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ClinicalTrials.gov public records Last synced Jul 23, 2026, 11:24 AM EDT

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Showing 1–24 of 43 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Condition: PI3K Gene Mutation Clear all
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 Jul 23, 2026, 11:24 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 Jul 23, 2026, 11:24 AM 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 Jul 23, 2026, 11:24 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 Jul 23, 2026, 11:24 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 Jul 23, 2026, 11:24 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Genetic Changes (MATCH-Subprotocol N)

NCT04439149
View directory record Official record
Conditions
Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Multiple Myeloma
Interventions
PI3K-beta Inhibitor GSK2636771
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2026
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 26, 2026 · Synced Jul 23, 2026, 11:24 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)

NCT04439175
View directory record Official record
Conditions
Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Multiple Myeloma
Interventions
Taselisib
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2027
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 5, 2026 · Synced Jul 23, 2026, 11:24 AM EDT
Recruiting Phase 2 Interventional

A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer

NCT07405801
View directory record Official record
Conditions
Breast Cancer
Interventions
Inavolisib, Ribociclib, Fulvestrant, Placebo
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
6
States / cities
Marshall, Minnesota • Aberdeen, South Dakota • Mitchell, South Dakota + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 12, 2026 · Synced Jul 23, 2026, 11:24 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 Jul 23, 2026, 11:24 AM 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 Jul 23, 2026, 11:24 AM EDT
Completed Phase 1 Interventional

PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer

NCT01613950
View directory record Official record
Conditions
Stomach Neoplasms Esophageal Neoplasms Metastatic Gastric Cancer Mutated PI3KCA Protein Overexpressed HER2 Protein
Interventions
AUY922, BYL719
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
2
States / cities
Boston, Massachusetts • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Dec 8, 2020 · Synced Jul 23, 2026, 11:24 AM 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 Jul 23, 2026, 11:24 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 Jul 6, 2026 · Synced Jul 23, 2026, 11:24 AM 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 Jul 23, 2026, 11:24 AM 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 Jul 23, 2026, 11:24 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 Jul 23, 2026, 11:24 AM EDT
Active, not recruiting Phase 2 Interventional

Genetic Testing in Guiding Treatment for Patients With Brain Metastases

NCT03994796
View directory record Official record
Conditions
CDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, NTRK Family Gene Mutation, PI3K Gene Mutation, ROS1 Gene Mutation, KRAS G12C Mutation
Interventions
Abemaciclib, PI3K Inhibitor paxalisib, Entrectinib, Adagrasib
Drug
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2028
U.S. locations
435
States / cities
Anchorage, Alaska • Phoenix, Arizona • Scottsdale, Arizona + 306 more
Source: ClinicalTrials.gov public record
Updated Apr 12, 2026 · Synced Jul 23, 2026, 11:24 AM EDT
Completed Phase 2 Interventional Results available

Akt Inhibitor MK2206 in Treating Patients With Previously Treated Colon or Rectal Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery

NCT01802320
View directory record Official record
Conditions
Colon Mucinous Adenocarcinoma, Colon Signet Ring Cell Adenocarcinoma, Rectal Mucinous Adenocarcinoma, Rectal Signet Ring Cell Adenocarcinoma, Recurrent Colon Carcinoma, Recurrent Rectal Carcinoma, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer
Interventions
Akt Inhibitor MK2206, Laboratory Biomarker Analysis, Pharmacological Study
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 19, 2019 · Synced Jul 23, 2026, 11:24 AM EDT
Terminated No phase listed Observational

Bile Acids in Acute Insulin Resistance

NCT05571670
View directory record Official record
Conditions
PI3K Gene Mutation, AKT Gene Mutation, MTOR Gene Mutation, Cancer, Insulin Resistance
Interventions
Drug-induced acute insulin resistance due to PI3K inhibitor, AKT inhibitor, or mTOR inhibitor
Drug
Lead sponsor
Columbia University
Other
Eligibility
18 Years to 99 Years
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jan 15, 2025 · Synced Jul 23, 2026, 11:24 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
117
States / cities
Anchorage, Alaska • Chandler, Arizona • Phoenix, Arizona + 102 more
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Jul 23, 2026, 11:24 AM EDT
Recruiting Phase 2 Interventional

A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study)

NCT06789913
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations, Vascular Malformations, PIK3CA Mutation, CLOVES Syndrome, Klippel Trenaunay Syndrome, Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP), Vascular Anomalies
Interventions
RLY-2608, Placebo
Drug
Lead sponsor
Relay Therapeutics, Inc.
Industry
Eligibility
2 Years and older
Enrollment
277 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
20
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Los Angeles, California + 17 more
Source: ClinicalTrials.gov public record
Updated Jun 11, 2026 · Synced Jul 23, 2026, 11:24 AM 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 Jul 13, 2026 · Synced Jul 23, 2026, 11:24 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 Jul 23, 2026, 11:24 AM 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 Jul 23, 2026, 11:24 AM EDT