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Recruiting Phase 2Phase 3 Interventional

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.

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ClinicalTrials.gov public records Last synced Sep 11, 2026, 2:21 PM 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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

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

Interventions

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
Aug 17, 2026

2023 – 2033

United States locations

U.S. sites
18
U.S. states
11
U.S. cities
16
Facility City State ZIP Site status
UCSF Benioff Children s Hospital Oakland California 94609 Recruiting
Childrens Hospital of Orange County Orange California 92868 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
UNC Chapel Hill Chapel Hill North Carolina 27599 Recruiting
Cinn Children Hosp Medical Center Cincinnati Ohio 45229-3039 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 43 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 Aug 17, 2026 · Synced Sep 11, 2026

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Open the official record

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

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