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FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas
Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Summary
A study to evaluate the efficacy of 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
167
Start Date
2023-06-20
Completion Date
2026-06-30
Last Updated
2025-03-06
Healthy Volunteers
No
Interventions
Test group (Group A): FCN-159 8 mg, orally, once daily;
After completing all screening visit items, qualified patients will be randomly assigned to the test group (Group A) or control group (Group B) in a 2:1 ratio, and receive FCN-159 or placebo within 3 days after randomization.
Control group (Group B): Placebo, orally, once daily;
After completing all screening visit items, qualified patients will be randomly assigned to the test group (Group A) or control group (Group B) in a 2:1 ratio, and receive FCN-159 or placebo within 3 days after randomization.
Locations (15)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China
Plastic Surgery Hospital,Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 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 Municipality, 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