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Observational Study to Evaluate the Effect and Safety of Selumetinib in Pediatric Patients With NF1-PNs

Study acronym: PEDIA
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later May 30, 2027 → Jun 30, 2027
See other at-risk trials from AstraZeneca

Record History

  1. Primary endpoints: details revised at 1 of 5 entries Primary and study completion pushed from May 30, 2027 to Jun 30, 2027 · Secondary endpoints: details revised at 3 of 4 entries · Eligibility criteria expanded, about 2 words Show 3 more changesShow less
    • Primary and study completion pushed from May 30, 2027 to Jun 30, 2027
    • Secondary endpoints: details revised at 3 of 4 entries
    • Eligibility criteria expanded, about 2 words
  2. 4 versions Re-verified since Oct 21, 2025, no change to tracked fieldsv17-v20
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 400 to confirmed 409 · Study sites: 33 to 25 · Primary and study completion dates: Nov 30, 2027 to May 30, 2027v16 Show 3 more changesShow less
    • Enrollment target: estimated 400 to confirmed 409
    • Study sites: 33 to 25
    • Primary and study completion dates: Nov 30, 2027 to May 30, 2027
  4. 5 versions Re-verified since Jan 14, 2025, no change to tracked fieldsv11-v15
  5. Study sites: 36 to 33v10
Show 8 earlier versionsHide 8 earlier versions
  1. 2 versions Re-verified since Sep 23, 2024, no change to tracked fieldsv8-v9
  2. Enrollment target: 100 to 400 Study sites: 1 to 36v7 Show 1 more changeShow less
    • Study sites: 1 to 36
  3. Primary and study completion dates: Jul 31, 2027 to Nov 30, 2027v6
  4. 3 versions Re-verified since Feb 29, 2024, no change to tracked fieldsv3-v5
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 31, 2024 to Dec 20, 2023 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 31, 2024 to Dec 20, 2023
    • Site details revised
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AstraZeneca
727 trials monitored
See 61 trials at risk
This is a prospective, multicenter, observational study of Chinese pediatric NF1-PN patients treated with selumetinib. The study will be conducted at approximately 12 centers in China and will include approximately 80-100 patients. Treatment centers that have PN diagnosis and/or selumetinib treatment experience will be targeted for recruitment. Patients/caregivers who are eligible and willing to participate will be enrolled into the study. Patients will start selumetinib treatment after enrollment. The study will have a 16-month enrollment period. Patients will be followed up until the end of a 24-month observation period after first dose of selumetinib, or patient death, lost to follow-up, withdrawal of consent, whichever occurs first. Patients will be followed within a 24-month period (starting after first dose received) in the study even if selumetinib is discontinued. The aims of this study are to expand understanding of disease characteristics and treatment pattern of NF1-PN in China in a real-world setting and to evaluate real-world effectiveness and safety of selumetinib for Chinese pediatric patients with NF1-PN
Trial Details
NCT Number NCT06175637
Lead Sponsor AstraZeneca
Conditions Neurofibroma, Plexiform
Enrollment 409 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov