Testing high dose omeprazole for pancreatic cancer treatment
A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers
This study is testing whether taking a high dose of omeprazole can help people with pancreatic cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT04930991 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effects of high dose omeprazole in patients diagnosed with exocrine pancreatic cancer. Participants will be divided into two groups, receiving either 80 mg of omeprazole twice daily or 20 mg once daily for a duration of 12-14 days. The study will monitor the patients during treatment and follow up for two months to assess outcomes. The total duration for patient accrual is expected to be two years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed exocrine pancreatic cancer who are eligible for surgical resection.
Not a fit: Patients with pancreatic cancer that is not adenocarcinoma or those who are not candidates for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with pancreatic cancer by enhancing the effectiveness of their surgical resection.
How similar studies have performed: While this approach is novel in the context of pancreatic cancer, similar studies have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oklahoma City, Oklahoma
- Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Ajay Jain, MD — University of Oklahoma
- Study coordinator: SCC IIT Office
- Email: SCC-IIT-Office@ouhsc.edu
- Phone: 405-271-8777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.