Pancreatic CancerPEGASUSNCT05132244
Monitoring and Managing Glucose Levels in People With Pancreatic Cancer
A study testing Glucose Measurements via Blood Draw in people with Pancreatic Cancer and PDAC - Pancreatic Ductal Adenocarcinoma, run by British Columbia Cancer Agency at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, PDAC - Pancreatic Ductal Adenocarcinoma, Hyperglycemia
- What is being tested?
- Glucose Measurements via Blood Draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 16 Apr 2024to Oct 2028
- Phase
- Interventional
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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Erica Tsang, MD, MPH, 416-946-2000, erica.tsang@uhn.ca
Robert Grant, MD, 416-946-2000, robert.grant@uhn.ca
- Recruiting
British Columbia Cancer
Vancouver, British Columbia, V5Z 4E6
Daniel Renouf, MD, MPH, 800-663-3333, drenouf@bccancer.bc.ca
Daniel Renouf, MD, MPH
About this study
Official title: 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.
- Being tested
- Glucose Measurements via Blood Draw
- Keywords
- Glycemic management, Prevalence of hyperglycemia, Blood draws, Standard treatments, First-line systemic therapy
- Medical subject headings
- Pancreatic Neoplasms, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose Measurements via Blood DrawProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Glucose Measurements via Blood Draws | Experimental | Participants will have glucose levels measured using blood drawn prior to each cycle of systemic therapy. Receives: Procedure: Glucose Measurements via Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who experience at least one episode of hyperglycemia
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%.
Measured: 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
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%.
Measured: From baseline (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months.
Secondary outcomes (3)
Overall response rate (ORR) of the cohort, as defined by RECIST 1.1
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.
Measured: 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
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.
Measured: 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
The length of time from the initiation of first-line systemic therapy that participants survive.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start16 Apr 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Lustgarten Foundation, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Daniel Renouf, MD, MPH, Principal investigator, BC Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132244
- Sponsor's protocol ID
- H21-03061
- Acronym
- PEGASUS
- Status last verified
- Sep 2026
- First submitted
- 10 Nov 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stott M, Stefanova I, Oldfield L, Evans A, Birch-Ford J, Rao R, Greenhalf W, Halloran C, Costello E. Prevalence of New-Onset Diabetes in Patients Undergoing Pancreatic Surgery and the Association of Glucose Dysregulation With Complications in Pancreatic Cancer. Ann Surg Open. 2025 Jun 11;6(2):e584. doi: 10.1097/AS9.0000000000000584. eCollection 2025 Jun.
PubMed 40557340Choe HJ, Han KD, Park JH, Lee J, Kwak MK, Choi YM, Moon SJ, Hong EG. Underweight and Mortality in Type 2 Diabetes: A Nationwide Retrospective Cohort Study. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70145. doi: 10.1002/jcsm.70145.
PubMed 41351230Becker S, Dossus L, Kaaks R. Obesity related hyperinsulinaemia and hyperglycaemia and cancer development. Arch Physiol Biochem. 2009 May;115(2):86-96. doi: 10.1080/13813450902878054.
PubMed 19485704Dawson DW, Hertzer K, Moro A, Donald G, Chang HH, Go VL, Pandol SJ, Lugea A, Gukovskaya AS, Li G, Hines OJ, Rozengurt E, Eibl G. High-fat, high-calorie diet promotes early pancreatic neoplasia in the conditional KrasG12D mouse model. Cancer Prev Res (Phila). 2013 Oct;6(10):1064-73. doi: 10.1158/1940-6207.CAPR-13-0065. Epub 2013 Aug 13.
PubMed 23943783Harris D, Barts A, Connors J, Dahl M, Elliott T, Kong J, Keane T, Thompson D, Stafford S, Ur E, Sirrs S. Glucocorticoid-induced hyperglycemia is prevalent and unpredictable for patients undergoing cancer therapy: an observational cohort study. Curr Oncol. 2013 Dec;20(6):e532-8. doi: 10.3747/co.20.1499.
