Targeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT04542291
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin will be provided for this trial
  • BIOSENSE meters — DEVICE
    -Being used in this trial to evaluate utility for assessing breath ketones

Study Details

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.

Key Dates

Start date
Feb 25, 2021
Status verified
Jan 2023
Primary completion
Dec 24, 2021
Completion
Jan 19, 2022

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    * Dapagliflozin is an oral drug which will be administered on an outpatient basis. Dosing will start at 5 mg daily and will increase to 10 mg daily after 2 weeks (after consulation with a study endrocrinologist) if the patient is tolerating the 5 mg dose. Dapagliflozin will be given for a total of 8 weeks (2 weeks at 5 mg and 6 weeks at 10 mg) * Treatment with dapagliflozin will be initiated on Cycle 1 Day 1 of standard of care chemotherapy. * Participants will use the BIOSENSE meter once daily

Primary Outcome Measure

Tolerability as Measured by Number of Participants With Related Adverse Events [ Time Frame: From start of treatment through 30 days after treatment (estimated to be 3 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Washington University School of Medicine· St Louis, MO

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