Clinical trial NCT04930991: High Dose Omeprazole in Patients With Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Exocrine Pancreatic Cancer
Keywords: pancreatic cancer
omeprazole
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion
timeFrame: 2 years
measure: Safety and Tolerability
timeFrame: 2 years
Secondary outcomes:
measure: v-ATPase LC3-I and LC3-II expression
timeFrame: 2 years
measure: pH
timeFrame: 2 years
measure: Correlation
timeFrame: 2 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Ajay Jain, MD
role: PRINCIPAL_INVESTIGATOR
References: