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

May 5, 2021 updated by: Bausch Health Americas, Inc.

A Phase II/III Adaptive Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer

This is an adaptive design study. During the first phase of the study, participants will be randomized in 2:1 ratio to receive either MNTX 450 milligrams (mg) once daily (QD) or placebo. An interim analysis will be performed for futility and at that point a higher dosage regimen may be utilized for the active treatment group if the futility criteria are met. For the second stage of the study, interim analyses will be conducted for futility and sample size reassessment.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68118
        • Bausch Site 001

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unresectable adenocarcinoma of the pancreas (other surgery on non-target lesion or unrelated to management of pancreatic adenocarcinoma is not excluded).
  • Measurable disease on computed tomography (CT) scan by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Refused standard chemotherapy, or failed at least one standard of care chemotherapy regimen for pancreatic cancer and refused additional chemotherapy.
  • Must be on stable dose of opioids within 2 weeks prior to randomization.
  • At least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
  • Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
  • Had no radiotherapy, chemotherapy, or immunotherapy within the 14 days prior to randomization.
  • Has no continuing toxicity or potential of delayed toxicity from any prior antineoplastic therapy that can be reasonably anticipated, in the opinion of the principal investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.
  • Life expectancy of at least 3 months from date of informed consent.
  • Baseline laboratory results as follows: Absolute neutrophil count (ANC) greater than or equal to (≥) 1.0 * 10^9/liter; Platelets ≥50 * 10^9/liter (without platelet transfusion); Bilirubin less than or equal to (≤) 1.5 * upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤5 * ULN; Alanine aminotransferase (ALT) ≤5 * ULN; Negative serum or urine pregnancy test for females of childbearing potential (premenopausal female capable of becoming pregnant).
  • Signed an informed consent/Health Insurance Portability and Accountability Act (HIPAA) form.
  • Willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.

Exclusion Criteria:

  • Concurrent therapy with any other investigational or non-investigational anticancer agent within 14 days of the baseline visit.
  • Radiation therapy except for palliative care on a non-target lesion.
  • Current use of a peripherally Acting mu-opioid receptor antagonist.
  • Be a pregnant or breast-feeding woman.
  • Female participants of childbearing potential must agree to use effective contraception method, except if she is of non-childbearing potential, defined as surgically sterile (that is; has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation at least 3 months earlier) or in a menopausal state (at least 1 year without menses). Male participants must agree to use effective contraception or be surgically sterile (vasectomized for greater than 6 months).
  • Have dementia or altered mental status that would prohibit informed consent.
  • Diarrhea ≥Grade 1 (Common Terminology Criteria Version 5.0 [CTC V5.0]).
  • Bowel obstruction.
  • Moderate or severe hepatic impairment (for example; Child-Pugh Class B or C).
  • Moderate or severe renal impairment (that is; creatinine clearance less than 60 milliliters/minute as estimated by Cockcroft Gault)
  • Have any other unstable 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylnaltrexone Bromide (MNTX)
Participants will receive methylnaltrexone bromide (MNTX) 450 mg (3 tablets of 150 mg each) QD orally. If the initial interim analysis suggests a lack of efficacy, subsequent participants will receive 450 mg MNTX twice daily (BID) or three times daily (TID). Treatment will continue until participant's death or early withdrawal from study or study completion at Day 168.
Drug: Methylnaltrexone bromide
Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.
Other Names:
  • Relistor®
Placebo Comparator: Placebo
Participants will receive placebo matching to MNTX until participant's death or early withdrawal from study or study completion at Day 168.
Drug: Placebo
Placebo matching to methylnaltrexone bromide will be administered as mentioned in the respective arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From randomization until death from any cause (up to Day 168)
From randomization until death from any cause (up to Day 168)

Collaborators and Investigators

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

Sponsor

Bausch Health Americas, Inc.

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 Major Dates

Study Start (Anticipated)

January 6, 2020

Primary Completion (Anticipated)

October 15, 2023

Study Completion (Anticipated)

October 15, 2023

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAL-REL-2042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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