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ClinicalTrials.gov public records Last synced Oct 18, 2026, 12:34 PM EDT

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Showing 1–24 of 44 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: PI3K Gene Mutation Clear all
Terminated Phase 2 Interventional Results available

Single-arm Study With Bimiralisib in Patients With HNSCC Harboring NOTCH1 Loss of Function Mutations

NCT03740100
View directory record Official record
Conditions
HNSCC
Interventions
Bimiralisib
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 14, 2023 · Synced Oct 18, 2026, 12:34 PM EDT
Active, not recruiting Phase 2 Interventional

Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)

NCT04980833
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years to 100 Years
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 14, 2026 · Synced Oct 18, 2026, 12:34 PM 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 20, 2019 · Synced Oct 18, 2026, 12:34 PM 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 Sep 18, 2026 · Synced Oct 18, 2026, 12:34 PM 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 18, 2026, 12:34 PM 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 18, 2026, 12:34 PM 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 Oct 5, 2026 · Synced Oct 18, 2026, 12:34 PM EDT
Terminated Phase 2Phase 3 Interventional Results available

Extension to the Study of Efficacy of CDZ173 in Patients With APDS/PASLI

NCT02859727
View directory record Official record
Conditions
Activated PI3Kdelta Syndrome (APDS); PASLI Disease
Interventions
CDZ173
Drug
Lead sponsor
Pharming Technologies B.V.
Industry
Eligibility
12 Years to 75 Years
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2025
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 30, 2026 · Synced Oct 18, 2026, 12:34 PM EDT
Completed Phase 2Phase 3 Interventional Results available

Study of Efficacy of CDZ173 in Patients With APDS/PASLI

NCT02435173
View directory record Official record
Conditions
Common Variable Immunodeficiency (CVID), APDS / PASLI
Interventions
CDZ173, Placebo
Drug · Other
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Years to 75 Years
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2021
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Aug 10, 2022 · Synced Oct 18, 2026, 12:34 PM 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
10
States / cities
Anaheim, California • Palo Alto, California • Jacksonville, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 6, 2026 · Synced Oct 18, 2026, 12:34 PM 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 18, 2026, 12:34 PM 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 7, 2026 · Synced Oct 18, 2026, 12:34 PM 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
800 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2033
U.S. locations
129
States / cities
Anchorage, Alaska • Chandler, Arizona • Phoenix, Arizona + 110 more
Source: ClinicalTrials.gov public record
Updated Oct 8, 2026 · Synced Oct 18, 2026, 12:34 PM 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
5
States / cities
Los Angeles, California • Houston, Texas • San Antonio, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 22, 2026 · Synced Oct 18, 2026, 12:34 PM EDT
Completed Phase 1 Interventional

A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

NCT01449058
View directory record Official record
Conditions
Advanced and Selected Solid Tumors, AML, High Risk and Very High Risk MDS
Interventions
BYL719, MEK162
Drug
Lead sponsor
Array BioPharma
Industry
Eligibility
18 Years and older
Enrollment
139 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
8
States / cities
La Jolla, California • Tampa, Florida • Chicago, Illinois + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2017 · Synced Oct 18, 2026, 12:34 PM 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 22, 2025 · Synced Oct 18, 2026, 12:34 PM 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 18, 2026, 12:34 PM 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 11, 2018 · Synced Oct 18, 2026, 12:34 PM 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 16, 2025 · Synced Oct 18, 2026, 12:34 PM 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 30, 2020 · Synced Oct 18, 2026, 12:34 PM EDT
Active, not recruiting Phase 1 Interventional

First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

NCT06239467
View directory record Official record
Conditions
Advanced Cancer, Breast Cancer, Advanced Solid Tumors, PI3K Gene Mutation
Interventions
OKI-219, Fulvestrant, Trastuzumab, Tucatinib, Atirmociclib, Ribociclib
Drug
Lead sponsor
OnKure, Inc.
Industry
Eligibility
18 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
12
States / cities
Encinitas, California • La Jolla, California • Los Angeles, California + 9 more
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Oct 18, 2026, 12:34 PM 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 18, 2026, 12:34 PM 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 27, 2026 · Synced Oct 18, 2026, 12:34 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients

NCT00877773
View directory record Official record
Conditions
Advanced Cancers
Interventions
Temsirolimus
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
Not listed
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2014
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Aug 25, 2016 · Synced Oct 18, 2026, 12:34 PM EDT