Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib

  • STATUS
    Recruiting
  • participants needed
    65
  • sponsor
    Novartis Pharmaceuticals
Updated on 19 February 2024

Summary

The study is a site-based retrospective non-interventional medical chart review of pediatric and adult male and female patients with PIK3CA-Related Overgrowth Spectrum (PROS). Patient-level data are abstracted from medical charts of all eligible patients at all participating sites.

Information from patients treated with alpelisib will be used to describe the efficacy and safety of alpelisib in PROS patients.

Details
Condition PIK3CA-Related Overgrowth Spectrum (PROS)
Age 2years - 100years
Clinical Study IdentifierNCT04285723
SponsorNovartis Pharmaceuticals
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient (adult or pediatric) is 2 years of age
Patient has a physician confirmed/documented diagnosis of PROS
Patient has a documented evidence of a mutation in the PIK3CA gene
Patient's condition was assessed by the treating physician as severe or life threatening and treatment was deemed necessary
Patient has been treated with at least one dose of alpelisib, initiated on or before 23-Sep-2019 (i.e. at least 24 weeks before the cut-off date of the 09-Mar-2020)
Patient has medical chart history available during enrollment in the Novartis MAP
Patient (or parent/guardian in case of pediatric patient) consented to participate in the study (as required by local ethics regulations) Inclusion criteria for MAP enrollment (assessed at the time of alpelisib initiation)
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