Exocrine Pancreatic CancerEarly Phase 1OU202005AJNCT04930991
High Dose Omeprazole in Patients With Pancreatic Cancer
A Early Phase 1 study testing Omeprazole in people with Exocrine Pancreatic Cancer, run by University of Oklahoma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Exocrine Pancreatic Cancer
- What is being tested?
- Omeprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to 3 Apr 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
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
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.
Read the 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.
- Conditions
- Exocrine Pancreatic Cancer
- Being tested
- Omeprazole
- Keywords
- pancreatic cancer, omeprazole
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (High Dose) | Experimental | 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. Receives: Drug: Omeprazole |
| Arm B (Normal Dose) | Placebo comparator | Omeprazole, 20 mg, PO, QD for 12-14 days prior to surgical therapy of pancreatectomy. Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion
Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery
Measured: 2 years
Safety and Tolerability
Frequency and severity of treatment related adverse events per CTCAE v5
Measured: 2 years
Secondary outcomes (3)
v-ATPase LC3-I and LC3-II expression
v-ATPase LC3-I and LC3-II expression on pancreatic tumor
Measured: 2 years
pH
pH of tumor tissue
Measured: 2 years
Correlation
Correlation of biomarker changes with potential cancer cell apoptosis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start7 Sep 2021
- Primary completion3 Mar 2026
- Study completion3 Apr 2026
Why it stopped: Translational scientist left university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exocrine Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Jain, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930991
- Sponsor's protocol ID
- OU-SCC-Omeprazole
- Acronym
- OU202005AJ
- Status last verified
- May 2026
- First submitted
- 29 Mar 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04930991
- Acronym / sponsor ID
- OU202005AJ / OU-SCC-Omeprazole
- Conditions
- Exocrine Pancreatic Cancer
- Keywords
- pancreatic cancer, omeprazole
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Translational scientist left university
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (High Dose) | Experimental | Drug: OmeprazoleOmeprazole, 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. |
| Arm B (Normal Dose) | Placebo comparator | Drug: OmeprazoleOmeprazole, 20 mg, PO, QD for 12-14 days prior to surgical therapy of pancreatectomy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleTreatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy. | Drug | Arm A (High Dose), Arm B (Normal Dose) |
Primary outcome
Proportion
Time frame: 2 years
Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery
Safety and Tolerability
Time frame: 2 years
Frequency and severity of treatment related adverse events per CTCAE v5
3 secondary outcomes
v-ATPase LC3-I and LC3-II expression
Time frame: 2 years
pH
Time frame: 2 years
Correlation
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Translational scientist left university). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Exocrine Pancreatic Cancer
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingObservational study
Pan-tumor MRD Study
Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer
RecruitingPhase 4
Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.
Unresectable Pancreatic Cancer
RecruitingObservational study
Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study
Chronic Pancreatitis, Exocrine Pancreas Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Jain, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Omeprazole in people with Exocrine Pancreatic Cancer, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Translational scientist left university). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.