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Conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Refractory Breast Carcinoma, Triple-Negative Breast Carcinoma
Interventions: Alpelisib, Nab-paclitaxel; Drug
Lead sponsor: M.D. Anderson Cancer Center; Other
Eligibility: 18 Years and older
Enrollment: 6 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2025
U.S. locations: 1
States / cities: Houston, Texas

Conditions: Advanced Solid Tumors With an Alteration of the PIK3CA Gene, Estrogen Receptor Positive Breast Cancer
Interventions: BYL719, Fulvestrant; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years and older
Enrollment: 221 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2010 – 2020
U.S. locations: 5
States / cities: San Francisco, California • Boston, Massachusetts • Nashville, Tennessee + 1 more

Conditions: Triple Negative Breast Cancer, Hormone-Resistant Breast Cancer, Non Small Cell Lung Cancer, Mesothelioma
Interventions: AG-01 Compound; Drug
Lead sponsor: A&G Pharmaceutical Inc.; Industry
Eligibility: 18 Years and older
Enrollment: 77 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2022 – 2026
U.S. locations: 1
States / cities: Baltimore, Maryland

Conditions: Solid Tumors
Interventions: Alpelisib, Cisplatin; Drug
Lead sponsor: Pamela Munster; Other
Eligibility: 18 Years and older
Enrollment: 28 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2016 – 2019
U.S. locations: 1
States / cities: San Francisco, California

Conditions: Uveal Melanoma
Interventions: AEB071, BYL719; Drug
Lead sponsor: Columbia University; Other
Eligibility: 18 Years and older
Enrollment: 30 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2018
U.S. locations: 3
States / cities: Miami, Florida • New York, New York

Conditions: Breast Cancer
Interventions: Not listed
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years and older
Enrollment: 1,093 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2021
U.S. locations: 1
States / cities: East Hanover, New Jersey

Conditions: Neoplasms, Breast Neoplasms, Kidney Neoplasms, Pancreatic Neuroendocine Neoplasms (pNETs)
Interventions: alpelisib, everolimus, exemestane; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years and older
Enrollment: 79 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2019
U.S. locations: 2
States / cities: Fayetteville, Arkansas • New York, New York

Conditions: HER2-positive Breast Cancer, Recurrent Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
Interventions: PI3K inhibitor BYL719, ado-trastuzumab emtansine, pharmacological study, laboratory biomarker analysis; Drug · Biological · Other
Lead sponsor: Northwestern University; Other
Eligibility: 18 Years and older · Female only
Enrollment: 17 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2017
U.S. locations: 1
States / cities: Chicago, Illinois

Conditions: Breast Cancer
Interventions: BYL719, LJM716, TRASTUZUMAB; Drug
Lead sponsor: Memorial Sloan Kettering Cancer Center; Other
Eligibility: 18 Years and older · Female only
Enrollment: 23 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2021
U.S. locations: 6
States / cities: Basking Ridge, New Jersey • Middletown, New Jersey • Commack, New York + 3 more

Conditions: Neoplasms, Breast Neoplasms, Head and Neck Neoplasms
Interventions: BYL719, Paclitaxel; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years and older
Enrollment: 19 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2016
U.S. locations: 2
States / cities: Fayetteville, Arkansas • Lafayette, Indiana

Conditions: Colorectal Cancer
Interventions: LGX818, Cetuximab, BYL719; Drug
Lead sponsor: Pfizer; Industry
Eligibility: 18 Years and older
Enrollment: 156 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2012 – 2019
U.S. locations: 32
States / cities: Los Angeles, California • Santa Monica, California • New Haven, Connecticut + 14 more

Conditions: PIK3CA-related Overgrowth Spectrum
Interventions: Alpelisib; Other
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 5 Years to 99 Years
Enrollment: 77 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2022 – 2024
U.S. locations: 1
States / cities: East Hanover, New Jersey

Conditions: Insulin Resistance, Hyperinsulinemia, Dyslipidemias
Interventions: Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg), Placebo (microcrystalline cellulose), 2 capsules, FreeStyle Libre Pro, Oral glucose tolerance test (OGTT) with Trutol glucose beverage, BOOST Plus nutritional beverage; Drug · Device · Diagnostic Test + 1 more
Lead sponsor: Columbia University; Other
Eligibility: 18 Years to 65 Years
Enrollment: 23 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2023
U.S. locations: 1
States / cities: New York, New York

