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

Phase 1b Combo w/ Ribociclib, Alpelisib, or Everolimus

Phase 1

Recruiting

Conditions: Metastatic Breast Cancer
Advanced Breast Cancer
ER-positive Breast Cancer
HER2-negative Breast Cancer
Breast Cancer

Interventions: Drug: OP-1250
Drug: Ribociclib
Drug: Alpelisib
Drug: Everolimus

First Posted Date: 2022-08-19

Last Posted Date: 2024-10-03

Lead Sponsor: Olema Pharmaceuticals, Inc.

Target Recruit Count: 155

Registration Number: NCT05508906

Locations: 🇺🇸
Advent Health Hematology and Oncology, Orlando, Florida, United States
🇺🇸
University of Iowa, Iowa City, Iowa, United States
🇺🇸
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

and more 13 locations

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

Phase 3

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Gedatolisib
Drug: Palbociclib
Drug: Alpelisib

First Posted Date: 2022-08-16

Last Posted Date: 2024-12-19

Lead Sponsor: Celcuity Inc

Target Recruit Count: 701

Registration Number: NCT05501886

Locations: 🇺🇸
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
🇺🇸
Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A., Winter Haven, Florida, United States
🇺🇸
John D. Archbold Memorial Hospital, Thomasville, Georgia, United States

and more 214 locations

Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma

Phase 1

Withdrawn

Conditions: PIK3CA Mutation
Solid Tumors, Adult
Human Papillomavirus-Related Carcinoma
Metastatic Malignant Solid Neoplasm
HPV-Related Squamous Cell Carcinoma
PIK3CA Mutation-Related Tumors
Human Papillomavirus-Related Squamous Cell Carcinoma
Locally Advanced Malignant Solid Neoplasm

Interventions: Drug: Alpelisib
Drug: Carboplatin
Drug: Hyperpolarized Carbon-13 (13C) Pyruvate
Device: Continuous Glucose Monitor (CGM)

First Posted Date: 2022-07-25

Last Posted Date: 2022-12-27

Lead Sponsor: Pamela Munster

Registration Number: NCT05472220

SMMART Adaptive Clinical Treatment (ACT) Trial

Early Phase 1

Withdrawn

Conditions: Advanced Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Stage II Pancreatic Cancer AJCC v8
Stage III Ovarian Cancer AJCC v8
Advanced Prostate Carcinoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Breast Carcinoma
Stage IV Ovarian Cancer AJCC v8
Advanced Malignant Solid Neoplasm
Advanced Ovarian Carcinoma

First Posted Date: 2022-02-14

Last Posted Date: 2024-01-23

Lead Sponsor: OHSU Knight Cancer Institute

Registration Number: NCT05238831

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

Phase 1

Recruiting

Conditions: HER2-positive Metastatic Breast Cancer

Interventions: Drug: Alpelisib
Drug: Tucatinib
Drug: Fulvestrant

First Posted Date: 2022-02-09

Last Posted Date: 2024-03-19

Lead Sponsor: Criterium, Inc.

Target Recruit Count: 40

Registration Number: NCT05230810

Locations: 🇺🇸
University of Colorado Cancer Center, Aurora, Colorado, United States
🇺🇸
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
🇺🇸
Louisiana State University Health Sciences Center, New Orleans, Louisiana, United States

and more 1 locations

Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer

Phase 1

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Alpelisib
Drug: Sacituzumab govitecan

First Posted Date: 2021-12-03

Last Posted Date: 2023-05-09

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 18

Registration Number: NCT05143229

Locations: 🇺🇸
The University of Kansas Cancer Center - Overland Park, Overland Park, Kansas, United States
🇺🇸
The University of Kansas Cancer Center - Indian Creek, Overland Park, Kansas, United States
🇺🇸
The University of Kansas Clinical Research Center, Fairway, Kansas, United States

and more 4 locations

Umbrella Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer

Phase 2

Active, not recruiting

Conditions: Breast Cancer
HER2-negative Breast Cancer
ER Positive Breast Cancer

Interventions: Drug: Alpelisib
Drug: Fulvestrant
Drug: Zotatifin
Drug: Tamoxifen

First Posted Date: 2021-11-01

Last Posted Date: 2024-07-11

Lead Sponsor: Stanford University

Target Recruit Count: 19

Registration Number: NCT05101564

Locations: 🇺🇸
Stanford University, Stanford, California, United States

Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer

Phase 2

Active, not recruiting

Conditions: Breast Cancer
Breast Cancer Stage IV
Metastatic Breast Cancer

Interventions: Dietary Supplement: Low Carbohydrate Diet
Dietary Supplement: Ketogenic Diet
Drug: Alpelisib
Drug: Fulvestrant
Drug: Canagliflozin

First Posted Date: 2021-10-22

Last Posted Date: 2024-11-04

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 15

Registration Number: NCT05090358

Locations: 🇺🇸
Ohio State University (Data Collection & Data Analysis), Columbus, Ohio, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

and more 6 locations

Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)

Phase 3

Active, not recruiting

Conditions: Advanced Breast Cancer

Interventions: Biological: Trastuzumab
Drug: Alpelisib
Drug: Vinorelbine
Drug: Fulvestrant
Drug: Capecitabine
Drug: Eribulin

First Posted Date: 2021-10-01

Last Posted Date: 2024-04-10

Lead Sponsor: Spanish Breast Cancer Research Group

Target Recruit Count: 27

Registration Number: NCT05063786

Locations: 🇪🇸
Hospital Galdakao-Usansolo, Bilbao, Spain
🇦🇹
Ordensklinikum Linz GmbH - BHS, Linz, Austria
🇦🇹
Pyhrn - Eisenwurzen Klinikum Steyr, Steyr, Austria

and more 103 locations

Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

Phase 3

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Alpelisib
Drug: Fulvestrant
Drug: Alpelisib-matching placebo

First Posted Date: 2021-09-09

Last Posted Date: 2024-11-14

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 234

Registration Number: NCT05038735

Locations: 🇪🇸
Novartis Investigative Site, Zaragoza, Spain

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