Trial Outcomes & Findings for Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency (NCT NCT04098237)

NCT ID: NCT04098237

Last Updated: 2026-01-23

Results Overview

Adherence to therapy of at least 50% of the needed total lipase units, recorded using a daily compliance diary.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2026-01-23

Participant Flow

Participant milestones

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Overall Study STARTED	36
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency

Baseline characteristics by cohort

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Age, Categorical <=18 years	0 Participants n=270 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=270 Participants
Age, Categorical >=65 years	21 Participants n=270 Participants
Age, Continuous	70 years n=270 Participants
Sex: Female, Male Female	22 Participants n=270 Participants
Sex: Female, Male Male	8 Participants n=270 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=270 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=270 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants
Race (NIH/OMB) Asian	10 Participants n=270 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants
Race (NIH/OMB) Black or African American	3 Participants n=270 Participants
Race (NIH/OMB) White	15 Participants n=270 Participants
Race (NIH/OMB) More than one race	2 Participants n=270 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants
Region of Enrollment United States	30 participants n=270 Participants

PRIMARY outcome

Timeframe: 8 weeks

Adherence to therapy of at least 50% of the needed total lipase units, recorded using a daily compliance diary.

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Feasibility of Completing Pancreatic Enzyme Replacement Therapy During the First 8 Weeks of the Study: Daily Compliance Diary	29 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=29 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Weight From Baseline Through the End-of-study Visit	-2.1931 lbs Standard Deviation 6.163831

SECONDARY outcome

Timeframe: 6 months

As measured by Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. The ASA24 is a system to collect 24-hour food recalls and provide complete nutrient analysis of the foods and beverages consumed during the collection timeframe. The tool is used in this study to measure total calories consumed.

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=27 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Calories Consumed From Baseline Through the End-of-study Visit	-169.2075 calories Standard Deviation 969.6394

SECONDARY outcome

Timeframe: 8 weeks

As measured by patient reported number of bowel movements in the past 24 hours. In this study, higher numbers represent more severe symptoms; a reduction in number of bowel movements in the past 24 hours represents improvement in symptoms.

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=27 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Stool Frequency From Baseline Through Cycle 3 Day 1	-0.96296 bowel movements/day Standard Deviation 2.457038

SECONDARY outcome

Timeframe: 8 weeks

As measured by patient reported stool consistency using the Bristol Stool Chart.The Bristol Stool Chart is a diagnostic scale to classify stool into 7 different groups, ranging from Type 1-7 (indicating solid to liquid consistency or time spent longest in the bowel to least time in the bowel). A normal stool should be either Type 3 or Type 4 (middle of the scale). Worsening of stool consistency is denoted by classifications located closer to the extreme ends of the scale (Type 1 or Type 7).

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=27 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Stool Consistency From Baseline Through Cycle 3 Day 1	-0.407407 units on Bristol Stool Form Scale Standard Deviation 1.906654

SECONDARY outcome

Timeframe: 6 months

Population: Some patients were missing vitamin values.

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin A	-0.5 mcg/dL Standard Deviation 14.70231

SECONDARY outcome

Timeframe: 6 months

Population: Some patients were missing vitamin values

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=21 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin D	-5.37619 ng/mL Standard Deviation 12.44841

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=20 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin E	0.495 mg/L Standard Deviation 3.988863

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=17 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K	-27.47059 pg/mL Standard Deviation 676.6716

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=21 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K PT	-0.2190476 pg/mL Standard Deviation 2.82889

SECONDARY outcome

Timeframe: 8 weeks

Microbiome analysis of stool samples

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

As measured by continuous daily wearable activity monitor

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Daily Activity (Steps Taken) From Baseline	-0.3 steps/day Standard Error 3.8

SECONDARY outcome

Timeframe: 6 months

As measured by continuous daily wearable activity monitor

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Daily Activity (Stairs Climbed) From Baseline	1332.6 stair steps/day Standard Error 539.4

SECONDARY outcome

Timeframe: 6 months

As measured by continuous daily wearable activity monitor

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Sleep Disturbance From Baseline	0.5 hours/night Standard Error 0.83

SECONDARY outcome

Timeframe: 6 months

As measured by continuous daily wearable activity monitor. An absolute change in the percentage of time during nighttime sleep in which participants experienced sleep disturbance is being reported.An absolute change in percent is understood to be calculated as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline).

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Duration of Sleep Disturbances From Baseline	4.43 % of nighttime sleep Standard Error 1.3

SECONDARY outcome

Timeframe: 6 months

As measured by continuous daily wearable activity monitor

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Average Heart Rate From Baseline	0.8 beats per minute Standard Error 2.6

SECONDARY outcome

Timeframe: 6 months

As measured by continuous daily wearable activity monitor

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Peak Heart Rate From Baseline	9.6 BPM Standard Error 5.4

SECONDARY outcome

Timeframe: 6 months

As measured by continuous daily wearable activity monitor

Outcome measures

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 Participants Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Mean Change in Daily Active Minutes From Baseline	3.0 minutes/day Standard Error 6.7

Adverse Events

Standard of Care Treatment With Pancreaze (Pancrelipase)

Serious events: 12 serious events

Other events: 7 other events

Deaths: 21 deaths

Serious adverse events

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 participants at risk Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
General disorders Ascites	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Cardiac disorders Atrial Fibrillation	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Infections and infestations Biliary Tract Infection	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Investigations Blood Bilirubin Increased	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Infections and infestations Colotis	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Gastrointestinal disorders Constipation	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Infections and infestations Enterocolitis Infectious	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Gastrointestinal disorders Gastrointestinal disorders - Other	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Infections and infestations Hepatic Infection	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Hepatobiliary disorders Hepatic Infection	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Infections and infestations Lung Infection	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
General disorders Other	6.7% 2/30 • Number of events 2 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Gastrointestinal disorders Pancreatitis	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Hepatobiliary disorders Portal Vein Thrombosis	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Infections and infestations Sepsis	3.3% 1/30 • Number of events 2 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
General disorders Sepsis	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Infections and infestations Skin Infection	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Infections and infestations Urinary Tract Infections	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Renal and urinary disorders Urinary Tract Obstruction	3.3% 1/30 • Number of events 1 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
Gastrointestinal disorders Visceral Arterial Ischemia	3.3% 1/30 • Number of events 2 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.

Other adverse events

Measure	Standard of Care Treatment With Pancreaze (Pancrelipase) n=30 participants at risk Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks Pancrelipase: Pancrelipase delayed-release capsules
Gastrointestinal disorders Abnominal Pain	16.7% 5/30 • Number of events 5 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.
General disorders Fatigue	6.7% 2/30 • Number of events 2 • 6 months The investigator or designee is responsible for ensuring that adverse events (both serious and non-serious) observed by the clinical team or reported by the subject which occur after the subject has initiated treatment and until the 30-day end-of-study visit, are fully recorded in the subject's medical records Adverse events will be assessed from time of treatment initiation for the duration of the study treatment period until the end-of-study visit.

Additional Information

Dr. Andrew Hendifar, MD

Cedars-Sinai Medical Center

Phone: 310-423-2217

Email: andrew.hendifar@cshs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place