High Dose Omeprazole in Patients With Pancreatic Cancer

Last updated: May 13, 2025
Sponsor: University of Oklahoma
Overall Status: Active - Recruiting

Phase

1

Condition

Digestive System Neoplasms

Treatment

Omeprazole

Clinical Study ID

NCT04930991
OU-SCC-Omeprazole
  • Ages 18-100
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed exocrine pancreatic cancer with either pathology, histology, orradiology 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 testwithin 14 days of registration. All women (regardless of sexual orientation, havingundergone a tubal ligation, or remaining celibate by choice) are considered to havechildbearing 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

Exclusion Criteria:

  • Patients with pancreatic malignant tumor histologically confirmed as neuroendocrineor any other type of malignancies

  • Positive pregnancy test, pregnant, or breastfeeding

  • Known hypersensitivity to any component of the formulation or substitutedbenzimidazoles

  • Any other clinically significant laboratory abnormality that would compromisepatient safety or the outcome of the study

  • Any clinically significant and/or uncontrolled cardiac-related abnormality thatwould compromise patient safety or the outcome of the study

  • Medical condition that might affect the absorption of study medications in theopinion of the investigator.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Omeprazole
Phase: 1
Study Start date:
September 07, 2021
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

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