High Dose Omeprazole in Patients With Pancreatic Cancer (OU202005AJ)

University of Oklahoma (OU)

Status and phase: Enrolling; Early Phase 1

Conditions: Exocrine Pancreatic Cancer

Treatments: Drug: Omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT04930991

OU-SCC-Omeprazole

Details and patient eligibility

About

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.

Full 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 14 days unless unacceptable toxicity
• Group B, will receive omeprazole 20 mg, once a day for 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed exocrine pancreatic cancer with pathology confirmed 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
• Adequate organ function for surgical therapy

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Arm A (High Dose)

Experimental group

Description:

Omeprazole, 80 mg, PO, BID for 2 weeks prior to surgical therapy of pancreatectomy. All 30 subjects in Arm A to be enrolled prior to Arm B cohort enrollment.

Treatment:

Drug: Omeprazole

Arm B (Normal Dose)

Placebo Comparator group

Description:

Omeprazole, 20 mg, PO, QD for 2 weeks prior to surgical therapy of pancreatectomy.

Treatment:

Drug: Omeprazole