drugset / Trial / NCT05948943
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpelisib | Small molecule | — | — |