A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers

Trial ID: NCT04930991

Interventional - Phase 1 - Terminated

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.

Conditions

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

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.

University of Oklahoma