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Showing 1–24 of 58 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: PIK3CA Mutation Clear all
Completed Phase 1 Interventional

Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours

NCT02260661
View directory record Official record
Conditions
Advanced Solid Malignancies, Breast Cancer - ER+, HER2 -, Breast Cancer - ER+, HER2-, PIK3CA Gene Mutation
Interventions
AZD8835, AZD8835 in combination with fulvestrant
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 130 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
5
States / cities
Denver, Colorado • Greenville, South Carolina • Nashville, Tennessee + 2 more
Source: ClinicalTrials.gov public record
Updated Oct 9, 2016 · Synced Jun 25, 2026, 9:52 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 Jun 25, 2026, 9:52 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 Jun 25, 2026, 9:52 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, 9:52 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, 9:52 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 Jun 25, 2026, 9:52 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, 9:52 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 Jun 25, 2026, 9:52 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, 9:52 AM EDT
Not listed Phase 2 Interventional

Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status

NCT03457896
View directory record Official record
Conditions
Metastatic Colorectal Cancer
Interventions
Trastuzumab, Cetuximab, Neratinib, Guardant360 Diagnostic Test
Drug · Diagnostic Test
Lead sponsor
NSABP Foundation Inc
Network
Eligibility
18 Years and older
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
48
States / cities
Anaheim, California • Baldwin Park, California • Bellflower, California + 40 more
Source: ClinicalTrials.gov public record
Updated Mar 30, 2022 · Synced Jun 25, 2026, 9:52 AM EDT
Completed Phase 2 Interventional Results available

Akt Inhibitor MK2206 in Treating Patients With Advanced Breast Cancer

NCT01277757
View directory record Official record
Conditions
Recurrent Breast Carcinoma, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast 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
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
5
States / cities
Boston, Massachusetts • New York, New York • Nashville, Tennessee + 1 more
Source: ClinicalTrials.gov public record
Updated Dec 18, 2018 · Synced Jun 25, 2026, 9:52 AM 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 Jun 25, 2026, 9:52 AM EDT
Completed Phase 1 Interventional

Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery

NCT03317119
View directory record Official record
Conditions
Metastatic Colon Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Rectal Carcinoma, RAS Family Gene Mutation, Stage III Colon Cancer AJCC v7, Stage III Colorectal Cancer AJCC v7, Stage III Rectal Cancer AJCC v7, Stage IIIA Colon Cancer AJCC v7, Stage IIIA Colorectal Cancer AJCC v7, Stage IIIA Rectal Cancer AJCC v7, Stage IIIB Colon Cancer AJCC v7, Stage IIIB Colorectal Cancer AJCC v7, Stage IIIB Rectal Cancer AJCC v7, Stage IIIC Colon Cancer AJCC v7, Stage IIIC Colorectal Cancer AJCC v7, Stage IIIC Rectal Cancer AJCC v7, Stage IV Colon Cancer AJCC v7, Stage IV Colorectal Cancer AJCC v7, Stage IV Rectal Cancer AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVA Rectal Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7, Stage IVB Rectal Cancer AJCC v7
Interventions
Laboratory Biomarker Analysis, Trametinib, Trifluridine and Tipiracil Hydrochloride
Other · Drug
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
8
States / cities
Corona, California • Duarte, California • Lancaster, California + 5 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2024 · Synced Jun 25, 2026, 9:52 AM EDT
Recruiting Phase 3 Interventional

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

NCT06790693
View directory record Official record
Conditions
Breast Cancer
Interventions
Inavolisib, Placebo, CDK4/6i, Letrozole
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2032
U.S. locations
51
States / cities
Phoenix, Arizona • Burbank, California • La Jolla, California + 39 more
Source: ClinicalTrials.gov public record
Updated Jun 2, 2026 · Synced Jun 25, 2026, 9:52 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, 9:52 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, 9:52 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, 9:52 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 Jun 25, 2026, 9:52 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 Jun 25, 2026, 9:52 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 Jun 25, 2026, 9:52 AM 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
RLY-2608, 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
51
States / cities
Gilbert, Arizona • Beverly Hills, California • Duarte, California + 41 more
Source: ClinicalTrials.gov public record
Updated Jun 10, 2026 · Synced Jun 25, 2026, 9:52 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, 9:52 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, 9:52 AM EDT
Recruiting Phase 2 Interventional

A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

NCT07054190
View directory record Official record
Conditions
Breast Cancer
Interventions
Inavolisib, Ribociclib, Letrozole
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older · Female only
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
4
States / cities
Los Angeles, California • Orange, California • Germantown, Tennessee + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Jun 25, 2026, 9:52 AM EDT