An Extension Study of Methylnaltrexone Bromide (MNTX) in... | NCT04151719

Studies
An Extension Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer

NCT04151719

Sponsor

Bausch Health Americas, Inc.

Status

Withdrawn

Last Update Posted

May 7, 2021Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Pancreatic Cancer

Interventions

Methylnaltrexone bromide (MNTX)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to pandemic challenges and consideration of a different study design in the future.

Expanded Access Info

Start Date

Feb 3, 2020Estimated

Primary Completion Date

Feb 3, 2024Estimated

Completion Date

Feb 3, 2024Estimated

First Submitted Date

Nov 1, 2019

First Submission Date that Met QC Criteria

Nov 1, 2019

First Posted Date

Nov 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2021

Last Update Posted Date

May 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Methylnaltrexone bromide (MNTX)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylnaltrexone bromide (MNTX)	Drug	Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.	MNTX 450 mg QD

Measure	Description	Time Frame
Overall Survival		From first MNTX dose administration until death from any cause (up to 4 years)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms