High Dose Omeprazole in Patients With Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Omeprazole

Criteria

Inclusion Criteria:

• Newly diagnosed exocrine pancreatic cancer with pathology confirmed 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

• Adequate organ function for surgical therapy

Exclusion Criteria:

• 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.