Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: PIK3CA-related Overgrowth Spectrum (PROS)
In brief
This is a prospective Phase II multi-center study with an initial 16-week, randomized, double-blind, placebo-controlled period, followed by two extension periods to assess the efficacy, safety and pharmacokinetics (PK) of alpelisib in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)
Key facts
- Study ID
- NCT04589650
- Run by
- Novartis Pharmaceuticals
- People needed
- 206
- Starts
- 2021-04-19
- Expected to finish
- 2031-01-09
- Last updated by the study team
- 2026-04-30
Who can join
Age: any, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCSF Birthmarks and Vascular Center — San Francisco, California, United States
- Childrens Hospital Colorado — Aurora, Colorado, United States
- Washington Univ School Of Medicine — St Louis, Missouri, United States
- Fink Childrens Ambulatory Care Ctr — New York, New York, United States
- UNC Chapel Hill — Chapel Hill, North Carolina, United States
- Cinn Children Hosp Medical Center — Cincinnati, Ohio, United States
- Cincinnati Children s Hospital Medical Center — Cincinnati, Ohio, United States
- CHOP Abramson Pediatric Resch Ctr — Philadelphia, Pennsylvania, United States
- Unv of TX Southwestern Medical Center — Dallas, Texas, United States
- Baylor College Of Medicine — Houston, Texas, United States
- Childrens Hospital and Regional Medical Center — Seattle, Washington, United States
- Novartis Investigative Site — Montreal, Quebec, Canada
- Novartis Investigative Site — Montreal, Quebec, Canada
- Novartis Investigative Site — Beijing, China
- Novartis Investigative Site — Shanghai, China
- Novartis Investigative Site — Bordeaux, France
- Novartis Investigative Site — Dijon, France
- Novartis Investigative Site — Paris, France
- Novartis Investigative Site — Tours, France
- Novartis Investigative Site — Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Novartis Investigative Site — Düsseldorf, North Rhine-Westphalia, Germany
- Novartis Investigative Site — Leipzig, Saxony, Germany
- Novartis Investigative Site — Hamburg, Germany
- Novartis Investigative Site — Heidelberg, Germany
- Novartis Investigative Site — Hong Kong, Hong Kong
Full record on ClinicalTrials.gov
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