High Dose Omeprazole in Patients With Pancreatic Cancer

NCT04930991 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: OU-SCC-Omeprazole
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Exocrine Pancreatic Cancer

Keywords

pancreatic cancer; omeprazole

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• v-ATPase LC3-I and LC3-II expression

  2 years

• pH

  2 years

• Correlation

  2 years

Study Arms (2)

Arm A (High Dose)

EXPERIMENTAL

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

Arm B (Normal Dose)

PLACEBO COMPARATOR

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

Drug: Omeprazole

Interventions

Omeprazole DRUG

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

Arm A (High Dose); Arm B (Normal Dose)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ajay Jain, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SCC IIT Office

CONTACT

405-271-8777; SCC-IIT-Office@ouhsc.edu

Ingrid Block

CONTACT

405-271-8777

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: June 18, 2021
• Study Start: September 7, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)