NCT07024394Not yet recruitingPhase 1/2
Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Ruvometinib Tablets (FCN-159 Tablets) in Pediatric Participants With Neurofibromatosis Type 1
Source: ClinicalTrials.gov · Last updated 17 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 3 Jun 2025
- Start date
- 12 Jun 2025
- Primary completion date
- 23 Sept 2029
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- Diseases
- Childhood cancers
- NCT number
- NCT07024394
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 65
- From 12 Jun 2025 to the primary completion date, 23 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any clinically significant condition that, in the investigator's judgment, may interfere with study participation or compliance with safety requirements.
Other
- Patients unable to comply with visit-related requirements.
Who the study is looking for
- 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.
Age in the registry: 2 years to 20 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Ninth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.