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ACTIVE NOT RECRUITING
NCT05913037
PHASE3

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

Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

View on ClinicalTrials.gov

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

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.

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