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NCT04930991 | RECRUITING | Exocrine Pancreatic Cancer

High Dose Omeprazole in Patients With Pancreatic Cancer
Sponsor:

University of Oklahoma

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.

Condition or disease

Exocrine Pancreatic Cancer

Intervention/treatment

Omeprazole

Phase

EARLY_PHASE1

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 14 days unless unacceptable toxicity * Group B, will receive omeprazole 20 mg, once a day for 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
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers
Actual Study Start Date : 2021-09-07
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Newly diagnosed exocrine pancreatic cancer with pathology confirmed 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
  • * Adequate organ function for surgical therapy
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.
High Dose Omeprazole in Patients With Pancreatic Cancer

Location Details

NCT04930991

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Oklahola

Stephenson Cancer Center

Ololama City, Okholohan, United States, 73104