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ClinicalTrials.gov public records Last synced Sep 22, 2026, 9:34 AM EDT

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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Intervention: Alpelisib Clear all
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 22, 2026, 9:34 AM 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 22, 2026, 9:34 AM EDT
Completed Phase 1 Interventional

Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer

NCT01623349
View directory record Official record
Conditions
Ovarian Cancer, Breast Cancer
Interventions
BKM120 and Olaparib, BYL719 and Olaparib
Drug
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
118 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2020
U.S. locations
5
States / cities
Boston, Massachusetts • New York, New York • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Feb 9, 2021 · Synced Sep 22, 2026, 9:34 AM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

Alpelisib Challenge Test (ACT)

NCT07778524
View directory record Official record
Conditions
Insulin Resistance, Type 2 Diabetes, Obesity & Overweight, Healthy Adult Participants
Interventions
Alpelisib 300 mg, Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib, Hyperglycemic clamp
Drug · Diagnostic Test
Lead sponsor
Columbia University
Other
Eligibility
18 Years to 70 Years
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2028
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Sep 22, 2026, 9:34 AM EDT
Terminated Phase 1 Interventional

Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

NCT02734615
View directory record Official record
Conditions
Advanced or Metastatic ER+ Breast Cancer
Interventions
LSZ102, LEE011, BYL719
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
199 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2021
U.S. locations
3
States / cities
Boston, Massachusetts • New York, New York • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 31, 2022 · Synced Sep 22, 2026, 9:34 AM EDT
Active, not recruiting Phase 1 Interventional

Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer

NCT05143229
View directory record Official record
Conditions
Breast Cancer
Interventions
Alpelisib, Sacituzumab govitecan
Drug
Lead sponsor
University of Kansas Medical Center
Other
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
7
States / cities
Fairway, Kansas • Overland Park, Kansas • Westwood, Kansas + 2 more
Source: ClinicalTrials.gov public record
Updated Apr 30, 2026 · Synced Sep 22, 2026, 9:34 AM 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 22, 2026, 9:34 AM 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 22, 2026, 9:34 AM EDT
Completed No phase listed Observational Results available

Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib

NCT04285723
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum (PROS)
Interventions
alpelisib
Other
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years and older
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 8, 2023 · Synced Sep 22, 2026, 9:34 AM 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 22, 2026, 9:34 AM 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 22, 2026, 9:34 AM EDT
Completed Phase 1Phase 2 Interventional

Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

NCT04997902
View directory record Official record
Conditions
HNSCC
Interventions
Tipifarnib, Alpelisib
Drug
Lead sponsor
Kura Oncology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
11
States / cities
Duarte, California • Orlando, Florida • Baltimore, Maryland + 7 more
Source: ClinicalTrials.gov public record
Updated Sep 7, 2026 · Synced Sep 22, 2026, 9:34 AM EDT
Recruiting Phase 2 Interventional

EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

NCT06997588
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years to 100 Years
Enrollment
104 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
9
States / cities
St Louis, Missouri • Chapel Hill, North Carolina • Cincinnati, Ohio + 5 more
Source: ClinicalTrials.gov public record
Updated Sep 17, 2026 · Synced Sep 22, 2026, 9:34 AM EDT
Terminated Phase 2 Interventional Results available

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

NCT03601507
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Apr 16, 2024 · Synced Sep 22, 2026, 9:34 AM 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 22, 2026, 9:34 AM EDT
Completed Phase 2 Interventional Results available

Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer

NCT05101564
View directory record Official record
Conditions
Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer
Interventions
Alpelisib, Tamoxifen, Zotatifin, Fulvestrant
Drug
Lead sponsor
Jennifer Lee Caswell-Jin
Other
Eligibility
18 Years and older
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Feb 11, 2026 · Synced Sep 22, 2026, 9:34 AM EDT
Completed Phase 1 Interventional

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

NCT02051751
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Dec 7, 2020 · Synced Sep 22, 2026, 9:34 AM EDT
Completed Phase 1 Interventional

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

NCT02167854
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jul 8, 2021 · Synced Sep 22, 2026, 9:34 AM 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 22, 2026, 9:34 AM EDT
Recruiting Phase 2 Interventional

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

NCT05933395
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jan 19, 2026 · Synced Sep 22, 2026, 9:34 AM 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 22, 2026, 9:34 AM EDT
Recruiting Phase 2Phase 3 Interventional

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

NCT05948943
View directory record Official record
Conditions
Lymphatic Malformations
Interventions
Alpelisib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
0 Years to 100 Years
Enrollment
232 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2033
U.S. locations
18
States / cities
Oakland, California • Orange, California • Palo Alto, California + 13 more
Source: ClinicalTrials.gov public record
Updated Sep 17, 2026 · Synced Sep 22, 2026, 9:34 AM EDT
Completed Phase 1Phase 2 Interventional Results available

BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer

NCT02379247
View directory record Official record
Conditions
Breast Cancer
Interventions
BYL-719 (alpelisib), Nab-paclitaxel
Drug
Lead sponsor
Priyanka Sharma
Other
Eligibility
18 Years and older
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2022
U.S. locations
4
States / cities
Kansas City, Kansas • Overland Park, Kansas • Lee's Summit, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 6, 2022 · Synced Sep 22, 2026, 9:34 AM EDT
Completed Phase 1 Interventional

Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer

NCT01300962
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
BMK120, Capecitabine, BYL719, Trastuzumab, Lapatinib
Drug
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Enrollment
47 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2018
U.S. locations
2
States / cities
Chapel Hill, North Carolina • Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Dec 3, 2023 · Synced Sep 22, 2026, 9:34 AM EDT