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

NCT04151719 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: SAL-REL-2043
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From first MNTX dose administration until death from any cause (up to 4 years)

Study Arms (1)

MNTX 450 mg QD

EXPERIMENTAL

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)

Interventions

Methylnaltrexone bromide (MNTX) DRUG

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

Also known as: Relistor®

MNTX 450 mg QD

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

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

Study Officials

• John Lahey

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: February 3, 2020
• Primary Completion: February 3, 2024
• Study Completion: February 3, 2024
• Last Updated: May 7, 2021

Record last verified: 2021-05