High Dose Omeprazole in Patients With Pancreatic Cancer

Exocrine Pancreatic Cancer Clinical Trial

— OU202005AJ  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04930991
• Other study ID #: OU-SCC-Omeprazole
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 7, 2021
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: SCC IIT Office
• Phone: 405-271-8777
• Email: SCC-IIT-Office[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exocrine Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Omeprazole
Treatment will consist of Omeprazole 2 weeks prior to surgical therapy of pancreatectomy.

Locations

Country	Name	City	State
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion	Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery	2 years
Primary	Safety and Tolerability	Frequency and severity of treatment related adverse events per CTCAE v5	2 years
Secondary	v-ATPase LC3-I and LC3-II expression	v-ATPase LC3-I and LC3-II expression on pancreatic tumor	2 years
Secondary	pH	pH of tumor tissue	2 years
Secondary	Correlation	Correlation of biomarker changes with potential cancer cell apoptosis	2 years