Efficacy and Safety of Sirolimus in Children and Adolescents With Juvenile Nasopharyngeal Angiofibroma (JNA)
Recruiting
Phase 3
Interventional Study
Juvenile Nasopharyngeal Angiofibroma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 7 – 18
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 117 (estimated)
- Sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Other
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About This Trial
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 JN…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Confirmed diagnosis of JNA.
* Male gender.
* Age 7-18 years.
* Signed informed consent of the parents or the official representative for patients under 14 years of age, the patient and the patient's parents for persons from 14 to 18 years of age.
* Adequate liver and kidney fu…
Contacts