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Pancreas CancerPhase 1NCT04542291

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

A Phase 1 study testing Dapagliflozin and BIOSENSE meters in people with Pancreas Cancer and Pancreatic Cancer, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dapagliflozin and BIOSENSE meters
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
25 Feb 2021to 19 Jan 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed metastatic or locally advanced pancreatic ductal adenocarcinoma, pancreatic adenosquamous carcinoma or squamous cell carcinoma
  • Patients with treated/stable brain metastases, defined as patients who have received prior therapy for their brain metastases and whose CNS disease is radiographically stable at study entry, are eligible.
  • Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
  • No prior systemic therapy for pancreatic ductal adenocarcinoma in the metastatic or locally advanced setting.
  • Planning to receive treatment with nab-paclitaxel and gemcitabine.
  • At least 18 years of age.
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  • ECOG performance status ≤ 1
  • Normal bone marrow and organ function as defined below:
  • Leukocytes ≥ 3,000/mcL
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelets ≥ 100,000/mcL
  • Total bilirubin ≤ 1.5 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  • Estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m^2
  • Because chemotherapeutic agents such as nab-paclitaxel and gemcitabine are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and at least one month after completion of the study
  • Agreement to adhere to Lifestyle Considerations throughout study duration
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Who cannot join

  • History of total pancreatectomy
  • Current or previous treatment with SGLT2i or thiazolidinedione.
  • Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone. Note that dexamethasone that can be prescribed for nausea on the day of chemotherapy, but in subsequent days will be replaced by a nonsteroidal anti-emetic for patients in this trial. Topical steroid ointments or creams for occasional skin rash is allowed.
  • A history of other malignancy with the exceptions of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell carcinoma.
  • History of stroke or transient ischemic attack (in the last 5 years).
  • HbA1c > 10% unless approved by endocrinologist
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  • Currently receiving any other investigational agents.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin, nab-paclitaxel, gemcitabine or other agents used in the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease (estimated glomerular filtration rate eGFR < 30 mL/min/1.73m2), symptomatic hypotension, and chronic/frequent urinary tract infections or yeast infections.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Being tested
Dapagliflozin, BIOSENSE meters
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    Also called Farxiga

    Dapagliflozin will be provided for this trial

  • BIOSENSE metersDevice

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

Study groups in NCT04542291
Study groupRoleWhat they receive
DapagliflozinExperimental* 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
Receives: Drug: Dapagliflozin; Device: BIOSENSE meters

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability as Measured by Number of Participants With Related Adverse Events

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

    Measured: From start of treatment through 30 days after treatment (estimated to be 3 months)

Secondary outcomes (9)

  1. Changes in Plasma Glucose

    Measured: 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)

  2. Changes in Ketones

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

    Measured: 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

  3. Changes in HbA1c

    Measured: Screening and Cycle 2 Day 15

  4. Changes in CA19-9

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, and End of Treatment, up to 8 weeks

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

    Measured: From pre-treatment and post-8 weeks of treatment

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

    Measured: From pre-treatment and post-8 weeks of treatment

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

    Measured: From pre-treatment and post-8 weeks of treatment

  8. Changes in CT-quantified Tumor Size

    Measured: From pre-treatment and post-8 weeks of treatment

  9. Change in Tumor Necrosis

    Measured: From pre-therapy to post-8 weeks of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start25 Feb 2021
  3. Primary completion24 Dec 2021
  4. Study completion19 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04542291
Sponsor's protocol ID
202011019
Other IDs
1P50CA196510-01A1
Status last verified
Jan 2023
First submitted
1 Sep 2020
Last updated
14 Feb 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Park LK, Lim KH, Volkman J, Abdiannia M, Johnston H, Nigogosyan Z, Siegel MJ, McGill JB, McKee AM, Salam M, Zhang RM, Ma D, Popuri K, Chow VTY, Beg MF, Hawkins WG, Peterson LR, Ippolito JE. Safety, tolerability, and effectiveness of the sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin in combination with standard chemotherapy for patients with advanced, inoperable pancreatic adenocarcinoma: a phase 1b observational study. Cancer Metab. 2023 May 18;11(1):6. doi: 10.1186/s40170-023-00306-2.

    PubMed 37202813

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dapagliflozin and BIOSENSE meters in people with Pancreas Cancer and Pancreatic Cancer, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04542291, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.

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