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

ClinicalTrials.gov ID: NCT05948943

Public ClinicalTrials.gov record NCT05948943. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced May 8, 2026, 3:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Two-stage Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

Study identification

NCT ID: NCT05948943
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 232 participants

Conditions and interventions

Conditions

Lymphatic Malformations

Interventions

Alpelisib Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 0 Years to 100 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 23, 2023
Primary completion: May 30, 2028
Completion: May 1, 2033
Last update posted: May 6, 2026

2023 – 2033

United States locations

U.S. sites: 16
U.S. states: 10
U.S. cities: 14

Facility	City	State	ZIP	Site status
UCSF Benioff Children s Hospital	Oakland	California	94609	Recruiting
Lucile Packard Childrens Hosp	Palo Alto	California	94304	Recruiting
Childrens National Medical Center	Washington D.C.	District of Columbia	20010-2970	Recruiting
Nemours Childrens Clinic	Jacksonville	Florida	32207	Recruiting
Childrens Hosp Boston Dept of Heme	Boston	Massachusetts	02115	Recruiting
WA Uni School Of Med	St Louis	Missouri	63110	Recruiting
Cinn Children Hosp Medical Center	Cincinnati	Ohio	45206	Recruiting
Univ Hospital Of Cleveland	Cleveland	Ohio	44106	Recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	44195	Recruiting
Nationwide Children s Hospital	Columbus	Ohio	43205	Recruiting
Oregon Health Science University	Portland	Oregon	97239	Recruiting
CHOP Abramson Pediatric Resch Ctr	Philadelphia	Pennsylvania	19104	Recruiting
Childrens Hosp Pittsburgh UPMC	Pittsburgh	Pennsylvania	15224	Recruiting
Baylor College Of Medicine	Houston	Texas	77030	Recruiting
U of TX Health Science Ct	Houston	Texas	77030	Recruiting
Childrens Hospital and Regional Medical Center	Seattle	Washington	98105	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05948943, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 6, 2026 · Synced May 8, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05948943 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →