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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083651
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Methylnaltrexone bromide Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II/III Adaptive Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer
Estimated Study Start Date : January 6, 2020
Estimated Primary Completion Date : October 15, 2023
Estimated Study Completion Date : October 15, 2023

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization until death from any cause (up to Day 168) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083651


Contacts
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Contact: Clinical Trial Manager 908-541-8615 Stephen.Rodgers@bauschhealth.com
Contact: Susan Harris Susan.Harris@bauschhealth.com

Locations
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United States, Nebraska
Bausch Site 001 Recruiting
Omaha, Nebraska, United States, 68118
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: John Lahey Bausch Health Americas, Inc.
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT04083651    
Other Study ID Numbers: SAL-REL-2042
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Bromides
Methylnaltrexone
Anticonvulsants
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents