ArticleTargeted oncology2025
Phase 1 Study of Luvometinib Use in Pediatric Patients with Neurofibromatosis Type 1-Related Unresectable Plexiform Neurofibromas.
Article in Targeted oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04954001 (A Multi-center, Open-label, Single-arm Phase I Dose-escalation and Phase II Dose-expansion Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1), which is not on this map. Not yet cited in PubMed.
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A Multi-center, Open-label, Single-arm Phase I Dose-escalation and Phase II Dose-expansion Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1
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21 authors.
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Abstract
backgroundNeurofibromatosis type 1 (NF1) is a genetic disorder characterized by plexiform neurofibromas (PNs), which are present in 20-60% of NF1 and may cause potentially life-threatening complications. Complete surgical resection of these PNs is generally not feasible, and regrowth after incomplete surgical resection has been observed. Luvometinib is a novel, oral, highly potent selective MEK1/2 inhibitor that has shown activity in adult NF1-related PN.
objectiveTo evaluate the safety and preliminary efficacy of luvometinib in a phase 1 trial in pediatric patients with NF1-related PN. PATIENTS AND
methodsThis multicenter, single-arm, phase 1 study included pediatric patients (2-18 years old) with unresectable NF1-related PN. Patients received luvometinib orally once daily in 28-day cycles until progression or unacceptable toxicity, using a population pharmacokinetics model-informed approach to identify the starting dose of 4 mg/m
resultsIn total, 19 patients were enrolled; 10 at 4 mg/m
conclusionsLuvometinib had a manageable safety profile in pediatric patients with unresectable NF1-related PN. Encouraging preliminary efficacy was observed, particularly among patients receiving the RP2D of 5 mg/m
trial registrationClinicalTrials.gov, NCT04954001 (first posted: 8 July 2021).
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