. In addition, a bioequivalence range will be computed for the log(AUC0-24\[1000 mg with fasting food\]), allowing for 20% differences in each side.
次要结局
- Accuracy of patient-collected DBS sampling technique(Day 3)
- Patient adherence to pre-defined sampling schedule(Up to day 14)
- Patient satisfaction of DBS method, measured using the Patient Questionnaire of DBS Sampling Method(Day 14)
研究者
Tom Beer
Principal Investigator
OHSU Knight Cancer Institute