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 now · Phase 2
Conditions studied: PIK3CA-related Overgrowth Spectrum (PROS)
In brief
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).
Key facts
- Study ID
- NCT06997588
- Run by
- Novartis Pharmaceuticals
- People needed
- 104
- Starts
- 2025-10-09
- Expected to finish
- 2030-09-30
- Last updated by the study team
- 2026-07-08
Who can join
Age: 2 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Washington University — St Louis, Missouri, United States (enrolling)
- UNC Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Cinn Children Hosp Medical Center — Cincinnati, Ohio, United States (enrolling)
- Childrens Hosp Pittsburgh UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
- Baylor College Of Medicine — Houston, Texas, United States (enrolling)
- UT Health Science Center — Houston, Texas, United States (enrolling)
- Novartis Investigative Site — Sydney, New South Wales, Australia (enrolling)
- Novartis Investigative Site — Sydney, New South Wales, Australia (enrolling)
- Novartis Investigative Site — North Adelaide, South Australia, Australia (enrolling)
- Novartis Investigative Site — Salzburg, Austria (enrolling)
- Novartis Investigative Site — Vienna, Austria (enrolling)
- Novartis Investigative Site — Ghent, Belgium (enrolling)
- Novartis Investigative Site — Angers, France (enrolling)
- Novartis Investigative Site — Bron, France (enrolling)
- Novartis Investigative Site — Dijon, France (enrolling)
- Novartis Investigative Site — Montpellier, France (enrolling)
- Novartis Investigative Site — Paris, France (enrolling)
- Novartis Investigative Site — Toulouse, France (enrolling)
- Novartis Investigative Site — Tours, France (enrolling)
- Novartis Investigative Site — Freiburg im Breisgau, Baden-Wurttemberg, Germany (enrolling)
- Novartis Investigative Site — Düsseldorf, North Rhine-Westphalia, Germany (enrolling)
- Novartis Investigative Site — Leipzig, Saxony, Germany (enrolling)
- Novartis Investigative Site — Halle, Saxony-Anhalt, Germany (enrolling)
- Novartis Investigative Site — Berlin, Germany (enrolling)
- Novartis Investigative Site — Stuttgart, Germany (enrolling)
Full record on ClinicalTrials.gov
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