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EPIK-P2: A Phase II Double-blind Study With an Upfront, 16-week Randomized, Placebo-controlled Period, to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

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Trial Profile

EPIK-P2: A Phase II Double-blind Study With an Upfront, 16-week Randomized, Placebo-controlled Period, to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 16 Aug 2025

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At a glance

  • Drugs Alpelisib (Primary)
  • Indications Growth disorders
  • Focus Therapeutic Use
  • Acronyms EPIK-P2
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 30 Jul 2025 Planned End Date changed from 21 Feb 2031 to 28 Feb 2031.
  • 02 Jul 2025 Planned End Date changed from 14 Feb 2031 to 21 Feb 2031.
  • 10 Feb 2025 Planned End Date changed from 28 Apr 2031 to 14 Feb 2031.

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