A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer
Status:
Withdrawn
Trial end date:
2023-10-15
Target enrollment:
Participant gender:
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.