- 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) — Recruiting • Phase II • NCT06997588.
- Alpelisib (a targeted drug) tested in children and adults with PIK3CA gene mutations causing abnormal tissue overgrowth.
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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). Conditions: PIK3CA-related Overgrowth Spectrum (PROS) Interventions: Alpelisib Lead Sponsor: Novartis Pharmaceuticals Planned Enrollment: 104 participants