Pancreatic CancerPhase 3NCT04151719
An Extension Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer
A Phase 3 study testing Methylnaltrexone bromide (MNTX) in people with Pancreatic Cancer, run by Bausch Health Americas, Inc..
Trial summary
This open-label extension study will evaluate the long-term safety and efficacy of oral MNTX in participants with advanced pancreatic cancer (adenocarcinoma) who were previously enrolled in Study SAL-REL-2042 (NCT04083651). 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 (MNTX)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2020to 3 Feb 2024
- Phase
- Phase 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
- Adult participants greater than or equal to (≥)18 years of age on the date the Informed Consent Form (ICF) is signed, with the capacity to provide voluntary informed consent.
- Enrolled in double-blind Study SAL-REL-2042 (NCT04083651) and completed an end of study (EOS) visit (Day 168) or completed Day 56 of the Study SAL-REL-2042 (NCT04083651).
- Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)-approved ICF and provide authorization, as appropriate, for local privacy regulations.
- Willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.
- Signed an informed consent/Health Insurance Portability and Accountability Act (HIPAA) form.
Who cannot join
- Concurrent therapy with any other investigational agent during the study.
- Current use of a peripherally acting mu-opioid-receptor antagonist.
- Current evidence of untreated brain metastasis(es).
- Diarrhea greater than Grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
- Bowel obstruction.
- Advanced liver disease.
- Renal disease.
- Any other severe, acute, or chronic 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.
About this study
Official title: An Open-Label Extension Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer
This open-label extension study will evaluate the long-term safety and efficacy of oral MNTX in participants with advanced pancreatic cancer (adenocarcinoma) who were previously enrolled in Study SAL-REL-2042 (NCT04083651).
- Conditions
- Pancreatic Cancer
- Being tested
- Methylnaltrexone bromide (MNTX)
- 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 bromide (MNTX)Drug
Also called Relistor®
Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| MNTX 450 mg QD | Experimental | Participants will receive methylnaltrexone bromide (MNTX) 450 milligrams (mg) (3 tablets of 150 mg each) once daily (QD) orally. Treatment will continue until participant's death or early withdrawal from the study or study termination by the sponsor. Receives: Drug: Methylnaltrexone bromide (MNTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From first MNTX dose administration until death from any cause (up to 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start3 Feb 2020 (estimated)
- Primary completion3 Feb 2024 (estimated)
- Study completion3 Feb 2024 (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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT04151719
- Sponsor's protocol ID
- SAL-REL-2043
- Status last verified
- May 2021
- First submitted
- 1 Nov 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
- An Open-Label Extension Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04151719
- Acronym / sponsor ID
- SAL-REL-2043
- Conditions
- Pancreatic Cancer
- Phase
- Phase 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
- 3 Feb 2020 (estimated)
- Primary completion
- 3 Feb 2024 (estimated)
- Study completion
- 3 Feb 2024 (estimated)
- First posted
- 5 Nov 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 open-label extension study will evaluate the long-term safety and efficacy of oral MNTX in participants with advanced pancreatic cancer (adenocarcinoma) who were previously enrolled in Study SAL-REL-2042 (NCT04083651).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MNTX 450 mg QD | Experimental | Drug: Methylnaltrexone bromide (MNTX)Participants will receive methylnaltrexone bromide (MNTX) 450 milligrams (mg) (3 tablets of 150 mg each) once daily (QD) orally. Treatment will continue until participant's death or early withdrawal from the study or study termination by the sponsor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult participants greater than or equal to (≥)18 years of age on the date the Informed Consent Form (ICF) is signed, with the capacity to provide voluntary informed consent.
- Enrolled in double-blind Study SAL-REL-2042 (NCT04083651) and completed an end of study (EOS) visit (Day 168) or completed Day 56 of the Study SAL-REL-2042 (NCT04083651).
- Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)-approved ICF and provide authorization, as appropriate, for local privacy regulations.
- Willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.
- Signed an informed consent/Health Insurance Portability and Accountability Act (HIPAA) form.
Key exclusion criteria (8 listed)
- Concurrent therapy with any other investigational agent during the study.
- Current use of a peripherally acting mu-opioid-receptor antagonist.
- Current evidence of untreated brain metastasis(es).
- Diarrhea greater than Grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
- Bowel obstruction.
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 bromide (MNTX)Also: Relistor®Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm. | Drug | MNTX 450 mg QD |
Primary outcome
Overall Survival
Time frame: From first MNTX dose administration until death from any cause (up to 4 years)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylnaltrexone bromide (MNTX) in people with Pancreatic Cancer, run by Bausch Health Americas, Inc..
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 5 inclusion and 8 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 first MNTX dose administration until death from any cause (up to 4 years)). 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.