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Translational scientist left university
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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.
During this study patients will receive treatment of omeprazole at the dose depending on group enrollment
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Arm B (Normal Dose) | Placebo Comparator | Omeprazole, 20 mg, PO, QD for 12-14 days prior to surgical therapy of pancreatectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion | Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery | 2 years |
| Safety and Tolerability | Frequency and severity of treatment related adverse events per CTCAE v5 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| v-ATPase LC3-I and LC3-II expression | v-ATPase LC3-I and LC3-II expression on pancreatic tumor | 2 years |
| pH | pH of tumor tissue | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ajay Jain, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Correlation | Correlation of biomarker changes with potential cancer cell apoptosis | 2 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |