A Phase 1/2 interventional study of Luvometinib Tablets in Neurofibromatosis 1, Plexiform Neurofibroma and NF1, sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 2 Years to 20 Years. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (part of Fosun Pharma) · Phase 1/2, Interventional, and Treatment
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.
176 studies on the registry are indexed under Neurofibromatosis 1; 43 are open to participants now.
This study's planned enrollment of 65 is above the median of 35 across 114 interventional studies indexed under Neurofibromatosis 1.
Browse Neurofibromatosis 1 studies →Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. is the lead sponsor of 34 studies on the registry; 21 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 form.
Exclusion Criteria:
Any 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study Drug: FCN-159 Dosing Regimen: FCN-159 to be administered once daily until disease progression or study completion, whichever occurs first
Drug: Luvometinib Tablets
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
Also known as: FCN-159
long term safty
Adverse events during treatment of FCN-159 will be assessed by the investigators according to CTCAE 5.0.
Time frame: Through study completion, about 5 years
Height in centimeters
Height will be measured in centimeters, with subsequent plotting of height growth curves and calculation of growth velocity.
Time frame: Through study completion, about 5 years
Weight in kilograms
Weight will be measured in kilograms, with subsequent plotting of weight growth curves.
Time frame: Through study completion, about 5 years
Tanner stage
Tanner stage will be examined, and the mean age for each Tanner stage will be calculated.
Time frame: Through study completion, about 5 years
Progression-Free Survival (PFS)
PFS assessed per REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) criteria by inverstigator
Time frame: Through study completion, about 5 years
Objective response rate (ORR)
ORR assessed per REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) criteria by inverstigator.
Time frame: 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".
Time frame: Through study completion, about 5 years
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Luvometinib
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