An Extension Study Of Methylnaltrexone Bromide (MNTX) In Participants With Advanced Pancreatic Cancer

Study Overview

An Extension Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer

This open-label extension study will evaluate the long-term safety and efficacy of oral MNTX in participants with advanced pancreatic cancer (adenocarcinoma) who were previously enrolled in Study SAL-REL-2042 (NCT04083651).

N/A

Pancreatic Cancer

DRUG: Methylnaltrexone bromide (MNTX)

SAL-REL-2043

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-11-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-05-05
First Submitted that Met QC Criteria 2019-11-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-05-07
First Posted (ACTUAL) 2019-11-05	Results First Posted N/A	Last Verified 2021-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: MNTX 450 mg QD Participants will receive methylnaltrexone bromide (MNTX) 450 milligrams (mg) (3 tablets of 150 mg each) once daily (QD) orally. Treatment will continue until participant's death or early withdrawal from the study or study termination by the sponsor.	DRUG: Methylnaltrexone bromide (MNTX) Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: MNTX 450 mg QD

Participants will receive methylnaltrexone bromide (MNTX) 450 milligrams (mg) (3 tablets of 150 mg each) once daily (QD) orally. Treatment will continue until participant's death or early withdrawal from the study or study termination by the sponsor.

DRUG: Methylnaltrexone bromide (MNTX)

Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival		From first MNTX dose administration until death from any cause (up to 4 years)

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Adult participants greater than or equal to (≥)18 years of age on the date the Informed Consent Form (ICF) is signed, with the capacity to provide voluntary informed consent.
Enrolled in double-blind Study SAL-REL-2042 (NCT04083651) and completed an end of study (EOS) visit (Day 168) or completed Day 56 of the Study SAL-REL-2042 (NCT04083651).
Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)-approved ICF and provide authorization, as appropriate, for local privacy regulations.
Willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.
Signed an informed consent/Health Insurance Portability and Accountability Act (HIPAA) form.

Concurrent therapy with any other investigational agent during the study.
Current use of a peripherally acting mu-opioid-receptor antagonist.
Current evidence of untreated brain metastasis(es).
Diarrhea greater than Grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
Bowel obstruction.
Advanced liver disease.
Renal disease.
Any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Principal Investigator, would make the participant inappropriate for the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: John Lahey, Bausch Health Americas, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record