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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2024-02-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer

NCT04083651

Pancreatic Cancer

WITHDRAWN PHASE2/PHASE3

A Study to Evaluate the Mass Balance, Metabolism, Elimination, and Drug Levels of [14C]-BMS-986504 (MRTX1719) in Participants With Advanced Solid Tumors With Homozygous Methylthioadenosine Phosphorylase Deletion

NCT06672523

Advanced Solid Tumors With Homozygous MTAP Deletion

RECRUITING PHASE1

17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma

NCT00004241

COMPLETED PHASE1

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

NCT05372640

Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Breast Carcinoma +3 more

RECRUITING PHASE1

Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors

NCT03634982

Solid Tumors

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MNTX 450 mg QD

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.

Group Type EXPERIMENTAL

Methylnaltrexone bromide (MNTX)

Intervention Type DRUG

Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methylnaltrexone bromide (MNTX)

Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Relistor®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No