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
- -
Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.
- First Posted Date
- 2015-12-08
- Last Posted Date
- 2020-12-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 23
- Registration Number
- NCT02624557
- Locations
- 🇺🇸
University of Miami / Clinical Research Services, Inc., Miami, Florida, United States
🇺🇸DaVita Clinical Research-Denver, Lakewood, Colorado, United States
🇺🇸DaVita Clinical Research, Minneapolis, Minnesota, United States
Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies
- First Posted Date
- 2015-12-03
- Last Posted Date
- 2020-01-10
- Lead Sponsor
- Pamela Munster
- Target Recruit Count
- 28
- Registration Number
- NCT02620839
- Locations
- 🇺🇸
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
- Conditions
- Interventions
- First Posted Date
- 2015-05-07
- Last Posted Date
- 2023-11-18
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 572
- Registration Number
- NCT02437318
- Locations
- 🇺🇸
Lahey Clinic, Burlington, Massachusetts, United States
🇺🇸Virginia Cancer Specialists SC, Fairfax, Virginia, United States
🇺🇸Highlands Oncology Group, Fayetteville, Arkansas, United States
Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors
- Conditions
- Interventions
- First Posted Date
- 2014-03-04
- Last Posted Date
- 2020-12-08
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 79
- Registration Number
- NCT02077933
- Locations
- 🇬🇧
Novartis Investigative Site, Manchester, United Kingdom
🇺🇸Memorial Sloan Kettering Cancer Center SC - BYL719Z2102, New York, New York, United States
🇺🇸Highlands Oncology Group, Fayetteville, Arkansas, United States
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
- First Posted Date
- 2013-08-15
- Last Posted Date
- 2018-09-14
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 340
- Registration Number
- NCT01923168
- Locations
- 🇺🇸
Emory University School of Medicine/Winship Cancer Institute SC, Atlanta, Georgia, United States
🇺🇸Los Angeles Hematology/Oncology Medical Group Onc Dept., Los Angeles, California, United States
🇺🇸Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp, Dallas, Texas, United States
Drug Development Updates
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