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ClinicalTrials.gov public records Last synced Sep 1, 2026, 8:51 AM EDT

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Showing 1–21 of 21 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Alpelisib 300 mg Clear all
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, 8:51 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, 8:51 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, 8:51 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, 8:51 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, 8:51 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, 8:51 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, 8:51 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 1, 2026, 8:51 AM 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, 8:51 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 1, 2026, 8:51 AM 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, 8:51 AM 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, 8:51 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 1, 2026, 8:51 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 1, 2026, 8:51 AM 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 1, 2026, 8:51 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 1, 2026, 8:51 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 1, 2026, 8:51 AM EDT
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 1, 2026, 8:51 AM 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 1, 2026, 8:51 AM EDT
Completed Phase 3 Interventional Results available

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

NCT02437318
View directory record Official record
Conditions
Breast Cancer
Interventions
Fulvestrant, Alpelisib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
572 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2023
U.S. locations
34
States / cities
Chandler, Arizona • Scottsdale, Arizona • Fayetteville, Arkansas + 31 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2025 · Synced Sep 1, 2026, 8:51 AM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

NCT05563220
View directory record Official record
Conditions
Breast Cancer, Metastatic Breast Cancer
Interventions
Elacestrant, Alpelisib, Everolimus, Ribociclib, Palbociclib, Capivasertib, Abemaciclib
Drug
Lead sponsor
Stemline Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
435 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
35
States / cities
Dothan, Alabama • Phoenix, Arizona • Springdale, Arkansas + 30 more
Source: ClinicalTrials.gov public record
Updated Jun 11, 2026 · Synced Sep 1, 2026, 8:51 AM EDT