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

Primary Purpose

Pancreatic Cancer

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Methylnaltrexone bromide (MNTX)
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MNTX 450 mg QD

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Overall Survival

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 2019
    Last Updated
    May 5, 2021
    Sponsor
    Bausch Health Americas, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04151719
    Brief Title
    An Extension Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer
    Official Title
    An Open-Label Extension Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to pandemic challenges and consideration of a different study design in the future.
    Study Start Date
    February 3, 2020 (Anticipated)
    Primary Completion Date
    February 3, 2024 (Anticipated)
    Study Completion Date
    February 3, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch Health Americas, Inc.

    4. Oversight

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

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MNTX 450 mg QD
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Methylnaltrexone bromide (MNTX)
    Other Intervention Name(s)
    Relistor®
    Intervention Description
    Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.
    Primary Outcome Measure Information:
    Title
    Overall Survival
    Time Frame
    From first MNTX dose administration until death from any cause (up to 4 years)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Lahey
    Organizational Affiliation
    Bausch Health Americas, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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