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ClinicalTrials.gov public records Last synced Sep 6, 2026, 2:46 PM EDT

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Showing 1–24 of 93 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Condition: PIK3CA Clear all
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 6, 2026, 2:46 PM EDT
Terminated Phase 2 Interventional Results available

Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations

NCT05082025
View directory record Official record
Conditions
Endometrial Cancer, Ovarian Cancer
Interventions
Copanlisib, fulvestrant
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jan 8, 2026 · Synced Sep 6, 2026, 2:46 PM EDT
Completed Phase 2Phase 3 Interventional

Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation

NCT03285802
View directory record Official record
Conditions
Uterine Cancer
Interventions
Letrozole, Everolimus
Drug
Lead sponsor
Greater Baltimore Medical Center
Other
Eligibility
18 Years and older · Female only
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Feb 4, 2020 · Synced Sep 6, 2026, 2:46 PM EDT
Recruiting Phase 2 Interventional

Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer

NCT06463028
View directory record Official record
Conditions
Endometrial Cancer
Interventions
Sapanisertib, Serabelisib, Paclitaxel
Drug
Lead sponsor
Faeth Therapeutics
Industry
Eligibility
18 Years and older · Female only
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
18
States / cities
La Jolla, California • San Francisco, California • Miami Beach, Florida + 15 more
Source: ClinicalTrials.gov public record
Updated Dec 23, 2025 · Synced Sep 6, 2026, 2:46 PM EDT
Terminated Phase 2 Interventional Results available

SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes

NCT02644122
View directory record Official record
Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Interventions
SF1126
Drug
Lead sponsor
Ezra Cohen
Other
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
1
States / cities
La Jolla, California
Source: ClinicalTrials.gov public record
Updated Jul 10, 2018 · Synced Sep 6, 2026, 2:46 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 6, 2026, 2:46 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 6, 2026, 2:46 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

NCT01602315
View directory record Official record
Conditions
Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
Interventions
BYL719 as film-coated (FC) whole tablets, BYL719 as dispersible tablets (DT), cetuximab, BYL719 drink suspension
Drug · Biological
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
179 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
14
States / cities
Sacramento, California • San Francisco, California • Aurora, Colorado + 10 more
Source: ClinicalTrials.gov public record
Updated Dec 28, 2020 · Synced Sep 6, 2026, 2:46 PM EDT
Completed Phase 1 Interventional Results available

MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer

NCT03767335
View directory record Official record
Conditions
Advanced or Metastatic Breast Cancer
Interventions
MEN1611, Trastuzumab, Fulvestrant
Drug
Lead sponsor
Menarini Group
Industry
Eligibility
18 Years and older
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
3
States / cities
Fort Lauderdale, Florida • Farmington Hills, Michigan • St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jun 25, 2025 · Synced Sep 6, 2026, 2:46 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 6, 2026, 2:46 PM EDT
Terminated Phase 2 Interventional Results available

Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer

NCT01776008
View directory record Official record
Conditions
Estrogen Receptor Positive, HER2/Neu Negative, Recurrent Breast Carcinoma, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Interventions
Akt Inhibitor MK2206, Anastrozole, Goserelin Acetate, Laboratory Biomarker Analysis, Neoadjuvant Therapy, Pharmacological Study, Therapeutic Conventional Surgery
Drug · Other · Procedure
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older · Female only
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
8
States / cities
Scottsdale, Arizona • Chicago, Illinois • Iowa City, Iowa + 5 more
Source: ClinicalTrials.gov public record
Updated May 7, 2018 · Synced Sep 6, 2026, 2:46 PM EDT
Completed Phase 1 Interventional

Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma

NCT01473095
View directory record Official record
Conditions
Solid Tumor, Malignant Lymphoma, Tumor
Interventions
ARQ 092
Drug
Lead sponsor
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Industry
Eligibility
18 Years and older
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2017
U.S. locations
7
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Miami, Florida + 3 more
Source: ClinicalTrials.gov public record
Updated Oct 22, 2017 · Synced Sep 6, 2026, 2:46 PM EDT
Recruiting Phase 3 Interventional

