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

Pancreatic Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04083651
Study type Interventional
Source Bausch Health Americas, Inc.
Contact
Status Withdrawn
Phase Phase 2/Phase 3
Start date January 6, 2020
Completion date October 15, 2023
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