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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 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
17
States / cities
Oakland, California • Palo Alto, California • Washington D.C., District of Columbia + 12 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Jun 25, 2026, 9:43 AM EDT
Recruiting Phase 3 Interventional

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

NCT05894239
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
Inavolisib, Phesgo, Placebo, Taxane-based Chemotherapy, Optional Endocrine Therapy of Investigator's Choice
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
230 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2032
U.S. locations
20
States / cities
Gilbert, Arizona • Burbank, California • Corona, California + 17 more
Source: ClinicalTrials.gov public record
Updated May 28, 2026 · Synced Jun 25, 2026, 9:43 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 Jun 25, 2026, 9:43 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 Jun 25, 2026, 9:43 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 4, 2026 · Synced Jun 25, 2026, 9:43 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 Jun 25, 2026, 9:43 AM EDT
Active, not recruiting Phase 2 Interventional

A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

NCT05154487
View directory record Official record
Conditions
Endometroid Endometrial Cancer
Interventions
Alpelisib Pill, Fulvestrant injection
Drug
Lead sponsor
GOG Foundation
Network
Eligibility
18 Years and older · Female only
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
18
States / cities
Duarte, California • Miami Beach, Florida • Orlando, Florida + 13 more
Source: ClinicalTrials.gov public record
Updated Mar 2, 2026 · Synced Jun 25, 2026, 9:43 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 Jun 25, 2026, 9:43 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
2
States / cities
Austin, Texas • Fairfax, Virginia
Source: ClinicalTrials.gov public record
Updated Jun 4, 2026 · Synced Jun 25, 2026, 9:43 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 Jun 25, 2026, 9:43 AM EDT
Recruiting Phase 2 Interventional

Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer

NCT06463028
View directory record Official record
Conditions
Endometrial Cancer
Interventions
Sapanisertib, Serabelisib, Paclitaxel
Drug
Lead sponsor
Faeth Therapeutics
Industry
Eligibility
18 Years and older · Female only
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
18
States / cities
La Jolla, California • San Francisco, California • Miami Beach, Florida + 15 more
Source: ClinicalTrials.gov public record
Updated Dec 23, 2025 · Synced Jun 25, 2026, 9:43 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 Jun 3, 2026 · Synced Jun 25, 2026, 9:43 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 Jun 25, 2026, 9:43 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 29, 2026 · Synced Jun 25, 2026, 9:43 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 Jun 25, 2026, 9:43 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
118
States / cities
Anchorage, Alaska • Chandler, Arizona • Phoenix, Arizona + 103 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Jun 25, 2026, 9:43 AM EDT
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
13
States / cities
Encinitas, California • La Jolla, California • Los Angeles, California + 10 more
Source: ClinicalTrials.gov public record
Updated Sep 8, 2025 · Synced Jun 25, 2026, 9:43 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 Jun 25, 2026, 9:43 AM EDT
Completed Phase 2 Interventional Results available

Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

NCT05054725
View directory record Official record
Conditions
Non-Small Cell Lung Cancer
Interventions
RMC-4630, Sotorasib
Drug
Lead sponsor
Revolution Medicines, Inc.
Industry
Eligibility
18 Years and older
Enrollment
47 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
23
States / cities
Fort Myers, Florida • Plantation, Florida • Saint Augustine, Florida + 20 more
Source: ClinicalTrials.gov public record
Updated Jan 5, 2026 · Synced Jun 25, 2026, 9:43 AM EDT
Active, not recruiting Phase 1 Interventional

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

NCT05307705
View directory record Official record
Conditions
Breast Cancer
Interventions
LOXO-783, Fulvestrant, Imlunestrant, Abemaciclib, Anastrozole, Exemestane, or Letrozole, Paclitaxel
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
193 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
17
States / cities
Scottsdale, Arizona • Los Angeles, California • San Francisco, California + 12 more
Source: ClinicalTrials.gov public record
Updated Apr 19, 2026 · Synced Jun 25, 2026, 9:43 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 Jun 25, 2026, 9:43 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 Jun 14, 2026 · Synced Jun 25, 2026, 9:43 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 Jun 25, 2026, 9:43 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 Jun 25, 2026, 9:43 AM EDT