Clinical trial · Interventional
High Dose Omeprazole in Patients With Pancreatic Cancer
A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers
NCT04930991CI-TRIAL-00113191OU202005AJterminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Translational scientist left university
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Exocrine Pancreatic Cancer | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omeprazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (High Dose)
- description
- 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.
- interventionNames
- Drug: Omeprazole
- type
- PLACEBO_COMPARATOR
- label
- Arm B (Normal Dose)
- description
- Omeprazole, 20 mg, PO, QD for 12-14 days prior to surgical therapy of pancreatectomy.
- interventionNames
- Drug: Omeprazole
Primary outcomes (2)
- measure
- Proportion
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.