drugset / Trial / NCT05948943

Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

NCT05948943

Phase 2/3 Recruiting 232 enrolled Novartis Pharmaceuticals
RandomizedSequentialQuadruple-blindTreatment

Summary

The main purpose of this study in participants with PIK3CA-mutated LyM is to assess the change in radiological response and symptom severity upon treatment with alpelisib film-coated tablets (FCT) as compared to placebo.

Timeline

Start
2023-11-24
Primary completion
2028-05-31
Completion
2033-05-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpelisib Small molecule