Condition: High-grade Glioma · Solid Tumor, Unspecified, Child · Sponsor: Laminar Pharmaceuticals
An open label, non-randomized study in pediatric patients with advanced high-grade gliomas and other solid tumors. The study will be performed in two phases: a dose escalation phase in up to 18 patients following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a "safe" dose of LAM561 followed by an expanded safety cohort of up to 10 patients treated at the Maximum Tolerated Dose (MTD). If the MTD is well tolerated in the expanded safety cohort, that dose becomes the Recommended Phase 2 Dose (RP2D). Glioma patients and other solid tumor patients (including non-glial brain tumors) will be treated as a single cohort. Patients with either tumor type will be allowed to enroll on the study as positions are made available. No tumor type will be given priority over another and there is no minimum number of glioma patients or solid tumor patients that must be enrolled on the trial.
This description comes directly from the study's public registry record.
Adrian Gerald McNicholl · +34971439886 · clinical.dev@laminarpharma.com
Always discuss trial participation with your own doctor first.
| Arkansas Children's Research Institute | Little Rock, Arkansas, United States | Recruiting |
| University of Miami Hospital | Miami, Florida, United States | Recruiting |
| Hackensack Meridian Health, Inc | Edison, New Jersey, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04299191