Alpelisib
- Generic Name
- Alpelisib
- Brand Names
- Piqray 300 Mg Daily Dose, Vijoice 50 Mg 28 Day, Piqray
- Drug Type
- Small Molecule
- Chemical Formula
- C19H22F3N5O2S
- CAS Number
- 1217486-61-7
- Unique Ingredient Identifier
- 08W5N2C97Q
- Background
Alpelisib is a phosphatidylinositol 3-kinase (PI3K) inhibitor with potent antitumor activity. It works by selectively inhibiting class I PI3K p110α , which is the catalytic subunit of PI3K, a lipid kinase that plays a role in various biological processes, including proliferation, survival, differentiation, and metabolism. Alpelisib was designed to target thi...
- Indication
Alpelisib is indicated in combination with fulvestrant to treat postmenopausal women, and men, with advanced or metastatic breast cancer. This cancer must be hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, and PIK3CA mutated. The cancer must be detected by an FDA-approved test following progression on or after an en...
- Associated Conditions
- HR+, HER2-, Advanced Breast Cancer, PIK3CA-Related Overgrowth Spectrum (PROS), Metastatic HR + HER2 - breast cancer
- Associated Therapies
- -
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2020-09-10
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 69
- Registration Number
- NCT04544189
- Locations
- 🇨🇳
Novartis Investigative Site, Tianjin, China
Alpelisib and Paclitaxel in PIK3CA-altered Gastric Cancer
- First Posted Date
- 2020-08-25
- Last Posted Date
- 2021-08-24
- Lead Sponsor
- Seoul National University Bundang Hospital
- Target Recruit Count
- 55
- Registration Number
- NCT04526470
- Locations
- 🇰🇷
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
🇰🇷Asan Medical Center, Seoul, Korea, Republic of
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2020-08-24
- Last Posted Date
- 2024-11-14
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 24
- Registration Number
- NCT04524000
- Locations
- 🇯🇵
Novartis Investigative Site, Niigata, Japan
Managed Access Program to Provide Access to Alpelisib for Patients With Advanced Breast Cancer
- Conditions
- First Posted Date
- 2020-07-16
- Last Posted Date
- 2024-10-29
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT04473040
Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients
- Conditions
- Interventions
- First Posted Date
- 2020-03-09
- Last Posted Date
- 2024-06-03
- Lead Sponsor
- MedSIR
- Target Recruit Count
- 69
- Registration Number
- NCT04300790
- Locations
- 🇪🇸
Hospital General Universitario de Alicante, Alicante, Spain
🇪🇸Hospital Universitario de Leon, León, Spain
🇪🇸Hospital Beata María Ana, Madrid, Spain
Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
- Conditions
- Interventions
- First Posted Date
- 2020-02-05
- Last Posted Date
- 2024-07-31
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 137
- Registration Number
- NCT04251533
- Locations
- 🇺🇸
University Of California LA Santa Monica Location, Los Angeles, California, United States
🇺🇸Park Nicollet Institute Dept Onc, Saint Louis Park, Minnesota, United States
🇬🇧Novartis Investigative Site, Oxford, United Kingdom
Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8
- Interventions
- First Posted Date
- 2020-01-02
- Last Posted Date
- 2024-10-28
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 8
- Registration Number
- NCT04216472
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
- Conditions
- Interventions
- First Posted Date
- 2019-12-23
- Last Posted Date
- 2024-11-15
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 19
- Registration Number
- NCT04208178
- Locations
- 🇺🇸
Highlands Oncology Group, Fayetteville, Arkansas, United States
🇺🇸University of California LA, Los Angeles, California, United States
🇪🇸Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-12-06
- Last Posted Date
- 2024-08-28
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 500
- Registration Number
- NCT04188548
- Locations
- 🇺🇸
Winship Cancer Center Emory University, Atlanta, Georgia, United States
🇺🇸Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Managed Access Program (MAP) to Provide Access to Alpelisib (BYL719) for Patients With PIK3CA-Related Overgrowth Spectrum (PROS)
- First Posted Date
- 2019-09-11
- Last Posted Date
- 2024-10-28
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT04085653
Drug Development Updates
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