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
-
Clinical Trials
Related News

Compassionate Use of BYL 719 Alpelisib

Conditions
Lymphangioma
First Posted Date
2019-05-08
Last Posted Date
2024-01-11
Lead Sponsor
New Mexico Cancer Care Alliance
Registration Number
NCT03941782
Locations
🇺🇸

University of New Mexico - Cancer Center, Albuquerque, New Mexico, United States

Managed Access Program to Provide Alpelisib for Patients With HR+ Advanced or Metastatic Breast Cancer

First Posted Date
2018-10-16
Last Posted Date
2021-07-19
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT03706573

Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas

First Posted Date
2018-08-15
Last Posted Date
2024-08-06
Lead Sponsor
Assistance Publique Hopitaux De Marseille
Target Recruit Count
25
Registration Number
NCT03631953
Locations
🇫🇷

Assistance Publique Hôpitaux de Marseille, Marseille, France

Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer

First Posted Date
2018-07-26
Last Posted Date
2024-04-17
Lead Sponsor
University of Arizona
Target Recruit Count
9
Registration Number
NCT03601507
Locations
🇺🇸

The University of Arizona Medical Center-University Campus, Tucson, Arizona, United States

Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant

First Posted Date
2018-02-20
Last Posted Date
2024-08-01
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
287
Registration Number
NCT03439046
Locations
🇮🇹

Novartis Investigative Site, Napoli, Italy

SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer

First Posted Date
2017-12-29
Last Posted Date
2022-11-28
Lead Sponsor
UNICANCER
Target Recruit Count
31
Registration Number
NCT03386162
Locations
🇫🇷

Institut Sainte-Catherine, Avignon, France

🇫🇷

Chd Vendee, La Roche Sur Yon, France

🇫🇷

CHU Dupuytren, Limoges, France

and more 11 locations

Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

First Posted Date
2017-09-15
Last Posted Date
2024-12-06
Lead Sponsor
Sanofi
Target Recruit Count
136
Registration Number
NCT03284957
Locations
🇨🇦

Investigational Site Number : 1240003, Vancouver, British Columbia, Canada

🇨🇦

Investigational Site Number : 1240002, Toronto, Ontario, Canada

🇨🇿

Investigational Site Number : 2030002, Brno, Czechia

and more 22 locations

Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer

First Posted Date
2017-07-02
Last Posted Date
2024-10-10
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
18
Registration Number
NCT03207529
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

First Posted Date
2017-02-17
Last Posted Date
2024-12-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
379
Registration Number
NCT03056755
Locations
🇺🇸

Kaiser Permanente Medical Group, Anaheim, California, United States

🇺🇸

UCSF, San Francisco, California, United States

🇺🇸

University of Louisville James Graham Brown Cancer Center, Louisville, Kentucky, United States

and more 23 locations

The Drug Rediscovery Protocol (DRUP Trial)

First Posted Date
2016-10-05
Last Posted Date
2024-01-24
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
1550
Registration Number
NCT02925234
Locations
🇳🇱

Meander medisch centrum, Amersfoort, Netherlands

🇳🇱

Netherlands Cancer Institute, Amsterdam, Netherlands

🇳🇱

Amsterdam UMC, locatie AMC, Amsterdam, Netherlands

and more 33 locations
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