Trials Sponsors Conditions Drugs Pricing

Conditions

Langerhans Cell Histiocytosis LCH

Outcome Measures

Primary Outcomes (1)

Objective Response Rate (ORR) Evaluated by Independent Review Committee (IRC) Based on PET Response Criteria (PRC)
ORR Evaluated by Independent Review Committee (IRC) Based on PET Response Criteria (PRC) is defined as the percentage of participants who achieved a best overall response of CMR or PMR assessed by IRC .
up to 24months

Secondary Outcomes (12)

Objective Response Rate (ORR) Evaluated by Investigator Based on PET Response Criteria (PRC) and Langerhans Cell Histiocytosis Evaluation and Treatment Guidelines (Histiocyte Society, April 2009, hereinafter referred to as "Guidelines")
up to 24months
Disease Control Rate (DCR) Evaluated by Investigator Based on PET Response Criteria (PRC) and "Guidelines".
up to 24months
Clinical benefit rate (CBR) Evaluated by Investigator Based on PRC and "Guidelines".
up to 24months
Time to Response (TTR) Evaluated by Investigator Based on PET Response Criteria (PRC) and "Guidelines"
up to 24months
One-year Progressive Free Survival (PFS) Rate Evaluated by Investigator Based on PET Response Criteria (PRC) and "Guidelines"
up to 12months
+7 more secondary outcomes

Study Arms (1)

FCN-159

EXPERIMENTAL

Experimental: FCN-159 Dosage form:tablet Specification: 1mg，4mg Dose: FCN-159 5mg/m² (Maximum dose does not exceed 8mg), orally, once daily

Drug: FCN-159

Interventions

FCN-159Drug

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

FCN-159

Eligibility Criteria

Age2 Years - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Age 2-16 (inclusive)
Patients with histologically confirmed Langerhans cell histiocytosis (LCH) diagnosed by the central laboratory.

Sponsors & Collaborators

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Industrylead

Study Sites (11)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Rui ZhangCONTACT

Rui Zhang, MDPRINCIPAL INVESTIGATOR

Children's Hospital Affiliated to the Capital Institute of Pediatrics

Beijing, Beijing Municipality, China

NOT_YET_RECRUITING

Rong Liu, MDCONTACT13601123876 liurong@shouer.com.cn

MeSH Terms

Conditions

Histiocytosis, Langerhans-Cell

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

Rui Zhang, MD
Beijing Children's Hospital,Captial Medical University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Zhang, MD

CONTACT

18611106187 ruizh1973@126.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 18, 2023

Study Start

September 28, 2023

Actual (reported)

Primary Completion

May 14, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

Patients who have received any of the following prior treatments:
Chemotherapy, targeted therapy, immunotherapy, biologic therapy, or herbal anti-tumor therapy for LCH within 4 weeks or \< 5 half-lives (whichever is shorter)before the start of the study drug .
Strong CYP3A4, CYP2C8, and CYP2C9 inhibitors or inducers within 14 days before the start of the study drug, except for topical skin application.
Gowth factors that promote platelet or white blood cell count or function within 7 days before the start of the study drug.
Radiotherapy or major surgical treatment (including craniotomy, thoracotomy, laparotomy, open bone or joint surgery, etc.) within 4 weeks before the start of the study drug.
Participated in other interventional clinical trials within 4 weeks before the start of the study drug.
MEK 1/2 inhibitors (those who have received this treatment for a short period of ≤ 2 weeks may be included).
Anticoagulants within 7 days before the start of the study drug for patients with brain tumors (intracranial masses).
Prednisone treatment \< 0.5mg/kg/day (or equivalent dose of other corticosteroids) is allowed within one month before enrollment, but must be discontinued 14 days before the start of the study drug. Patients with brain lesions receiving corticosteroid therapy for brain edema must maintain a stable dose for 14 days before enrollment. Hormone replacement therapy is allowed for patients with hypopituitarism due to primary disease involvement of the pituitary.
Patients with a history of other malignant tumors or concurrent other malignant tumors (excluding cured non-melanoma skin basal cell carcinoma, ductal carcinoma in situ of the breast, or cervical carcinoma in situ).
Uncontrolled hypertension (with medication treatment): Blood pressure (BP) greater than or equal to the 95th percentile for age, height, and sex, as described in Appendix 6.
Patients with dysphagia, active gastrointestinal disease, malabsorption syndrome, or other conditions that may affect the absorption of the study drug.
Prior or current history of retinal vein obstruction (RVO), retinal pigment epithelial detachment (RPED), glaucoma, and other clinically significant abnormal ophthalmologic examination results.
Interstitial pneumonia, including clinically significant radiation pneumonitis. Except for interstitial pneumonia caused by pulmonary involvement of the primary disease.
Patients will be excluded if their cardiac function or comorbidities meet any of the following criteria:
+9 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (1)

FCN-159

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (1)

FCN-159

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations