Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Hypoglycemic Agents

All Drugs and Chemicals

Dapagliflozin

Sodium-Glucose Transporter 2 Inhibitors

* 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

Dapagliflozin will be provided for this trial

-Being used in this trial to evaluate utility for assessing breath ketones

BIOSENSE meters

Kian-Huat Lim, M.D.

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.

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

* Adverse events will be graded with CTCAE v. 5.0.
* Related indicates adverse events possibly, probably, or definitely related to treatment.

-Patients are to collect and test ketones weekly while on treatment.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Washington University School of Medicine

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Anemia

Atrial fibrillation

Colitis

Constipation

Diarrhea

Dry mouth

Nausea

Vomiting

Chills

Edema limbs

Fatigue

Fever

Sepsis

Skin infection

Alanine aminotransferase increased

Alkaline phosphatase increased

Aspartate aminotransferase increased

Lymphocyte count decreased

Neutrophil count decreased

Platelet count decreased

White blood cell decreased

Anorexia

Hypoalbuminemia

Hyponatremia

Dysgeusia

Headache

Peripheral sensory neuropathy

Chronic kidney disease

Proteinuria

Alopecia

Hyperhidrosis

Pruritus

Rash maculo-papular

Rash on arm

Hypotension

Tolerability as Measured by Number of Participants With Related Adverse Events

Screening

Cycle 1 Day 1

Cycle 1 Day 15

Cycle 2 Day 1

Cycle 2 Day 15

End of Treatment

The three patients who did not complete treatment are not evaluable for this outcome measure.

Changes in Plasma Glucose

Cycle 1 Day 8

Cycle 1 Day 22

Cycle 2 Day 8

Cycle 2 Day 22

The three patients who did not complete treatment are not included in this outcome measure and an additional patient is not included as they didn't collect any ketone readings. There are additional patients who missed ketone readings at additional time points.

Changes in Ketones

Changes in HbA1c

The three patients who did not complete treatment are not evaluable for this outcome measure. There are 3 additional patients not evaluable for this outcome measure because 2 patients did not have detectable levels of CA19-9 prior to treatment and 1 patient did not have the end of treatment CA19-9 drawn.

Changes in CA19-9

Pre-treatment

Post-8 weeks of treatment

Changes in Total Fat Volume in Visceral Fat Area as Assessed by CT-based Body Composition

Changes in Total Skeletal Muscle Volume in Visceral Fat Area as Assessed by CT-based Body Composition

Changes in Total Muscle to Fat Ratio in Visceral Fat Area as Assessed by CT-based Body Composition

Changes in CT-quantified Tumor Size

The CT scans were unable to determine the scope of tumor necrosis.

Change in Tumor Necrosis

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Targeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition	NCT04542291	Pancreas Cancer Pancreatic Canc... Cancer of the P...	Dapagliflozin BIOSENSE meters	18 Years -	Washington University School of Medicine
Targeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition	NCT04542291	Pancreas Cancer Pancreatic Canc... Cancer of the P...	Dapagliflozin BIOSENSE meters	18 Years -	Washington University School of Medicine

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