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Showing 1–24 of 57 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: PI3K inhibitor BYL719 Clear all
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 24, 2026, 11:46 PM 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 24, 2026, 11:46 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.

NCT02624557
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Dec 8, 2020 · Synced Sep 24, 2026, 11:46 PM 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 24, 2026, 11:46 PM EDT
Active, not recruiting Phase 2 Interventional

Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)

NCT04980833
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
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 1, 2026 · Synced Sep 24, 2026, 11:46 PM EDT
Terminated Phase 2 Interventional Results available

Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant

NCT04899349
View directory record Official record
Conditions
Breast Cancer
Interventions
Alpelisib, Fulvestrant, Metformin XR, Dapagliflozin + metformin XR, Dapagliflozin
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Oct 8, 2024 · Synced Sep 24, 2026, 11:46 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 24, 2026, 11:46 PM 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 24, 2026, 11:46 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 24, 2026, 11:46 PM EDT
Completed Phase 1 Interventional

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

NCT02088684
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Dec 16, 2020 · Synced Sep 24, 2026, 11:46 PM EDT
Completed Phase 1 Interventional

A Dose-finding Study of a Combination of Imatinib and BYL719 in the Treatment of 3rd Line GIST Patients

NCT01735968
View directory record Official record
Conditions
3rd Line GIST
Interventions
ST571 + BYL719
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2018
U.S. locations
1
States / cities
Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Dec 20, 2020 · Synced Sep 24, 2026, 11:46 PM EDT
Active, not recruiting Phase 2 Interventional

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

NCT05090358
View directory record Official record
Conditions
Breast Cancer, Breast Cancer Stage IV, Metastatic Breast Cancer
Interventions
Ketogenic Diet, Low Carbohydrate Diet, Alpelisib, Fulvestrant, Canagliflozin
Dietary Supplement · Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
9
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 5 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 24, 2026, 11:46 PM 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
259 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 Sep 17, 2026 · Synced Sep 24, 2026, 11:46 PM EDT
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 24, 2026, 11:46 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 24, 2026, 11:46 PM EDT
Terminated Phase 3 Interventional Results available

Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

NCT04729387
View directory record Official record
Conditions
Ovarian Cancer
Interventions
Alpelisib, Olaparib, Paclitaxel, Pegylated liposomal doxorubicin (PLD)
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
358 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
16
States / cities
Phoenix, Arizona • Fort Myers, Florida • West Palm Beach, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2026 · Synced Sep 24, 2026, 11:46 PM 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 24, 2026, 11:46 PM 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 24, 2026, 11:46 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 Sep 9, 2026 · Synced Sep 24, 2026, 11:46 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 24, 2026, 11:46 PM EDT
Terminated Phase 1 Interventional Results available

BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study

NCT02550743
View directory record Official record
Conditions
Rectal Cancer
Interventions
BYL719, Capecitabine, Radiation
Drug · Radiation
Lead sponsor
howard safran
Other
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Mar 11, 2021 · Synced Sep 24, 2026, 11:46 PM 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 24, 2026, 11:46 PM EDT
Active, not recruiting Phase 3 Interventional

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)

NCT05501886
View directory record Official record
Conditions
Breast Cancer
Interventions
Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Drug
Lead sponsor
Celcuity Inc
Industry
Eligibility
18 Years and older
Enrollment
701 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
71
States / cities
Birmingham, Alabama • Goodyear, Arizona • Jonesboro, Arkansas + 62 more
Source: ClinicalTrials.gov public record
Updated Feb 9, 2026 · Synced Sep 24, 2026, 11:46 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 24, 2026, 11:46 PM EDT