Trials / Withdrawn
WithdrawnNCT04083651
A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer
A Phase II/III Adaptive Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer
- Status
- Withdrawn
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Methylnaltrexone bromide | Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm. |
| DRUG | Placebo | Placebo matching to methylnaltrexone bromide will be administered as mentioned in the respective arm. |
Timeline
- Start date
- 2020-01-06
- Primary completion
- 2023-10-15
- Completion
- 2023-10-15
- First posted
- 2019-09-10
- Last updated
- 2021-05-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04083651. Inclusion in this directory is not an endorsement.