Neuromuscular Complications of MEK Inhibitors: a French Case Series and a Systematic Review of the Literature

February 16, 2025 updated by: Pauline DUCATEL, Central Hospital, Nancy, France

MEK inhibitors (trametinib, cobimetinib, selumetinib or binimetinib) have been used since 2016 to treat metastatic melanoma, by targeting the MAPK pathway Neuromuscular complications (neuropathy, myasthenia or myositis) have been reported in patients treated with MEK inhibitors.

With the growing use of these new oncology therapies, neurologists, oncologists and other clinicians are likely to be increasingly confronted with MEK inhibitor-induced neuropathy, myasthenia or myositis.

Yet, so far, these complications have only been documented in a few single case reports.

Our aim was to characterize the neuromuscular complications associated with MEK inhibitors used either alone or in combination.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with neuromuscular complications treated with MEK inhibitors at a Neuromuscular Reference Center in France

Description

Inclusion Criteria:

  • Patients with neuromuscular complications of MEK inhibitors used alone or in combination
  • Age > 18 years

Exclusion Criteria:

  • Refusal of data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Type of neuromuscular complications
Time Frame: up to 8 years
up to 8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to onset after introduction of MEK inhibitors
Time Frame: up to 8 years
up to 8 years
Severity of neuromuscular complications
Time Frame: up to 8 years
up to 8 years
Progression with or without treatment
Time Frame: up to 8 years
up to 8 years
Reintroduction of MEK inhibitors
Time Frame: up to 8 years
up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Pauline Ducatel, Doctor, CHRU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

December 8, 2024

First Submitted That Met QC Criteria

December 14, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 16, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PI240

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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