Targeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition
NCT04542291 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2023-02-14
Summary
This is a first-in-human, pilot study of the feasibility and safety of dapagliflozin (in addition to standard of care treatment) for the treatment of patients with metastatic pancreatic ductal adenocarcinoma. The primary hypothesis is that dapagliflozin is well-tolerated and safe to use in this patient population. The investigators also hypothesize that dapagliflozin will be efficacious as an adjunct to front-line chemotherapy assessed by decreased tumor markers mediated by its pleiotropic metabolic effects.
Conditions
- Pancreas Cancer
- Pancreatic Cancer
- Cancer of the Pancreas
Interventions
- DRUG
-
Dapagliflozin will be provided for this trial
- DEVICE
-
BIOSENSE meters
-Being used in this trial to evaluate utility for assessing breath ketones
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Cancer Institute (NCI)
collaborator NIH -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Kian-Huat Lim, M.D. · Washington University School of Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-25
- Primary Completion
- 2021-12-24
- Completion
- 2022-01-19
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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