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A Two-stage Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation

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Trial Profile

A Two-stage Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 14 Nov 2025

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At a glance

  • Drugs Alpelisib (Primary) ; Alpelisib (Primary)
  • Indications Lymphatic disorders
  • Focus Therapeutic Use
  • Acronyms EPIK-L1
  • Sponsors Novartis Pharmaceuticals

Most Recent Events

  • 30 Oct 2025 Planned End Date changed from 2 May 2033 to 31 May 2028.
  • 08 May 2025 Planned number of patients changed from 230 to 232.
  • 08 May 2025 Planned End Date changed from 5 May 2030 to 2 May 2033.

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