Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma

NCT03469258 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 17-450
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating a study drug to treat pancreatic exocrine insufficiency (PEI) during the first year after the diagnosis of pancreatic cancer while the participant is recovering from surgery and receiving adjuvant treatment. The study drug involved in this study is:

• Zenpep

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Effect of Pancreatic Enzyme Replacement Therapy on the Completion Rate of Adjuvant Chemotherapy and Radiation After Surgery for Early Stage Pancreatic Cancer

  Completion, or not, of all doses of chemotherapy and fractions of radiation prescribed by the treating oncologist prior to the start of adjuvant treatment

  40 weeks

Secondary Outcomes (8)

• Initiation Rate of Adjuvant Treatment for Resected Pancreatic Cancer

  84 days after surgery

• Subject Adherence to Pancreatic Enzyme Replacement Therapy as Determined by Pill Count

  52 weeks

• Subject Adherence to Pancreatic Enzyme Replacement Therapy During Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer

  52 weeks

• Measure Serum Albumin Levels Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer

  52 weeks

• Measure Body Weight Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer

  52 weeks

Study Arms (1)

Zenpep

EXPERIMENTAL

* Pancrelipase (Zenpep) will be administered with every meal (breakfast, lunch, dinner) and snack(s), continuously. * Participants will begin pancrelipase on the day of enrollment and continue therapy until 1 year after surgery per calendar date

Drug: Pancrelipase

Interventions

Pancrelipase DRUG

Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer.

Also known as: Zenpep

Zenpep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically or cytologically confirmed pancreatic ductal adenocarcinoma. Variants or mixed histology will be included if the predominant histology is adenocarcinoma.
• Participants must have potentially resectable pancreatic cancer defined as: (1) no detectable metastases (2) signed consent for attempted resection of pancreatic cancer per treating surgeon.
• ECOG performance status ≤2.
• Age \>18 years. Participants \<18 years old are excluded from this study because subsequent adjuvant therapy is based on therapy guidelines in the adult population.
• Willingness to consider adjuvant therapy following surgical resection of disease, signed in the consent form attestation.
• Ability to understand and willingness to provide written informed consent.
• Pre-operative laboratory values adequate to undergo resection of pancreatic cancer, as defined below:
• Hemoglobin \> 7.0 g/dL;
• Platelets ≥ 40,000/mL;
• Creatinine \< 2.5 mg/dL or; Creatinine clearance ≥ 20 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.

You may not qualify if:

• Pancreatic resection not performed. Intraoperative findings and unforeseen medical exigent circumstances may preclude pancreatic resection. Such outcomes include undetected metastases or vascular involvement, which preclude resection with intent to cure, as well as perioperative medical events including cardiopulmonary complications.
• Final pathology other than pancreatic ductal adenocarcinoma or primary component other than adenocarcinoma.
• Any prior chemotherapy and/or radiation for pancreatic cancer at the time of study enrollment, including neoadjuvant chemotherapy and/or radiation therapy.
• Second malignancy with active disease.
• History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to pancrelipase
• Pregnant women are excluded from this study because subsequent adjuvant therapy needed for the primary endpoint is teratogenic. Pancrelipase is category C. Animal reproduction studies have not been conducted on pancrelipase and minimal data is available.
• Participants unable to self-administer pancrelipase.
• Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Participants who are receiving any other investigational agents.
• Participant unable to tolerate oral nutrition.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Allergan: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Limitations and Caveats

Early termination per sponsor leading to small numbers of subjects enrolled. Those subjects who were enrolled did not meet pathologic criteria to remain on study and would have been replaced had the study continued.

Results Point of Contact

• Title: A. James Moser, MD
• Organization: Beth Israel Deaconess Medical Center

ajmoser@bidmc.harvard.edu

(617) 632-1032

Study Officials

• Arthur James Moser, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: March 19, 2018
• Study Start: April 13, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: August 3, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)