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
- -
Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
- First Posted Date
- 2021-08-10
- Last Posted Date
- 2023-10-25
- Lead Sponsor
- Kura Oncology, Inc.
- Target Recruit Count
- 40
- Registration Number
- NCT04997902
- Locations
- 🇺🇸
University of Maryland School of Medicine (Marlene and Stewart Greenebaum Comprehensive Cancer Center), Baltimore, Maryland, United States
🇺🇸Johns Hopkins University School of Medicine (Sidney Kimmel Comprehensive Cancer Center), Baltimore, Maryland, United States
🇺🇸City of Hope Comprehensive Cancer Center, Duarte, California, United States
Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)
- Conditions
- Interventions
- First Posted Date
- 2021-07-28
- Last Posted Date
- 2024-10-10
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 41
- Registration Number
- NCT04980833
- Locations
- 🇺🇸
Boston Childrens Hospital ., Boston, Massachusetts, United States
🇪🇸Novartis Investigative Site, Madrid, Spain
Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
- Conditions
- Interventions
- First Posted Date
- 2021-05-24
- Last Posted Date
- 2024-10-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 2
- Registration Number
- NCT04899349
- Locations
- 🇺🇸
Washington Uni School of Med Siteman Cancer Center, Saint Louis, Missouri, United States
🇲🇾Novartis Investigative Site, Kuala Lumpur, Malaysia
Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant
- Conditions
- Interventions
- First Posted Date
- 2021-04-27
- Last Posted Date
- 2024-06-20
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 2
- Registration Number
- NCT04862143
- Locations
- 🇸🇪
Novartis Investigative Site, Orebro, Sweden
Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.
- First Posted Date
- 2021-04-21
- Last Posted Date
- 2021-04-21
- Lead Sponsor
- Blokhin's Russian Cancer Research Center
- Target Recruit Count
- 1000
- Registration Number
- NCT04852081
- Locations
- 🇷🇺
N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russian Federation
Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study
- Conditions
- Interventions
- First Posted Date
- 2021-03-17
- Last Posted Date
- 2023-05-10
- Lead Sponsor
- Peter MacCallum Cancer Centre, Australia
- Target Recruit Count
- 3
- Registration Number
- NCT04801966
- Locations
- 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer
- First Posted Date
- 2021-02-21
- Last Posted Date
- 2024-10-30
- Lead Sponsor
- Marina N Sharifi
- Target Recruit Count
- 44
- Registration Number
- NCT04762979
- Locations
- 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸University of Illinois Cancer Center, Chicago, Illinois, United States
🇺🇸University of Wisconsin, Madison, Wisconsin, United States
Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected
- Conditions
- Interventions
- First Posted Date
- 2021-01-28
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 358
- Registration Number
- NCT04729387
- Locations
- 🇺🇸
Arizona Oncology Associates, Phoenix, Arizona, United States
🇺🇸Highlands Oncology Group, Fayetteville, Arkansas, United States
🇺🇸Maryland Oncology Hematology P A, Silver Spring, Maryland, United States
The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy
- Conditions
- Interventions
- Drug: Oncology DrugsDrug: ErlotinibDrug: TrastuzumabDrug: Trastuzumab emtansineDrug: PertuzumabDrug: LapatinibDrug: EverolimusDrug: VemurafenibDrug: CobimetinibDrug: AlectinibDrug: BrigatinibDrug: PalbociclibDrug: PonatinibDrug: VismogedibDrug: ItacitinibDrug: IpatasertibDrug: EntrectinibDrug: AtezolizumabDrug: NivolumabDrug: IpilimumabDrug: PemigatinibDrug: PralsetinibDrug: SelpercatinibDrug: TalazoparibDrug: TepotinibDrug: Alpelisib
- First Posted Date
- 2020-10-19
- Last Posted Date
- 2023-10-03
- Lead Sponsor
- Fondazione per la Medicina Personalizzata
- Target Recruit Count
- 400
- Registration Number
- NCT04591431
- Locations
- 🇮🇹
I.R.S.T. Srl Irccs, Meldola, Italy
🇮🇹Ospedale Classificato Sacro Cuore - Don Calabria, Negrar, Italy
🇮🇹I.R.C.C.S. Istituto Oncologico Veneto, Padova, Italy
Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum
- Conditions
- Interventions
- First Posted Date
- 2020-10-19
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 189
- Registration Number
- NCT04589650
- Locations
- 🇺🇸
University of Wisconsin Hospital, Madison, Wisconsin, United States
🇬🇧Novartis Investigative Site, Manchester, United Kingdom
🇺🇸Childrens Hospital Colorado, Aurora, Colorado, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.