FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

167

Participants

Timeline

Start Date

June 20, 2023

Primary Completion Date

August 19, 2025

Study Completion Date

June 30, 2026

Conditions
Neurofibromatosis 1Plexiform NeurofibromaNF1
Interventions
DRUG

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.

DRUG

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.

Trial Locations (15)

Unknown

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing

Plastic Surgery Hospital,Chinese Academy of Medical Sciences, Beijing

Nanfang Hospital, Southern Medical University, Guangzhou

Sun Yat-sen University Cancer Center, Guangzhou

Peking University Shenzhen Hospital, Shenzhen

The Fourth Hospital of Hebei Medical University, Shijiazhuang

The Second Hospital of Hebei Medical University, Shijiazhuang

Renmin Hospital of Wuhan University, Wuhan

TongJi Hospital,TongJi Medical College Huazhong University of Science and Technology, Wuhan

The First Hospial of China Medical University, Shenyang

Fudan University Shanghai Cancer center, Shanghai

West China Hospital,Sichuan University, Chengdu

Hangzhou First People's Hospital, Hangzhou

Zhejiang Provincial People'S Hospital, Hanzhou

All Listed Sponsors
lead

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

INDUSTRY