SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma (NCT04923126) | Clinical Trial Compass
RecruitingPhase 1/2
SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma
United States132 participantsStarted 2021-06-21
Plain-language summary
This is an open-label, multi-center, Phase 1/2 study of the brain-penetrant MEK inhibitor, mirdametinib (PD-0325901), in patients with pediatric low-grade glioma (pLGG).
Who can participate
Age range
2 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: Screening Phase
* Participants with histologically confirmed or suspected low-grade glioma, including neuronal and mixed neuronal-glial tumors
* Participant must have adequate tumor tissue from primary and/or relapsed tumor for central pathology review
* For Phase 1: Projected to be ≥ 2 years and \< 25 years at the time of study enrollment
* Participant's body surface area (BSA) at time of study enrollment must fall within the range outlined in the protocol for the specific dose level under evaluation:
* Phase 1: Dose Finding/Dose-escalation
* For Phase 1 participant's BSA must fall within the range specified in the protocol for the specific dose level under evaluation.
* Phase 2: All Cohorts:
* For Phase 2 of the study the upper BSA restrictions will be removed.
* Participant and/or guardian can understand and is willing to sign a written informed consent document according to institutional guidelines
Exclusion Criteria: Screening Phase
* Participants with known current retinal pathology that is consistent with or a precursor for central serous retinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration
* Participants with a known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of mirdametinib (e.g., gastric bypass, lap band, or other gastric procedures)
* Participant with a known history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Estimate the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of mirdametinib dosed twice daily on a continuous schedule in pediatric patients with progressive or recurrent low-grade glioma.
Timeframe: 1 month after start of mirdametinib treatment
2
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.
Timeframe: Up to 25 months after start of mirdametinib treatment
3
Characterize the maximum plasma concentration and area under the concentration-time curve (AUC0-8h) of mirdametinib.
Timeframe: Course 1: Days 1 and 15
4
Phase 2, Cohort 1: Objective response rate observed anytime during active treatment and sustained for at least 8 weeks
Timeframe: Up to 24 months after start of mirdametinib treatment
5
Phase 2, Cohort 2: Objective response rate observed anytime during active treatment and sustained for at least 8 weeks
Timeframe: Up to 24 months after start of mirdametinib treatment