Ignite Creation Date:
2024-05-06 @ 1:38 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04083651
Status:
WITHDRAWN
Last Update Posted:
2021-05-07
First Post:
2019-09-06
Brief Title:
A Study of Methylnaltrexone Bromide MNTX in Participants With Advanced Pancreatic Cancer
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
A Phase IIIII Adaptive Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer
Status:
WITHDRAWN
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to pandemic challenges and consideration of a different study design in the future
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an adaptive design study During the first phase of the study participants will be randomized in 21 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None