Conditions: Melanoma (Skin Cancer), Breast Cancer, Brain Metastasases
Interventions: Alpelisib + Pembrolizumab; Drug
Lead sponsor: M.D. Anderson Cancer Center; Other
Eligibility: 18 Years and older
Enrollment: 50 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2029
U.S. locations: 1
States / cities: Houston, Texas

Conditions: CDKN2A-p16 Positive, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Stage I Oropharyngeal Squamous Cell Carcinoma AJCC V7, Stage II Oropharyngeal Squamous Cell Carcinoma AJCC V7, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
Interventions: Alpelisib, Laboratory Biomarker Analysis, Pharmacodynamic Study, Therapeutic Conventional Surgery; Drug · Other · Procedure
Lead sponsor: University of Arizona; Other
Eligibility: Not listed
Enrollment: 9 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2019 – 2022
U.S. locations: 1
States / cities: Tucson, Arizona

Conditions: Triple Negative Breast Neoplasms
Interventions: alpelisib, placebo, nab-paclitaxel; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years to 100 Years
Enrollment: 137 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2026
U.S. locations: 5
States / cities: Los Angeles, California • Baton Rouge, Louisiana • Rochester, Minnesota + 2 more

Conditions: Stomach Neoplasms Esophageal Neoplasms Metastatic Gastric Cancer Mutated PI3KCA Protein Overexpressed HER2 Protein
Interventions: AUY922, BYL719; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years and older
Enrollment: 18 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2012 – 2014
U.S. locations: 2
States / cities: Boston, Massachusetts • Houston, Texas

Conditions: HER2-negative Breast Cancer, Metastatic Breast Cancer, Metaplastic Breast Carcinoma, TNBC - Triple-Negative Breast Cancer
Interventions: L-NMMA; Drug
Lead sponsor: The Methodist Hospital Research Institute; Other
Eligibility: 18 Years and older
Enrollment: 36 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2028
U.S. locations: 3
States / cities: Bethesda, Maryland • Houston, Texas

Conditions: Breast Cancer
Interventions: Fulvestrant, Alpelisib, Placebo; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years to 100 Years
Enrollment: 572 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2015 – 2023
U.S. locations: 34
States / cities: Chandler, Arizona • Scottsdale, Arizona • Fayetteville, Arkansas + 31 more

Conditions: Advanced Breast Cancer
Interventions: Fulvestrant, Neratinib, Alpelisib, Everolimus, Abemaciclib; Drug
Lead sponsor: Dartmouth-Hitchcock Medical Center; Other
Eligibility: 18 Years and older · Female only
Enrollment: 135 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2031
U.S. locations: 1
States / cities: Lebanon, New Hampshire

Conditions: Hepatic Impairment
Interventions: Alpelisib; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years to 75 Years
Enrollment: 23 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2015 – 2017
U.S. locations: 4
States / cities: Lakewood, Colorado • Miami, Florida • Orlando, Florida + 1 more

Conditions: Insulin Resistance, Prediabetic State, Overweight and Obesity, Non-Alcoholic Fatty Liver Disease
Interventions: Alpelisib 300 mg, Placebo, [1-13C] sodium acetate, [6,6-2H2] D-glucose, Mixed Meal Tolerance Test, Nestlé BOOST Plus; Drug · Diagnostic Test · Dietary Supplement
Lead sponsor: Columbia University; Other
Eligibility: 18 Years to 70 Years
Enrollment: 32 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2024 – 2026
U.S. locations: 1
States / cities: New York, New York

Conditions: Metastatic or Locally-advanced Unresectable Breast Cancer
Interventions: BYL719, Letrozole, Exemestane; Drug
Lead sponsor: Memorial Sloan Kettering Cancer Center; Other
Eligibility: 18 Years and older · Female only
Enrollment: 52 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2013 – 2022
U.S. locations: 1
States / cities: New York, New York

Conditions: Breast Cancer
Interventions: LEE011, BYL719, fulvestrant, BKM120; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years and older · Female only
Enrollment: 70 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2018
U.S. locations: 3
States / cities: Birmingham, Alabama • Boston, Massachusetts • Nashville, Tennessee

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Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies

Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies

Trial of AEB071 in Combination With BYL719 in Patients With Melanoma

Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer

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

BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx

Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer

A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer

Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer

Health-related Quality of Life, Symptom Severity, and Pain Among Patients With PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study

Effect of Alpelisib in Healthy Volunteers

Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)

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

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer

Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)

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.

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

Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.

Human Models of Selective Insulin Resistance: Alpelisib, Part I

BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer

Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer