Clinical Trial: 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)

U.S., May 31 -- ClinicalTrials.gov registry received information related to the study (NCT06997588) titled '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)' on May 21.

Brief Summary: 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).

Study Start Date: Oct. 21, 2025

Study Type: INTERVENTIONAL

Condition: PIK3CA-related Overgrowth Spectrum (PROS)

Intervention: DRUG: Alpelisib

Oral Film-Coated Tablet (FCT):

* Group 1: 250 mg once daily

* Group 2, 6 to <18 years: 125 mg once ...