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

NCT06982521
View directory record Official record
Conditions
PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer
Interventions
Zovegalisib, Capivasertib, Fulvestrant
Drug
Lead sponsor
Relay Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
540 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
52
States / cities
Gilbert, Arizona • Beverly Hills, California • Duarte, California + 42 more
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Sep 6, 2026, 2:46 PM 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 Jun 4, 2026 · Synced Sep 6, 2026, 2:46 PM 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 6, 2026, 2:46 PM EDT
Terminated Phase 2 Interventional Results available

Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations

NCT04216472
View directory record Official record
Conditions
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Refractory Breast Carcinoma, Triple-Negative Breast Carcinoma
Interventions
Alpelisib, Nab-paclitaxel
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Sep 6, 2026, 2:46 PM EDT
Completed Phase 1 Interventional

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

NCT05759949
View directory record Official record
Conditions
PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor, Hormone Receptor Positive Tumor
Interventions
RLY-5836, Fulvestrant, Palbociclib, Ribociclib, Abemaciclib
Drug
Lead sponsor
Relay Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
7
States / cities
Orlando, Florida • Indianapolis, Indiana • Boston, Massachusetts + 4 more
Source: ClinicalTrials.gov public record
Updated May 15, 2025 · Synced Sep 6, 2026, 2:46 PM EDT
Completed Phase 1 Interventional

A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies

NCT01470209
View directory record Official record
Conditions
Solid Tumors, Lung Cancer
Interventions
BKM120, Everolimus
Drug
Lead sponsor
Emory University
Other
Eligibility
18 Years and older
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Mar 18, 2018 · Synced Sep 6, 2026, 2:46 PM EDT
Terminated Phase 1 Interventional

Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations

NCT05300048
View directory record Official record
Conditions
Advanced Solid Tumor, PIK3CA Mutation, PTEN Loss of Function Mutation
Interventions
Serabelisib, Insulin Suppressing Diet, Nab paclitaxel
Drug · Other
Lead sponsor
Faeth Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
17
States / cities
Birmingham, Alabama • Anaheim, California • Los Angeles, California + 14 more
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced Sep 6, 2026, 2:46 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer

NCT04108858
View directory record Official record
Conditions
Anatomic Stage IV Breast Cancer AJCC v8, HER2-Positive Breast Carcinoma, Metastatic Breast Carcinoma
Interventions
Copanlisib, Pertuzumab, Trastuzumab
Drug · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
5
States / cities
Los Angeles, California • Aurora, Colorado • Oklahoma City, Oklahoma + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 30, 2025 · Synced Sep 6, 2026, 2:46 PM EDT
Terminated Phase 2 Interventional Results available

Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer

NCT01186705
View directory record Official record
Conditions
Colon Cancer, Rectal Cancer
Interventions
MK-2206
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Nov 17, 2015 · Synced Sep 6, 2026, 2:46 PM EDT
Active, not recruiting Phase 2 Interventional Results available

Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)

NCT05490771
View directory record Official record
Conditions
Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Multiple Myeloma
Interventions
Biopsy Procedure, Computed Tomography, Copanlisib Hydrochloride, Magnetic Resonance Imaging
Procedure · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2027
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 4, 2026 · Synced Sep 6, 2026, 2:46 PM EDT
Completed Phase 2 Interventional Results available

Akt Inhibitor MK2206 in Treating Patients With Recurrent or Advanced Endometrial Cancer

NCT01307631
View directory record Official record
Conditions
Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Recurrent Uterine Corpus Carcinoma
Interventions
Akt Inhibitor MK2206, Laboratory Biomarker Analysis
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older · Female only
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
7
States / cities
Boston, Massachusetts • Charlestown, Massachusetts • Newton, Massachusetts + 2 more
Source: ClinicalTrials.gov public record
Updated Feb 10, 2022 · Synced Sep 6, 2026, 2:46 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 6, 2026, 2:46 PM EDT