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MEK inhibitor

Mirdametinib for Brain Tumor

Phase 1 & 2
Recruiting
Led By Anna Vinitsky, MD, MS
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Phase 1: Projected to be ≥ 2 years and < 25 years at the time of study enrollment
Participant must be ≥ 2 years and < 25 years of age at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after start of mirdametinib treatment
Awards & highlights

Study Summary

This trial is testing a new cancer drug for kids with brain tumors.

Who is the study for?
This trial is for children, adolescents, and young adults up to 25 years old with a specific type of brain tumor called low-grade glioma. They must have relapsed or progressed after previous treatments but can't have had any MEK inhibitors before (except in certain cases). Participants need proper organ function and no history of liver disease or other serious medical conditions that could affect the study.Check my eligibility
What is being tested?
The trial is testing Mirdametinib, a drug designed to penetrate the brain and target tumors by inhibiting a protein called MEK. It's an open-label Phase 1/2 study, meaning both researchers and participants know what treatment is being given, aimed at seeing how well this drug works in pediatric patients with low-grade glioma.See study design
What are the potential side effects?
Potential side effects are not listed explicitly here but based on similar medications; they may include digestive issues, skin rash, fatigue, vision changes due to retinal problems, increased blood pressure, liver enzyme changes indicating potential liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 2 and 25 years old at the time of joining the study.
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I am between 2 and 24 years old.
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I can do most activities and am expected to live at least 6 more weeks.
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I have never taken MEK inhibitor medications.
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My cancer has worsened or returned after my last treatment.
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I have a diagnosis or suspicion of a low-grade brain tumor.
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I have enough tumor tissue available for testing.
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My last radiation treatment was over 3 months ago.
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My bone marrow and organs are functioning well.
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My low-grade glioma diagnosis has been confirmed by a central pathology review.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after start of mirdametinib treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after start of mirdametinib treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Characterize the maximum plasma concentration and area under the concentration-time curve (AUC0-8h) of mirdametinib.
Describe the toxicity profile of mirdametinib by cohort.
Phase 1: Determine the safety and tolerability of mirdametinib dosed twice daily on a continuous schedule in pediatric patients with progressive or recurrent low-grade glioma.
+5 more
Secondary outcome measures
Longitudinal change in academic achievement, by cohort
Longitudinal change in adaptive behavior, by cohort
Executive Function
+11 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase I: Recurrent and/or progressive low-grade glioma without prior exposure to MEK inhibitorsExperimental Treatment1 Intervention
Participants will receive mirdametinib at one of the dose levels twice daily days 1-28. For the first cycle of treatment, participants will take mirdametinib tablets dissolved in water. After the first cycle of treatment, participants may receive the medicine the same way (dissolved in water) or may receive capsules. Treatment repeats every 28 days for up to 26 cycles of treatment (24 months) in the absence of disease progression or unacceptable toxicity.
Group II: Phase 2, Cohort 3b:Experimental Treatment1 Intervention
Participants with recurrent and/or progressive low-grade glioma who previously received ≥ 6 courses MEK inhibitor (including mirdametinib) and did not progress while on active MEKi therapy. Participants will receive the RP2D of mirdametinib. Participants may take mirdametinib tablets dissolved in water, or receive capsules. Therapy will be administered in cycles of 28 days and may be continued for up to 24 months (26 cycles) in absence of disease progression or unacceptable toxicity.
Group III: Phase 2, Cohort 3a:Experimental Treatment1 Intervention
Participants with recurrent and/or progressive low-grade glioma who previously received ≥ 6 courses MEK inhibitor (including mirdametinib) and did not progress while on active MEKi therapy. Participants will receive the RP2D of mirdametinib. Participants with previous exposure to mirdametinib may receive a starting dose lower than the RP2D, depending on the dose they tolerated during their previous exposure. Participants may take mirdametinib tablets dissolved in water, or receive capsules. Therapy will be administered in cycles of 28 days and may be continued for up to 24 months (26 cycles) in absence of disease progression or unacceptable toxicity.
Group IV: Phase 2, Cohort 2: Recurrent and/or Progressive without prior exposure to MEK inhibitorsExperimental Treatment1 Intervention
Participants will receive the RP2D of mirdametinib. Participants may take mirdametinib tablets dissolved in water, or receive capsules. Therapy will be administered in cycles of 28 days and may be continued for up to 24 months (26 cycles) in absence of disease progression or unacceptable toxicity.
Group V: Phase 2, Cohort 1: Newly diagnosed and/or previously untreated (except surgery)Experimental Treatment1 Intervention
Participants will receive the RP2D of mirdametinib. Therapy will be administered in cycles of 28 days and may be continued for up to 24 months (26 cycles) in absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PD-0325901
Not yet FDA approved

Find a Location

Who is running the clinical trial?

SpringWorks Therapeutics, Inc.Industry Sponsor
12 Previous Clinical Trials
834 Total Patients Enrolled
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,481 Total Patients Enrolled
Anna Vinitsky, MD, MSPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

Mirdametinib (MEK inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04923126 — Phase 1 & 2
Low Grade Glioma Research Study Groups: Phase 2, Cohort 3a:, Phase 2, Cohort 1: Newly diagnosed and/or previously untreated (except surgery), Phase I: Recurrent and/or progressive low-grade glioma without prior exposure to MEK inhibitors, Phase 2, Cohort 2: Recurrent and/or Progressive without prior exposure to MEK inhibitors, Phase 2, Cohort 3b:
Low Grade Glioma Clinical Trial 2023: Mirdametinib Highlights & Side Effects. Trial Name: NCT04923126 — Phase 1 & 2
Mirdametinib (MEK inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04923126 — Phase 1 & 2

Frequently Asked Questions

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

How many individuals have signed up to take part in this medical research?

"Affirmative. Clinicaltrials.gov confirms that this research project, initially posted on June 21st 2021, is actively searching for participants. 132 patients need to be recruiter from 1 medical centre."

Answered by AI

What is the primary purpose of this investigation?

"This clinical study assesses the toxicity profile of mirdametinib over a one-month period and further evaluates its efficacy in terms of attention, executive function, memory and rates of stable disease. To measure these outcomes various instruments will be employed such as Cogstate to evaluate attention, working memory and processing speed; WPPSI-IV (4-5.11 years), WISC-V (6-16.11) or WAIS IV (17+) for brief attention/working memory assessment; Kaufman Test of Educational Achievement III for verbal fluency among 4 - 25 year olds; BRIEF 2 to gauge behavioral"

Answered by AI

Could you expound upon other research projects involving Mirdametinib?

"Currently, 4 live trials for Mirdametinib are underway with no Phase 3 studies. Most of the clinical research is hosted in Melbourne, Victoria; however, there are 63 sites conducting Mirdametinib trials worldwide."

Answered by AI

Is the age limit for this trial restricted to those over 25 years old?

"In order to be accepted into this clinical trial, participants must fall between the ages of 2 and 24. There are 136 studies for minors under 18 years old and 240 trials for senior citizens aged 65 or higher."

Answered by AI

To whom is this clinical experiment accessible?

"This clinical trial, which seeks approximately 132 participants, is looking for individuals aged 2 to 24 with a glioma diagnosis."

Answered by AI

Is this research currently open to participants?

"Per the information on clinicaltrials.gov, this medical research is still recruiting participants. This experiment was initially advertised on June 21st 2021 and has recently been modified as of October 24th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma
2021. "SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04923126.
~88 spots leftby Jun 2031
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