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ClinicalTrials.gov public records Last synced Sep 1, 2026, 10:23 PM EDT

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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: BYL719 Clear all
Active, not recruiting Phase 2 Interventional

24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs

NCT07543822
View directory record Official record
Conditions
Vascular Anomalies, Vascular Anomaly, TIE2/PIK3CA Pathway Driven Vascular Anomalies
Interventions
alpelisib (BYL719)
Drug
Lead sponsor
Children's Hospital of Philadelphia
Other
Eligibility
2 Years to 30 Years
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 21, 2026 · Synced Sep 1, 2026, 10:23 PM EDT
Terminated Phase 2 Interventional Results available

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

NCT04216472
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Sep 1, 2026, 10:23 PM EDT
Recruiting Phase 1Phase 2 Interventional

First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

NCT05768139
View directory record Official record
Conditions
Breast Cancer, Solid Tumors, Adult
Interventions
STX-478, Fulvestrant, Ribociclib, Palbociclib, Letrozole, Anastrozole, Exemestane, Tamoxifen, Abemaciclib, Imlunestrant, Metformin
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
880 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2030
U.S. locations
28
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 22 more
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Sep 1, 2026, 10:23 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

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

NCT03284957
View directory record Official record
Conditions
Breast Cancer
Interventions
Amcenestrant, Palbociclib, Alpelisib, Everolimus, Abemaciclib
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older · Female only
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
4
States / cities
Aurora, Colorado • Boston, Massachusetts • New York, New York + 1 more
Source: ClinicalTrials.gov public record
Updated Nov 23, 2025 · Synced Sep 1, 2026, 10:23 PM EDT
Completed Phase 1 Interventional

Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

NCT01928459
View directory record Official record
Conditions
Advanced Solid Tumors, Metastatic Solid Tumors
Interventions
BGJ398, BYL719
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
7
States / cities
Tampa, Florida • Ann Arbor, Michigan • Detroit, Michigan + 4 more
Source: ClinicalTrials.gov public record
Updated Dec 8, 2020 · Synced Sep 1, 2026, 10:23 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

NCT01602315
View directory record Official record
Conditions
Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
Interventions
BYL719 as film-coated (FC) whole tablets, BYL719 as dispersible tablets (DT), cetuximab, BYL719 drink suspension
Drug · Biological
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
179 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
14
States / cities
Sacramento, California • San Francisco, California • Aurora, Colorado + 10 more
Source: ClinicalTrials.gov public record
Updated Dec 28, 2020 · Synced Sep 1, 2026, 10:23 PM EDT
Completed No phase listed Observational

A Real-world Study of Effectiveness and Safety in HR+/HER2- Breast Cancer Patients Treated With Ribociclib or Alpelisib

NCT06705504
View directory record Official record
Conditions
Hormone Receptor Positive HER-2 Negative Breast Cancer
Interventions
Not listed
Lead sponsor
Novartis
Industry
Eligibility
18 Years and older
Enrollment
435 participants
Timeline
2021 – 2023
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Nov 25, 2024 · Synced Sep 1, 2026, 10:23 PM EDT
Completed No phase listed Observational

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

NCT06083038
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
Alpelisib, FreeStyle Libre 2 Continuous Glucose Monitor
Drug · Device
Lead sponsor
HealthPartners Institute
Other
Eligibility
18 Years and older
Enrollment
8 participants
Timeline
2023 – 2026
U.S. locations
1
States / cities
Saint Louis Park, Minnesota
Source: ClinicalTrials.gov public record
Updated May 5, 2026 · Synced Sep 1, 2026, 10:23 PM EDT
Completed Phase 1 Interventional Results available

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

NCT02038010
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jun 28, 2020 · Synced Sep 1, 2026, 10:23 PM EDT
Recruiting Phase 1 Interventional

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

NCT06545682
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Aug 24, 2026 · Synced Sep 1, 2026, 10:23 PM EDT
Completed Phase 1 Interventional

Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

NCT01822613
View directory record Official record
Conditions
Esophageal Squamous Cell Carcinoma
Interventions
LJM716, BYL719, Paclitaxel, Docetaxel, Irinotecan
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
3
States / cities
Chicago, Illinois • Detroit, Michigan • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 1, 2026, 10:23 PM EDT
Terminated Phase 2 Interventional Results available

