# 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)

> **NCT06997588** · PHASE2 · RECRUITING · sponsor: **Novartis Pharmaceuticals** · enrollment: 104 (estimated)

## Conditions studied

- PIK3CA-related Overgrowth Spectrum (PROS)

## Interventions

- **DRUG:** Alpelisib

## Key facts

- **NCT ID:** NCT06997588
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-10-09
- **Primary completion:** 2028-08-02
- **Final completion:** 2030-09-30
- **Target enrollment:** 104 (ESTIMATED)
- **Last updated:** 2026-04-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06997588

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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)". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT06997588. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*