High Dose Omeprazole in Patients With Pancreatic Cancer (OU202005AJ)
Primary Purpose
Exocrine Pancreatic Cancer
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Exocrine Pancreatic Cancer focused on measuring pancreatic cancer, omeprazole
Eligibility Criteria
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.
Sites / Locations
- Stephenson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm A (High Dose)
Arm B (Normal Dose)
Arm 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.
Omeprazole, 20 mg, PO, QD for 2 weeks prior to surgical therapy of pancreatectomy.
Outcomes
Primary Outcome Measures
Proportion
Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery
Safety and Tolerability
Frequency and severity of treatment related adverse events per CTCAE v5
Secondary Outcome Measures
v-ATPase LC3-I and LC3-II expression
v-ATPase LC3-I and LC3-II expression on pancreatic tumor
pH
pH of tumor tissue
Correlation
Correlation of biomarker changes with potential cancer cell apoptosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04930991
Brief Title
High Dose Omeprazole in Patients With Pancreatic Cancer
Acronym
OU202005AJ
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exocrine Pancreatic Cancer
Keywords
pancreatic cancer, omeprazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A (High Dose)
Arm Type
Experimental
Arm 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.
Arm Title
Arm B (Normal Dose)
Arm Type
Placebo Comparator
Arm Description
Omeprazole, 20 mg, PO, QD for 2 weeks prior to surgical therapy of pancreatectomy.
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Description
Treatment will consist of Omeprazole 2 weeks prior to surgical therapy of pancreatectomy.
Primary Outcome Measure Information:
Title
Proportion
Description
Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery
Time Frame
2 years
Title
Safety and Tolerability
Description
Frequency and severity of treatment related adverse events per CTCAE v5
Time Frame
2 years
Secondary Outcome Measure Information:
Title
v-ATPase LC3-I and LC3-II expression
Description
v-ATPase LC3-I and LC3-II expression on pancreatic tumor
Time Frame
2 years
Title
pH
Description
pH of tumor tissue
Time Frame
2 years
Title
Correlation
Description
Correlation of biomarker changes with potential cancer cell apoptosis
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SCC IIT Office
Phone
405-271-8777
Email
SCC-IIT-Office@ouhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid Block
Phone
405-271-8777
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Jain, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SCC IIT Office
Phone
405-271-8777
Email
SCC-IIT-Office@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Ajay Jain, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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High Dose Omeprazole in Patients With Pancreatic Cancer
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