RecruitingEarly Phase 1NCT04930991
High Dose Omeprazole in Patients With Pancreatic Cancer
A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers
Sponsor
University of Oklahoma
Enrollment
60 participants
Start Date
Sep 7, 2021
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria10
- 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
Exclusion Criteria6
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGOmeprazole
Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04930991