Monitoring and Managing Glucose Levels in People With Pancreatic Cancer (PEGASUS)

September 10, 2026 updated by: British Columbia Cancer Agency

Pancreatic Cancer Glucose Assessment and Regulation Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • British Columbia Cancer
        • Principal Investigator:
          • Daniel Renouf, MD, MPH
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

    1. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L.
    2. Platelet count greater than or equal to 75 x 10^9/L.
    3. Hemoglobin greater than or equal to 9.0 g/dL.
    4. Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min.
    5. Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gault formula.
    6. Potassium within normal limits, or corrected with supplements.
    7. International normalized ratio (INR) less than or equal to 1.5.
    8. 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).
    9. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glucose Measurements via Blood Draws
Participants will have glucose levels measured using blood drawn prior to each cycle of systemic therapy.
Procedure: Glucose Measurements via Blood Draw
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
From baseline (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months.
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%.
From baseline (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, assessed up to 24 months.
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.
From the date of first dose of first-line systemic therapy until the date of confirmed progression, assessed up to 24 months.
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.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, assessed up to 24 months.
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.
From the date of first dose of first-line systemic therapy until the date of confirmed progression, assessed up to 24 months.
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.
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.
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.
From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, assessed up to 24 months.
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.
From the date of first dose of first-line systemic therapy until the date of confirmed progression, assessed up to 24 months.
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.
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.
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.
From the date of screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).
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.
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).
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.
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).
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

University Health Network, Toronto
University of British Columbia
Lustgarten Foundation

Investigators

  • Principal Investigator: Daniel Renouf, MD, MPH, BC Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21-03061

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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