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Clinical Trial Summary

The study was a site-based retrospective non-interventional medical chart review of pediatric and adult male and female patients with PIK3CA-Related Overgrowth Spectrum (PROS) who initiated alpelisib at least 24 weeks before the cut-off date at a MAP site. The study cut-off date was 09-Mar-2020. Patient-level data were abstracted from medical charts of all eligible patients at all participating sites. Study completion date refers to the last date data was extracted. Information from patients treated with alpelisib was used to describe the efficacy and safety of alpelisib in PROS patients.


Clinical Trial Description

The index date (baseline) is defined as the date of alpelisib initiation. The study period is the period from the index date up to the most recent data available at the time of the cut-off date. The maximum follow-up was 187 weeks. ;


Study Design


Related Conditions & MeSH terms

  • PIK3CA-Related Overgrowth Spectrum (PROS)

NCT number NCT04285723
Study type Observational
Source Novartis
Contact
Status Completed
Phase
Start date June 9, 2020
Completion date April 16, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04980833 - Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1) Phase 2
Completed NCT02428296 - Study of Sirolimus Therapy for Segmental Overgrowth Caused by Somatic PI3K Activation Phase 2
Recruiting NCT04589650 - Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum Phase 2
Available NCT04085653 - Managed Access Program (MAP) to Provide Access to Alpelisib (BYL719) for Patients With PIK3CA-Related Overgrowth Spectrum (PROS)
No longer available NCT03317366 - Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies