Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
FCN-159 (Luvometinib Tablets), an orally available and highly potent selective inhibitor of MEK1/2,demonstrated good tolerability and exhibited notable anti-tumor activity in pediatric pts with NF1-related PN in study NCT04954001.This study is a 5-year long-term follow-up of the FCN-159-002 study, involving all enrolled patients to further assess safety, growth and development effects, and treatment efficacy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FCN-159 | Experimental | Study Drug: FCN-159 Dosing Regimen: FCN-159 to be administered once daily until disease progression or study completion, whichever occurs first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luvometinib Tablets | Drug | 5mg/m² (Maximum dose does not exceed 8mg, the recommended oral dose for adults), orally, once daily, until disease progression or study completion, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| long term safty | Adverse events during treatment of FCN-159 will be assessed by the investigators according to CTCAE 5.0. | Through study completion, about 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Height in centimeters | Height will be measured in centimeters, with subsequent plotting of height growth curves and calculation of growth velocity. | Through study completion, about 5 years |
| Weight in kilograms |
Not provided
Inclusion Criteria:
Patients from the pediatric cohort of the FCN-159-002 study. Willing to participate in the long-term follow-up study and capable of understanding and voluntarily signing the informed consent form.
Exclusion Criteria:
Any clinically significant condition that, in the investigator's judgment, may interfere with study participation or compliance with safety requirements.
Patients unable to comply with visit-related requirements.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojie Hu | Contact | +86 13701997136 | hxjie2002@hotmail.com | |
| Xiaoxi Lin | Contact | +86 18017681268 | linxiaoxi@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital | Shanghai | Shanghai Municipality | 200011 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Weight will be measured in kilograms, with subsequent plotting of weight growth curves.
| Through study completion, about 5 years |
| Tanner stage | Tanner stage will be examined, and the mean age for each Tanner stage will be calculated. | Through study completion, about 5 years |
| Progression-Free Survival (PFS) | PFS assessed per REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) criteria by inverstigator | Through study completion, about 5 years |
| Objective response rate (ORR) | ORR assessed per REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) criteria by inverstigator. | Through study completion, about 5 years |
| Changes in pain intensity | Changes in pain intensity score relative to baseline will be assessed according to 11-point Numerical Rating Scale (NRS-11).NRS-11 quantifies pain intensity on a scale from 0 to 10, 0 represents "No pain" ,10 represents "The worst pain imaginable". | Through study completion, about 5 years |
| ID | Term |
|---|---|
| D009456 | Neurofibromatosis 1 |
| D018318 | Neurofibroma, Plexiform |
| ID | Term |
|---|---|
| D017253 | Neurofibromatoses |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
Not provided
Not provided