OncoMatch/Clinical Trials/NCT05948943
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
Is NCT05948943 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies Alpelisib for lymphatic malformations.
Treatment: Alpelisib — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: PIK3CA somatic mutation
evidence of a somatic mutation(s) in the PIK3CA gene prior to randomization
Prior therapy
Cannot have received: PI3K inhibitor (alpelisib)
Exception: treatment duration longer than 2 weeks
previous treatment with alpelisib and/or any other PI3K inhibitors with treatment duration longer than 2 weeks
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCSF Benioff Children s Hospital · Oakland, California
- Lucile Packard Childrens Hosp · Palo Alto, California
- Childrens National Medical Center · Washington D.C., District of Columbia
- Childrens Hosp Boston Dept of Heme · Boston, Massachusetts
- WA Uni School Of Med · St Louis, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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