NCT06997588 - 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) | Biotech Hunter

Enrollment

104

Participants

Timeline

Start Date

October 9, 2025

Primary Completion Date

August 2, 2028

Study Completion Date

September 30, 2030

Conditions

PIK3CA-related Overgrowth Spectrum (PROS)

Interventions

DRUG

Alpelisib

"Oral Film-Coated Tablet (FCT):~* Group 1: 250 mg once daily~* Group 2, 6 to \<18 years: 125 mg once daily (starting dose)~Granules:~• Group 2, 2 to \<6 years: 50 mg once daily (starting dose)"

Trial Locations (2)

2010

RECRUITING

Novartis Investigative Site, Darlinghurst

2031

RECRUITING

Novartis Investigative Site, Randwick