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ClinicalTrials.gov public records Last synced Jun 25, 2026, 8:10 AM EDT

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Showing 25–43 of 19 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Condition: PIK3CA Mutations Clear all
Active, not recruiting Phase 1 Interventional

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

NCT05307705
View directory record Official record
Conditions
Breast Cancer
Interventions
LOXO-783, Fulvestrant, Imlunestrant, Abemaciclib, Anastrozole, Exemestane, or Letrozole, Paclitaxel
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
193 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
17
States / cities
Scottsdale, Arizona • Los Angeles, California • San Francisco, California + 12 more
Source: ClinicalTrials.gov public record
Updated Apr 19, 2026 · Synced Jun 25, 2026, 8:10 AM 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 Jun 25, 2026, 8:10 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 May 10, 2026 · Synced Jun 25, 2026, 8:10 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 Jun 25, 2026, 8:10 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 Jun 25, 2026, 8:10 AM EDT
Active, not recruiting Phase 1 Interventional

GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases

NCT04192981
View directory record Official record
Conditions
Brain Metastases, Leptomeningeal Metastasis
Interventions
GDC-0084, whole brain radiation therapy radiation
Drug · Radiation
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
9
States / cities
Miami, Florida • Basking Ridge, New Jersey • Middletown, New Jersey + 6 more
Source: ClinicalTrials.gov public record
Updated Apr 21, 2026 · Synced Jun 25, 2026, 8:10 AM EDT
Terminated Phase 1Phase 2 Interventional

First in Human Trial of Topical VT30 in Pts With Venous/Lymphatic Malformations Assoc With PIK3CA or TEK Gene Mutations

NCT04409145
View directory record Official record
Conditions
Venous Malformation, Lymphatic Malformation, Venolymphatic Malformation
Interventions
VT30
Drug
Lead sponsor
Venthera, Inc., a BridgeBio company
Industry
Eligibility
18 Years to 60 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
15
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Palo Alto, California + 12 more
Source: ClinicalTrials.gov public record
Updated Aug 3, 2022 · Synced Jun 25, 2026, 8:10 AM EDT
Completed Phase 1 Interventional

Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

NCT01226316
View directory record Official record
Conditions
Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, Tumour Response, Advanced or Metastatic Breast Cancer, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, PIK3CA, AKT1, PTEN, ER Positive, HER2 Positive
Interventions
AZD5363
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 130 Years
Enrollment
285 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2024
U.S. locations
12
States / cities
Los Angeles, California • Stanford, California • West Hollywood, California + 8 more
Source: ClinicalTrials.gov public record
Updated Jun 28, 2025 · Synced Jun 25, 2026, 8:10 AM 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 Jun 25, 2026, 8:10 AM EDT
Recruiting Phase 3 Interventional

A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

NCT07174336
View directory record Official record
Conditions
Breast Neoplasms, Neoplasm Metastasis
Interventions
LY4064809, Placebo, Ribociclib, Palbociclib, Abemaciclib, Anastrozole, Letrozole, Exemestane, Fulvestrant
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
920 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2033
U.S. locations
118
States / cities
Anchorage, Alaska • Chandler, Arizona • Phoenix, Arizona + 103 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Jun 25, 2026, 8:10 AM EDT
Recruiting Phase 1 Interventional

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

NCT05216432
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
Interventions
RLY-2608, Fulvestrant, Palbociclib 125mg, Ribociclib 400mg, Ribociclib 600mg, PF-07220060 100mg, PF-07220060 300 mg
Drug
Lead sponsor
Relay Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
930 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
24
States / cities
Tucson, Arizona • San Diego, California • Denver, Colorado + 17 more
Source: ClinicalTrials.gov public record
Updated Sep 21, 2025 · Synced Jun 25, 2026, 8:10 AM EDT
Terminated Phase 1 Interventional

Open-label Phase 1b Study of ARQ 092 in Combination With Anastrozole

NCT02476955
View directory record Official record
Conditions
Solid Tumors, Ovarian Cancer, Endometrial Cancer
Interventions
ARQ 092 + carboplatin + paclitaxel (Closed), ARQ 092 + paclitaxel (Closed), ARQ 092 + anastrozole
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 · Female only
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
5
States / cities
Grand Rapids, Michigan • New York, New York • Oklahoma City, Oklahoma + 2 more
Source: ClinicalTrials.gov public record
Updated Sep 29, 2020 · Synced Jun 25, 2026, 8:10 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 Jun 25, 2026, 8:10 AM EDT
Completed Phase 2 Interventional Results available

Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer

NCT02728258
View directory record Official record
Conditions
Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Undifferentiated Carcinoma, Metastatic Endometrioid Adenocarcinoma, Recurrent Uterine Corpus Cancer
Interventions
Copanlisib, Laboratory Biomarker Analysis
Drug · Other
Lead sponsor
NRG Oncology
Other
Eligibility
18 Years and older · Female only
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
43
States / cities
New Haven, Connecticut • Deerfield Beach, Florida • Miami, Florida + 35 more
Source: ClinicalTrials.gov public record
Updated Feb 14, 2022 · Synced Jun 25, 2026, 8:10 AM EDT
Terminated Phase 1 Interventional Results available

Vevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations (MK-4440-001)

NCT02761694
View directory record Official record
Conditions
Cancer, Solid Tumors
Interventions
Vevorisertib, Fulvestrant, Paclitaxel
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
78 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2021
U.S. locations
6
States / cities
Las Vegas, Nevada • Oklahoma City, Oklahoma • Charleston, South Carolina + 3 more
Source: ClinicalTrials.gov public record
Updated May 5, 2023 · Synced Jun 25, 2026, 8:10 AM EDT
Recruiting Phase 1Phase 2 Interventional

Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer

NCT05455619
View directory record Official record
Conditions
HR+/HER2-negative Breast Cancer, Metastatic Breast Cancer
Interventions
Evexomostat
Drug
Lead sponsor
SynDevRx, Inc.
Industry
Eligibility
18 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
10
States / cities
Loma Linda, California • Newport, California • San Diego, California + 7 more
Source: ClinicalTrials.gov public record
Updated Apr 21, 2026 · Synced Jun 25, 2026, 8:10 AM 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 Jun 25, 2026, 8:10 AM EDT
Recruiting Phase 1 Interventional

Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors

NCT07524322
View directory record Official record
Conditions
Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation, HER2- Negative Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor, Hormone Receptor Positive Tumor, Cervical Cancer
Interventions
RGT-490
Drug
Lead sponsor
Regor Pharmaceuticals Inc.
Industry
Eligibility
18 Years and older
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
4
States / cities
Los Angeles, California • Houston, Texas • San Antonio, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2026 · Synced Jun 25, 2026, 8:10 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 Jun 3, 2026 · Synced Jun 25, 2026, 8:10 AM EDT