Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
Recruiting now · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Lymphatic Malformations
In brief
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.
Key facts
- Study ID
- NCT05948943
- Run by
- Novartis Pharmaceuticals
- People needed
- 232
- Starts
- 2023-11-24
- Expected to finish
- 2033-05-02
- Last updated by the study team
- 2026-07-14
Who can join
Age: any, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Childrens Hospital of Orange County — Orange, California, United States (enrolling)
- Lucile Packard Childrens Hosp — Palo Alto, California, United States (enrolling)
- Childrens National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
- Nemours Childrens Clinic — Jacksonville, Florida, United States (enrolling)
- Childrens Hosp Boston Dept of Heme — Boston, Massachusetts, United States (enrolling)
- WA Uni School Of Med — St Louis, Missouri, United States (enrolling)
- UNC Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Cinn Children Hosp Medical Center — Cincinnati, Ohio, United States (enrolling)
- Univ Hospital Of Cleveland — Cleveland, Ohio, United States (enrolling)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
- Nationwide Children s Hospital — Columbus, Ohio, United States (enrolling)
- Oregon Health Science University — Portland, Oregon, United States (enrolling)
- CHOP Abramson Pediatric Resch Ctr — Philadelphia, Pennsylvania, United States (enrolling)
- Childrens Hosp Pittsburgh UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
- Baylor College Of Medicine — Houston, Texas, United States (enrolling)
- U of TX Health Science Ct — Houston, Texas, United States (enrolling)
- Childrens Hospital and Regional Medical Center — Seattle, Washington, United States (enrolling)
- Novartis Investigative Site — CABA, Buenos Aires, Argentina (enrolling)
- Novartis Investigative Site — CABA, Buenos Aires, Argentina (enrolling)
- Novartis Investigative Site — Capital Federal, Argentina (enrolling)
- Novartis Investigative Site — Sydney, New South Wales, Australia (enrolling)
- Novartis Investigative Site — Sydney, New South Wales, Australia (enrolling)
- Novartis Investigative Site — Brisbane, Queensland, Australia (enrolling)
- Novartis Investigative Site — Brussels, Belgium (enrolling)
- UCSF Benioff Children s Hospital — Oakland, California, United States (enrolling)
Full record on ClinicalTrials.gov
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