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NCT Number: NCT05132244

Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

This study will investigate the prevalence of hyperglycemia (high blood sugar) in approximately 50 participants with pancreatic cancer. Sugar levels will be monitored with blood draws prior to each cycle of anti-cancer treatment until treatment ends or the participant's cancer worsens. Participants may receive any first-line systemic therapy for pancreatic cancer, including treatments given as part of another clinical trial. If treatment is needed to manage blood sugar levels, the treatment will be given according to the standard of care. All participants will be enrolled into the same group.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Cancer, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).
  • Planned to undergo first-line systemic therapy.
  • Age greater than or equal to 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Adequate bone marrow and organ function as defined by the following laboratory values:
  • Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L.
  • Platelet count greater than or equal to 75 x 10^9/L.
  • Hemoglobin greater than or equal to 9.0 g/dL.
  • Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min.
  • Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gault formula.
  • Potassium within normal limits, or corrected with supplements.
  • International normalized ratio (INR) less than or equal to 1.5.
  • Total serum bilirubin less than or equal to 2 x upper limit of normal (ULN) (any elevated bilirubin should be asymptomatic at enrollment) except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin less than or equal to 3 x ULN or direct bilirubin less than or equal to 1.5 x ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (or less than or equal to 5 x ULN if liver metastases are present).
  • Able to understand and voluntarily sign the informed consent form.
  • Able to comply with the study visit schedule and other protocol requirements.
  • Able to swallow oral medications.
  • Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at baseline.
  • Life expectancy of more than 90 days as judged by the study doctor.

Exclusion criteria

  • Absence of distant or lymph node metastases. Participants with borderline resectable or locally advanced PDAC are not eligible.
  • Received prior systemic therapy (chemotherapy or any other anti-cancer agent) for treatment of metastatic PDAC. Participants who received adjuvant chemotherapy after surgical resection of early stage disease are eligible.
  • Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent).
  • Presence of brain metastases.
  • Known diagnosis of type I diabetes where strict glucose control and close Endocrinology follow-up is already indicated.
  • Known diagnosis of type II diabetes and already followed by Endocrinologist.
  • Participants with a positive pregnancy test.
  • Participants who are not safe to include in the study as judged by the study doctor for any medical or non-medical reason.
  • Unable to comply with study assessments and follow-up.

Treatment and study plan

Glucose Measurements via Blood Draw

Procedure

Blood glucose levels will be measured using blood drawn prior to each cycle of systemic therapy. Anti-cancer treatment can follow standard care protocols or be given within another clinical trial. Anti-hyperglycemic treatment will be administered when indicated by and following standard care protocols.

Primary outcomes

  1. Proportion of participants who experience at least one episode of hyperglycemia

    Time frame: From baseline (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months.

    The proportion of participants who experience at least one episode of hyperglycemia. Hyperglycemia is defined by standard non-fasting criteria: random plasma glucose greater than or equal to 11.1 mmol/L or hemoglobin A1c greater than or equal to 6.5%.

  2. Percentage of glucose measurements above the target range

    Time frame: From baseline (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months.

    The percentage of random plasma glucose measurements that are greater than or equal to 11.1 mmol/L or hemoglobin A1c measurements that are greater than or equal to 6.5%.

Secondary outcomes

  1. Overall response rate (ORR) of the cohort, as defined by RECIST 1.1

    Time frame: From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, assessed up to 24 months.

    The proportion of participants who have a complete response (CR) or partial response (PR) to first-line systemic therapy, as defined by RECIST 1.1.

  2. Progression-free survival (PFS) of the cohort from the initiation of first-line systemic therapy

    Time frame: From the date of first dose of first-line systemic therapy until the date of confirmed progression, assessed up to 24 months.

    The length of time from the first dose of first-line systemic therapy until the date of progressive disease (PD), as defined by RECIST 1.1.

  3. Overall survival (OS) of the cohort from the initiation of first-line systemic therapy

    Time frame: From the date of first dose of first-line systemic therapy until the date of death or end of study, assessed up to 24 months.

    The length of time from the initiation of first-line systemic therapy that participants survive.

Other outcomes

  1. Overall response rate (ORR) of the cohort, as defined by RECIST 1.1 and stratified by prognostic and metabolic gene expression subtypes of PDAC

    Time frame: From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, assessed up to 24 months.

    The proportion of participants stratified by prognostic and metabolic gene expression subtypes of PDAC who have a complete response (CR) or partial response (PR) to first-line systemic therapy, as defined by RECIST 1.1.

  2. Progression-free survival (PFS) of the cohort stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of first-line systemic therapy

    Time frame: From the date of first dose of first-line systemic therapy until the date of confirmed progression, assessed up to 24 months.

    The length of time from the first dose of first-line systemic therapy until the date of progressive disease (PD), as defined by RECIST 1.1, for participants stratified by prognostic and metabolic gene expression subtypes of PDAC.

  3. Overall survival (OS) of the cohort stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of first-line systemic therapy

    Time frame: From the date of first dose of first-line systemic therapy until the date of death or end of study, assessed up to 24 months.

    The length of time from the initiation of first-line systemic therapy that participants survive stratified by prognostic and metabolic gene expression subtypes of PDAC.

  4. Overall response rate (ORR) of the cohort, as defined by RECIST 1.1 and stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles

    Time frame: From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, assessed up to 24 months.

    The proportion of participants stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles who have a complete response (CR) or partial response (PR) to first-line systemic therapy, as defined by RECIST 1.1.

  5. Progression-free survival (PFS) of the cohort, stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles from the initiation of first-line systemic therapy

    Time frame: From the date of first dose of first-line systemic therapy until the date of confirmed progression, assessed up to 24 months.

    The length of time from the first dose of first-line systemic therapy until the date of progressive disease (PD), as defined by RECIST 1.1, for participants stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles.

  6. Overall survival (OS) of the cohort stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles from the initiation of first-line systemic therapy

    Time frame: From the date of first dose of first-line systemic therapy until the date of death or end of study, assessed up to 24 months.

    The length of time from the initiation of first-line systemic therapy that participants survive stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles.

  7. Amount of insulin, measured in molar, for participants from screening until the end of study visit

    Time frame: From the date of screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

    The quantity of insulin, measured in molar from immunoassays, from blood samples collected throughout the study.

  8. Amount of proinsulin, measured in molar, for participants from screening until the end of study visit

    Time frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

    The quantity of proinsulin, measured in molar from immunoassays, from blood samples collected throughout the study.

  9. Amount of C-peptide, measured in molar, for participants from screening until the end of study visit

    Time frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

    The quantity of C-peptide, measured in molar from immunoassays, from blood samples collected throughout the study.

  10. Amount of circulating biomarkers, measured in molar, for participants from screening until the end of study visit

    Time frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

    The quantity of circulating biomarkers, measured in molar from immunoassays, from blood samples collected throughout the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Renouf, MD, MPH

CONTACT

[email protected]

800-663-3333

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • Lustgarten Foundation
  • University Health Network, Toronto
  • University of British Columbia

Registry information

Official study title

Pancreatic Cancer Glucose Assessment and Regulation Study

Acronym: PEGASUS

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 24, 2021
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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