137
Participants
Start Date
June 8, 2020
Primary Completion Date
May 31, 2023
Study Completion Date
January 13, 2026
alpelisib
300 mg orally, once per day (QD), tablets
placebo
300 mg orally, once per day (QD), tablets
nab-paclitaxel
100 mg/m\^2 IV infusion, once per day (QD)
Novartis Investigative Site, Ljubljana
Novartis Investigative Site, Lausanne
Novartis Investigative Site, Budapest
Novartis Investigative Site, Johannesburg
Novartis Investigative Site, Melbourne
Novartis Investigative Site, Plovdiv
Novartis Investigative Site, Nedlands
Novartis Investigative Site, Innsbruck
Novartis Investigative Site, Port Elizabeth
Novartis Investigative Site, Zagreb
Novartis Investigative Site, Taipei
Novartis Investigative Site, Taipei
Novartis Investigative Site, Trujillo
Novartis Investigative Site, Istanbul
Novartis Investigative Site, Istanbul
SCRI Oncology Partners, Nashville
Novartis Investigative Site, Saint-Herblain
Novartis Investigative Site, Essen
Novartis Investigative Site, Petaling Jaya
Novartis Investigative Site, Meldola
Novartis Investigative Site, Angers
Park Nicollet Institute, Saint Louis Park
Mayo Clinic Rochester, Rochester
Novartis Investigative Site, Kuala Lumpur
Novartis Investigative Site, Monterrey
Hematology and Oncology Clinic, Baton Rouge
Novartis Investigative Site, Napoli
Novartis Investigative Site, Bratislava
University of California LA, Los Angeles
Novartis Investigative Site, Saint-Cloud
Novartis Investigative Site, Villejuif
Novartis Investigative Site, Shenyang
Novartis Investigative Site, Shengyang
Novartis Investigative Site, Bogotá
Novartis Investigative Site, Dalian
Novartis Investigative Site, Moscow
Novartis Investigative Site, Moscow
Novartis Investigative Site, Changchun
Novartis Investigative Site, Arkhangelsk
Novartis Investigative Site, Saint Petersburg
Novartis Investigative Site, Shanghai
Novartis Investigative Site, Nanjing
Novartis Investigative Site, Hefei
Novartis Investigative Site, Tianjin
Novartis Investigative Site, Hangzhou
Novartis Investigative Site, Nanchang
Novartis Investigative Site, Mumbai
Novartis Investigative Site, Changsha
Novartis Investigative Site, Chelyabinsk
Novartis Investigative Site, Hyderabad
Novartis Investigative Site, Chengdu
Novartis Investigative Site, Tel Aviv
Novartis Investigative Site, Rosario
Novartis Investigative Site, CABA
Novartis Investigative Site, Leoben
Novartis Investigative Site, Barretos
Novartis Investigative Site, São Paulo
Novartis Investigative Site, São Paulo
Novartis Investigative Site, Shijiazhuang
Novartis Investigative Site, Dresden
Novartis Investigative Site, Leipzig
Novartis Investigative Site, Faridabad
Novartis Investigative Site, Vellore
Novartis Investigative Site, Roma
Novartis Investigative Site, Oslo
Novartis Investigative Site, Gdynia
Novartis Investigative Site, Opole
Novartis Investigative Site, Poznan
Novartis Investigative Site, Bratislava
Novartis Investigative Site, Košice
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, Palma
Novartis Investigative Site, Badajoz
Novartis Investigative Site, Alicante
Novartis Investigative Site, Nottingham
Novartis Investigative Site, Oxford
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY