Spots Global Cancer Trial Database for A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer
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Trial Identification
Brief Title: A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer
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
Study ID: NCT04083651
Conditions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Bausch Site 001, Omaha, Nebraska, United States
Contact Details
Name: John Lahey
Affiliation: Bausch Health Americas, Inc.
Role: STUDY_DIRECTOR
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