High Dose Omeprazole in Patients With Pancreatic Cancer (OU202005AJ)

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

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.

Study Overview

• Status: Terminated
• Conditions: Exocrine Pancreatic Cancer
• Intervention / Treatment: Drug: Omeprazole

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Omeprazole; Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.
Placebo Comparator: Arm B (Normal Dose); Omeprazole, 20 mg, PO, QD for 12-14 days prior to surgical therapy of pancreatectomy.	Drug: Omeprazole; Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion	Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery	2 years
Safety and Tolerability	Frequency and severity of treatment related adverse events per CTCAE v5	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
v-ATPase LC3-I and LC3-II expression	v-ATPase LC3-I and LC3-II expression on pancreatic tumor	2 years
pH	pH of tumor tissue	2 years
Correlation	Correlation of biomarker changes with potential cancer cell apoptosis	2 years

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Ajay Jain, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): March 3, 2026
• Study Completion (Actual): April 3, 2026

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pancreatic cancer; omeprazole
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole
• Other Study ID Numbers: OU-SCC-Omeprazole

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes