Pancreatic CancerPhase 2/3NCT04083651
A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer
A Phase 2/3 study testing Methylnaltrexone bromide in people with Pancreatic Cancer, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Methylnaltrexone bromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 15 Oct 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Pancreatic Cancer
- Being tested
- Methylnaltrexone bromide, Placebo
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylnaltrexone bromideDrug
Also called Relistor®
Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.
PlaceboDrug
Placebo matching to methylnaltrexone bromide will be administered as mentioned in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Methylnaltrexone bromide |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From randomization until death from any cause (up to Day 168)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start6 Jan 2020 (estimated)
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Why it stopped: Due to pandemic challenges and consideration of a different study design in the future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Lahey, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083651
- Sponsor's protocol ID
- SAL-REL-2042
- Status last verified
- May 2021
- First submitted
- 6 Sep 2019
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04083651
- Acronym / sponsor ID
- SAL-REL-2042
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to pandemic challenges and consideration of a different study design in the future.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (estimated)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylnaltrexone Bromide (MNTX) | Experimental | Drug: Methylnaltrexone bromideParticipants 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 | Drug: PlaceboParticipants will receive placebo matching to MNTX until participant's death or early withdrawal from study or study completion at Day 168. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylnaltrexone bromideAlso: Relistor®Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm. | Drug | Methylnaltrexone Bromide (MNTX) |
| PlaceboPlacebo matching to methylnaltrexone bromide will be administered as mentioned in the respective arm. | Drug | Placebo |
Primary outcome
Overall Survival
Time frame: From randomization until death from any cause (up to Day 168)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Lahey study director
Bausch Health Americas, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylnaltrexone bromide in people with Pancreatic Cancer, run by Bausch Health Americas, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From randomization until death from any cause (up to Day 168)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.