clinical trial · NCT07024394
Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.·phase2·not yet recruiting·n = 65
Neurofibromatosis 1Plexiform NeurofibromaNF1Luvometinib Tablets
brief summary
FCN-159 (Luvometinib Tablets), an orally available and highly potent selective inhibitor of MEK1/2,demonstrated good tolerability and exhibited notable anti-tumor activity in pediatric pts with NF1-related PN in study NCT04954001.This study is a 5-year long-term follow-up of the FCN-159-002 study, involving all enrolled patients to further assess safety, growth and development effects, and treatment efficacy.
started
Jun 12, 2025
primary completion
Sep 23, 2029
completion
Sep 23, 2029
last updated
Jun 17, 2025
official title
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Ruvometinib Tablets (FCN-159 Tablets) in Pediatric Participants With Neurofibromatosis Type 1
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol