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A Phase II Study to Evaluate the Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)

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Trial Profile

A Phase II Study to Evaluate the Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)

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

Latest Information Update: 12 Oct 2024

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At a glance

  • Drugs Alpelisib (Primary)
  • Indications Growth disorders
  • Focus Adverse reactions
  • Acronyms EPIK-P3
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 19 Mar 2024 Planned End Date changed from 23 Aug 2027 to 1 Sep 2027.
  • 19 Mar 2024 Planned primary completion date changed from 26 Jul 2027 to 5 Aug 2027.
  • 28 Jul 2023 Planned End Date changed from 10 Sep 2027 to 23 Aug 2027.

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