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

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.

Timeline

Start

2020-01-06

Primary completion

2023-10-15

Completion

2023-10-15

Drugs

Indications