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ClinicalTrials.gov public records Last synced Sep 6, 2026, 10:52 AM EDT

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Showing 1–24 of 60 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: PTEN Clear all
Recruiting Phase 1 Interventional

Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and HER2 Negative Breast Cancer

NCT04997993
View directory record Official record
Conditions
PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer
Interventions
Leflunomide
Drug
Lead sponsor
Deborah Doroshow
Other
Eligibility
18 Years and older
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 14, 2026 · Synced Sep 6, 2026, 10:52 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer

NCT04737109
View directory record Official record
Conditions
Castrate Resistant Prostate Cancer
Interventions
Ipatasertib, Darolutamide, Androgen Deprivation Therapy
Drug
Lead sponsor
David VanderWeele
Other
Eligibility
18 Years and older · Male only
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
3
States / cities
Chicago, Illinois • Indianapolis, Indiana • Hershey, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Nov 12, 2023 · Synced Sep 6, 2026, 10:52 AM EDT
Terminated Phase 2 Interventional Results available

Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations

NCT05082025
View directory record Official record
Conditions
Endometrial Cancer, Ovarian Cancer
Interventions
Copanlisib, fulvestrant
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jan 8, 2026 · Synced Sep 6, 2026, 10:52 AM 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 26, 2026 · Synced Sep 6, 2026, 10:52 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Loss of Expression (MATCH-Subprotocol P)

NCT04439188
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
35 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 26, 2026 · Synced Sep 6, 2026, 10:52 AM EDT
Recruiting Phase 1Phase 2 Interventional

A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

NCT07109726
View directory record Official record
Conditions
Breast Cancer, Endometrial Cancer, Ovarian Cancer, Lung Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Solid Tumor, Cervical Cancer
Interventions
TER-2013, Fulvestrant injection
Drug
Lead sponsor
Terremoto Biosciences Inc.
Industry
Eligibility
18 Years and older
Enrollment
205 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
17
States / cities
Duarte, California • Irvine, California • Orlando, Florida + 14 more
Source: ClinicalTrials.gov public record
Updated Aug 20, 2026 · Synced Sep 6, 2026, 10:52 AM EDT
Not yet recruiting Phase 2Phase 3 Interventional

Double-Blind Trial of Everolimus for Improving Social Abilities in PTEN Germline Mutations

NCT07218575
View directory record Official record
Conditions
Cowden's Disease, Cowden's Syndrome, Lhermitte-Duclos Disease, Cerebellum Dysplastic Gangliocytoma, Bannayan Zonana Syndrome, Myhre Riley Smith Syndrome, Riley Smith Syndrome, PTEN Hamartoma Tumor Syndrome, Bannayan Riley Ruvalcaba Syndrome
Interventions
Everolimus blinded oral capsules, Placebo
Drug
Lead sponsor
Boston Children's Hospital
Other
Eligibility
5 Years to 45 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
3
States / cities
Stanford, California • Boston, Massachusetts • Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Jun 3, 2026 · Synced Sep 6, 2026, 10:52 AM EDT
Completed Phase 2 Interventional Results available

Sirolimus to Treat Cowden Syndrome and Other PTEN Hamartomatous Tumor Syndromes

NCT00971789
View directory record Official record
Conditions
Cowden's Disease, Hamartoma Syndrome, Multiple
Interventions
fludeoxyglucose F 18, sirolimus, Clinical Videography
Radiation · Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2012
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Sep 29, 2015 · Synced Sep 6, 2026, 10:52 AM EDT
Completed Phase 2 Interventional Results available

Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors

NCT02401347
View directory record Official record
Conditions
Advanced Breast Cancer, HER2/Neu Negative, Triple-Negative Breast Cancer
Interventions
Talazoparib Tosylate
Drug
Lead sponsor
Melinda Telli
Other
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2022
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Feb 20, 2023 · Synced Sep 6, 2026, 10:52 AM EDT
Completed Phase 1Phase 2 Interventional

