232
Participants
Start Date
November 24, 2023
Primary Completion Date
September 22, 2028
Study Completion Date
May 2, 2033
Alpelisib
"In Stage 1: adult participants (≥18 years of age) will receive dose 1 or dose 2 of alpelisib; pediatric participants (6-17 years of age) will receive dose 2 or dose 3 of alpelisib.~In Stage 2: Adult participants will receive alpelisib at the dose selected for confirmatory phase in adult participants; pediatric participants (6-17 years of age) will will receive alpelisib at the dose selected for confirmatory phase in pediatric participants; and pediatric participants of 0-5 years of age will receive dose 3 of alpelisib"
Placebo
In Stage 2, participants will receive matching placebo for 24 weeks of the study
RECRUITING
Novartis Investigative Site, Brussels
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Novartis Investigative Site, Darlinghurst
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Novartis Investigative Site, Randwick
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Novartis Investigative Site, Brisbane
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Novartis Investigative Site, Marseille
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Novartis Investigative Site, Caen
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Novartis Investigative Site, A Coruña
RECRUITING
CHOP Abramson Pediatric Resch Ctr, Philadelphia
RECRUITING
Novartis Investigative Site, Milan
RECRUITING
Novartis Investigative Site, Dijon
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Novartis Investigative Site, Madrid
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Novartis Investigative Site, Madrid
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Novartis Investigative Site, Toulouse
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Novartis Investigative Site, Bordeaux
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Novartis Investigative Site, Montpellier
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Novartis Investigative Site, Tours
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Novartis Investigative Site, Bologna
RECRUITING
UHO Cleveland Or Ireland Canc Ct, Cleveland
RECRUITING
Novartis Investigative Site, Cologne
RECRUITING
Novartis Investigative Site, Lille
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WA Uni School Of Med, St Louis
RECRUITING
Novartis Investigative Site, Mannheim
RECRUITING
Novartis Investigative Site, Bron
RECRUITING
Novartis Investigative Site, Paris
RECRUITING
Novartis Investigative Site, Paris
RECRUITING
Baylor College Of Medicine, Houston
RECRUITING
U of TX Health Science Ct, Houston
RECRUITING
Novartis Investigative Site, Freiburg im Breisgau
RECRUITING
Novartis Investigative Site, Napoli
RECRUITING
Lucile Packard Childrens Hosp, Palo Alto
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UCSF Benioff Children s Hospital, Oakland
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Oregon Health Science University, Portland
RECRUITING
Childrens Hospital and Regional Medical Center, Seattle
RECRUITING
Childrens National Medical Center, Washington D.C.
RECRUITING
Childrens Hosp Boston Dept of Heme, Boston
RECRUITING
Cinn Children Hosp Medical Center, Cincinnati
RECRUITING
Novartis Investigative Site, Leipzig
RECRUITING
Novartis Investigative Site, Roma
RECRUITING
Novartis Investigative Site, Roma
RECRUITING
Novartis Investigative Site, Esplugues de Llobregat
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY