Trials / Active Not Recruiting
Active Not RecruitingNCT05642962
Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)
A Randomized Double Blind Study of Pancreatic Enzyme Replacement Therapy for Patients With Metastatic Pancreatic Ductal Adenocarcinoma
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to see how pancrelipase affects the body mass index (BMI) in people with metastatic PDAC. BMI is a measure based on a person's height and weight. Other study goals are to explore two different dosing schedules of pancrelipase and to evaluate pancrelipase in people who do not have symptoms of EPI.
Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma
- Metastatic Pancreatic Cancer
- Metastatic Pancreatic Adenocarcinoma
- Metastatic Pancreatic Carcinoma
- Pancreatic Carcinoma
- Pancreatic Carcinoma Metastatic
- Pancreatic Carcinoma Non-resectable
- Pancreatic Cancer
- Pancreatic Cancer Non-resectable
- Pancreatic Cancer Stage IV
- Pancreatic Cancer Metastatic
- PDAC
- PDAC - Pancreatic Ductal Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pertzye | Treatment with standard dose or higher dose Pancrelipase will continue for 20 weeks from enrollment. Participants will consume assigned blinded weight based Pancrelipase dose concurrent with first bite of every meal and snack for the duration of enrollment. |
Timeline
- Start date
- 2022-11-30
- Primary completion
- 2026-11-30
- Completion
- 2026-11-30
- First posted
- 2022-12-08
- Last updated
- 2026-02-25
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05642962. Inclusion in this directory is not an endorsement.