Status:
COMPLETED
Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
PIK3CA-Related Overgrowth Spectrum (PROS)
Eligibility:
All Genders
2+ years
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 16 2021
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04285723
Start Date
June 9 2020
End Date
April 16 2021
Last Update
February 9 2023
Active Locations (7)
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1
Boston Childrens Hospital
Boston, Massachusetts, United States, 02215
2
Novartis Investigative Site
Parkville, Victoria, Australia, 3052
3
Novartis Investigative Site
Montpellier, Herault, France, 34059
4
Novartis Investigative Site
Dijon, France, 21000