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ClinicalTrials.gov public records Last synced May 21, 2026, 9:02 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Showing 1–24 of 93 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: PIK3CA Clear all
Active, not recruiting Phase 2 Interventional
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)
Interventions
Miransertib
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
2 Years to 120 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2030
U.S. locations
5
States / cities
Atlanta, Georgia • Boston, Massachusetts • Cincinnati, Ohio + 2 more
Source: ClinicalTrials.gov public record
Updated Feb 6, 2025 · Synced May 21, 2026, 9:02 PM EDT
Completed Phase 1 Interventional
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 May 21, 2026, 9:02 PM EDT
Completed Phase 1 Interventional Results available
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 8, 2017 · Synced May 21, 2026, 9:02 PM EDT
Active, not recruiting Phase 1 Interventional
View directory record Official record
Conditions
Breast Cancer, Solid Tumor
Interventions
Inavolisib, Fulvestrant, Letrozole, Palbociclib, Metformin, Trastuzumab, Pertuzumab
Drug
Lead sponsor
Genentech, Inc.
Industry
Eligibility
18 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2026
U.S. locations
5
States / cities
Boston, Massachusetts • New York, New York • Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Mar 10, 2026 · Synced May 21, 2026, 9:02 PM EDT
Recruiting Phase 3 Interventional
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
RLY-2608, 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
51
States / cities
Gilbert, Arizona • Beverly Hills, California • Duarte, California + 41 more
Source: ClinicalTrials.gov public record
Updated May 7, 2026 · Synced May 21, 2026, 9:02 PM EDT
Recruiting Phase 2 Interventional
View directory record Official record
Conditions
Breast Cancer
Interventions
Inavolisib, Ribociclib, Letrozole
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older · Female only
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Orange, California
Source: ClinicalTrials.gov public record
Updated Apr 26, 2026 · Synced May 21, 2026, 9:02 PM EDT
Completed No phase listed Observational
View directory record Official record
Conditions
PIK3CA-Related Overgrowth Spectrum
Interventions
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years and older
Enrollment
3,605 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Oct 28, 2025 · Synced May 21, 2026, 9:02 PM EDT
Completed Phase 1 Interventional
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 May 21, 2026, 9:02 PM EDT
Recruiting Phase 3 Interventional
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 Apr 30, 2026 · Synced May 21, 2026, 9:02 PM EDT
Active, not recruiting Phase 2 Interventional Results available
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 May 21, 2026, 9:02 PM EDT
Completed Phase 1 Interventional Results available
View directory record Official record
Conditions
Advanced or Metastatic Breast Cancer
Interventions
MEN1611, Trastuzumab, Fulvestrant
Drug
Lead sponsor
Menarini Group
Industry
Eligibility
18 Years and older
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
3
States / cities
Fort Lauderdale, Florida • Farmington Hills, Michigan • St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jun 25, 2025 · Synced May 21, 2026, 9:02 PM EDT
Terminated Phase 1Phase 2 Interventional Results available
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 May 21, 2026, 9:02 PM EDT
Recruiting Phase 2 Interventional
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
104 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
2
States / cities
St Louis, Missouri • Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced May 21, 2026, 9:02 PM EDT
Terminated Phase 2 Interventional
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 Sep 29, 2025 · Synced May 21, 2026, 9:02 PM EDT
Active, not recruiting Phase 1 Interventional
View directory record Official record
Conditions
Brain Metastases, Leptomeningeal Metastasis
Interventions
GDC-0084, whole brain radiation therapy radiation
Drug · Radiation
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
9
States / cities
Miami, Florida • Basking Ridge, New Jersey • Middletown, New Jersey + 6 more
Source: ClinicalTrials.gov public record
Updated Apr 21, 2026 · Synced May 21, 2026, 9:02 PM EDT
Active, not recruiting Phase 1 Interventional
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 May 21, 2026, 9:02 PM EDT
Active, not recruiting Phase 2 Interventional Results available
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
206 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 Apr 29, 2026 · Synced May 21, 2026, 9:02 PM EDT
Active, not recruiting Phase 3 Interventional
View directory record Official record
Conditions
Breast Cancer
Interventions
Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Drug
Lead sponsor
Celcuity Inc
Industry
Eligibility
18 Years and older
Enrollment
701 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
71
States / cities
Birmingham, Alabama • Goodyear, Arizona • Jonesboro, Arkansas + 62 more
Source: ClinicalTrials.gov public record
Updated Feb 9, 2026 · Synced May 21, 2026, 9:02 PM EDT
Completed Phase 2Phase 3 Interventional
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 4, 2020 · Synced May 21, 2026, 9:02 PM EDT
Active, not recruiting Phase 2 Interventional
View directory record Official record
Conditions
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer, PIK3CA Mutant Metastatic Breast Cancer
Interventions
Alpelisib, Fulvestrant, Aromatase inhibitor
Drug
Lead sponsor
Marina N Sharifi
Other
Eligibility
18 Years and older
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
4
States / cities
Chicago, Illinois • Omaha, Nebraska • Hershey, Pennsylvania + 1 more
Source: ClinicalTrials.gov public record
Updated Jan 1, 2026 · Synced May 21, 2026, 9:02 PM EDT
Active, not recruiting Phase 2 Interventional
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 – 2026
U.S. locations
9
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 26, 2025 · Synced May 21, 2026, 9:02 PM EDT
Recruiting Phase 2Phase 3 Interventional
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
16
States / cities
Oakland, California • Palo Alto, California • Washington D.C., District of Columbia + 11 more
Source: ClinicalTrials.gov public record
Updated May 11, 2026 · Synced May 21, 2026, 9:02 PM EDT
Active, not recruiting Phase 3 Interventional
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
14
States / cities
Los Alamitos, California • Los Angeles, California • Sacramento, California + 8 more
Source: ClinicalTrials.gov public record
Updated May 5, 2026 · Synced May 21, 2026, 9:02 PM EDT
Completed No phase listed Observational
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 May 21, 2026, 9:02 PM EDT