Selumetinib in Chinese Paediatric With Post-operative NF1-PNs, PhaseⅡ, Double-Blinded, Placebo-Controlled Study

Sponsor
AstraZeneca
Study ID
NCT05825365
Phase
PHASE2
Status
Withdrawn

Conditions

  • Neurofibromatosis Type 1
  • Plexiform Neurofibromas
  • Post-operative

Eligibility Criteria

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

Interventions

  • Selumetinib — DRUG
    Selumetinib
  • Placebo — DRUG
    Placebo (Transfer to selumetinib on REiNS-defined PD)

Study Details

This is a phase II, multicenter, randomised, parallel, double-blind, placebo-controlled study assessing the efficacy and safety of the MEKi selumetinib compared with placebo in Chinese paediatric participants with post-operative NF1-associated PNs.

Key Dates

Start date
Aug 31, 2023
Status verified
Aug 2023
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Selumetinib
    Participants will orally receive selumetinib twice daily (BID) (approximately every 12 hours) at a dose of 25 mg per square meter of body surface area (BSA) on a continuous dosing schedule (28-day per cycle with no rest periods between cycles) for a maximum of 36 cycles.
  • Placebo Comparator: Placebo
    Participants will orally receive placebo twice daily (BID) (approximately every12 hours) at a dose of 25 mg per square meter of body surface area (BSA) on a continuous dosing schedule (28-day per cycle with no rest periods between cycles) for a maximum of 36 cycles. Transfer to selumetinib on REiNS-defined PD.

Primary Outcome Measure

2-year progression-free survival (PFS) Rate [ Time Frame: 2 years ]

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