PubMed 24311953Hart AR, Kennedy H, Harvey I. Pancreatic cancer: a review of the evidence on causation. Clin Gastroenterol Hepatol. 2008 Mar;6(3):275-82. doi: 10.1016/j.cgh.2007.12.041.
PubMed 18328435Hassan MM, Bondy ML, Wolff RA, Abbruzzese JL, Vauthey JN, Pisters PW, Evans DB, Khan R, Chou TH, Lenzi R, Jiao L, Li D. Risk factors for pancreatic cancer: case-control study. Am J Gastroenterol. 2007 Dec;102(12):2696-707. doi: 10.1111/j.1572-0241.2007.01510.x. Epub 2007 Aug 31.
PubMed 17764494Hjartaker A, Langseth H, Weiderpass E. Obesity and diabetes epidemics: cancer repercussions. Adv Exp Med Biol. 2008;630:72-93. doi: 10.1007/978-0-387-78818-0_6.
PubMed 18637486Huxley R, Ansary-Moghaddam A, Berrington de Gonzalez A, Barzi F, Woodward M. Type-II diabetes and pancreatic cancer: a meta-analysis of 36 studies. Br J Cancer. 2005 Jun 6;92(11):2076-83. doi: 10.1038/sj.bjc.6602619.
PubMed 15886696Karasinska JM, Topham JT, Kalloger SE, Jang GH, Denroche RE, Culibrk L, Williamson LM, Wong HL, Lee MKC, O'Kane GM, Moore RA, Mungall AJ, Moore MJ, Warren C, Metcalfe A, Notta F, Knox JJ, Gallinger S, Laskin J, Marra MA, Jones SJM, Renouf DJ, Schaeffer DF. Altered Gene Expression along the Glycolysis-Cholesterol Synthesis Axis Is Associated with Outcome in Pancreatic Cancer. Clin Cancer Res. 2020 Jan 1;26(1):135-146. doi: 10.1158/1078-0432.CCR-19-1543. Epub 2019 Sep 3.
PubMed 31481506Kawada K, Toda K, Sakai Y. Targeting metabolic reprogramming in KRAS-driven cancers. Int J Clin Oncol. 2017 Aug;22(4):651-659. doi: 10.1007/s10147-017-1156-4. Epub 2017 Jun 24.
PubMed 28647837Kenner BJ, Chari ST, Maitra A, Srivastava S, Cleeter DF, Go VL, Rothschild LJ, Goldberg AE. Early Detection of Pancreatic Cancer-a Defined Future Using Lessons From Other Cancers: A White Paper. Pancreas. 2016 Sep;45(8):1073-9. doi: 10.1097/MPA.0000000000000701.
PubMed 27518362Kleeff J, Costello E, Jackson R, Halloran C, Greenhalf W, Ghaneh P, Lamb RF, Lerch MM, Mayerle J, Palmer D, Cox T, Rawcliffe CL, Strobel O, Buchler MW, Neoptolemos JP. The impact of diabetes mellitus on survival following resection and adjuvant chemotherapy for pancreatic cancer. Br J Cancer. 2016 Sep 27;115(7):887-94. doi: 10.1038/bjc.2016.277. Epub 2016 Sep 1.
PubMed 27584663Koorstra JB, Hustinx SR, Offerhaus GJ, Maitra A. Pancreatic carcinogenesis. Pancreatology. 2008;8(2):110-25. doi: 10.1159/000123838. Epub 2008 Apr 1.
PubMed 18382097Kopp JL, von Figura G, Mayes E, Liu FF, Dubois CL, Morris JP 4th, Pan FC, Akiyama H, Wright CV, Jensen K, Hebrok M, Sander M. Identification of Sox9-dependent acinar-to-ductal reprogramming as the principal mechanism for initiation of pancreatic ductal adenocarcinoma. Cancer Cell. 2012 Dec 11;22(6):737-50. doi: 10.1016/j.ccr.2012.10.025. Epub 2012 Nov 29.
PubMed 23201164