Clinical trialPhase 1Completed
Targeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 25 February 2021
- Expected end
- 19 January 2022
- Enrollment
- 15 participants
- Sites
- 1
- Primary outcomes
- Tolerability as Measured by Number of Participants With Related Adverse Events
- Sponsor
- Other
- Results posted
- 2023-01-17
- Last update
- 14 February 2023
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Tolerability as Measured by Number of Participants With Related Adverse Events [From start of treatment through 30 days after treatment (estimated to be 3 months)]. Count Of Participants, Participants. Anemia: Dapagliflozin (n=15): 15. Atrial fibrillation: Dapagliflozin (n=15): 1. Colitis: Dapagliflozin (n=15): 1. Constipation: Dapagliflozin (n=15): 1. Diarrhea: Dapagliflozin (n=15): 6. Dry mouth: Dapagliflozin (n=15): 1. Nausea: Dapagliflozin (n=15): 5. Vomiting: Dapagliflozin (n=15): 3. Chills: Dapagliflozin (n=15): 2. Edema limbs: Dapagliflozin (n=15): 2. Fatigue: Dapagliflozin (n=15): 6. Fever: Dapagliflozin (n=15): 2. Sepsis: Dapagliflozin (n=15): 1. Skin infection: Dapagliflozin (n=15): 1. Alanine aminotransferase increased: Dapagliflozin (n=15): 8. Alkaline phosphatase increased: Dapagliflozin (n=15): 5. Aspartate aminotransferase increased: Dapagliflozin (n=15): 6. Lymphocyte count decreased: Dapagliflozin (n=15): 7. Neutrophil count decreased: Dapagliflozin (n=15): 7. Platelet count decreased: Dapagliflozin (n=15): 12. White blood cell decreased: Dapagliflozin (n=15): 10. Anorexia: Dapagliflozin (n=15): 5. Hypoalbuminemia: Dapagliflozin (n=15): 2. Hyponatremia: Dapagliflozin (n=15): 2. Dysgeusia: Dapagliflozin (n=15): 1. Headache: Dapagliflozin (n=15): 1. Peripheral sensory neuropathy: Dapagliflozin (n=15): 4. Chronic kidney disease: Dapagliflozin (n=15): 2. Proteinuria: Dapagliflozin (n=15): 1. Alopecia: Dapagliflozin (n=15): 11. Hyperhidrosis: Dapagliflozin (n=15): 1. Pruritus: Dapagliflozin (n=15): 1. Rash maculo-papular: Dapagliflozin (n=15): 2. Rash on arm: Dapagliflozin (n=15): 1. Hypotension: Dapagliflozin (n=15): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Changes in Plasma Glucose [Screening, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, and End of Treatment (estimated to be 2 months)]. Median, mg/dL (Full Range). Screening: Dapagliflozin (n=12): 110 (71 to 158). Cycle 1 Day 1: Dapagliflozin (n=12): 106.5 (74 to 138). Cycle 1 Day 15: Dapagliflozin (n=12): 108.5 (79 to 138). Cycle 2 Day 1: Dapagliflozin (n=12): 100.5 (79 to 164). Cycle 2 Day 15: Dapagliflozin (n=12): 102.5 (82 to 172). End of Treatment: Dapagliflozin (n=12): 98 (81 to 195).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Changes in Ketones [Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, and Cycle 2 Day 22]. Median, mg/dL (Full Range). Cycle 1 Day 1: Dapagliflozin (n=11): 0.5 (0 to 5). Cycle 1 Day 8: Dapagliflozin (n=11): 0 (0 to 5). Cycle 1 Day 15: Dapagliflozin (n=11): 0 (0 to 5). Cycle 1 Day 22: Dapagliflozin (n=11): 0 (0 to 5). Cycle 2 Day 1: Dapagliflozin (n=11): 0 (0 to 5). Cycle 2 Day 8: Dapagliflozin (n=11): 0 (0 to 5). Cycle 2 Day 15: Dapagliflozin (n=11): 0 (0 to 5). Cycle 2 Day 22: Dapagliflozin (n=11): 0 (0 to 5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Changes in HbA1c [Screening and Cycle 2 Day 15]. Median, percentage of glycosylated hemoglobin (Full Range). Screening: Dapagliflozin (n=12): 5.95 (4.2 to 7.2). Cycle 2 Day 15: Dapagliflozin (n=12): 5.95 (5.2 to 7.2).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Changes in CA19-9 [Cycle 1 Day 1, Cycle 2 Day 1, and End of Treatment, up to 8 weeks]. Median, U/mL (Full Range). Cycle 1 Day 1: Dapagliflozin (n=9): 1060 (27.3 to 25010). Cycle 2 Day 1: Dapagliflozin (n=9): 315.6 (23.3 to 9250). End of Treatment: Dapagliflozin (n=9): 256.1 (11.3 to 30330).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Changes in Total Fat Volume in Visceral Fat Area as Assessed by CT-based Body Composition [From pre-treatment and post-8 weeks of treatment]. Mean, cm^3 (Standard Deviation). Pre-treatment: Dapagliflozin (n=12): 5009.845557 (1894.271988). Post-8 weeks of treatment: Dapagliflozin (n=12): 4334.134004 (2127.102525).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Changes in Total Skeletal Muscle Volume in Visceral Fat Area as Assessed by CT-based Body Composition [From pre-treatment and post-8 weeks of treatment]. Mean, cm^3 (Standard Deviation). Pre-treatment: Dapagliflozin (n=12): 1494.813884 (324.0522377). Post-8 weeks of treatment: Dapagliflozin (n=12): 1360.211117 (315.4997407).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Changes in Total Muscle to Fat Ratio in Visceral Fat Area as Assessed by CT-based Body Composition [From pre-treatment and post-8 weeks of treatment]. Mean, ratio (Standard Deviation). Pre-treatment: Dapagliflozin (n=12): 0.378776105 (0.274872687). Post-8 weeks of treatment: Dapagliflozin (n=12): 0.518539627 (0.638171644).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Changes in CT-quantified Tumor Size [From pre-treatment and post-8 weeks of treatment]. Mean, cm (Standard Deviation). Pre-treatment: Dapagliflozin (n=12): 7.541666667 (4.825775177). Post-8 weeks of treatment: Dapagliflozin (n=12): 7.358333333 (5.946038916).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Change in Tumor Necrosis [From pre-therapy to post-8 weeks of therapy].