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.
Withdrawn
Phase 2/Phase 3
| Drug | Synonyms | Arms |
|---|---|---|
| Methylnaltrexone bromide | Relistor® | Methylnaltrexone Bromide (MNTX) |
| Placebo | Placebo |
| Name | Type | Description | Interventions |
|---|---|---|---|
| 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. |
|
Inclusion Criteria:
- Unresectable adenocarcinoma of the pancreas (other surgery on non-target lesion or
unrelated to management of pancreatic adenocarcinoma is not excluded).
- Measurable disease on computed tomography (CT) scan by Response Evaluation Criteria in
Solid Tumors (RECIST) 1.1.
- Refused standard chemotherapy, or failed at least one standard of care chemotherapy
regimen for pancreatic cancer and refused additional chemotherapy.
- Must be on stable dose of opioids within 2 weeks prior to randomization.
- At least 18 years of age on the date the Informed Consent Form (ICF) is signed and
with the capacity to provide voluntary informed consent.
- Must be able to read, understand and provide written informed consent on the
Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide
authorization as appropriate for local privacy regulations.
- Had no radiotherapy, chemotherapy, or immunotherapy within the 14 days prior to
randomization.
- Has no continuing toxicity or potential of delayed toxicity from any prior
antineoplastic therapy that can be reasonably anticipated, in the opinion of the
principal investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.
- Life expectancy of at least 3 months from date of informed consent.
- Baseline laboratory results as follows: Absolute neutrophil count (ANC) greater than
or equal to (≥) 1.0 * 10^9/liter; Platelets ≥50 * 10^9/liter (without platelet
transfusion); Bilirubin less than or equal to (≤) 1.5 * upper limit of normal (ULN);
Aspartate aminotransferase (AST) ≤5 * ULN; Alanine aminotransferase (ALT) ≤5 * ULN;
Negative serum or urine pregnancy test for females of childbearing potential
(premenopausal female capable of becoming pregnant).
- Signed an informed consent/Health Insurance Portability and Accountability Act (HIPAA)
form.
- Willing and able to comply with scheduled visits, the treatment plan, and laboratory
tests.
Exclusion Criteria:
- Concurrent therapy with any other investigational or non-investigational anticancer
agent within 14 days of the baseline visit.
- Radiation therapy except for palliative care on a non-target lesion.
- Current use of a peripherally Acting mu-opioid receptor antagonist.
- Be a pregnant or breast-feeding woman.
- Female participants of childbearing potential must agree to use effective
contraception method, except if she is of non-childbearing potential, defined as
surgically sterile (that is; has undergone complete hysterectomy, bilateral
oophorectomy, or tubal ligation at least 3 months earlier) or in a menopausal state
(at least 1 year without menses). Male participants must agree to use effective
contraception or be surgically sterile (vasectomized for greater than 6 months).
- Have dementia or altered mental status that would prohibit informed consent.
- Diarrhea ≥Grade 1 (Common Terminology Criteria Version 5.0 [CTC V5.0]).
- Bowel obstruction.
- Moderate or severe hepatic impairment (for example; Child-Pugh Class B or C).
- Moderate or severe renal impairment (that is; creatinine clearance less than 60
milliliters/minute as estimated by Cockcroft Gault)
- Have any other unstable medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or study drug
administration or may interfere with the interpretation of study results and, in the
judgment of the Principal Investigator, would make the participant inappropriate for
the study.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Overall Survival |
| Time Frame: | From randomization until death from any cause (up to Day 168) |
| Safety Issue: | |
| Description: |
| Phase: | Phase 2/Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Withdrawn |
| Lead Sponsor: | Bausch Health Americas, Inc. |
May 7, 2021
