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Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

Primary Purpose

Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pertzye
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Ductal Adenocarcinoma focused on measuring Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, Pancrelipase, Memorial Sloan Kettering Cancer Center, 21-419

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histopathologic or cytologic diagnosis of pancreatic adenocarcinoma, or adenosquamous cancer, or any non-neuroendocrine primary pancreas variant, including acinar cancer. De novo or recurrent diagnosis of previously untreated stage IV PDAC with intent to receive FOLFIRINOX/mFOLFIRINOX. ECOG 0-2. No use of pancreatic enzyme replacement therapy within prior 2 weeks. Patients with biliary obstruction are eligible provided biliary stenting has or will occur before treatment with FOLFIRINOX. Ability to understand and the willingness to sign an informed consent document. Ability to swallow capsules. Age ≥18 years. Anticipated life expectancy of at least 6 months. Exclusion Criteria: Chronic illness associated with malabsorption (celiac disease, cystic fibrosis, chronic pancreatitis, Crohn's disease). Fibrosing colonopathy. Prior history of surgical resection of the pancreas or gastric bypass. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pancrelipase. Patients cannot receive radiation, IRE, or other localized therapy directed to the pancreas while on study.

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 384 units lipase/kg of body weight per meal or snack

Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 1350 units lipase/kg of body weight per meal or snack

Outcomes

Primary Outcome Measures

Change in body mass index/BMI from baseline to 4 months
The primary objective is a change in body mass index (BMI) 4 months from baseline while on pancreatic enzyme replacement therapy (PERT).

Secondary Outcome Measures

Full Information

First Posted
November 30, 2022
Last Updated
June 29, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05642962
Brief Title
Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)
Official Title
A Randomized Double Blind Study of Pancreatic Enzyme Replacement Therapy for Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, Pancrelipase, Memorial Sloan Kettering Cancer Center, 21-419

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 384 units lipase/kg of body weight per meal or snack
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 1350 units lipase/kg of body weight per meal or snack
Intervention Type
Drug
Intervention Name(s)
Pertzye
Other Intervention Name(s)
Pancrelipase
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body mass index/BMI from baseline to 4 months
Description
The primary objective is a change in body mass index (BMI) 4 months from baseline while on pancreatic enzyme replacement therapy (PERT).
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histopathologic or cytologic diagnosis of pancreatic adenocarcinoma, or adenosquamous cancer, or any non-neuroendocrine primary pancreas variant, including acinar cancer. De novo or recurrent diagnosis of previously untreated stage IV PDAC with intent to receive FOLFIRINOX/mFOLFIRINOX. ECOG 0-2. No use of pancreatic enzyme replacement therapy within prior 2 weeks. Patients with biliary obstruction are eligible provided biliary stenting has or will occur before treatment with FOLFIRINOX. Ability to understand and the willingness to sign an informed consent document. Ability to swallow capsules. Age ≥18 years. Anticipated life expectancy of at least 6 months. Exclusion Criteria: Chronic illness associated with malabsorption (celiac disease, cystic fibrosis, chronic pancreatitis, Crohn's disease). Fibrosing colonopathy. Prior history of surgical resection of the pancreas or gastric bypass. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pancrelipase. Patients cannot receive radiation, IRE, or other localized therapy directed to the pancreas while on study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen O'Reilly, MD
Phone
646-888-4182
Email
oreillye@MSKCC.ORG
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Schattner, MD
Phone
212-639-3148
Email
schattnm@MSKCC.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen O'Reilly, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen O'Reilly, MD
Phone
646-888-4182
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen O'Reilly, MD
Phone
646-888-4182
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen O'Reilly, MD
Phone
646-888-4182
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen O'Reilly, MD
Phone
646-888-4182
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen O'Reilly, MD
Phone
646-888-4182
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen O'Reilly, MD
Phone
646-888-4182
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen O'Reilly, MD
Phone
646-888-4182

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

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