Biology Guided Therapy for Breast Cancer for ER Positive

NCT04965688
View directory record Official record
Conditions
Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
Interventions
Biopsy-Guided Therapy Selection
Drug
Lead sponsor
Inova Health Care Services
Other
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
1
States / cities
Fairfax, Virginia
Source: ClinicalTrials.gov public record
Updated Apr 9, 2025 · Synced Sep 1, 2026, 10:23 PM EDT
Completed Phase 1 Interventional

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

NCT01219699
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Sep 21, 2020 · Synced Sep 1, 2026, 10:23 PM EDT
Completed Phase 1 Interventional

Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC)

NCT02282371
View directory record Official record
Conditions
Head and Neck Squamous Cell Cancer
Interventions
Cetuximab, BYL719, IMRT (Intensity-Modulated Radiation Therapy)
Drug · Radiation
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
16 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
Source: ClinicalTrials.gov public record
Updated Oct 25, 2021 · Synced Sep 1, 2026, 10:23 PM EDT
Completed Phase 2 Interventional Results available

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

NCT03056755
View directory record Official record
Conditions
Breast Cancer
Interventions
Alpelisib, Fulvestrant, Letrozole, Goserelin, Leuprolide
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 99 Years
Enrollment
383 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
25
States / cities
Gilbert, Arizona • Phoenix, Arizona • Anaheim, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jan 12, 2026 · Synced Sep 1, 2026, 10:23 PM EDT
Completed Phase 2 Interventional Results available

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

NCT01719380
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jun 22, 2021 · Synced Sep 1, 2026, 10:23 PM EDT
Terminated Phase 3 Interventional Results available

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

NCT04251533
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jul 13, 2026 · Synced Sep 1, 2026, 10:23 PM EDT
Completed Phase 1 Interventional

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

NCT02077933
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Dec 7, 2020 · Synced Sep 1, 2026, 10:23 PM EDT
Recruiting Phase 3 Interventional

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

NCT05646862
View directory record Official record
Conditions
Breast Cancer
Interventions
Inavolisib, Fulvestrant, Alpelisib, Bupropion, Omeprazole, Midazolam
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
420 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
39
States / cities
Greenbrae, California • Los Alamitos, California • Los Angeles, California + 32 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2026 · Synced Sep 1, 2026, 10:23 PM EDT
Active, not recruiting Phase 2 Interventional

Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

NCT04762979
View directory record Official record
Conditions
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer, PIK3CA Mutant Metastatic Breast Cancer
Interventions
Alpelisib, Fulvestrant, Aromatase inhibitor
Drug
Lead sponsor
Marina N Sharifi
Other
Eligibility
18 Years and older
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
4
States / cities
Chicago, Illinois • Omaha, Nebraska • Hershey, Pennsylvania + 1 more
Source: ClinicalTrials.gov public record
Updated Jan 1, 2026 · Synced Sep 1, 2026, 10:23 PM EDT
Completed Phase 1 Interventional

Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma

NCT02144038
View directory record Official record
Conditions
Relapsed and Refractory Multiple Myeloma
Interventions
LGH447, BYL719
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
3
States / cities
Houston, Texas • Seattle, Washington • Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Dec 16, 2020 · Synced Sep 1, 2026, 10:23 PM EDT
Not listed Phase 2 Interventional

Alpelisib, Fulvestrant and Dapagliflozin for the Treatment of HR+, HER2 -, PIK3CA Mutant Metastatic Breast Cancer

NCT05025735
View directory record Official record
Conditions
Metastatic Breast Cancer, HER2-negative Breast Cancer
Interventions
Dapagliflozin 10Mg Tab
Drug
Lead sponsor
Saint Luke's Health System
Other
Eligibility
18 Years to 65 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
1
States / cities
Kansas City, Missouri
Source: ClinicalTrials.gov public record
Updated Oct 18, 2021 · Synced Sep 1, 2026, 10:23 PM EDT
Completed Phase 1 Interventional

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

NCT01613950
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Dec 8, 2020 · Synced Sep 1, 2026, 10:23 PM EDT
Completed Phase 2 Interventional Results available

Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

NCT01923168
View directory record Official record
Conditions
Breast Cancer
Interventions
alpelisib, buparlisib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Female only
Enrollment
340 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
23
States / cities
Birmingham, Alabama • Fayetteville, Arkansas • Los Angeles, California + 16 more
Source: ClinicalTrials.gov public record
Updated Sep 13, 2018 · Synced Sep 1, 2026, 10:23 PM EDT