Low-dose Selumetinib for the Treatment of Plexiform Neurofibromas in Chinese Children

Sponsor
West China Hospital
Study ID
NCT06763315
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Plexiform Neurofibromas (PN)

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Selumetinib — DRUG
    Use of the internationally recommended standard dose and low dose of the same drug

Study Details

The goal of this study is to compare the efficacy and safety of low-dose and internationally recommended standard dose of selumetinib in the treatment of plexiform neurofibromas in Chinese children.

Key Dates

Start date
Jan 1, 2025
Status verified
Dec 2024
Primary completion
Jan 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Regular dose of selumetinib
    The total daily dose is 25 mg/m², twice a day, once every 12 hours, and the treatment is continued and followed up for 24 cycles (28 days as one cycle).
  • Experimental: Low dose of selumetinib
    The total daily dose is 20 mg/m², twice a day, once every 12 hours, and the treatment is continued and followed up for 24 cycles (28 days as one cycle).

Primary Outcome Measure

The change in tumor volume of plexiform neurofibromas [ Time Frame: Once every 3 cycles for the first 12 cycles, once every 6 cycles for the next 12 cycles (each cycle is 28 days). ]

Central Contacts