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Clinical Trial ● Currently Recruiting Phase II 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)

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…

📅 29 Apr 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase II
NCT ID
NCT06997588
Start
2025-10-09
Completion
2028-08-02
ClinicaliQ Trial Snapshot
  • 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.

Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.

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  • Quick orientation before opening the registry record.
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  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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