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Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 12, 2024 (before its estimated February 28, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints revised (3)
    • Secondary endpoints: 19 to 18
    • Eligibility criteria expanded, about 3 words
    v7
  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 12 to 14
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Study sites: 10 to 12v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary endpoints: 2 to 3
    • Study sites: 0 to 10
    • Primary completion date: Nov 30, 2024 to Feb 28, 2025
    • Study completion date: Apr 30, 2025 to Mar 30, 2025
    • Start date changed from estimate of Aug 2021 to Mar 26, 2021
    • Secondary endpoints expanded, about 260 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04954001
Lead Sponsor Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Conditions
(from sponsor)		 Neurofibromatosis 1, Plexiform Neurofibroma, NF1
Related terms Neurofibroma, Plexiform, Neurofibromatosis 1
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov