● Recruiting

EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

Condition: PIK3CA-related Overgrowth Spectrum (PROS) · Sponsor: Novartis Pharmaceuticals

PhasePhase 2

Planned participants104

Who can joinAll sexes, 2 Years to 100 Years

Healthy volunteersNo

About this study

This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).

This description comes directly from the study's public registry record.

Talk to the study team

Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com

Novartis Pharmaceuticals · +41613241111 · novartis.email@novartis.com

Always discuss trial participation with your own doctor first.

Locations (35)

Washington University	St Louis, Missouri, United States	Recruiting
UNC Chapel Hill	Chapel Hill, North Carolina, United States	Recruiting
Cinn Children Hosp Medical Center	Cincinnati, Ohio, United States	Recruiting
Childrens Hosp Pittsburgh UPMC	Pittsburgh, Pennsylvania, United States	Recruiting
Baylor College Of Medicine	Houston, Texas, United States	Recruiting
UT Health Science Center	Houston, Texas, United States	Recruiting
Novartis Investigative Site	Sydney, New South Wales, Australia	Recruiting
Novartis Investigative Site	Sydney, New South Wales, Australia	Recruiting
Novartis Investigative Site	North Adelaide, South Australia, Australia	Recruiting
Novartis Investigative Site	Salzburg, Austria	Recruiting
Novartis Investigative Site	Vienna, Austria	Recruiting
Novartis Investigative Site	Ghent, Belgium	Recruiting

+ 23 more locations — full list on the registry record.

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT06997588