Alpelisib

Generic Name: Alpelisib

Brand Names: Piqray 300 Mg Daily Dose, Vijoice 50 Mg 28 Day, Piqray

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₂F_₃N_₅O_₂S

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

Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib

Active, not recruiting

Conditions: Metastatic Breast Cancer

Interventions: Drug: Alpelisib
Device: FreeStyle Libre 2 Continuous Glucose Monitor

First Posted Date: 2023-10-13

Last Posted Date: 2024-12-09

Lead Sponsor: HealthPartners Institute

Target Recruit Count: 15

Registration Number: NCT06083038

Locations: 🇺🇸
HealthPartners Cancer Research Center, Saint Louis Park, Minnesota, United States

A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations

Phase 2

Recruiting

Conditions: Venous Malformation
Slow-Flow Vascular Malformation
Fast-Flow Vascular Malformation
Arteriovenous Malformations
PIK3CA-related Overgrowth Spectrum
Lymphatic Malformation, Low Flow
Lymphatic Malformation
Vascular Anomaly
KRAS G12D
Vascular Malformations

Interventions: Drug: Alpelisib
Drug: Mirdametinib

First Posted Date: 2023-08-09

Last Posted Date: 2024-11-27

Lead Sponsor: Murdoch Childrens Research Institute

Target Recruit Count: 50

Registration Number: NCT05983159

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Parkville, Victoria, Australia
🇦🇺
The Royal Children's Hospital, Parkville, Victoria, Australia

Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial

Phase 2

Withdrawn

Conditions: Metastatic HER2-Negative Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Unresectable HER2-Negative Breast Carcinoma

Interventions: Drug: Alpelisib
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Drug: Olaparib
Procedure: Positron Emission Tomography

First Posted Date: 2023-08-01

Last Posted Date: 2024-03-20

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT05967286

Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

Phase 2

Recruiting

Conditions: Lymphatic Malformations

Interventions: Drug: Alpelisib
Drug: Placebo

First Posted Date: 2023-07-17

Last Posted Date: 2024-11-15

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 230

Registration Number: NCT05948943

Locations: 🇺🇸
Lucile Packard Childrens Hosp, Palo Alto, California, United States
🇺🇸
WA Uni School Of Med, Saint Louis, Missouri, United States
🇺🇸
Cinn Children Hosp Medical Center, Cincinnati, Ohio, United States

and more 4 locations

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Phase 2

Recruiting

Conditions: Advanced Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Neratinib
Drug: Alpelisib
Drug: Everolimus
Drug: Abemaciclib

First Posted Date: 2023-07-06

Last Posted Date: 2023-10-26

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 135

Registration Number: NCT05933395

Locations: 🇺🇸
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

Phase 3

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Inavolisib
Drug: Fulvestrant
Drug: Alpelisib

First Posted Date: 2022-12-12

Last Posted Date: 2024-11-25

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 400

Registration Number: NCT05646862

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇧🇷
Instituto D'Or de Pesquisa e Ensino, Rio de Janeiro, RJ, Brazil
🇺🇸
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

and more 205 locations

Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment

Phase 4

Recruiting

Conditions: Advanced Breast Cancer

Interventions: Drug: Alpelisib
Drug: Fulvestrant

First Posted Date: 2022-11-30

Last Posted Date: 2024-10-10

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 100

Registration Number: NCT05631795

Locations: 🇮🇳
Novartis Investigative Site, New Delhi, India

Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib

Phase 2

Recruiting

Conditions: Breast Cancer Stage IV

Interventions: Drug: Alpelisib
Drug: Ribociclib

First Posted Date: 2022-11-22

Last Posted Date: 2024-06-24

Lead Sponsor: UNICANCER

Target Recruit Count: 162

Registration Number: NCT05625087

Locations: 🇫🇷
Clinique de l'Europe Amiens - CTHE, Amiens, France
🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷
Centre Hospitalier de Boulogne-sur-Mer, Boulogne-sur-Mer, France

and more 40 locations

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

Phase 1

Recruiting

Conditions: Breast Cancer
Metastatic Breast Cancer

Interventions: Drug: Elacestrant
Drug: Ribociclib
Drug: Everolimus
Drug: Alpelisib
Drug: Capivasertib
Drug: Palbociclib
Drug: Abemaciclib

First Posted Date: 2022-10-03

Last Posted Date: 2024-11-18

Lead Sponsor: Stemline Therapeutics, Inc.

Target Recruit Count: 400

Registration Number: NCT05563220

Locations: 🇩🇪
Universitaetsklinikum Mannheim, Mannheim, Baden-Wuerttemberg, Germany
🇺🇸
Dothan Hematology and Oncology, Dothan, Alabama, United States
🇺🇸
Mayo Clinic - Arizona, Phoenix, Arizona, United States

and more 108 locations

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Phase 2

Recruiting

Conditions: Metastatic HER2-Negative Breast Carcinoma
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Malignant Female Reproductive System Neoplasm
Recurrent Ovarian Carcinoma
Unresectable HER2-Negative Breast Carcinoma
Unresectable Malignant Solid Neoplasm
Advanced Malignant Solid Neoplasm

First Posted Date: 2022-10-03

Last Posted Date: 2024-12-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2900

Registration Number: NCT05564377

Locations: 🇺🇸
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States
🇺🇸
Corewell Health Dearborn Hospital, Dearborn, Michigan, United States
🇺🇸
Corewell Health Farmington Hills Hospital, Farmington Hills, Michigan, United States

and more 422 locations

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