To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH

PHASE2RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

September 28, 2023

Primary Completion Date

May 14, 2025

Study Completion Date

May 14, 2027

Conditions
Langerhans Cell HistiocytosisLCH
Interventions
DRUG

FCN-159

5mg/m² (Maximum dose does not exceed 8mg, the recommended oral dose for adults), orally, once daily, continuously for 28 days per cycle.

Trial Locations (11)

Unknown

RECRUITING

Beijing Children's Hospital, Capital Medical University, Beijing

NOT_YET_RECRUITING

Children's Hospital Affiliated to the Capital Institute of Pediatrics, Beijing

RECRUITING

Children's Hospital of Chongqing Medical University, Chongqing

NOT_YET_RECRUITING

Sun Yat-Sen Memorial Hpsipital,Sun Yat-Sen Unniversity, Guangzhou

NOT_YET_RECRUITING

The First Affiliated Hospital,Sun Yat-sen University, Guangzhou

NOT_YET_RECRUITING

Shenzhen Children's Hospital, Shenzhen

NOT_YET_RECRUITING

Henan Children's Hospital Zhengzhou Children's Hospital, Zhengzhou

NOT_YET_RECRUITING

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan

NOT_YET_RECRUITING

West China Second University Hospital,Sihuan University/West China women's and Children's Hospital, Chengdu

NOT_YET_RECRUITING

Children's Hospital, Zhejiang University School of Medicine, Hangzhou

NOT_YET_RECRUITING

Children's Hospital of Soochow University, Suzhou

All Listed Sponsors
lead

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

INDUSTRY

NCT05997602 - To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH | Biotech Hunter | Biotech Hunter