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Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1
Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
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.
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
Key Details
Gender
All
Age Range
2 Years - 20 Years
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2025-06-12
Completion Date
2029-09-23
Last Updated
2025-06-17
Healthy Volunteers
No
Interventions
Luvometinib Tablets
5mg/m² (Maximum dose does not exceed 8mg, the recommended oral dose for adults), orally, once daily, until disease progression or study completion, whichever occurs first
Locations (1)
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China