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MEK Inhibitor

Mirdametinib for Langerhans Cell Histiocytosis

Phase 2

Recruiting

Led By Ashish Kumar, MD, PhD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

multi-focal bone disease

isolated CNS/pituitary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years (completion of 26 four week cycles)

Awards & highlights

Study Summary

This trial will test if a new drug is better than current treatments for a rare disease that affects the immune system. #histiocytosis

Who is the study for?

This trial is for individuals aged 2 years or older with a confirmed diagnosis of histiocytic disorders like LCH, JXG, RDD, or others with specific gene mutations. They must have measurable disease and not have received certain myelosuppressive chemotherapy within the last 14 days. Adults unable to consent or those without biopsy material (except in specific CNS cases) cannot participate.Check my eligibility

What is being tested?

The study tests mirdametinib's effectiveness on patients with various histiocytic disorders compared to current treatments. It aims to determine if this treatment offers better outcomes and fewer side effects than existing options.See study design

What are the potential side effects?

While the trial description does not specify side effects, similar medications can cause fatigue, skin changes, gastrointestinal issues, muscle pain, and increased liver enzymes. Individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have cancer that has spread to multiple bones.

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My cancer is limited to my brain or pituitary gland.

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I have a bone lesion in my skull that could lead to brain disease.

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I can make my own medical decisions.

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I am at least 2 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years (completion of 26 four week cycles)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years (completion of 26 four week cycles)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years (completion of 26 four week cycles) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response rate to mirdametinib

Secondary outcome measures

Area under the plasma concentration time curve (AUC)

Feasibility of uninterrupted prolonged mirdametinib administration

Maximum Plasma Concentration (Cmax)

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: MirdametinibExperimental Treatment1 Intervention

Mirdametinib will be dosed by mouth twice a day at a dose of 2 mg/m2 BID with a max of 4 mg BID (8 mg per day max).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirdametinib

2021

Completed Phase 2

~10

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,541 Total Patients Enrolled

Ashish Kumar, MD, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Allison Bartlett, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

1 Previous Clinical Trials

24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Mirdametinib been given the greenlight by regulatory bodies?

"With Phase 2 trial data proving its safety, Mirdametinib receives a score of 2 on our team's scale. Unfortunately, no efficacy information has been collected as of yet."

Answered by AI

How many participants are currently receiving treatment in this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this medical study is still recruiting, having been originally posted on December 1st 2023 and most recently altered on the 6th of December 2023. This trial demands 50 participants from one clinical site."

Answered by AI

Is enrollment still available for this medical experiment?

"Affirmative. Information found on clinicaltrials.gov confirms that the medical trial, which debuted on December 1st 2023, is actively enrolling participants. Specifically, 50 individuals need to be recruited from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mirdametinib in Histiocytic Disorders

2024. "Mirdametinib in Histiocytic Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06153173.