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Brief Title: FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-center Phase III Clinical Study to Evaluate the Efficacy and Safety of FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas
Study ID: NCT05913037
Brief Summary: A study to evaluate the efficacy of FCN-159 in adult patients with symptomatic, inoperable neurofibromatosis type 1-related plexiform neurofibromas.
Detailed Description: This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of FCN-159 in adult patients with symptomatic, inoperable neurofibromatosis type 1-related plexiform neurofibromas.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, Beijing, China
Plastic Surgery Hospital,Chinese Academy of Medical Sciences, Beijing, Beijing, China
Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Peking University Shenzhen Hospital, Shenzhen, Guangdong, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Renmin Hospital of Wuhan University, Wuhan, Hubei, China
TongJi Hospital,TongJi Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
The First Hospial of China Medical University, Shenyang, Liaoning, China
Fudan University Shanghai Cancer center, Shanghai, Shanghai, China
West China Hospital,Sichuan University, Chengdu, Sichuan, China
Hangzhou First People's Hospital, Hangzhou, Zhejiang, China
Zhejiang Provincial People'S Hospital, Hanzhou, Zhejiang, China
Name: Wenbin Li, MD
Affiliation: Beijing Tiantan Hospital
Role: PRINCIPAL_INVESTIGATOR