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Efficacy and Safety of Sirolimus in Children and Adolescents With Juvenile Nasopharyngeal Angiofibroma (JNA)

StatusRecruiting
PhasePhase 3
Started2022-05-30
View on ClinicalTrials.gov ↗
Juvenile nasopharyngeal angiofibroma (JNA) is a pathologically benign yet locally aggressive and destructive tumor that develops in the choana and nasopharynx. Historical treatment of JNA has included embolization, surgical resection, and radiation. mTOR signaling way demonstrated to be involved in regulation of growth and angiogenesis of JNA. Sirolimus, as mTOR inhibitor, is a potential target JNA therapy. The main purpose of the study is to evaluate the efficacy and safety of sirolimus in children and adolescents with primary or recurrent JNA. Efficacy will be estimated based on dynamics of the JNA progression. Historical control group will be used for comparison as standard therapy. Due to limited experience of sirolimus in JNA in routine practice, study should be conducted in 2 phases: pilot and extended. Decision regarding extended phase will be based on the results of pilot phase.
Trial Details
NCT Number NCT05549167
Lead Sponsor Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions Juvenile Nasopharyngeal Angiofibroma
Enrollment 117 participants
Start Date 2022-05-30
Primary Completion 2029-09-30 (estimated)
Study Completion 2029-12-30 (estimated)
Updated on ClinicalTrials.gov 2022-09-22