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ClinicalTrials.gov public records Last synced Sep 3, 2026, 9:47 AM EDT

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Showing 1–24 of 77 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Alpelisib Clear all
Recruiting Phase 1 Interventional Accepts healthy volunteers

Human Models of Selective Insulin Resistance: Alpelisib, Part I

NCT06354088
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Aug 23, 2026 · Synced Sep 3, 2026, 9:47 AM 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 3, 2026, 9:47 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 3, 2026, 9:47 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 3, 2026, 9:47 AM EDT
Recruiting Phase 1Phase 2 Interventional

Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

NCT06993844
View directory record Official record
Conditions
Advanced Solid Tumors, Advanced Breast Cancer
Interventions
ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
Drug
Lead sponsor
Ensem Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
233 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
10
States / cities
Newport Beach, California • San Francisco, California • New Haven, Connecticut + 6 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Sep 3, 2026, 9:47 AM EDT
Active, not recruiting Phase 2 Interventional

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer

NCT05826964
View directory record Official record
Conditions
Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
Interventions
AI+CDK4/6i, SERD+CDK4/6i, mTOR inhibitor + AI, mTOR inhibitor + SERD, mTOR inhibitor + Selective estrogen receptor modulator, PI3K inhibitor + SERD, PI3K inhibitor + AI, Chemotherapy, Oral SERD, PARPi, AKT inhibitor, Step 3 Arm 2
Drug · Other
Lead sponsor
University of Miami
Other
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Jan 12, 2026 · Synced Sep 3, 2026, 9:47 AM EDT
Recruiting Phase 1 Interventional

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

NCT05627960
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Nov 27, 2022 · Synced Sep 3, 2026, 9:47 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 3, 2026, 9:47 AM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

NCT01872260
View directory record Official record
Conditions
Breast Cancer
Interventions
LEE011, Letrozole, BYL719
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Female only
Enrollment
255 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2027
U.S. locations
10
States / cities
San Diego, California • San Francisco, California • Tampa, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Jun 10, 2026 · Synced Sep 3, 2026, 9:47 AM EDT
Completed No phase listed Observational

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

NCT05982886
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Aug 8, 2023 · Synced Sep 3, 2026, 9:47 AM EDT
Active, not recruiting Phase 1 Interventional

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

NCT04188548
View directory record Official record
Conditions
Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, Endometrial Cancer
Interventions
LY3484356, Abemaciclib, Everolimus, Alpelisib, Trastuzumab, Aromatase Inhibitor (AI), Pertuzumab
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
379 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2027
U.S. locations
42
States / cities
Gilbert, Arizona • Phoenix, Arizona • Springdale, Arkansas + 31 more
Source: ClinicalTrials.gov public record
Updated Jun 21, 2026 · Synced Sep 3, 2026, 9:47 AM EDT
Terminated Phase 1 Interventional

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

NCT02620839
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jan 9, 2020 · Synced Sep 3, 2026, 9:47 AM 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 3, 2026, 9:47 AM EDT
Completed Phase 1 Interventional

Trial of AEB071 in Combination With BYL719 in Patients With Melanoma

NCT02273219
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Aug 14, 2023 · Synced Sep 3, 2026, 9:47 AM EDT
Completed No phase listed Observational

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

NCT05294289
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jun 23, 2025 · Synced Sep 3, 2026, 9:47 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Effect of Alpelisib in Healthy Volunteers

NCT05733455
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Dec 20, 2023 · Synced Sep 3, 2026, 9:47 AM 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 3, 2026, 9:47 AM EDT
Completed Phase 1 Interventional Results available

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

NCT01870505
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Dec 8, 2024 · Synced Sep 3, 2026, 9:47 AM EDT
Completed Phase 1 Interventional

A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

NCT01449058
View directory record Official record
Conditions
Advanced and Selected Solid Tumors, AML, High Risk and Very High Risk MDS
Interventions
BYL719, MEK162
Drug
Lead sponsor
Array BioPharma
Industry
Eligibility
18 Years and older
Enrollment
139 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
8
States / cities
La Jolla, California • Tampa, Florida • Chicago, Illinois + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 1, 2017 · Synced Sep 3, 2026, 9:47 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 3, 2026, 9:47 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 3, 2026, 9:47 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum

NCT04589650
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
0 Days to 100 Years
Enrollment
206 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2031
U.S. locations
11
States / cities
San Francisco, California • Aurora, Colorado • St Louis, Missouri + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 17, 2026 · Synced Sep 3, 2026, 9:47 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 3, 2026, 9:47 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
8
States / cities
St Louis, Missouri • Chapel Hill, North Carolina • Cincinnati, Ohio + 4 more
Source: ClinicalTrials.gov public record
Updated Aug 17, 2026 · Synced Sep 3, 2026, 9:47 AM EDT