Leflunomide in Previously Treated Metastatic Triple Negative Cancers

NCT03709446
View directory record Official record
Conditions
Breast Neoplasms, Breast Diseases, Metastatic Triple Negative Breast Cancer
Interventions
Leflunomide
Drug
Lead sponsor
Joseph Sparano
Other
Eligibility
18 Years and older · Female only
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
3
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Mar 18, 2026 · Synced Sep 6, 2026, 10:52 AM EDT
Not listed No phase listed Observational

Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer

NCT01514565
View directory record Official record
Conditions
Breast Cancer
Interventions
Not listed
Lead sponsor
Thomas Jefferson University
Other
Eligibility
18 Years and older · Female only
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2018
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Mar 17, 2015 · Synced Sep 6, 2026, 10:52 AM EDT
Terminated Phase 2 Interventional Results available

Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations

NCT04216472
View directory record Official record
Conditions
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Refractory Breast Carcinoma, Triple-Negative Breast Carcinoma
Interventions
Alpelisib, Nab-paclitaxel
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Sep 6, 2026, 10:52 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 18, 2018 · Synced Sep 6, 2026, 10:52 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 Sep 6, 2026, 10:52 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 Sep 6, 2026, 10:52 AM EDT
Completed Phase 1 Interventional

Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients

NCT01430572
View directory record Official record
Conditions
Advanced Cancers, Solid Tumors
Interventions
Pazopanib, Everolimus
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
16 Years and older
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2020
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jun 5, 2023 · Synced Sep 6, 2026, 10:52 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations

NCT04042831
View directory record Official record
Conditions
Bile Duct Adenocarcinoma, Fanconi Anemia Complementation Group Gene Mutation, Metastatic Bile Duct Carcinoma, PTEN Gene Deletion
Interventions
Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Olaparib
Procedure · Drug
Lead sponsor
Academic and Community Cancer Research United
Other
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
5
States / cities
Scottsdale, Arizona • Jacksonville, Florida • Rochester, Minnesota + 2 more
Source: ClinicalTrials.gov public record
Updated May 14, 2026 · Synced Sep 6, 2026, 10:52 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 Sep 6, 2026, 10:52 AM EDT
Terminated Phase 1 Interventional

TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations

NCT04770246
View directory record Official record
Conditions
Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations, Advanced or Metastatic Solid Tumors With Germline PTEN Inactivating Mutations
Interventions
TAS-117
Drug
Lead sponsor
Taiho Oncology, Inc.
Industry
Eligibility
12 Years and older
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
5
States / cities
Santa Monica, California • New York, New York • Cleveland, Ohio + 2 more
Source: ClinicalTrials.gov public record
Updated Sep 3, 2024 · Synced Sep 6, 2026, 10:52 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G)

NCT06360588
View directory record Official record
Conditions
Malignant Solid Neoplasm
Interventions
Biopsy Procedure, Biospecimen Collection, Copanlisib, Radiologic Examination
Procedure · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
Not listed
Enrollment
22 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 27, 2026 · Synced Sep 6, 2026, 10:52 AM EDT
Recruiting Not applicable Interventional Accepts healthy volunteers

An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk and An Intervention to Help Patients and Their Primary Care Providers Stay Up-to-date About Uncertain Genetic Test Results

NCT05420064
View directory record Official record
Conditions
BRCA1 Mutation, POLD1 Gene Mutation, CDKN2A Mutation, BRCA2 Mutation, POLE Gene Mutation, APC Gene Mutation, ATM Gene Mutation, MLH1 Gene Mutation, BARD1 Gene Mutation, MSH2 Gene Mutation, BRIP1 Gene Mutation, MSH6 Gene Mutation, CHEK2 Gene Mutation, PMS2 Gene Mutation, PALB2 Gene Mutation, EPCAM Gene Mutation, RAD51C Gene Mutation, BMPR1A Gene Mutation, RAD51D Gene Mutation, SMAD4, PTEN Gene Mutation, GREM1
Interventions
Intervention Arm At-risk Relative/ARR Contacts, MyGene Portal, Standard of Care
Behavioral
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
25 Years and older
Enrollment
1,000 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2027
U.S. locations
8
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 4 more
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Sep 6, 2026, 10:52 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 Sep 6, 2026, 10:52 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 6, 2026, 10:52 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 Sep 6, 2026, 10:52 AM EDT