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NCT04954001 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1
A Phase 1 study of Neurofibromatosis 1 and Plexiform Neurofibroma, sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co..
- Active
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
- 14
- Study locations
NCT04954001: Active Phase 1 study of Neurofibromatosis 1 and Plexiform Neurofibroma, sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co..
NCT04954001 is a Phase 1 study of Neurofibromatosis 1 and Plexiform Neurofibroma that is active but no longer recruiting, run by Shanghai Fosun Pharmaceutical Industrial Development Co.. The registered enrollment target is 160 participants, below the 1,029-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (84% lower). The trial reports 14 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04954001, a Phase 1 study of Neurofibromatosis 1 and Plexiform Neurofibroma, is active but no longer recruiting, sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
- 14
- Study locations
Study Summary
FCN-159 is a highly active MEK1/2 inhibitor that was designed, synthesized and screened on the basis of the structure of trametinib. FCN-159 is an orally available and highly potent selective inhibitor of MEK1/2, which is expected to be a targeted therapy for the treatment of advanced solid tumors and neurofibromatosis type 1.
Conditions Studied
Interventions
- DRUG FCN-159
Study Locations (14)
Other
- Research Site - Beijing
- Research Site - Guangzhou
- Research Site - Hangzhou
- Research Site - Shanghai
- Research Site - Shijiazhuang
- Research Site - Wuhan
- Hospital Universitario Vall d'Hebron - Barcelona
- Hospital Universitario 12 de Octubre - Madrid
- Hospital Universitario La Paz - Madrid
Florida
- Principal Investigator Hans - Gainesville
- John Hopkins All Children Hospital - St. Petersburg
California
- Children's Hospital Los Angeles - Los Angeles
Michigan
- Henry Ford Health System - Detroit
South Carolina
- Medical University of South Carolina - Hollings Cancer Center - PPDS - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2021-03-26 |
| Est. Completion | 2025-03-30 |
| Phase | Phase 1 |
What the registry record for NCT04954001 still lists
NCT04954001 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 1,029-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (84% lower).
The record links to 3 conditions, with Neurofibromatosis 1 appearing as the primary indexed condition, and to 1 intervention - of which FCN-159 is the first listed.
NCT04954001 lists 14 locations in 5 states (Other, Florida, California).
Frequently Asked Questions
What is clinical trial NCT04954001 about?
NCT04954001 is a clinical study titled "Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1". FCN-159 is a highly active MEK1/2 inhibitor that was designed, synthesized and screened on the basis of the structure of trametinib. FCN-159 is an orally available and highly potent selective inhibitor of MEK1/2, which is expected to be a targeted therapy for the treatment of advanced solid tumors a...
What is the current status of trial NCT04954001?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2021-03-26. Estimated completion is 2025-03-30.
What conditions does trial NCT04954001 study?
This clinical trial studies the following conditions: Neurofibromatosis 1, Plexiform Neurofibroma, NF1.
What interventions are being tested in trial NCT04954001?
The interventions under investigation include: FCN-159 (DRUG).
Who is sponsoring clinical trial NCT04954001?
This trial is sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04954001 being conducted?
This trial has 14 study locations across California, Florida, Michigan, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neurofibromatosis 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04954001's enrollment target sits among peer trials
160 10th of 24 higher than 15 of 24 other Neurofibromatosis 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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