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ClinicalTrials.gov public records Last synced Sep 9, 2026, 11:41 AM EDT

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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: PIK3CA Mutation Clear all
Recruiting Phase 3 Interventional

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

NCT05646862
View directory record Official record
Conditions
Breast Cancer
Interventions
Inavolisib, Fulvestrant, Alpelisib, Bupropion, Omeprazole, Midazolam
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
420 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
39
States / cities
Greenbrae, California • Los Alamitos, California • Los Angeles, California + 32 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2026 · Synced Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 AM EDT
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 Sep 9, 2026, 11:41 AM EDT
Completed Phase 1Phase 2 Interventional Results available

MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)

NCT04495621
View directory record Official record
Conditions
Metastatic Colorectal Cancer
Interventions
MEN1611, Cetuximab
Drug
Lead sponsor
Menarini Group
Industry
Eligibility
18 Years and older
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
3
States / cities
Phoenix, Arizona • Anaheim, California • Tacoma, Washington
Source: ClinicalTrials.gov public record
Updated Apr 30, 2025 · Synced Sep 9, 2026, 11:41 AM EDT
Completed No phase listed Observational

INST 1204: PIK3CA Mutations as Biomarkers for Metastasis in Colon Cancer

NCT03951389
View directory record Official record
Conditions
Colon Cancer
Interventions
Non-interventional
Other
Lead sponsor
New Mexico Cancer Research Alliance
Other
Eligibility
18 Years and older
Enrollment
750 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2019
U.S. locations
1
States / cities
Albuquerque, New Mexico
Source: ClinicalTrials.gov public record
Updated May 17, 2021 · Synced Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 AM EDT
Recruiting Phase 1Phase 2 Interventional

Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

NCT06993844
View directory record Official record
Conditions
Advanced Solid Tumors, Advanced Breast Cancer
Interventions
ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
Drug
Lead sponsor
Ensem Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
233 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
10
States / cities
Newport Beach, California • San Francisco, California • New Haven, Connecticut + 6 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Sep 9, 2026, 11:41 AM 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 9, 2026, 11:41 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 1, 2026 · Synced Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 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
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 9, 2026, 11:41 AM 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 Sep 7, 2026 · Synced Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 AM EDT
Completed Phase 1 Interventional

Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors

NCT04344795
View directory record Official record
Conditions
Solid Tumor, Colorectal Cancer, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma, Endometrial Cancer, Gastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma, Solid Tumors With PIK3Ca Mutation
Interventions
TPST-1495 twice daily, TPST-1495 once daily or on intermittent schedule, Pembrolizumab
Drug
Lead sponsor
Tempest Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
89 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
11
States / cities
Aurora, Colorado • Baltimore, Maryland • Springfield, Massachusetts + 8 more
Source: ClinicalTrials.gov public record
Updated Sep 11, 2025 · Synced Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 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 Sep 9, 2026, 11:41 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 Aug 30, 2026 · Synced Sep 9, 2026, 11:41 AM EDT