A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Proportion
研究概览
简要总结
The purpose of this study is to test the safety of high dose omeprazole and see what effects that it has on patients with exocrine pancreatic cancer.
详细描述
During this study patients will receive treatment of omeprazole at the dose depending on group enrollment
- Group A will receive omeprazole 80 mg, twice a day for 12-14 days unless unacceptable toxicity
- Group B, will receive omeprazole 20 mg, once a day for 12-14 days
Patients will receive treatment for 2~3 weeks during the study, and 2 months of follow up.
Total accrual is anticipated to take 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed exocrine pancreatic cancer with either pathology, histology, or radiology imaging documented as adenocarcinoma
- •Patient is a candidate for surgical resection of pancreatic cancer
- •≥ 18 years old at the time of informed consent
- •ECOG Performance Status 0-2
- •Patients with or without neoadjuvant chemotherapy will be eligible
- •Ability to provide written informed consent and HIPAA authorization
- •Women of childbearing potential definition must have a negative pregnancy test within 14 days of registration. All women (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) are considered to have childbearing potential unless they meet one of the following criteria:
- •Prior hysterectomy or bilateral oophorectomy;
- •Has not had menses at any time in the preceding 24 consecutive months
- •Candidate for surgery per standard of care of per surgeon's discretion
排除标准
- •Patients with pancreatic malignant tumor histologically confirmed as neuroendocrine or any other type of malignancies
- •Positive pregnancy test, pregnant, or breastfeeding
- •Known hypersensitivity to any component of the formulation or substituted benzimidazoles
- •Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study
- •Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study
- •Medical condition that might affect the absorption of study medications in the opinion of the investigator.
研究组 & 干预措施
Arm B (Normal Dose)
Omeprazole, 20 mg, PO, QD for 12-14 days prior to surgical therapy of pancreatectomy.
干预措施: Omeprazole (Drug)
Arm A (High Dose)
Omeprazole, 80 mg, PO, BID for 12-14 days prior to surgical therapy of pancreatectomy. All 30 subjects in Arm A to be enrolled prior to Arm B cohort enrollment.
干预措施: Omeprazole (Drug)
结局指标
主要结局
Proportion
时间窗: 2 years
Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery
Safety and Tolerability
时间窗: 2 years
Frequency and severity of treatment related adverse events per CTCAE v5
次要结局
- v-ATPase LC3-I and LC3-II expression(2 years)
- Correlation(2 years)
- pH(2 years)