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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
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 Jun 4, 2026 · Synced Sep 1, 2026, 10:42 AM 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 1, 2026, 10:42 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 1, 2026, 10:42 AM EDT
No Longer Available No phase listed Expanded access

Compassionate Use of BYL 719 Alpelisib

NCT03941782
View directory record Official record
Conditions
Lymphangioma
Interventions
Alpelisib
Drug
Lead sponsor
New Mexico Cancer Research Alliance
Other
Eligibility
18 Years and older
U.S. locations
1
States / cities
Albuquerque, New Mexico
Source: ClinicalTrials.gov public record
Updated Jan 10, 2024 · Synced Sep 1, 2026, 10:42 AM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

NCT05230810
View directory record Official record
Conditions
HER2-positive Metastatic Breast Cancer
Interventions
Alpelisib, Tucatinib, Fulvestrant
Drug
Lead sponsor
Criterium, Inc.
Industry
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
4
States / cities
Aurora, Colorado • Fort Collins, Colorado • New Orleans, Louisiana + 1 more
Source: ClinicalTrials.gov public record
Updated Mar 15, 2026 · Synced Sep 1, 2026, 10:42 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 1, 2026, 10:42 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 1, 2026, 10:42 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors

NCT01708161
View directory record Official record
Conditions
PIK3CA Mutated Advanced Solid Tumors, PIK3CA Amplified Advanced Solid Tumors
Interventions
BYL719, AMG 479
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
47 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
4
States / cities
Los Angeles, California • Boston, Massachusetts • New York, New York + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 12, 2018 · Synced Sep 1, 2026, 10:42 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 1, 2026, 10:42 AM EDT
Active, not recruiting Phase 2 Interventional

A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

NCT05154487
View directory record Official record
Conditions
Endometroid Endometrial Cancer
Interventions
Alpelisib Pill, Fulvestrant injection
Drug
Lead sponsor
GOG Foundation
Network
Eligibility
18 Years and older · Female only
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
21
States / cities
Duarte, California • Miami Beach, Florida • Orlando, Florida + 16 more
Source: ClinicalTrials.gov public record
Updated Jul 29, 2026 · Synced Sep 1, 2026, 10:42 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 1, 2026, 10:42 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 1, 2026, 10:42 AM EDT
Not yet 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 Aug 20, 2026 · Synced Sep 1, 2026, 10:42 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 1, 2026, 10:42 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 1, 2026, 10:42 AM EDT
Active, not recruiting Phase 3 Interventional

Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

NCT04208178
View directory record Official record
Conditions
Advanced HER2+Breast Cancer
Interventions
Alpelisib, Alpelisib matching Placebo, Trastuzumab, Pertuzumab
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
2
States / cities
Fayetteville, Arkansas • Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jun 10, 2026 · Synced Sep 1, 2026, 10:42 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 1, 2026, 10:42 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 1, 2026, 10:42 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 1, 2026, 10:42 AM 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 1, 2026, 10:42 AM EDT
Recruiting Phase 2 Interventional

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

NCT05660083
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jun 3, 2026 · Synced Sep 1, 2026, 10:42 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 1, 2026, 10:42 AM EDT
Completed Phase 1 Interventional

BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer

NCT01791478
View directory record Official record
Conditions
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
Interventions
PI3K inhibitor BYL719, letrozole, laboratory biomarker analysis, pharmacological studies
Drug · Other
Lead sponsor
Vanderbilt-Ingram Cancer Center
Other
Eligibility
18 Years and older · Female only
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2022
U.S. locations
2
States / cities
Boston, Massachusetts • Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Aug 18, 2026 · Synced Sep 1, 2026, 10:42 AM 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 1, 2026, 10:42 AM EDT