Observational Study of the Real-world Effectiveness and Safety of Selumetinib Treating Adult Patients With Neurofibromatosis Type 1 (NF1) Who Have Symptomatic, Inoperable Plexiform Neurofibroma (PN)

Study acronym: PROCEED
StatusRecruiting
PhaseNot specified
Started

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Record History

  1. Study First Submitted
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This is a prospective, multicentre, observational registry study with primary data collection designed to evaluate the real-world effectiveness and safety of selumetinib in adult patients with NF1 who have symptomatic, inoperable PN. A total of approximately 800 participants who initiate selumetinib treatment will be enrolled across about 45 investigational sites in China. Sites will be selected based on their diagnostic and treatment expertise in NF1-PN, research capability and sufficient patient pool. Patients who are eligible and willing to participate will be enrolled into the study. The study includes an approximately 25-month enrolment period and a 96-week observation period. Patients will be followed up until the end of the 96-weeks 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 96 weeks period (starting after first dose received) in the study even if selumetinib is discontinued. The study will end until the last participant has the opportunity to complete 96 weeks' assessment.
Trial Details
NCT Number NCT07888517
Lead Sponsor AstraZeneca
Conditions
(from sponsor)
Neurofibromatosis Type 1 (NF1)
Related terms Neurofibromatosis 1
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov