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Due to pandemic challenges and consideration of a different study design in the future.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylnaltrexone Bromide (MNTX) | Experimental | 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. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matching to MNTX until participant's death or early withdrawal from study or study completion at Day 168. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylnaltrexone bromide | Drug | Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From randomization until death from any cause (up to Day 168) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Lahey | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 001 | Omaha | Nebraska | 68118 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
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| Placebo | Drug | Placebo matching to methylnaltrexone bromide will be administered as mentioned in the respective arm. |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |