A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers

Who is this study for? Patients with Exocrine Pancreatic Cancer
What treatments are being studied? Omeprazole
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
United States
Oklahoma
Stephenson Cancer Center
RECRUITING
Oklahoma City
Contact Information
Primary
SCC IIT Office
SCC-IIT-Office@ouhsc.edu
405-271-8777
Backup
Ingrid Block
405-271-8777
Time Frame
Start Date: 2021-09-07
Estimated Completion Date: 2026-06
Participants
Target number of participants: 60
Treatments
Experimental: Arm A (High Dose)
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.
Placebo_comparator: Arm B (Normal Dose)
Omeprazole, 20 mg, PO, QD for 12-14 days prior to surgical therapy of pancreatectomy.
Related Therapeutic Areas
Sponsors
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov