Overview

Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum

Status:
Recruiting
Trial end date:
2029-12-26
Target enrollment:
Participant gender:
Summary
This is a prospective Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and pharmacokinetics of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth spectrum (PROS).
Phase:
Phase 2
Details
Lead Sponsor:
Novartis Pharmaceuticals