High Dose Omeprazole in Patients With Pancreatic Cancer

NCT ID: NCT04930991

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2027-09-30

Brief 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.

Detailed Description

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.

Conditions

Exocrine Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Omeprazole

Intervention Type: DRUG

Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.

Arm B (Normal Dose)

Omeprazole, 20 mg, PO, QD for 12-14 days prior to surgical therapy of pancreatectomy.

Group Type: PLACEBO_COMPARATOR

Omeprazole

Intervention Type: DRUG

Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.

Interventions

Omeprazole

Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ajay Jain, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

SCC IIT Office

Role: CONTACT

SCC-IIT-Office@ouhsc.edu

405-271-8777

Ingrid Block

Role: CONTACT

405-271-8777

Facility Contacts

SCC IIT Office

Role: primary

SCC-IIT-Office@ouhsc.edu

405-271-8777

Other Identifiers

OU-SCC-Omeprazole

Identifier Type: -

Identifier Source: org_study_id