A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04083651|
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : January 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Methylnaltrexone bromide Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Estimated Study Start Date :||January 6, 2020|
|Estimated Primary Completion Date :||October 15, 2023|
|Estimated Study Completion Date :||October 15, 2023|
Experimental: Methylnaltrexone Bromide (MNTX)
Participants will receive methylnaltrexone bromide (MNTX) 450 mg (3 tablets of 150 mg each) QD orally. If the initial interim analysis suggests a lack of efficacy, subsequent participants will receive 450 mg MNTX twice daily (BID) or three times daily (TID). Treatment will continue until participant's death or early withdrawal from study or study completion at Day 168.
Drug: Methylnaltrexone bromide
Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.
Other Name: Relistor®
Placebo Comparator: Placebo
Participants will receive placebo matching to MNTX until participant's death or early withdrawal from study or study completion at Day 168.
Placebo matching to methylnaltrexone bromide will be administered as mentioned in the respective arm.
- Overall Survival [ Time Frame: From randomization until death from any cause (up to Day 168) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083651
|Contact: Clinical Trial Manager||908-541-8615||Stephen.Rodgers@bauschhealth.com|
|Contact: Susan Harris||Susan.Harris@bauschhealth.com|
|United States, Nebraska|
|Bausch Site 001||Recruiting|
|Omaha, Nebraska, United States, 68118|
|Study Director:||John Lahey||Bausch Health Americas, Inc.|