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ClinicalTrials.gov public records Last synced Oct 22, 2026, 4:12 AM EDT

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Showing 1–24 of 95 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: PIK3CA Clear all
Recruiting Phase 1Phase 2 Interventional

REC-7735 in Participants With Solid Tumors

NCT07819136
View directory record Official record
Conditions
Solid Tumors
Interventions
REC-7735
Drug
Lead sponsor
Recursion Pharmaceuticals Inc.
Industry
Eligibility
18 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
3
States / cities
Grand Rapids, Michigan • Irving, Texas • Fairfax, Virginia
Source: ClinicalTrials.gov public record
Updated Sep 29, 2026 · Synced Oct 22, 2026, 4:12 AM EDT
Recruiting Phase 1 Interventional

A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors

NCT07383506
View directory record Official record
Conditions
PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2-low Breast Cancer
Interventions
CGT6297
Drug
Lead sponsor
Cogent Biosciences, Inc.
Industry
Eligibility
18 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
11
States / cities
Scottsdale, Arizona • Los Angeles, California • Denver, Colorado + 8 more
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Oct 22, 2026, 4:12 AM 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
236 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 Oct 7, 2026 · Synced Oct 22, 2026, 4:12 AM EDT
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 16, 2026 · Synced Oct 22, 2026, 4:12 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 Sep 10, 2026 · Synced Oct 22, 2026, 4:12 AM 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 30, 2026 · Synced Oct 22, 2026, 4:12 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)

NCT03094832
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome
Interventions
Miransertib
Drug
Lead sponsor
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Industry
Eligibility
2 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
6
States / cities
Atlanta, Georgia • Chicago, Illinois • Boston, Massachusetts + 3 more
Source: ClinicalTrials.gov public record
Updated Apr 13, 2023 · Synced Oct 22, 2026, 4:12 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 22, 2026 · Synced Oct 22, 2026, 4:12 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, Giredestrant
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older · Female only
Enrollment
120 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 Sep 25, 2026 · Synced Oct 22, 2026, 4:12 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 Oct 9, 2026 · Synced Oct 22, 2026, 4:12 AM EDT
Recruiting Phase 1Phase 2 Interventional

Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer

NCT07558733
View directory record Official record
Conditions
HR+ HER2- Breast Cancer
Interventions
Serabelisib, Sapanisertib, Fulvestrant
Drug
Lead sponsor
Faeth Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
7
States / cities
Los Angeles, California • Lone Tree, Colorado • Springfield, Oregon + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 2, 2026 · Synced Oct 22, 2026, 4:12 AM EDT
Terminated Phase 1 Interventional

Study of ASN003 in Subjects With Advanced Solid Tumors

NCT02961283
View directory record Official record
Conditions
Neoplasms, Melanoma, Colorectal Neoplasm, Carcinoma, Non-small Cell Lung
Interventions
ASN003 ascending doses, ASN003 MTD
Drug
Lead sponsor
Asana BioSciences
Industry
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
5
States / cities
Los Angeles, California • Tampa, Florida • Boston, Massachusetts + 2 more
Source: ClinicalTrials.gov public record
Updated May 9, 2023 · Synced Oct 22, 2026, 4:12 AM EDT
Completed Phase 1 Interventional Results available

Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer

NCT01449370
View directory record Official record
Conditions
Metastatic Solid Tumors
Interventions
TAK-117
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2016
U.S. locations
3
States / cities
Boston, Massachusetts • Detroit, Michigan • Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Mar 9, 2017 · Synced Oct 22, 2026, 4:12 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 9, 2023 · Synced Oct 22, 2026, 4:12 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 5, 2020 · Synced Oct 22, 2026, 4:12 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 31, 2022 · Synced Oct 22, 2026, 4:12 AM EDT
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 Oct 19, 2026 · Synced Oct 22, 2026, 4:12 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 6, 2023 · Synced Oct 22, 2026, 4:12 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 19, 2018 · Synced Oct 22, 2026, 4:12 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 6, 2026 · Synced Oct 22, 2026, 4:12 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 11, 2026 · Synced Oct 22, 2026, 4:12 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 5, 2026 · Synced Oct 22, 2026, 4:12 AM 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 19, 2018 · Synced Oct 22, 2026, 4:12 AM EDT
Recruiting Phase 2 Interventional

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

NCT07368998
View directory record Official record
Conditions
Breast Cancer
Interventions
Inavolisib, Fulvestrant
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
4
States / cities
Los Angeles, California • Jacksonville, Florida • Kansas City, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Oct 6, 2026 · Synced Oct 22, 2026, 4:12 AM EDT