About this trial
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).
Eligibility criteria
Qualifiers
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
Phase 1: Dose Finding/Dose-escalation
Disqualifiers
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 syndrome or asymptomatic gallstones)
Participants with a clinically significant history of chronic interstitial lung disease (such as bronchopulmonary dysplasia, chronic bronchiolitis, obliterative bronchiolitis, chronic aspiration pneumonia, surfactant protein disorder, or other serious chronic pulmonary condition). Participants with a history of asthma, reactive airways disease, or viral pneumonitis are not to be excluded if disease has resolved or is well-controlled.
Trial design
Treatments tested in this trial
- Mirdametinib
Treatment groups
Sponsors and collaborators
St. Jude Children's Research Hospital
Lead sponsor
SpringWorks Therapeutics, Inc.
Collaborator