Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

ConditionsPancreatic Cancer PDAC - Pancreatic Ductal Adenocarcinoma Hyperglycemia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBritish Columbia Cancer Agency

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Glucose Measurements via Blood Draw
Procedure/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.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Glucose Measurements via Blood DrawsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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%.

Time frame

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%.

Time frame

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

Secondary outcomes

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.

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.

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.

Time frame

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.

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.

Other outcomes

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

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.

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.

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

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.

Time frame

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

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.

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.

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

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.

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.