PRevention Using EPA Against coloREctal Cancer

NCT04216251 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 19-402
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma. \- The name of the study drug involved in this study is: \-- AMR101 (VASCEPA).

Conditions

Colorectal Adenoma; Colorectal Cancer; Endoscopic Surgery; Eicosapentaenoic Acid; Gastrointestinal Microbiome

Keywords

Colorectal Adenoma; Colorectal Cancer; colonoscopic Surgery; Endoscopic Surgery; Eicosapentaenoic acid; Gastrointestinal Microbiome; Mucosal Tissue

Outcome Measures

Primary Outcomes (1)

• Change in the Marine Omega-3 Polyunsaturated Fatty Acid (MO3PUFA) Composition in Colorectal Tissues as a Result of the AMR101 Treatment.

  Measured using the extraction of fatty acid with gas chromatography-mass spectrometry from the biopsy tissue.

  8-12 weeks

Secondary Outcomes (2)

• Change in the Gut Microbiome Composition

  8-12 weeks 8-12 weeks 8-12 weeks 8-12 weeks

• Change in Fecal Metabolite Levels (Butyrate)

  8-12 weeks

Study Arms (1)

AMR101

EXPERIMENTAL

Study procedures include screening for eligibility and study treatment including ARM101 Lifestyle questionnaire, Nutritional survey. Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample),blood, evaluations, and follow up visits. \- AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks

Drug: AMR101

Interventions

AMR101 DRUG

AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks

Also known as: VASCEPA

AMR101

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• Underwent screening or surveillance colonoscopy with removal of at least one adenoma;
• Age 18-80 years.
• This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults. Patients over age 80 will not be enrolled since the benefits and risks of AMR101 over the age of 80 have not yet been well-characterized.
• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
• The effects of AMR101 on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
• Subjects must be able and willing to follow study procedures and instructions.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study
• Currently using or have used any fish oil supplement at any dose more than once per week within the last month
• Regularly consuming more than three servings of fish per week.
• History of allergic reactions attributed to fish or compounds of similar chemical or biologic composition to omega-3 fatty acid.
• Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis
• Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of nonmelanoma skin) in which there has been any active treatment within the last three years.
• Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome).
• Any adenoma that was not completely removed during previous colonoscopy.
• Known bleeding tendency/condition (e.g. von Willebrand disease) or history of peptic ulcer or gastrointestinal bleed, endoscopic complications, or contraindication to colonoscopy.
• Current use of anticoagulant therapies, including Heparin, Warfarin, Dalteparin sodium,Bivalirudin, Argatroban, Lepirudin, Heparin Sodium, Heparin/Dextrose, and an unwillingness or inability to discontinue anticoagulants.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Inability or unwillingness to abstain from non-protocol use of fish oil supplements or to provide blood or stool samples or colon biopsies during the study.
• Participants who are receiving any other investigational agents.
• Inability or unwillingness to swallow pills.
• Pregnant or breastfeeding. The effects of AMR101 on the developing human fetus are unknown. For this reason,women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Similarly, lactating women are excluded from this study because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with AMR101. Consequently, breastfeeding should be discontinued if the mother is enrolled on the study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Andrew T. Chan, MD, MPH
• Organization: Massachusetts General Hspital

achan@partners.org

617-726-3212

Study Officials

• Mingyang Song, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 2, 2020
• Study Start: December 9, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 3, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)